,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32339032,SAFETY AND EFFICACY OF DDP4-INHIBITORS FOR MANAGEMENT OF HOSPITALIZED GENERAL MEDICINE AND SURGERY PATIENTS WITH TYPE 2 DIABETES.,"Background:  DPP4-inhibitors (DPP4-i) have been shown to be effective for the management of inpatient diabetes. We report pooled data from three prospective studies using DPP4-i in general medicine and surgery patients with type 2 diabetes (T2D).  Research Design and Methods:  We combined data from three randomized studies comparing DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen. Medicine (n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with diet, oral agents or low-dose insulin therapy were included. Patients received DPP4-i alone (n=144), DPP4-i plus basal insulin (n=158) or basal bolus regimen (n=283). All groups received correctional doses with rapid-acting insulin for BG >140mg/dl. The primary endpoint was differences in mean daily BG between groups. Secondary endpoints included differences in hypoglycemia and hospital complications.  Results:  There were no differences in mean hospital daily BG among patients treated with DPP4-i alone (170±37 mg/dl), DPP4-i plus basal (172±42 mg/dl) or basal bolus (172±43 mg/dl), p=0.94; or in the percentage of BG readings within target of 70-180 mg/dl (63±32%, 60±31% and 64±28% respectively, p=0.42). There were no differences in length of stay or complications, but hypoglycemia was less common with DPP4-i alone (2%) compared to DPP4-i plus basal (9%) and basal bolus (10%), p=0.004.  Conclusion:  Treatment with DPP4-i alone or in combination with basal insulin is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin re gimen in general medicine and surgery patients with T2D.",2020,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"['general medicine and surgery patients with T2D', 'general medicine and surgery patients with type 2 diabetes (T2D', 'n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with']","['DPP4-i alone', 'correctional doses with rapid-acting insulin for BG >140mg/dl', 'DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen', ':  DPP4-inhibitors (DPP4-i', 'diet, oral agents or low-dose insulin therapy', 'DPP4-i plus basal insulin (n=158) or basal bolus regimen', 'DPP4-i', 'DPP4-i alone or in combination with basal insulin', 'Medicine']","['hypoglycemia and hospital complications', 'mean daily BG', 'mean hospital daily BG', 'length of stay or complications, but hypoglycemia', 'hypoglycemia']","[{'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0952002,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lorenzo-González', 'Affiliation': 'From: Department of Endocrinology and Nutrition, Hospital Universitario Nuestra Señora de La Candelaria, Tenerife, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Atienza-Sánchez', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Universitario Príncipe de Asturias, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reyes-Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Schoolf of Public Health, Emory University.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2019-0481']
1,32394777,"Randomized Trial of Combined Aerobic, Resistance, and Cognitive Training to Improve Recovery From Stroke: Feasibility and Safety.","Background Physical exercise and cognitive training have been recommended to improve cognitive outcomes poststroke, but a multifaceted strategy including aerobic, resistance, and cognitive training to facilitate poststroke recovery has not been investigated. We aimed to assess the feasibility, adherence, and safety of a combined aerobic, resistance, and cognitive training intervention (CARET+CTI) after stroke. Methods and Results We prospectively randomized patients presenting with recent stroke to a comparison of a supervised 12-week CARET+CTI program and a control group receiving sham CARET+CTI. Participants were scheduled for 3 weekly CARET and CTI sessions. All participants underwent pre- and postintervention assessments of strength, endurance, and cognition. The primary outcomes were feasibility and adherence, defined as the ratio of scheduled and observed visits, and safety. We enrolled 131 participants, of whom 37 withdrew from the study. There were 17 (20%) withdrawals in the CARET+CTI and 20 (44%) in the control group. The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (0.74±0.30 versus 0.54±0.38;  P =0.003). A total of 99 adverse events were reported by 59 participants, none of which were serious and related to the intervention. Greater gains in physical, cognitive, and mood outcomes were found in the CARET+CTI group than in the control group, but were not statistically significant after adjustments. Conclusions A CARET+CTI intervention, after stroke, is safe, feasible, and has satisfactory participant adherence over 12 weeks. REGISTRATION URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT02272426.",2020,The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (,"['Stroke', 'We enrolled 131 participants, of whom 37 withdrew from the study', 'patients presenting with recent stroke to a comparison of a']","['Combined Aerobic, Resistance, and Cognitive Training', 'combined aerobic, resistance, and cognitive training intervention (CARET+CTI', 'supervised 12-week CARET+CTI program and a control group receiving sham CARET+CTI', ' Physical exercise and cognitive training']","['Greater gains in physical, cognitive, and mood outcomes', 'feasibility, adherence, and safety', 'feasibility and adherence, defined as the ratio of scheduled and observed visits, and safety', 'strength, endurance, and cognition', 'Feasibility and Safety', 'observed-over-expected visit ratio']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",131.0,0.0361699,The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Tiozzo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Marialaura', 'Initials': 'M', 'LastName': 'Simonetto', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Clinton B', 'Initials': 'CB', 'LastName': 'Wright', 'Affiliation': 'National Institute of Neurological Disorders and Stroke (NINDS) Bethesda MD.'}, {'ForeName': 'Chuanhui', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bustillo', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Perez-Pinzon', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Kunjan R', 'Initials': 'KR', 'LastName': 'Dave', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Carolina M', 'Initials': 'CM', 'LastName': 'Gutierrez', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lewis', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Marti', 'Initials': 'M', 'LastName': 'Flothmann', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'M Carolina', 'Initials': 'MC', 'LastName': 'Mendoza-Puccini', 'Affiliation': 'National Institute of Neurological Disorders and Stroke (NINDS) Bethesda MD.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Junco', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Zuzel', 'Initials': 'Z', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Gomes-Osman', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Rundek', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Ralph L', 'Initials': 'RL', 'LastName': 'Sacco', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015377']
2,32394024,"Detection of Aspiration, Penetration, and Pharyngeal Residue During Flexible Endoscopic Evaluation of Swallowing (FEES): Comparing the Effects of Color, Coating, and Opacity.","The aim of this study was to assess the effects of color, coating, and opacity on the detection of aspiration, penetration, and residue during flexible endoscopic evaluations of swallowing (FEES). Thirty dysphagic adults underwent FEES while swallowing five 5 mL thin liquid boluses (1 × each, randomized): white water, blue water, white milk, blue milk, and barium water. To assess the effects of color, blue milk was compared to white milk. To assess the effects of coating, barium, white water, and white milk were compared to each other. To assess the effects of opacity, blue milk was compared to blue water. Videos were blindly analyzed and judged for the presence of pharyngeal residue, penetration, and aspiration. Repeated measures analyses were used to assess differences in the frequency of detection across bolus types. Pharyngeal residue was detected more frequently for liquids that were blue, had a coating effect, or were opaque (p < 0.05) when compared to liquids that were white, did not have a coating effect, or were translucent, respectively. Penetration and aspiration were detected more frequently for liquids that had a coating effect (p < 0.05), but not for liquids that were colored blue or opaque (p > 0.05). Coating appears to be the most important factor detecting thin liquid residue, penetration, and aspiration during FEES. Given these findings, standardized use of boluses that possess a coating effect (e.g., white-dyed water or barium) is highly recommended to enhance the sensitivity of identifying impairments in swallowing safety and efficiency during FEES.",2021,"Penetration and aspiration were detected more frequently for liquids that had a coating effect (p < 0.05), but not for liquids that were colored blue or opaque (p > 0.05).",['Thirty dysphagic adults underwent'],"['Flexible Endoscopic Evaluation of Swallowing (FEES', 'FEES while swallowing five 5\xa0mL thin liquid boluses', 'Color, Coating, and Opacity']","['Pharyngeal residue', 'Detection of Aspiration, Penetration, and Pharyngeal Residue', 'Penetration and aspiration']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}]","[{'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}]",30.0,0.019729,"Penetration and aspiration were detected more frequently for liquids that had a coating effect (p < 0.05), but not for liquids that were colored blue or opaque (p > 0.05).","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Curtis', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, Thorndike Building, Room 955, New York, NY, 10027, USA. jac2406@tc.columbia.edu.'}, {'ForeName': 'Zeina N', 'Initials': 'ZN', 'LastName': 'Seikaly', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, Thorndike Building, Room 955, New York, NY, 10027, USA.'}, {'ForeName': 'Avery E', 'Initials': 'AE', 'LastName': 'Dakin', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, Thorndike Building, Room 955, New York, NY, 10027, USA.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Troche', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, Thorndike Building, Room 955, New York, NY, 10027, USA.'}]",Dysphagia,['10.1007/s00455-020-10131-0']
3,32294561,"Efficacy of incobotulinumtoxinA for the treatment of adult lower-limb post-stroke spasticity, including pes equinovarus.","BACKGROUND


Lower-limb spasticity can impair ambulation and gait, impacting quality of life.
OBJECTIVES


This ancillary analysis of the TOWER study (NCT01603459) assessed the efficacy of incobotulinumtoxinA for lower-limb post-stroke spasticity including pes equinovarus.
METHODS


Participants received escalating incobotulinumtoxinA doses (400-800U) across 3 injection cycles. Changes were compared for those treated in the lower limb (with/without upper-limb treatment) or the upper limb only or for participants treated or untreated for pes equinovarus. Outcome measures were those used in the seminal study: resistance to passive movement scale (REPAS), Ashworth Scale (AS), functional ambulation and lower-limb goal attainment.
RESULTS


Among 132/155 (85%) participants with post-stroke spasticity, in cycles 1, 2 and 3, 99, 119 and 121 participants received lower-limb treatment with mean (SD) total limb incobotulinumtoxinA doses of 189.2 (99.2), 257.1 (115.0) and 321.3 (129.2) U, respectively. Of these, 80, 105 and 107, respectively, were treated for pes equinovarus. The mean (SD) improvement in REPAS lower-limb score was greater with treatment in the lower limb versus the upper limb only: -1.6 (2.1) versus-0.4 (1.4); -1.9 (1.9) versus -0.6 (1.6); -2.2 (2.2) versus -1.0 (0.0) (P=0.0005, P=0.0133 and P=0.3581; analysis of covariance [ANCOVA], between-group differences) in cycles 1, 2 and 3, respectively. For all cycles, the mean improvement in ankle joint AS score from injection to 4 weeks post-treatment was greater for participants treated versus not treated for pes equinovarus, with a significant between-group difference in cycle 1 (P=0.0099; ANCOVA). At the end of cycle 3, 42% of participants walked independently and 63% achieved 2 of 2 lower-limb treatment goals (baseline 23% and 34%, respectively).
CONCLUSIONS


This study supports the efficacy of incobotulinumtoxinA for treatment of pes equinovarus and other patterns of lower-limb post-stroke spasticity.",2021,"For all cycles, the mean improvement in ankle joint AS score from injection to 4 weeks post-treatment was greater for participants treated versus not treated for pes equinovarus, with a significant between-group difference in cycle 1 (P = 0.0099; ANCOVA).","['adult lower-limb post-stroke spasticity, including pes equinovarus']","['escalating incobotulinumtoxinA', 'incobotulinumtoxinA']","['ankle joint AS score', 'mean (SD) improvement in REPAS lower-limb score', 'seminal study: resistance to passive movement scale (REPAS), Ashworth Scale (AS), functional ambulation and lower-limb goal attainment', '2 of 2 lower-limb treatment goals']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009081', 'cui_str': 'Talipes equinovarus'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}]","[{'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.121136,"For all cycles, the mean improvement in ankle joint AS score from injection to 4 weeks post-treatment was greater for participants treated versus not treated for pes equinovarus, with a significant between-group difference in cycle 1 (P = 0.0099; ANCOVA).","[{'ForeName': 'Djamel', 'Initials': 'D', 'LastName': 'Bensmail', 'Affiliation': 'Raymond-Poincaré Hospital, AP-HP, University of Versailles Saint Quentin, Boulevard Raymond Poincaré, 92380 Garches, France. Electronic address: djamel.bensmail@aphp.fr.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Wissel', 'Affiliation': 'Department of Neurology, Vivantes Hospital Spandau, Neue Bergstaße, 13585 Berlin, Germany. Electronic address: joerg.wissel@vivantes.de.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Laffont', 'Affiliation': 'Lapeyronie University Hospital, Avenue du Doyen Gaston Giraud, 34295 Montpellier, France; Euromov, Montpellier University, IFRH, Avenue du Pic Saint Loup, 34090 Montpellier, France. Electronic address: i-laffont@chu-montpellier.fr.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Simon', 'Affiliation': 'Formerly of Merz Pharmaceuticals GmbH, Eckenheimer Landstraße, 60318 Frankfurt am Main, Germany. Electronic address: simonolivier77@gmail.com.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Scheschonka', 'Affiliation': 'Merz Pharmaceuticals GmbH, Eckenheimer Landstraße, 60318 Frankfurt am Main, Germany. Electronic address: Astrid.Scheschonka@merz.de.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Flatau-Baqué', 'Affiliation': 'Merz Pharmaceuticals GmbH, Eckenheimer Landstraße, 60318 Frankfurt am Main, Germany. Electronic address: Birgit.Flatau-Baque@merz.de.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Dressler', 'Affiliation': 'Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Street, 30625 Hannover, Germany. Electronic address: Dressler.Dirk@mh-hannover.de.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Simpson', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, One Gustave Levy Place, New York 10029, USA. Electronic address: david.simpson@mssm.edu.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.03.005']
4,31667678,Impact of Male Partner Involvement on Women's Adherence to the Dapivirine Vaginal Ring During a Phase III HIV Prevention Trial.,"Although vaginal microbicides for HIV prevention are designed to be female-initiated, male partner influence has been identified as one of the most significant factors impacting women's willingness and ability to use them. As a result, research teams have sought to increase male partner involvement by encouraging disclosure of product use to male partners, promoting male partner engagement in the study through attendance at the study clinic, and helping women to garner male partner support for product use. This paper aims to assess the impact of these three elements of male partner involvement on women's adherence to the dapivirine vaginal ring during MTN-020/ASPIRE, a phase III randomized placebo-controlled clinical trial involving 2629 women in Malawi, South Africa, Uganda, and Zimbabwe. During the study, 64-80% of participants reported disclosure of ring use at each quarterly visit, and 13% reported that their partners had attended the study clinic at some point during the study. At study exit, 66% reported that their partner was supportive, 18% unsupportive, and 17% were unsure. After adjusting for age, site and time in study, women were more likely to have low ring adherence if they had an unsupportive male partner (aRR 1.29, 95% CI 1.03-1.62). Neither disclosure nor clinic attendance directly predicted ring adherence, but disclosure increased the probability of having a supportive partner (aRRR 24.17, 95% CI 16.38-35.66) or an unsupportive partner (aRRR 4.10, 95% CI 2.70-6.24), relative to an unknown level of partner support. Women were also more likely to have a supportive partner if their partner had attended the clinic (aRRR 3.77, 95% CI 1.36-10.42). This study suggests that although the vaginal ring is relatively discreet, lack of support from male partners remains a relevant barrier to use. Though both disclosure and clinic attendance may increase partner support, disclosure may also increase partner opposition. Interventions to reduce male partner opposition are needed to maximize the potential impact of the ring and other PrEP products for HIV prevention.",2020,"Neither disclosure nor clinic attendance directly predicted ring adherence, but disclosure increased the probability of having a supportive partner (aRRR 24.17, 95% CI 16.38-35.66) or an unsupportive partner (aRRR 4.10, 95% CI 2.70-6.24), relative to an unknown level of partner support.","[""male partner involvement on women's adherence to the dapivirine vaginal ring during MTN-020/ASPIRE, a phase III randomized"", '2629 women in Malawi, South Africa, Uganda, and Zimbabwe']","['placebo', 'Dapivirine Vaginal Ring']",['probability of having a supportive partner'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]",2629.0,0.0402475,"Neither disclosure nor clinic attendance directly predicted ring adherence, but disclosure increased the probability of having a supportive partner (aRRR 24.17, 95% CI 16.38-35.66) or an unsupportive partner (aRRR 4.10, 95% CI 2.70-6.24), relative to an unknown level of partner support.","[{'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Roberts', 'Affiliation': ""Women's Global Health Imperative, RTI International, 351 California Street, Ste. 500, San Francisco, CA, 94104, USA. sroberts@rti.org.""}, {'ForeName': 'Gonasagrie', 'Initials': 'G', 'LastName': 'Nair', 'Affiliation': 'Desmond Tutu HIV Research Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Philips', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg, South Africa.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Schwartz', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Krishnaveni', 'Initials': 'K', 'LastName': 'Reddy', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg, South Africa.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Kabwigu', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Matovu Kiweewa', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Vaneshree', 'Initials': 'V', 'LastName': 'Govender', 'Affiliation': 'HIV Prevention Research Unit (HPRU), Medical Research Council (MRC), Durban, South Africa.'}, {'ForeName': 'Zakir', 'Initials': 'Z', 'LastName': 'Gaffoor', 'Affiliation': 'HIV Prevention Research Unit (HPRU), Medical Research Council (MRC), Durban, South Africa.'}, {'ForeName': 'Nishanta', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'HIV Prevention Research Unit (HPRU), Medical Research Council (MRC), Durban, South Africa.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Siva', 'Affiliation': 'HIV Prevention Research Unit (HPRU), Medical Research Council (MRC), Durban, South Africa.'}, {'ForeName': 'Kalendri', 'Initials': 'K', 'LastName': 'Naidoo', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Montgomery', 'Affiliation': ""Women's Global Health Imperative, RTI International, 351 California Street, Ste. 500, San Francisco, CA, 94104, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-019-02707-1']
5,30358181,Prevention: Necessary But Insufficient? A 2-Year Follow-Up of an Effective First-Grade Mathematics Intervention.,"We present first-grade, second-grade, and third-grade impacts for a first-grade intervention targeting the conceptual and procedural bases that support arithmetic. At-risk students (average age at pretest = 6.5) were randomly assigned to three conditions: a control group (n = 224) and two variants of the intervention (same conceptual instruction but different forms of practice: speeded [n = 211] vs. nonspeeded [n = 204]). Impacts on all first-grade content outcomes were significant and positive, but no follow-up impacts were significant. Many intervention children achieved average mathematics achievement at the end of third grade, and prior math and reading assessment performance predicted which students will require sustained intervention. Finally, projecting impacts 2 years later based on nonexperimental estimates of effects of first-grade math skills overestimates long-term intervention effects.",2020,"Impacts on all first-grade content outcomes were significant and positive, but no follow-up impacts were significant.",['At-risk students (average age at pretest\xa0=\xa06.5'],['control group (n\xa0=\xa0224) and two variants of the intervention (same conceptual instruction but different forms of practice: speeded [n\xa0=\xa0211] vs. nonspeeded [n\xa0=\xa0204'],['average mathematics achievement'],"[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844007', 'cui_str': '6.5'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0376315', 'cui_str': 'Form'}]","[{'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",224.0,0.0180623,"Impacts on all first-grade content outcomes were significant and positive, but no follow-up impacts were significant.","[{'ForeName': 'Drew H', 'Initials': 'DH', 'LastName': 'Bailey', 'Affiliation': 'University of California, Irvine.'}, {'ForeName': 'Lynn S', 'Initials': 'LS', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Gilbert', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Geary', 'Affiliation': 'University of Missouri.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University.'}]",Child development,['10.1111/cdev.13175']
6,31242752,Inhibition of Angiopoietin-Like Protein 3 With a Monoclonal Antibody Reduces Triglycerides in Hypertriglyceridemia.,"BACKGROUND


Hypertriglyceridemia is associated with increased cardiovascular risk and may be caused by impaired lipoprotein clearance. Angiopoietin-like protein 3 (ANGPTL3) inhibits lipoprotein lipase activity, increasing triglycerides and other lipids. Evinacumab, an ANGPTL3 inhibitor, reduced triglycerides in healthy human volunteers and in homozygous familial hypercholesterolemic individuals. Results from 2 Phase 1 studies in hypertriglyceridemic subjects are reported here.
METHODS


Subjects with triglycerides >150 but ≤450 mg/dL and low-density lipoprotein cholesterol ≥100 mg/dL (n=83 for single ascending dose study [SAD]; n=56 for multiple ascending dose study [MAD]) were randomized 3:1 to evinacumab:placebo. SAD subjects received evinacumab subcutaneously at 75/150/250 mg, or intravenously at 5/10/20 mg/kg, monitored up to day 126. MAD subjects received evinacumab subcutaneously at 150/300/450 mg once weekly, 300/450 mg every 2 weeks, or intravenously at 20 mg/kg once every 4 weeks up to day 56 with 6 months of follow-up. The primary outcomes were incidence and severity of treatment-emergent adverse events. Efficacy analyses included changes in triglycerides and other lipids over time.
RESULTS


In the SAD, 32 (51.6%) versus 9 (42.9%) subjects on evinacumab versus placebo reported treatment-emergent adverse events. In the MAD, 21 (67.7%) versus 9 (75.0%) subjects on subcutaneously evinacumab versus placebo and 6 (85.7%) versus 1 (50.0%) on intravenously evinacumab versus placebo reported treatment-emergent adverse events. No serious treatment-emergent adverse events or events leading to death or treatment discontinuation were reported. Elevations in alanine aminotransferase (7 [11.3%] SAD), aspartate aminotransferase (4 [6.5%] SAD), and creatinine phosphokinase (2 [3.2%) SAD, 1 [14.3%] MAD) were observed with evinacumab (none in the placebo groups), which were single elevations and were not dose-related. Dose-dependent reductions in triglycerides were observed in both studies, with maximum reduction of 76.9% at day 3 with 10 mg/kg intravenously (P<0.0001) in the SAD and of 83.1% at day 2 with 20 mg/kg intravenously once every 4 weeks (P=0.0003) in the MAD. Significant reductions in other lipids were observed with most evinacumab doses versus placebo.
CONCLUSION


Evinacumab was well-tolerated in 2 Phase 1 studies. Lipid changes in hypertriglyceridemic subjects were similar to those observed with ANGPTL3 loss-of-function mutations. Because the latter is associated with reduced cardiovascular risk, ANGPTL3 inhibition may improve clinical outcomes.
CLINICAL TRIAL REGISTRATION


https://www.clinicaltrials.gov. Unique identifiers: NCT01749878 and NCT02107872.",2019,"Elevations in alanine aminotransferase (7 [11.3%] SAD), aspartate aminotransferase (4 [6.5%] SAD), and creatinine phosphokinase (2 [3.2%)","['healthy human volunteers and in homozygous familial hypercholesterolemic individuals', 'n=83 for single ascending dose study [SAD]; n=56 for multiple ascending dose study [MAD', 'hypertriglyceridemic subjects', 'Subjects with triglycerides >150 but ≤450 mg/dL and LDL-C ≥100 mg/dL']","['evinacumab SC', 'evinacumab subcutaneously (SC', 'Evinacumab', 'placebo', 'Angiopoietin-like protein 3', 'evinacumab:placebo']","['triglycerides', 'changes in triglycerides and other lipids over time', 'aspartate aminotransferase', 'Elevations in alanine aminotransferase', 'Lipid changes', 'No serious TEAEs or events leading to death or treatment discontinuation', 'incidence and severity of treatment-emergent adverse events (TEAEs', 'creatinine phosphokinase']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]","[{'cui': 'C4508522', 'cui_str': 'evinacumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505321', 'cui_str': 'Angiopoietin-related Protein'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",,0.249051,"Elevations in alanine aminotransferase (7 [11.3%] SAD), aspartate aminotransferase (4 [6.5%] SAD), and creatinine phosphokinase (2 [3.2%)","[{'ForeName': 'Zahid', 'Initials': 'Z', 'LastName': 'Ahmad', 'Affiliation': 'Division of Nutrition and Metabolic Diseases, Department of Internal Medicine, Center for Human Nutrition, University of Texas Southwestern Medical Center, Dallas (Z.A.).'}, {'ForeName': 'Poulabi', 'Initials': 'P', 'LastName': 'Banerjee', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hamon', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Kuo-Chen', 'Initials': 'KC', 'LastName': 'Chan', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Bouzelmat', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sasiela', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Mellis', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Hayes', 'Initials': 'H', 'LastName': 'Dansky', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Gipe', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Dunbar', 'Affiliation': 'Division of Translational Medicine and Human Genetics, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia (R.L.D.).'}]",Circulation,['10.1161/CIRCULATIONAHA.118.039107']
7,31810378,Impact of Sleep Deprivation on Respiratory Motor Output and Endurance. A Physiological Study.,"Rationale:  Sleep deprivation can alter endurance of skeletal muscles, but its impact on respiratory command is unknown. Objectives:  We aimed to assess the effect of sleep deprivation on respiratory motor output and inspiratory endurance. Methods:  Inspiratory endurance was investigated twice in random order, following a normal sleep night and a sleepless night. Healthy participants were asked to breathe as long as possible until task failure against a moderate inspiratory threshold constraint. Transdiaphragmatic pressure and diaphragm electrical activity were measured throughout the trial to assess pressure output of the diaphragm and overall respiratory motor output. Cortical contribution to respiratory motor output was assessed by measurement of preinspiratory motor potential amplitude and by cervical magnetic simulation. Measurements and Main Results:  Twenty healthy male participants were studied. Time to task failure was significantly shorter after sleep deprivation than after normal sleep: (30 min [interquartile range [IQR], 17-41] vs. 60 min [IQR, 45-60],  P  = 0.002). At the beginning of the trial, preinspiratory motor potential amplitude was significantly lower in the sleep-deprivation condition (4.5 μV [IQR, 2.5-6.4] vs. 7.3 μV [IQR, 4.3-10.4],  P  = 0.02) and correlated significantly with the duration of the endurance trial. In the sleep-deprivation condition, preinspiratory motor potential amplitude, electrical activity of the diaphragm, pressure output of the diaphragm, and Vt decreased and the respiratory rate increased significantly from the beginning to the end of the trial. Such decreases did not occur in the normal-sleep condition. Conclusions:  One night of sleep deprivation reduces respiratory motor output by altering its cortical component with subsequent reduction of inspiratory endurance by half. These results suggest that altered sleep triggers severe brain dysfunctions that could precipitate respiratory failure.",2020,"At the beginning of the trial, preinspiratory motor potential amplitude was significantly lower in the sleep-deprivation condition (4.5 μV [IQR, 2.5-6.4] vs. 7.3 μV [IQR, 4.3-10.4],  P  = 0.02) and correlated significantly with the duration of the endurance trial.","['Healthy participants', 'Twenty healthy male participants']","['Sleep Deprivation', 'sleep deprivation']","['sleep-deprivation condition', 'Time to task failure', 'Transdiaphragmatic pressure and diaphragm electrical activity', 'respiratory motor output and inspiratory endurance', 'Respiratory Motor Output and Endurance', 'sleep-deprivation condition, preinspiratory motor potential amplitude, electrical activity of the diaphragm, pressure output of the diaphragm, and Vt decreased and the respiratory rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205504', 'cui_str': 'Transdiaphragmatic approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0429441', 'cui_str': 'Motor-potential'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",20.0,0.107918,"At the beginning of the trial, preinspiratory motor potential amplitude was significantly lower in the sleep-deprivation condition (4.5 μV [IQR, 2.5-6.4] vs. 7.3 μV [IQR, 4.3-10.4],  P  = 0.02) and correlated significantly with the duration of the endurance trial.","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Rault', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Sangaré', 'Affiliation': 'Service de Neurophysiologie Clinique.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diaz', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Raux', 'Affiliation': 'Sorbonne Universités, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Similowski', 'Affiliation': 'Sorbonne Universités, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Robert', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Arnaud W', 'Initials': 'AW', 'LastName': 'Thille', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Drouot', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201904-0819OC']
8,32265361,"Early Progression and Immune Reconstitution Inflammatory Syndrome During Treatment of Mild-To-Moderate Kaposi Sarcoma in Sub-Saharan Africa and South America: Incidence, Long-Term Outcomes, and Effects of Early Chemotherapy.","BACKGROUND


Early progression of AIDS-associated Kaposi sarcoma (KS-PD) and immune reconstitution inflammatory syndrome (KS-IRIS) sometimes occur after the initiation of antiretroviral therapy (ART).
METHODS


Early KS-PD and KS-IRIS were assessed in the A5264/AMC-067 trial in which participants with mild-to-moderate AIDS-KS were randomized to initiate ART with either immediate or as-needed oral etoposide. Early KS-PD was defined as tumor progression within 12 weeks of ART initiation. When investigators had concern that early KS-PD was KS-IRIS, additional evaluations were performed. Suspected KS-IRIS was defined as early KS-PD accompanied by a CD4 count increase of ≥50 cells per cubic millimeter or plasma HIV-1 RNA decrease of ≥0.5 log10 copies/mL. Clinical outcome was a composite end point categorized as failure, stable, and response at 48 and 96 weeks compared with baseline.
RESULTS


Fifty of 190 participants had early KS-PD (27%): 28 had KS-IRIS and 22 were not evaluated for KS-IRIS. Early KS-PD and KS-IRIS incidences with immediate etoposide versus ART alone were 16% versus 39%, and 7% versus 21%, respectively. Week 48 clinical outcome was 45% failure, 18% stable, and 37% response for no early KS-PD; 82% failure, 2% stable, and 16% response for early KS-PD; and 88% failure, 0% stable, and 12% response for KS-IRIS. Cumulative incidence of KS tumor response by week 96 was 64% for no early KS-PD, 22% with early KS-PD, and 18% with KS-IRIS.
CONCLUSIONS


Early KS-PD, including suspected KS-IRIS, was common after starting ART for AIDS-KS and was associated with worse long-term clinical outcomes. Starting ART concurrently with etoposide reduced the incidence of both early KS-PD and KS-IRIS compared with ART alone.",2020,Week 48 clinical outcome was 45%,"['mild-to-moderate Kaposi sarcoma in sub-Saharan Africa and South America', 'Fifty of 190 participants had early KS-PD (27%): 28 had KS-IRIS, 22 were not evaluated for KS-IRIS', 'participants with mild-to-moderate AIDS-KS']","['immediate etoposide', 'early chemotherapy', 'etoposide']","['incidence of both early KS-PD and KS-IRIS', 'Early KS-PD and KS-IRIS incidences', 'Early KS-PD and KS-IRIS', 'Cumulative incidence of KS tumor response', 'plasma HIV-1']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0036220', 'cui_str': ""Kaposi's sarcoma""}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3495846', 'cui_str': ""Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma""}, {'cui': 'C0001175', 'cui_str': 'AIDS'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3495846', 'cui_str': ""Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma""}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}]",,0.10907,Week 48 clinical outcome was 45%,"[{'ForeName': 'Mulinda', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Johns Hopkins Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'McNeil', 'Initials': 'M', 'LastName': 'Ngongondo', 'Affiliation': 'UNC Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Minhee', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Triin', 'Initials': 'T', 'LastName': 'Umbleja', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Krown', 'Affiliation': 'AIDS Malignancy Consortium, New York, NY.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Godfrey', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': 'Department of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Mngqibisa', 'Affiliation': 'Durban International Clinical Research Site, Enhancing Care Foundation, Durban, South Africa.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Hoagland', 'Affiliation': 'Oswaldo Cruz Foundation, Evandro Chagas National Institute of Infectious Diseases, Rio de Janeiro, Brazil.'}, {'ForeName': 'Noluthando', 'Initials': 'N', 'LastName': 'Mwelase', 'Affiliation': 'University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Caruso', 'Affiliation': 'Frontier Science Foundation, Amherst, New York, NY.'}, {'ForeName': 'Oto', 'Initials': 'O', 'LastName': 'Martinez-Maza', 'Affiliation': 'Department of Obstetrics and Gynecology, David Geffen School of Medicine at UCLA, University of California, Los Angeles, CA.'}, {'ForeName': 'Dirk P', 'Initials': 'DP', 'LastName': 'Dittmer', 'Affiliation': 'Department of Microbiology & Immunology, University of North Carolina School of Medicine, and Lineberger Comprehensive Cancer Center, Chapel Hill, NC; and.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Borok', 'Affiliation': 'Department of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'UNC Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine/Division of Infectious Diseases, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002361']
9,32396700,Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial.,"INTRODUCTION


Global guidelines emphasize the ethical obligation of investigators to help participants in HIV-endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre-exposure prophylaxis (PrEP) has increasingly become part of state-of-the-art HIV prevention. Here we describe the process of integrating oral PrEP delivery into the HIV prevention package of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial.
METHODS


ECHO was an open-label randomized clinical trial that compared HIV incidence among women randomized to one of three effective contraceptives. In total, 7830 women aged 16 to 35 years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18 months, from 2015 to 2018. Part-way through the course of the trial, oral PrEP was provided to study participants either off-site via referral or on site via trained trial staff. PrEP uptake was compared between different contraceptive users using Chi-squared tests or t-tests. HIV seroincidence rates were compared between participants who never versus ever initiated PrEP using exact Poisson regression.
RESULTS


PrEP access in ECHO began through public availability in Kenya in May 2017 and was available at all sites by June 2018. When PrEP became available, 3626 (46.3%) eligible women were still in follow-up in the study, and of these, 622 (17.2%) initiated PrEP. Women initiating PrEP were slightly older; more likely to be unmarried, not living with their partner, having multiple partners; and less likely to be earning their own income and receiving financial support from partners (all p < 0.05). PrEP initiation did not differ across study randomized groups (p = 0.7). Two-thirds of PrEP users were continuing PrEP at study exit.
CONCLUSIONS


There is a need for improved HIV prevention services in clinical trials with HIV endpoints, especially trials among African women. PrEP as a component of a comprehensive HIV prevention package provided to women in a large clinical trial is practical and feasible. Provision of PrEP within clinical trials with HIV outcomes should be standard of prevention.",2020,PrEP initiation did not differ across study randomized groups (p = 0.7).,"['participants either off-site via referral or on site via trained trial staff', 'African women', '7830 women aged 16 to 35\xa0years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18\xa0months, from 2015 to 2018', 'African women in a large HIV endpoint-driven clinical trial']",['Oral pre-exposure prophylaxis (PrEP'],"['PrEP uptake', 'HIV seroincidence rates']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0454695', 'cui_str': 'African country'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",7830.0,0.194832,PrEP initiation did not differ across study randomized groups (p = 0.7).,"[{'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Beesham', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Julia D', 'Initials': 'JD', 'LastName': 'Welch', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Pleaner', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Kidoguchi', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Khatija', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Setshaba Research Centre, Tshwane, South Africa.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Baron', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Louw', 'Affiliation': 'Madibeng Centre for Research, Brits, South Africa.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Mastro', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Smit', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Joanne R', 'Initials': 'JR', 'LastName': 'Batting', 'Affiliation': 'Effective Care Research Unit (ECRU), Fort Hare and Eastern Cape Department of Health, Universities of the Witwatersrand, East London, South Africa.'}, {'ForeName': 'Mookho', 'Initials': 'M', 'LastName': 'Malahleha', 'Affiliation': 'Setshaba Research Centre, Tshwane, South Africa.'}, {'ForeName': 'Veronique C', 'Initials': 'VC', 'LastName': 'Bailey', 'Affiliation': 'Setshaba Research Centre, Tshwane, South Africa.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25491']
10,31999753,The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes-A randomized clinical trial.,"BACKGROUND


Given well documented challenges faced by pregnant women living with HIV taking lifetime ART, it is critical to understand the impact of short-term ART exposure followed by treatment interruption on maternal health outcomes.
METHODS


HIV+ breastfeeding (BF) and Formula Feeding (FF) women with CD4 counts > 350 cells/mm3, enrolled in the 1077BF/1077FF PROMISE trial were followed to assess the effect of ART during pregnancy and breastfeeding respectively. The first analysis compared ART use limited to the antepartum period (AP-only) relative to women randomized to Zidovudine. The second analysis included women with no pregnancy combination ART exposure; and compared women randomized to either ART or no ART during postpartum (PP-only). Both analyses included follow-up time beyond breastfeeding period. The primary outcome was progression to AIDS and/or death. Secondary outcomes included adverse events and HIV-related events.
RESULTS


3490 and 1137 HIV+ women were enrolled from 14 sites in Africa and India from April 2011 through September 2014 in cohort AP-only and PP-only, respectively. Most were Black African (96%); median age was 27 years; 97% were WHO Clinical Stage I; and most had a screening CD4 count ≥500 cells/mm3 (78%). The rate of progression to AIDS and/or death was similar and low across all comparison arms (AP comparison, HR = 1.14, 95%CI (0.44, 2.96), p-value = 0.79). In the PP-only cohort, the rate of WHO stage 2-3 events was lower for women randomized to ART(HR = 0.65, 95% CI 0.42, 1.01, p-value = 0.05).
CONCLUSION


The incidence of AIDS and/or death was low in pregnant/postpartum HIV+ women with highCD4 cell counts for all comparison arms. This provides some reassurance that there were limited consequences for short term ART interruption in this group of asymptomatic HIV+ women during up to 4 years of follow up; and underscores that even short term ART exposure postpartum may reduce the risk of WHO grade 2-3 disease progression.",2020,The incidence of AIDS and/or death was low in pregnant/postpartum HIV+ women with highCD4 cell counts for all comparison arms.,"['women with no pregnancy combination ART exposure; and compared women randomized to either', 'pregnant women living with HIV taking lifetime ART', 'HIV+ breastfeeding (BF) and', '3490 and 1137 HIV+ women were enrolled from 14 sites in Africa and India from April 2011 through September 2014 in cohort AP-only and PP-only, respectively', 'women with CD4 counts']","['Formula Feeding (FF', 'ART or no ART', 'short term Antiretroviral Therapy (ART) interruptions', 'Zidovudine']","['adverse events and HIV-related events', 'rate of progression to AIDS and/or death', 'incidence of AIDS and/or death', 'rate of WHO stage 2-3 events', 'progression to AIDS and/or death']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}]",,0.354778,The incidence of AIDS and/or death was low in pregnant/postpartum HIV+ women with highCD4 cell counts for all comparison arms.,"[{'ForeName': 'Patience', 'Initials': 'P', 'LastName': 'Atuhaire', 'Affiliation': 'Makerere University -John Hopkins University Research Collaboration (MUJHU CARE LTD) CRS, Kampala, Uganda.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'S Brummel', 'Affiliation': 'Harvard School of Public Health, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Blandina Theophil', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Christian Medical Centre (KCMC), Moshi, Tanzania.'}, {'ForeName': 'Konstantia', 'Initials': 'K', 'LastName': 'Angelidou', 'Affiliation': 'Harvard School of Public Health, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits RHI Shandukani Research Centre CRS, Johannesburg, South Africa.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'Soweto IMPAACT CRS, Johannesburg, South Africa.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'FAM-CRU CRS, Cape Town, South Africa.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Mukuzunga', 'Affiliation': 'Malawi CRS, Lilongwe, Malawi.'}, {'ForeName': 'Sajeeda', 'Initials': 'S', 'LastName': 'Mawlana', 'Affiliation': 'Durban Paediatric HIV CRS, Durban, South Africa.'}, {'ForeName': 'Mwangelwa', 'Initials': 'M', 'LastName': 'Mubiana-Mbewe', 'Affiliation': 'George CRS, Lusaka, Zambia.'}, {'ForeName': 'Megeshinee', 'Initials': 'M', 'LastName': 'Naidoo', 'Affiliation': 'Umlazi CRS, Durban, South Africa.'}, {'ForeName': 'Bonus', 'Initials': 'B', 'LastName': 'Makanani', 'Affiliation': 'Blantyre CRS, Blantyre, Malawi.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Mandima', 'Affiliation': 'St Marys CRS, Harare, Zimbabwe.'}, {'ForeName': 'Teacler', 'Initials': 'T', 'LastName': 'Nematadzira', 'Affiliation': 'Seke North CRS, Harare, Zimbabwe.'}, {'ForeName': 'Nishi', 'Initials': 'N', 'LastName': 'Suryavanshi', 'Affiliation': 'Byramjee Jeejeebhoy Medical College (BJMC) CRS, Pune, India.'}, {'ForeName': 'Tapiwa', 'Initials': 'T', 'LastName': 'Mbengeranwa', 'Affiliation': 'Harare Family Care CRS, Harare, Zimbabwe.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Loftis', 'Affiliation': 'UNC, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Basar', 'Affiliation': 'Frontier Science, Amherst, Massachusetts, United States of America.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'McCarthy', 'Affiliation': 'FHI 360, Durham, North Carolina, United States of America.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'UCLA center for Clinical AIDS Research and Education, Los Angeles, California, United States of America.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Departments of Pathology and Epidemiology, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0228003']
11,31790343,"Detecting noncredible performance with the neuropsychological assessment battery, screening module: A simulation study.","OBJECTIVE


While the Neuropsychological Assessment Battery, Screening Module (S-NAB) is a commonly used cognitive screening measure, no composite embedded performance validity test (PVT) formula has yet been described within it. This study sought to empirically derive PVT formulas within the S-NAB using an analog simulation paradigm.
METHOD


Seventy-two university students ( M  age = 18.92) were randomly assigned to either an Asymptomatic (AS) or simulated mild traumatic brain injury (S-mTBI) group and were administered a neuropsychological test battery that included the S-NAB and standalone and embedded PVTs. The AS group was instructed to perform optimally, and the S-mTBI group received symptom and test coaching to help simulate mTBI-related impairment. Both groups received warnings regarding the presence of PVTs throughout the test battery.
RESULTS


Groups showed significant differences (all  p s < .001) on all S-NAB domain scores and PVTs. In the S-NAB, the Attention (S-ATT) and Executive Function (S-EXE) domains showed the largest effect sizes (Cohen's  d s = 2.02 and 1.79, respectively). Seven raw scores from S-ATT and S-EXE subtests were entered as predictor variables in a direct logistic regression (LR). The model accurately classified 90.3% of cases. Two PVT formulas were described: (1) an exponentiated equation from LR results and (2) an arithmetic formula using four individually meaningful variables. Both formulas demonstrated outstanding discriminability between groups (AUCs = .96-.97) and yielded good classification statistics compared to other PVTs.
CONCLUSIONS


This study is the first to describe composite, embedded PVT formulas within the S-NAB. Implications, limitations, and appropriate future directions of inquiry are discussed.",2021,Groups showed significant differences (all  p s < .001) on all S-NAB domain scores and PVTs.,['Method:  Seventy-two university students ( M  age\u2009=\u200918.92'],"['neuropsychological assessment battery, screening module', 'Asymptomatic (AS) or simulated mild traumatic brain injury (S-mTBI) group and were administered a neuropsychological test battery that included the S-NAB and standalone and embedded PVTs']",[],"[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],7.0,0.0306443,Groups showed significant differences (all  p s < .001) on all S-NAB domain scores and PVTs.,"[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Lace', 'Affiliation': 'Department of Psychology, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Alex F', 'Initials': 'AF', 'LastName': 'Grant', 'Affiliation': 'Department of Psychology, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Ruppert', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'David A S', 'Initials': 'DAS', 'LastName': 'Kaufman', 'Affiliation': 'Department of Psychology, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Carson L', 'Initials': 'CL', 'LastName': 'Teague', 'Affiliation': 'Department of Psychology, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Lowell', 'Affiliation': 'Department of Psychology, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Gfeller', 'Affiliation': 'Department of Psychology, Saint Louis University, St. Louis, MO, USA.'}]",The Clinical neuropsychologist,['10.1080/13854046.2019.1694703']
12,31866286,Short-term effects of angiotensin receptor-neprilysin inhibitors on diastolic strain and tissue doppler parameters in heart failure patients with reduced ejection fraction: A pilot trial.,"OBJECTIVE


Although sacubitril/valsartan has recently shown its long-term benefits on morbidity and mortality in symptomatic patients with chronic heart failure with reduced ejection fraction (HFrEF), its short-term effects on diastolic function remain uncertain. We sought to assess 30-day effects of sacubitril/valsartan on left ventricular (LV) diastolic paremeters determined by speckle tracking and tissue Doppler imaging (STI and TDI respectively) as well as their association with functional capacity change evaluated by peak oxygen uptake (VO 2 max) in stable patients with symptomatic HFrEF.
METHODS


A total of 35 patients (aged 61 ± 9 years) eligible for sacubitril/valsartan underwent a complete two-dimension (2D) echocardiographic study and a cardiopulmonary exercise test at baseline and 30 days after the initiation of therapy.
RESULTS


Significant improvements in ratio of trans-mitral inflow early diastolic velocity E to mitral annulus early diastolic velocity E' (ΔΕ//Ε' = -35.9%, p = 0.001), peak early diastolic strain rate SRE (ΔSRE = +22.5%, p = 0.024) and ratio E/SRE (ΔE/SRE = -33.2%, p = 0.025) were observed after 1-month therapy. Compared with baseline, VO 2 max also increased significantly by 16.7 % (p = 0.001). Baseline E/SRE and ΔE/SRE were the strongest independent predictors of VO 2 max improvement (beta = -0.43, p = 0.004 and beta = 0.45, p = 0.021 respectively) in the multivariate analysis.
CONCLUSION


Sacubitril/valsartan was associated with early improvement in LV diastolic function determined by TDI and 2D STI. Baseline E/SRE was stronger than standard echocardiographic parameters in predicting the early benefit of sacubitril/valsartan therapy.",2020,"Compared with baseline, VO2max also increased significantly by 16.7 % (p = 0.001).","['stable patients with symptomatic HFrEF', 'heart failure patients with reduced ejection fraction', '35 patients (aged 61 ± 9 years) eligible for sacubitril/valsartan underwent a complete two-dimension (2D) echocardiographic study and a cardiopulmonary exercise test at baseline and 30 days after the initiation of therapy', 'symptomatic patients with chronic heart failure with reduced ejection fraction (HFrEF']","['sacubitril/valsartan', 'angiotensin receptor-neprilysin inhibitors', 'Sacubitril/valsartan']","['peak early diastolic strain rate SRE', 'ratio E/SRE', 'peak oxygen uptake (VO 2 max', 'left ventricular (LV) diastolic paremeters', 'LV diastolic function', 'diastolic strain and tissue doppler parameters', 'ratio of trans-mitral inflow early diastolic velocity E to mitral annulus early diastolic velocity E']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]","[{'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",,0.133912,"Compared with baseline, VO2max also increased significantly by 16.7 % (p = 0.001).","[{'ForeName': 'Eleni S', 'Initials': 'ES', 'LastName': 'Nakou', 'Affiliation': ""Department of Cardiology, King's College Hospital NHS Foundation Trust, London, United Kingdom; Barts Heart Centre, St Bartholomew's Hospital, Institute of Cardiovascular Science, United Kingdom. Electronic address: EleniSNakou@yahoo.gr.""}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Marketou', 'Affiliation': 'Department of Cardiology, Heraklion University Hospital, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Patrianakos', 'Affiliation': 'Department of Cardiology, Heraklion University Hospital, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Protonotarios', 'Affiliation': ""Barts Heart Centre, St Bartholomew's Hospital, Institute of Cardiovascular Science, United Kingdom.""}, {'ForeName': 'Panos E', 'Initials': 'PE', 'LastName': 'Vardas', 'Affiliation': 'Department of Cardiology, Heraklion University Hospital, Greece.'}, {'ForeName': 'Fragiskos I', 'Initials': 'FI', 'LastName': 'Parthenakis', 'Affiliation': 'Department of Cardiology, Heraklion University Hospital, Greece.'}]",Hellenic journal of cardiology : HJC = Hellenike kardiologike epitheorese,['10.1016/j.hjc.2019.12.003']
13,31945300,Early Bactericidal Activity of Different Isoniazid Doses for Drug Resistant TB (INHindsight): A Randomized Open-label Clinical Trial.,"RATIONALE


High-dose isoniazid is recommended in short-course regimens for multidrug-resistant TB (MDR-TB). The optimal dose of isoniazid and its individual contribution to efficacy against TB strains with inhA or katG mutations are unknown.
OBJECTIVE


Define the optimal dose of isoniazid for patients with isoniazid-resistant TB mediated by inhA mutations.
METHODS


AIDS Clinical Trials Group A5312 is a Phase 2A, open-label trial in which individuals with smear-positive pulmonary TB with isoniazid resistance mediated by an inhA mutation were randomized to receive isoniazid 5, 10 or 15 mg/kg daily for 7 days (inhA group), and controls with drug-sensitive TB received standard dose (5 mg/kg/day). Overnight sputum cultures were collected daily. The 7-day early bactericidal activity of isoniazid was estimated as the average daily change in log10 colony forming units on solid media (EBACFU0-7) or as time to positivity in liquid media in hours (EBATTP0-7) using nonlinear mixed effects models.
MEASUREMENTS AND MAIN RESULTS


Fifty-nine participants, 88% with cavitary disease, 20% HIV-positive, 16 with isoniazid-sensitive and 41 with isoniazid mono-resistant or MDR TB, were enrolled at one site in South Africa. Mean EBACFU0-7 at doses of 5, 10 and 15 mg/kg in the inhA group was 0.07, 0.17 and 0.22 log10CFU/mL/day, respectively, and 0.16 log10CFU/mL/day in controls. EBATTP0-7 patterns were similar. There were no drug-related Grade >3 adverse events.
CONCLUSIONS


Isoniazid 10-15 mg/kg daily had similar activity against TB strains with inhA mutations as 5 mg/kg against drug-sensitive strains. The activity of high-dose isoniazid against strains with katG mutations will be explored next. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT01936831.",2020,"There were no drug-related Grade >3 adverse events.
","['Fifty-nine participants, 88% with cavitary disease, 20% HIV-positive, 16 with isoniazid-sensitive and 41 with isoniazid mono-resistant or MDR TB, were enrolled at one site in South Africa', 'individuals with smear-positive pulmonary TB with isoniazid resistance mediated by an inhA mutation', 'Drug Resistant TB (INHindsight', 'patients with isoniazid-resistant TB mediated by inhA mutations']","['Isoniazid', 'isoniazid']",[],"[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}]",[],59.0,0.319838,"There were no drug-related Grade >3 adverse events.
","[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Johns Hopkins University, Medicine, Baltimore, Maryland, United States; kdooley1@jhmi.edu.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Miyahara', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Boston, Massachusetts, United States.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'von Groote-Bidlingmaier', 'Affiliation': 'Stellenbosch University Faculty of Medicine and Health Sciences, 121470, TASK Applied Science, Cape Town, South Africa.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Boston, Massachusetts, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hafner', 'Affiliation': 'National Institutes of Health, Division of AIDS, Bethesda, Maryland, United States.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Rosenkranz', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Boston, Massachusetts, United States.'}, {'ForeName': 'Elisa H', 'Initials': 'EH', 'LastName': 'Ignatius', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, United States.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Nuermberger', 'Affiliation': 'Johns Hopkins University, Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moran', 'Affiliation': 'Social & Scientific Systems Inc, 43740, Silver Spring, Maryland, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Donahue', 'Affiliation': 'Frontier Science and Technology Research Foundation, 2402, Boston, Massachusetts, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Swindells', 'Affiliation': 'Nebraska Medicine, 21039, Omaha, Nebraska, United States.'}, {'ForeName': 'Naadira', 'Initials': 'N', 'LastName': 'Vanker', 'Affiliation': 'TASK Applied Science, Cape Town, South Africa.'}, {'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Diacon', 'Affiliation': 'University of Stellenbosch, Internal Medicine, Tygerberg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201910-1960OC']
14,31961489,Effectiveness of Stepped-Care Intervention in Overweight and Obese Patients With Medial Tibiofemoral Osteoarthritis: A Randomized Controlled Trial.,"OBJECTIVE


To test the effectiveness of a 32-week, stepped-care intervention on disease remission rates in overweight and obese patients with medial tibiofemoral osteoarthritis (OA) compared to controls.
METHODS


In this randomized controlled trial, eligible participants were ≥50 years of age with a body mass index of ≥28 kg/m 2  and radiographic evidence of medial tibiofemoral OA. Participants were randomized to stepped-care (n = 87) or control group (n = 84). The stepped-care group received a 2-step intervention. The first step consisted of an 18-week diet and exercise program. The second step consisted of 4 treatment subgroups: 1) diet and exercise maintenance; 2) cognitive-behavioral therapy; 3) unloader knee brace; and 4) muscle strengthening exercises. Allocation into subgroups was based on disease remission state and clinical characteristics. The primary end point was the disease remission rate (yes/no) at 32 weeks, which was reached when participants achieved the Patient Acceptable Symptom State cutoff value for pain and for the patient global assessment of disease activity and/or functional impairment.
RESULTS


Disease remission at 32 weeks was achieved by 18 of 68 (26%) in the control group and 32 of 82 (39%) in the stepped-care group (difference 12.6% [95% confidence interval -2.3, 27.4], P = 0.10). The stepped-care group showed an improvement in pain and function between baseline and 20 weeks. While functional improvement was maintained at 32 weeks, pain levels tended to get worse between weeks 20 and 32.
CONCLUSION


The proposed intervention did not promote a significant difference in the rate of disease remission in comparison to the control group for overweight or obese patients with medial tibiofemoral OA.",2021,The proposed intervention did not promote a significant difference in the rate of disease remission in comparison to control group for overweight or obese people with medial tibiofemoral OA.,"['eligible participants were ≥50 years-old with a body mass index ≥28 kg', 'overweight and obese people with medial tibiofemoral osteoarthritis (OA', 'overweight and obese people with medial tibiofemoral osteoarthritis']","['18-week diet and exercise program', '32-week stepped-care intervention', 'diet and exercise maintenance; (2) cognitive behavioural therapy (CBT); (3) unloader knee brace and; (4) muscle strengthening exercises', 'stepped-care']","['Disease remission', 'patient acceptable symptom state (PASS) for pain plus the patient global assessment of disease activity and/or functional impairment', 'disease remission rate', 'disease remission rates', 'pain and function', 'rate of disease remission', 'pain levels']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",,0.150396,The proposed intervention did not promote a significant difference in the rate of disease remission in comparison to control group for overweight or obese people with medial tibiofemoral OA.,"[{'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Robbins', 'Affiliation': 'The University of Sydney and Royal North Shore Hospital, Saint Leonards, New South Wales, Australia.'}, {'ForeName': 'Luciano R S', 'Initials': 'LRS', 'LastName': 'Melo', 'Affiliation': 'The Sax Institute, Haymarket, New South Wales, Australia.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Urban', 'Affiliation': 'The University of Sydney and Royal North Shore Hospital, Saint Leonards, New South Wales, Australia.'}, {'ForeName': 'Leticia A', 'Initials': 'LA', 'LastName': 'Deveza', 'Affiliation': 'The University of Sydney and Royal North Shore Hospital, Saint Leonards, New South Wales, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Johnson', 'Affiliation': 'The University of Sydney and Royal North Shore Hospital, Saint Leonards, New South Wales, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'The University of Sydney and Royal North Shore Hospital, Saint Leonards, New South Wales, Australia.'}]",Arthritis care & research,['10.1002/acr.24148']
15,26239086,"Hemostatic efficacy, safety, and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease.","This phase 3 trial evaluated the safety and hemostatic efficacy of a recombinant von Willebrand factor (rVWF) for treatment of bleeds in severe von Willebrand disease (VWD). rVWF was initially administered together with recombinant factor VIII (rFVIII) and subsequently alone, as long as hemostatic factor VIII activity (FVIII : C) levels were maintained. Pharmacokinetics (PK) were evaluated in a randomized cross-over design (rVWF vs rVWF:rFVIII at 50 IU VWF:ristocetin cofactor activity [RCo]/kg). Bleed control for all treated bleeds (N = 192 bleeds in 22 subjects) was rated good or excellent (96.9% excellent; 119 of 122 minor, 59 of 61 moderate, and 6 of 7 major bleeds) on a 4-point scale (4 = none to 1 = excellent). A single infusion was effective in 81.8% of bleeds. Treatment success, defined as the number of subjects with a mean efficacy rating of <2.5, was 100%. The PK profile of rVWF was not influenced by rFVIII (mean VWF:RCo terminal half-life: 21.9 hours for rVWF and 19.6 hours for rVWF:rFVIII). FVIII : C levels increased rapidly after rVWF alone, with hemostatic levels achieved within 6 hours and sustained through 72 hours after infusion. Eight adverse events (AEs; 6 nonserious AEs in 4 subjects and 2 serious AEs [chest discomfort and increased heart rate, without cardiac symptomatology] concurrently in 1 subject) were associated with rVWF. There were no thrombotic events or severe allergic reactions. No VWF or FVIII inhibitors, anti-VWF binding antibodies, or antibodies against host cell proteins were detected. These results show that rVWF was safe and effective in treating bleeds in VWD patients and stabilizes endogenous FVIII : C, which may eliminate the need for rFVIII after the first infusion. This trial was registered at www.clinicaltrials.gov as #NCT01410227.",2015,"No VWF or FVIII inhibitors, anti-VWF binding antibodies, or antibodies against host cell proteins were detected.","['severe von Willebrand disease', 'severe von Willebrand disease (VWD']","['FVIII ', 'recombinant von Willebrand factor', 'recombinant factor VIII (rFVIII', 'rVWF', 'recombinant von Willebrand factor (rVWF']","['number of subjects with a mean efficacy rating', 'heart rate, without cardiac symptomatology', 'Hemostatic efficacy, safety, and pharmacokinetics', 'PK profile of rVWF', 'C levels', 'VWF or FVIII inhibitors, anti-VWF binding antibodies, or antibodies against host cell proteins', 'Pharmacokinetics (PK', 'hemostatic levels', 'thrombotic events or severe allergic reactions', 'safety and hemostatic efficacy']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042974', 'cui_str': ""Von Willebrand's Factor Deficiency""}]","[{'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}]",192.0,0.0539573,"No VWF or FVIII inhibitors, anti-VWF binding antibodies, or antibodies against host cell proteins were detected.","[{'ForeName': 'Joan C', 'Initials': 'JC', 'LastName': 'Gill', 'Affiliation': 'Blood Center of Wisconsin, Milwaukee, WI; Medical College of Wisconsin, Milwaukee, WI;'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Castaman', 'Affiliation': 'Department of Hematology, San Bortolo Hospital, Vicenza, Italy; University Hospital, Center for Bleeding Disorders, Florence, Italy;'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Windyga', 'Affiliation': 'Institute of Hematology and Transfusion Medicine, Warsaw, Poland;'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kouides', 'Affiliation': 'University of Rochester School of Medicine, Rochester, NY; Mary Gooley Hemophilia Center, Rochester, NY;'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Ragni', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA; Hemophilia Center of Western Pennsylvania, Pittsburgh, PA;'}, {'ForeName': 'Frank W G', 'Initials': 'FW', 'LastName': 'Leebeek', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, The Netherlands;'}, {'ForeName': 'Ortrun', 'Initials': 'O', 'LastName': 'Obermann-Slupetzky', 'Affiliation': 'Baxalta Innovations, GmbH, Vienna, Austria; and.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Chapman', 'Affiliation': 'Baxalta Innovations, GmbH, Vienna, Austria; and.'}, {'ForeName': 'Sandor', 'Initials': 'S', 'LastName': 'Fritsch', 'Affiliation': 'Baxalta Innovations, GmbH, Vienna, Austria; and.'}, {'ForeName': 'Borislava G', 'Initials': 'BG', 'LastName': 'Pavlova', 'Affiliation': 'Baxalta Innovations, GmbH, Vienna, Austria; and.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Presch', 'Affiliation': 'Baxalta Innovations, GmbH, Vienna, Austria; and.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Ewenstein', 'Affiliation': 'Baxalta US Inc, Cambridge, MA.'}]",Blood,['10.1182/blood-2015-02-629873']
16,32282386,Effect of Dural Puncture Epidural Technique Combined With Programmed Intermittent Epidural Bolus on Labor Analgesia Onset and Maintenance: A Randomized Controlled Trial.,"BACKGROUND


The dural puncture epidural (DPE) technique is associated with faster onset than the conventional epidural (EP) technique for labor analgesia. The programmed intermittent epidural bolus (PIEB) mode for maintaining labor analgesia allows for lower anesthetic drug consumption than the continuous epidural infusion (CEI) mode. Whether DPE technique with PIEB mode offers additional benefits for analgesia onset, local anesthetic drug consumption, and side effects versus EP or DPE techniques with CEI mode remains unclear.
METHODS


Nulliparous women with a visual analog scale (VAS) pain score >50 mm and cervical dilation <5 cm were randomly assigned to receive EP + CEI, DPE + CEI, or DPE + PIEB for labor analgesia. A 25-gauge needle was used for dural puncture. Analgesia was initiated with 10 mL of 0.1% ropivacaine with 0.3 µg/mL of sufentanil and maintained with the same solution at 8 mL/h in all groups. A 5-mL patient-controlled epidural analgesia (PCEA) bolus was programmed with a 20-minute lockout. Breakthrough pain not amendable by PCEA was treated with provider boluses of 5 mL of 0.125% ropivacaine. The primary outcome was ""time to adequate analgesia,"" defined as a VAS pain score ≤30 mm during 2 consecutive contractions, and was analyzed using Kaplan-Meier curves and a Cox proportional hazard model. Secondary outcomes included the VAS scores, ropivacaine consumption, sensory block level to ice, PCEA and provider boluses intervention, mode of delivery, duration of labor, Bromage scores, Apgar scores, occurrence of side effects, and maternal satisfaction with the anesthesia.
RESULTS


A total of 116 women were included (38 in the EP + CEI group, 40 in the DPE + CEI group, and 38 in the DPE + PIEB group). Adequate anesthesia was achieved faster in the DPE + CEI and DPE + PIEB groups than in the EP + CEI group (hazard ratio = 1.705; 95% confidence interval [CI], 1.039-2.800; P = .015; and hazard ratio = 1.774; 95% CI, 1.070-2.941; P = .012, respectively). DPE technique with PIEB mode was associated with the fewest PCEA boluses and the lowest hourly ropivacaine consumption (both P < .001). There were no differences in the duration of labor, mode of delivery, Bromage scores, newborn Apgar scores, incidence of side effects, and maternal satisfaction scores among the groups.
CONCLUSIONS


The use of DPE technique for neuraxial analgesia was associated with faster onset than the use of the EP technique. DPE technique with PIEB mode achieved the greatest drug-sparing effect without increasing maternal or neonatal side effects.",2021,"Adequate anesthesia was achieved faster in the DPE + CEI and DPE + PIEB groups than in the EP + CEI group (hazard ratio = 1.705; 95% confidence interval [CI], 1.039-2.800; P = .015; and hazard ratio = 1.774; 95% CI, 1.070-2.941; P = .012, respectively).","['A total of 116 women were included (38 in the EP + CEI group, 40 in the DPE + CEI group, and 38 in the DPE + PIEB group', 'Nulliparous women with a visual analog scale (VAS) pain score >50 mm and cervical dilation <5 cm']","['conventional epidural (EP) technique', 'dural puncture epidural (DPE) technique', 'PCEA', 'DPE technique', 'EP + CEI', '25-gauge needle', 'sufentanil', 'ropivacaine', 'EP+CEI, DPE+CEI, or DPE+PIEB for labor analgesia', 'Dural Puncture Epidural Technique Combined With Programmed Intermittent Epidural Bolus', '5-mL patient-controlled epidural analgesia (PCEA']","['Labor Analgesia Onset and Maintenance', 'Breakthrough pain', 'lowest hourly ropivacaine consumption', 'duration of labor, mode of delivery, Bromage scores, newborn Apgar scores, incidence of side effects, and maternal satisfaction scores', ' time to adequate analgesia, "" defined as a VAS pain score ≤30 mm during 2 consecutive contractions', 'VAS scores, ropivacaine consumption, sensory block level to ice, PCEA and provider boluses intervention, mode of delivery, duration of labor, Bromage scores, Apgar scores, occurrence of side effects, and maternal satisfaction with the anesthesia']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0450400', 'cui_str': '50mm'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",116.0,0.162953,"Adequate anesthesia was achieved faster in the DPE + CEI and DPE + PIEB groups than in the EP + CEI group (hazard ratio = 1.705; 95% confidence interval [CI], 1.039-2.800; P = .015; and hazard ratio = 1.774; 95% CI, 1.070-2.941; P = .012, respectively).","[{'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'From the Department of Anesthesiology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': ''}, {'ForeName': 'Shuangqiong', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004768']
17,31288829,Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial.,"BACKGROUND


Critical illness increases the risk for poor mental health outcomes among both patients and their informal caregivers, especially their surrogate decision-makers. Surrogates who must make life-and-death medical decisions on behalf of incapacitated patients may experience additional distress. EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) is a novel cognitive-behavioral, acceptance-based intervention delivered in the intensive care unit (ICU) setting to surrogate decision-makers designed to improve both patients' quality of life and death and dying as well as surrogates' mental health.
METHODS


Clinician stakeholder and surrogate participant feedback (n = 15), as well as results from an open trial (n = 10), will be used to refine the intervention, which will then be evaluated through a multisite randomized controlled trial (RCT) (n = 60) to examine clinical superiority to usual care. Feasibility, tolerability, and acceptability of the intervention will be evaluated through self-report assessments. Hierarchical linear modeling will be used to adjust for clustering within interventionists to determine the effect of EMPOWER on surrogate differences in the primary outcome, peritraumatic stress. Secondary outcomes will include symptoms of post-traumatic stress disorder, prolonged grief disorder, and experiential avoidance. Exploratory outcomes will include symptoms of anxiety, depression, and decision regret, all measured at 1 and 3 months from post-intervention assessment. Linear regression models will examine the effects of assignment to EMPOWER versus the enhanced usual care group on patient quality of life or quality of death and intensity of care the patient received during the indexed ICU stay assessed at the time of the post-intervention assessment. Participant exit interviews will be conducted at the 3-month assessment time point and will be analyzed using qualitative thematic data analysis methods.
DISCUSSION


The EMPOWER study is unique in its application of evidence-based psychotherapy targeting peritraumatic stress to improve patient and caregiver outcomes in the setting of critical illness. The experimental intervention will be strengthened through the input of a variety of ICU stakeholders, including behavioral health clinicians, physicians, bereaved informal caregivers, and open trial participants. Results of the RCT will be submitted for publication in a peer-reviewed journal and serve as preliminary data for a larger, multisite RCT grant application.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03276559 . Retrospectively registered on 8 September 2017.",2019,"Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) is a novel cognitive-behavioral, acceptance-based intervention delivered in the intensive care unit (ICU) setting to surrogate decision-makers designed to improve both patients' quality of life and death and dying as well as surrogates' mental health.
","['Clinician stakeholder and surrogate participant feedback (n\u2009=\u200915), as well as results from an open trial (n\u2009=\u200910']",['RCT'],"['symptoms of anxiety, depression, and decision regret', 'symptoms of post-traumatic stress disorder, prolonged grief disorder, and experiential avoidance', 'Feasibility, tolerability, and acceptability', 'patient quality of life or quality of death and intensity of care']","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",[],"[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder (finding)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",,0.101242,"Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) is a novel cognitive-behavioral, acceptance-based intervention delivered in the intensive care unit (ICU) setting to surrogate decision-makers designed to improve both patients' quality of life and death and dying as well as surrogates' mental health.
","[{'ForeName': 'Holly G', 'Initials': 'HG', 'LastName': 'Prigerson', 'Affiliation': 'Center for Research on End-of-Life Care, Weill Cornell Medicine, New York, NY, USA. hgp2001@med.cornell.edu.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Viola', 'Affiliation': 'Center for Research on End-of-Life Care, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Chris R', 'Initials': 'CR', 'LastName': 'Brewin', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ouyang', 'Affiliation': 'Center for Research on End-of-Life Care, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Rogers', 'Affiliation': 'Center for Research on End-of-Life Care, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Cynthia X', 'Initials': 'CX', 'LastName': 'Pan', 'Affiliation': 'NewYork-Presbyterian Queens, New York, NY, USA.'}, {'ForeName': 'Shayna', 'Initials': 'S', 'LastName': 'Rabin', 'Affiliation': 'Center for Research on End-of-Life Care, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Jiehui', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Center for Research on End-of-Life Care, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Vaughan', 'Affiliation': 'Department of Psychiatry, Columbia College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Janna S', 'Initials': 'JS', 'LastName': 'Gordon-Elliot', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Berlin', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Lief', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Wendy G', 'Initials': 'WG', 'LastName': 'Lichtenthal', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, New York, NY, USA.'}]",Trials,['10.1186/s13063-019-3515-0']
18,31309857,Neurodevelopmental outcome of monochorionic twins with selective intrauterine growth restriction (SIUGR) type II: laser versus expectant management.,"OBJECTIVE


To compare the neurodevelopmental outcome of monochorionic-diamniotic twins (MCDA) with type II selective intrauterine growth restriction (SIUGR-II) managed  in utero  either expectantly or with laser.
MATERIALS AND METHODS


Postnatal neurodevelopmental assessment was conducted on the children of patients that had been antenatally diagnosed with SIUGR-II between 16 and 26 weeks gestational age (GA) and that had been randomly assigned to expectant management (EM) versus laser therapy (LT). The assessment was conducted by trained specialists using the Battelle Developmental Inventory (BDI-2). BDI-2 total and domain (adaptive, personal-social, communication, motor, and cognitive) composite scores for the appropriately grown (AGA) and growth-restricted (IUGR) twins were compared by treatment arm.
RESULTS


Twenty patients diagnosed with SIUGR had undergone block randomization between two centers to either expectant management (EM) (6) or laser therapy (LT) (14). The mean (SD) GA at diagnosis was no different between the EM and LT groups [21.5 (2.0) versus 21.1 (2.8) weeks,  p  = .7414, respectively]. However, GA at delivery was significantly lower in the EM versus LT groups [28.3 (1.8) versus 33.4 (3.8) weeks,  p  = .0039]. At 6 months, all 20 AGA babies were alive, whereas only 3/6 (50%) of the IUGR babies in the EM group and 4/14 (29%) in the LT group were alive ( p  = .6126). One family in the EM group and two families in the LT group declined BDI-2 assessment. The mean (SD) age at BDI-2 assessment was no different between the EM and LT groups [75.6 (14.4) versus 70.7 (18.2) months,  p  = .5618, respectively]. For the AGA children, there were no significant differences in total BDI-2 scores for the EM versus LT [97.4 (10.4) versus 98.0 (19.6),  p  = .8741], nor in any of the domain composite scores. For the IUGR children, no statistically significant differences were detected in total BDI-2 scores between the EM and LT [72.0 (31.1) versus 92.8 (22.1),  p  = .643], nor in any of the domain composite scores. The comparison of standardized scores between the AGA and IUGR pairs was significantly different, but within the normal range.
CONCLUSIONS


Neurodevelopmental outcomes for SIUGR-II MCDA twins were similarly favorable, whether managed expectantly or with laser treated. However, the significantly different GA at delivery (28.3 versus 33.4 weeks,  p  = .0039, expectant versus laser, respectively) may suggest improved outcomes in laser-treated patients in a larger cohort.",2021,"For the IUGR children, no statistically significant differences were detected in total BDI-2 scores between the EM and LT [72.0 (31.1) versus 92.8 (22.1),  p  = .643], nor in any of the domain composite scores.","['Twenty patients diagnosed with SIUGR had undergone block randomization between two centers to either expectant management (EM) (6) or laser therapy (LT) (14', 'utero  either expectantly or with laser', 'monochorionic twins with', 'children of patients that had been antenatally diagnosed with SIUGR-II between 16 and 26\u2009weeks gestational age (GA) and that had been randomly assigned to']","['monochorionic-diamniotic twins (MCDA) with type II selective intrauterine growth restriction (SIUGR-II) managed', 'selective intrauterine growth restriction (SIUGR) type II: laser versus expectant management', 'expectant management (EM) versus laser therapy (LT']","['BDI-2 total and domain (adaptive, personal-social, communication, motor, and cognitive) composite scores for the appropriately grown (AGA) and growth-restricted (IUGR', 'mean (SD) GA at diagnosis', 'GA at delivery', 'total BDI-2 scores', 'mean (SD) age at BDI-2 assessment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2585455', 'cui_str': 'Expectant management (procedure)'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C2585455', 'cui_str': 'Expectant management (procedure)'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0612105,"For the IUGR children, no statistically significant differences were detected in total BDI-2 scores between the EM and LT [72.0 (31.1) versus 92.8 (22.1),  p  = .643], nor in any of the domain composite scores.","[{'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Quintero', 'Affiliation': 'USFetus Research Consortium, Miami, FL, USA.'}, {'ForeName': 'Eftichia', 'Initials': 'E', 'LastName': 'Kontopoulos', 'Affiliation': 'USFetus Research Consortium, Miami, FL, USA.'}, {'ForeName': 'Marian E', 'Initials': 'ME', 'LastName': 'Williams', 'Affiliation': ""Children's Hospital Los Angeles University Center for Excellence in Developmental Disabilities, University of Southern California, Los Angeles, CA, USA.""}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Sloop', 'Affiliation': 'JSloop Consulting, LLC, Boynton Beach, FL, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Vanderbilt', 'Affiliation': 'Department of Pediatrics, Division of General Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Ramen H', 'Initials': 'RH', 'LastName': 'Chmait', 'Affiliation': 'USFetus Research Consortium, Miami, FL, USA.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1638902']
19,31860567,A Comparative Study on the Effects of High-Intensity Focused Electromagnetic Technology and Electrostimulation for the Treatment of Pelvic Floor Muscles and Urinary Incontinence in Parous Women: Analysis of Posttreatment Data.,"OBJECTIVES


Pelvic floor muscles (PFMs) weakening and urinary incontinence (UI) represent health issues that have a negative impact on daily life. This study compares the immediate efficiency of high-intensity focused electromagnetic (HIFEM) therapy and electrostimulation for the treatment of weakened PFMs, accompanied by the UI.
METHODS


Ninety-five parous women were considered for the study. Symptomatic patients received either HIFEM or electrostimulation treatment. Treated patients completed 10 therapies scheduled 2 to 3 times per week (HIFEM) or every other day (electrostimulation). Patients underwent examination by 3-dimensional transperienal ultrasound at the baseline and posttreatments. Levator-urethra gap, anteroposterior diameter, laterolateral diameter of levator hiatus, and hiatal area were measured. In addition, Pelvic Floor Disability Index 20 questionnaire and subjective evaluation of patient's intimate health were assessed.
RESULTS


Enrolled patients were divided into group I (n = 50, HIFEM), group II (n = 25, electrostimulation), and group III (n = 20, control) according the indication and treatment modality. Three-dimensional ultrasounds showed positive changes in dynamics of the pelvic floor posttreatment (decreased anteroposterior diameter, laterolateral diameter, and hiatal area). However, the significant (P < 0.05) changes of pelvic floor integrity were observed only in group I. In addition, group I achieved greater level of improvement in Pelvic Floor Disability Index 20 questionnaire compared with group II (52% and 18% respectively; P < 0.001). Substantially fewer patients in group I reported urine leakage after treatments.
CONCLUSIONS


Posttreatment results suggest that HIFEM technology is suitable for treatment of PFMs weakening and showed to be more effective when compared with electrostimulation in short-term. Therefore, we recommend HIFEM as treatment option for weakened PFMs and UI.",2021,"Three-dimensional ultrasounds showed positive changes in dynamics of the pelvic floor posttreatment (decreased anteroposterior diameter, laterolateral diameter, and hiatal area).","['Parous Women', 'Ninety-five parous women were considered for the study']","['HIFEM', 'HIFEM or electrostimulation treatment', 'high-intensity focused electromagnetic (HIFEM) therapy and electrostimulation', 'High-Intensity Focused Electromagnetic Technology and Electrostimulation']","['Pelvic Floor Muscles and Urinary Incontinence', 'urine leakage', 'Levator-urethra gap, anteroposterior diameter, laterolateral diameter of levator hiatus, and hiatal area', 'pelvic floor integrity', 'pelvic floor posttreatment (decreased anteroposterior diameter, laterolateral diameter, and hiatal area', 'Pelvic Floor Disability Index 20 questionnaire', ""Pelvic Floor Disability Index 20 questionnaire and subjective evaluation of patient's intimate health""]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C2729328', 'cui_str': 'Electromagnetic therapy'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0042037'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0699756', 'cui_str': 'Intimate (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",95.0,0.0330277,"Three-dimensional ultrasounds showed positive changes in dynamics of the pelvic floor posttreatment (decreased anteroposterior diameter, laterolateral diameter, and hiatal area).","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Silantyeva', 'Affiliation': 'From the Hospital Lapino MD Medical Group, Moscow, Russia.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Zarkovic', 'Affiliation': 'Charles University, Faculty of Physical Education and Sport, Department of Anatomy and Biomechanics, Prague, Czech Republic.'}, {'ForeName': 'Evgeniia', 'Initials': 'E', 'LastName': 'Astafeva', 'Affiliation': 'From the Hospital Lapino MD Medical Group, Moscow, Russia.'}, {'ForeName': 'Ramina', 'Initials': 'R', 'LastName': 'Soldatskaia', 'Affiliation': 'From the Hospital Lapino MD Medical Group, Moscow, Russia.'}, {'ForeName': 'Mekan', 'Initials': 'M', 'LastName': 'Orazov', 'Affiliation': 'RUDN University, Medical Faculty, Moscow, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Belkovskaya', 'Affiliation': 'From the Hospital Lapino MD Medical Group, Moscow, Russia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kurtser', 'Affiliation': 'From the Hospital Lapino MD Medical Group, Moscow, Russia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000807']
20,32438338,"A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living With HIV: Protocol for a Randomized Controlled Trial.","BACKGROUND


Adherence to HIV care is complex, as barriers to care are multidimensional, particularly for ethnic minority women. Mobile health (mHealth) solutions are supportive in improving HIV health care outcomes. In the United States, however, mHealth interventions are not widely implemented in public HIV clinics and have not been customized for women. There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV.
OBJECTIVE


This study aims to describe a protocol investigating the feasibility of an mHealth intervention for treatment adherence among women living with HIV. This is a two-phase, mixed methods, pilot randomized controlled trial that begins with qualitative patient interviews to inform the system design. Participants will be block randomized by language (English, Spanish, and Haitian Creole) to 1 of 2 study arms.
METHODS


Women (age ≥18 years) who were followed up at the women's HIV clinic of an academic medical center, with a recent history of nonadherence to HIV care (missed appointments, unsuppressed viral load, or not taking medications as prescribed), will be enrolled. The experimental arm will receive the intervention, which includes health reminders and psychoeducational messaging, plus clinical standard of care reminders. The psychoeducational messaging will target patient-level barriers of HIV stigma and medical mistrust and resilience as a patient-level strength. The control arm will receive standard of care reminders only (ie, mailed appointments and automated telephone calls). All aspects of the study and intervention will be offered in the participants' preferred language. The primary outcome is the feasibility and acceptability of the study. The secondary outcomes are changes in self-reported medication adherence, depression symptoms, HIV stigma, medical mistrust, resilience, and clinic attendance and viral suppression extracted from the participants' medical records. Data will be assessed at baseline (T0) and 2 subsequent clinic visits-approximately 3 to 4 months from the baseline (time 1; T1) and 6 to 9 months from the baseline (time 2; T2). Qualitative data will be transcribed and analyzed iteratively. Bivariate analyses will compare data by the study group (chi-square, odds ratios, and t tests). Exploratory analyses will be conducted for each outcome variable-T1 and T2 values will be compared with values at T0 by the study group.
RESULTS


As of March 2020, baseline quantitative data were collected on 54 participants (28 English speakers, 14 Spanish speakers, and 12 Haitian Creole speakers). The first 3 focus groups (1 in each of the 3 languages) were completed, with a total of 20 participants. The findings are currently being integrated into the beta version of the mHealth texting system.
CONCLUSIONS


The findings of this novel HIV adherence intervention may shed light on the barriers and facilitators of HIV health care and the mechanisms of an mHealth intervention that is customized for ethnic minority women living with HIV.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03738410; https://clinicaltrials.gov/ct2/show/NCT03738410.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17656.",2020,"There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV (WLWH).
","['54 participants (28 English speakers, 14 Spanish speakers, and 12 Haitian Creole speakers', 'minority women living with HIV (WLWH', 'ethnic minority women', ""Women (aged ≥18 years) followed up at the women's HIV clinic of an academic medical center, with a recent history of nonadherence to HIV care (missed appointments, unsuppressed viral load, or not taking medications as prescribed) will be enrolled"", 'Women Living With HIV']","['Mobile health (mHealth) solutions', 'health reminders and psychoeducational messaging, plus clinic standard of care reminders']","['feasibility and acceptability', ""changes in self-reported medication adherence, depressive symptoms, HIV stigma, medical mistrust, resilience, and clinic attendance and viral suppression extracted from the participants' medical records""]","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}]",54.0,0.132302,"There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV (WLWH).
","[{'ForeName': 'Lunthita M', 'Initials': 'LM', 'LastName': 'Duthely', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Services, Miller School of Medicine, University of Miami, Miami, FL, United States.'}, {'ForeName': 'Alex P', 'Initials': 'AP', 'LastName': 'Sanchez-Covarrubias', 'Affiliation': 'Miami Clinical and Translational Sciences Institute, Miller School of Medicine, University of Miami, Miami, FL, United States.'}, {'ForeName': 'Adhar B', 'Initials': 'AB', 'LastName': 'Mohamed', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Services, Miller School of Medicine, University of Miami, Miami, FL, United States.'}, {'ForeName': 'JoNell E', 'Initials': 'JE', 'LastName': 'Potter', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Services, Miller School of Medicine, University of Miami, Miami, FL, United States.'}]",JMIR research protocols,['10.2196/17656']
21,31591263,Absolute Quantification of Apolipoproteins Following Treatment with Omega-3 Carboxylic Acids and Fenofibrate Using a High Precision Stable Isotope-labeled Recombinant Protein Fragments Based SRM Assay.,"Stable isotope-labeled standard (SIS) peptides are used as internal standards in targeted proteomics to provide robust protein quantification, which is required in clinical settings. However, SIS peptides are typically added post trypsin digestion and, as the digestion efficiency can vary significantly between peptides within a protein, the accuracy and precision of the assay may be compromised. These drawbacks can be remedied by a new class of internal standards introduced by the Human Protein Atlas project, which are based on SIS recombinant protein fragments called SIS PrESTs. SIS PrESTs are added initially to the sample and SIS peptides are released on trypsin digestion. The SIS PrEST technology is promising for absolute quantification of protein biomarkers but has not previously been evaluated in a clinical setting. An automated and scalable solid phase extraction workflow for desalting and enrichment of plasma digests was established enabling simultaneous preparation of up to 96 samples. Robust high-precision quantification of 13 apolipoproteins was achieved using a novel multiplex SIS PrEST-based LC-SRM/MS Tier 2 assay in non-depleted human plasma. The assay exhibited inter-day coefficients of variation between 1.5% and 14.5% (median = 3.5%) and was subsequently used to investigate the effects of omega-3 carboxylic acids (OM3-CA) and fenofibrate on these 13 apolipoproteins in human plasma samples from a randomized placebo-controlled trial, EFFECT I (NCT02354976). No significant changes were observed in the OM3-CA arm, whereas treatment with fenofibrate significantly increased apoAII and reduced apoB, apoCI, apoE and apoCIV levels. The reduction in apoCIV following fenofibrate treatment is a novel finding. The study demonstrates that SIS PrESTs can facilitate the generation of robust multiplexed biomarker Tier 2 assays for absolute quantification of proteins in clinical studies.",2019,"No significant changes were observed in the OM3-CA arm, while treatment with fenofibrate significantly increased apoAII and reduced apoB, apoCI, apoE and apoCIV levels.",[],"['OM3-CA', 'Omega-3 Carboxylic Acids and Fenofibrate', 'Stable isotope-labeled standard (SIS) peptides', 'fenofibrate', 'omega-3 carboxylic acids (OM3-CA) and fenofibrate']","['apoAII and reduced apoB, apoCI, apoE and apoCIV levels']",[],"[{'cui': 'C3832882', 'cui_str': 'Omega-3 carboxylic acids'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope (substance)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}]","[{'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0003595', 'cui_str': 'Apo-E'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.013594,"No significant changes were observed in the OM3-CA arm, while treatment with fenofibrate significantly increased apoAII and reduced apoB, apoCI, apoE and apoCIV levels.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hober', 'Affiliation': 'Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden; Department of Protein Science, KTH - Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Edfors', 'Affiliation': 'Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden; Department of Protein Science, KTH - Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ryaboshapkina', 'Affiliation': 'Translational Science, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Malmqvist', 'Affiliation': 'Translational Science, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Rosengren', 'Affiliation': 'Translational Science, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Percy', 'Affiliation': 'Department of Applications Development, Cambridge Isotope Laboratories, Inc., Tewksbury, MA 01876.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lind', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Forsström', 'Affiliation': 'Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden; Department of Protein Science, KTH - Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Uhlén', 'Affiliation': 'Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden; Department of Protein Science, KTH - Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'Global Medicines Development, Cardiovascular, Renal and Metabolism, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Tasso', 'Initials': 'T', 'LastName': 'Miliotis', 'Affiliation': 'Translational Science, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden. Electronic address: Tasso.Miliotis@astrazeneca.com.'}]",Molecular & cellular proteomics : MCP,['10.1074/mcp.RA119.001765']
22,31520741,Interim monitoring in a treatment strategy trial with a composite primary endpoint.,"When a clinical trial has a composite endpoint and a comparison of treatment strategies with multiple intervention components, interim data reviews by a data safety and monitoring board (DSMB) can be challenging as the data evolve on multiple fronts. We illustrate with a study in the treatment of Kaposi sarcoma (KS), an HIV-associated cancer with a multi-faceted disease presentation. The study, ACTG-A5264/AMC-067, was a 1:1 randomized trial to compare two strategies: immediate initiation of etoposide with antiretroviral therapy (ART), or ART with delayed etoposide upon disease progression. The outcome was a composite endpoint that included the following events, ordered from worst to best in the following three categories: (1) KS progression at 48 weeks, death, initiation of alternate KS treatment, loss to study follow-up; (2) stable KS; and (3) partial or complete KS response at 48 weeks. We present the interim results on the composite endpoint and the individual components, where components favored different study arms at an interim review. To facilitate interim data monitoring for complex trials, we recommend clear communications between the study team and the DSMB prior to the initiation of the trial on the need for a composite endpoint, the intentions behind the defined strategies, and relative importance of individual components of the composite endpoint. We also recommend flexibility in the timing of data reviews by the DSMB to interpret emerging data in multiple dimensions. Clinicaltrials.govNCT01352117.",2019,"To facilitate interim data monitoring for complex trials, we recommend clear communications between the study team and the DSMB prior to the initiation of the trial on the need for a composite endpoint, the intentions behind the defined strategies, and relative importance of individual components of the composite endpoint.","['Kaposi sarcoma (KS), an HIV-associated cancer with a multi-faceted disease presentation']","['etoposide with antiretroviral therapy (ART), or ART with delayed etoposide']","['KS progression at 48\u202fweeks, death, initiation of alternate KS treatment, loss to study follow-up; (2) stable KS; and (3) partial or complete KS response']","[{'cui': 'C0036220', 'cui_str': 'Kaposi Sarcoma'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}]","[{'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.0430354,"To facilitate interim data monitoring for complex trials, we recommend clear communications between the study team and the DSMB prior to the initiation of the trial on the need for a composite endpoint, the intentions behind the defined strategies, and relative importance of individual components of the composite endpoint.","[{'ForeName': 'Minhee', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA. Electronic address: mkang@hsph.harvard.edu.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Grund', 'Affiliation': 'School of Statistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': 'Biostatistics Research Branch, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Glidden', 'Affiliation': 'School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Volberding', 'Affiliation': 'School of Medicine, University of California, San Francisco, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105846']
23,32431208,Effects of Morning Versus Evening Home-Based Exercise on Subjective and Objective Sleep Parameters in Older Adults: A Randomized Controlled Trial.,"OBJECTIVE


This study aimed to determine whether the timing of exercise influenced the effects of home-based low-intensity stepping exercises on the sleep parameters of older adults.
METHOD


For 8 weeks, 60 healthy older adults participated in a randomized controlled trial, performing low-intensity aerobic exercise (70-80 bpm) for about 30 minutes every day at home, either in the morning (from waking until 12:00) or evening (18:00 to bedtime).
RESULTS


In the evening exercise group, both subjectively and objectively measured sleep latency significantly improved throughout the intervention. Further, postintervention subjective sleep satisfaction was significantly higher in the evening group (6.2 ± 1.3 points) than in the morning group (5.2 ± 1.4 points;  P  = .006). Additionally, sleep variables related to evening exercise had larger effect sizes (Cohen  d ) than those performed in the morning.
CONCLUSION


Engaging in low-intensity stepping exercises during the evening is potentially a useful nonpharmacological approach to improving sleep quality among older adults.",2021,"Further, postintervention subjective sleep satisfaction was significantly higher in the evening group (6.2 ± 1.3 points) than in the morning group (5.2 ± 1.4 points;  P  = .006).","['60 healthy older adults', 'Older Adults', 'older adults']","['low-intensity aerobic exercise', 'Morning Versus Evening Home-Based Exercise', 'home-based low-intensity stepping exercises']","['Subjective and Objective Sleep Parameters', 'postintervention subjective sleep satisfaction', 'sleep quality', 'sleep latency']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}]",60.0,0.0826357,"Further, postintervention subjective sleep satisfaction was significantly higher in the evening group (6.2 ± 1.3 points) than in the morning group (5.2 ± 1.4 points;  P  = .006).","[{'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Seol', 'Affiliation': 'Doctoral Program in Physical Education, Health and Sport Sciences, 13121University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Fujii', 'Affiliation': 'Doctoral Program in Physical Education, Health and Sport Sciences, 13121University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Taiki', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': ""Master's Program in Physical Education, Health and Sport Sciences, 13121University of Tsukuba, Ibaraki, Japan.""}, {'ForeName': 'Naruki', 'Initials': 'N', 'LastName': 'Kitano', 'Affiliation': 'Physical Fitness Research Institute, 68376Meiji Yasuda Life Foundation of Health and Welfare, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tsunoda', 'Affiliation': 'Faculty of Social Welfare, 57951Yamaguchi Prefectural University, Yamaguchi, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Okura', 'Affiliation': 'Faculty of Health and Sport Sciences, 13121University of Tsukuba, Ibaraki, Japan.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988720924709']
24,30195949,The interplay between externalizing disorders polygenic risk scores and contextual factors on the development of marijuana use disorders.,"Externalizing disorders have been extensively linked to substance use problems. However, less is known about whether genetic factors underpinning externalizing disorders and environmental features interact to predict substance use disorders (i.e., marijuana abuse and dependence) among urban African Americans. We examined whether polygenic risk scores (PRS) for conduct disorder (CD) and attention-deficit hyperactivity disorder (ADHD) interacted with contextual factors (i.e., parental monitoring, community disadvantage) to influence risk for marijuana use disorders in a sample of African American youth. Participants (N=1,050; 44.2% male) were initially recruited for an elementary school-based universal prevention trial in a Mid-Atlantic city and followed through age 20. Participants reported on their parental monitoring in sixth grade and whether they were diagnosed with marijuana abuse or dependence at age 20. Blood or saliva samples were genotyped using the Affymetrix 6.0 microarrays. The CD and ADHD PRS were created based on genome-wide association studies conducted by Dick et al. (2010) and Demontis et al. (2017), respectively. Community disadvantage was calculated based on census data when participants were in sixth grade. There was an interaction between the CD PRS and community disadvantage such that a higher CD PRS was associated with greater risk for a marijuana use disorder at higher levels of neighborhood disadvantage. This finding should be interpreted with caution owing to the number of significance tests performed. Implications for etiological models and future research directions are presented.",2018,There was an interaction between the CD PRS and community disadvantage such that a higher CD PRS was associated with greater risk for a marijuana use disorder at higher levels of neighborhood disadvantage.,"['African American youth', 'Participants reported on their parental monitoring in sixth grade and whether they were diagnosed with marijuana abuse or dependence at age 20', 'Participants (N=1,050; 44.2% male) were initially recruited for an elementary school-based universal prevention trial in a Mid-Atlantic city and followed through age 20', 'urban African Americans']",[],"['polygenic risk scores (PRS', 'Blood or saliva samples']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0024809', 'cui_str': 'Marijuana Abuse'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",,0.0302031,There was an interaction between the CD PRS and community disadvantage such that a higher CD PRS was associated with greater risk for a marijuana use disorder at higher levels of neighborhood disadvantage.,"[{'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Rabinowitz', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, 624 N. Broadway, Baltimore, MD 21205, United States. Electronic address: Jrabino3@jhu.edu.'}, {'ForeName': 'Rashelle J', 'Initials': 'RJ', 'LastName': 'Musci', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, 624 N. Broadway, Baltimore, MD 21205, United States.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Milam', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, 624 N. Broadway, Baltimore, MD 21205, United States.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Benke', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, 624 N. Broadway, Baltimore, MD 21205, United States.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Uhl', 'Affiliation': 'New Mexico VA Healthcare System, 1501 San Pedro Drive, SE, Albuquerque, NM, 87108 United States.'}, {'ForeName': 'Danielle Y', 'Initials': 'DY', 'LastName': 'Sisto', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, 624 N. Broadway, Baltimore, MD 21205, United States.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Ialongo', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, 624 N. Broadway, Baltimore, MD 21205, United States.'}, {'ForeName': 'Brion S', 'Initials': 'BS', 'LastName': 'Maher', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, 624 N. Broadway, Baltimore, MD 21205, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2018.07.016']
25,25354350,"The theory, development, and implementation of an e-intervention to prevent excessive gestational weight gain: e-Moms Roc.","BACKGROUND


Gaining more weight during pregnancy than is recommended by the Institute of Medicine is prevalent and contributes to the development of obesity in women. This article describes the development and use of e-Moms of Rochester (e-Moms Roc), an electronic intervention (e-intervention), to address this health issue in a socioeconomically diverse sample of pregnant women.
MATERIALS AND METHODS


Formative research in the form of intercept interviews, in-depth interviews, and focus groups was conducted to inform the design of the e-intervention. The Web site continuously tracked each participant's use of e-intervention features.
RESULTS


An e-intervention, including Web site and mobile phone components, was developed and implemented in a randomized control trial. Formative research informed the design. Participants in all arms accessed blogs, local resources, articles, frequently asked questions, and events. Participants in the intervention arms also accessed the weight gain tracker and diet and physical activity goal-setting tools. Overall, 80% of women logged into the Web site and used a tool or feature at least twice. Among those in the intervention arm, 70% used the weight gain tracker, but only 40% used the diet and physical activity goal-setting tools.
CONCLUSIONS


To maximize and sustain potential usage of e-Moms Roc over time, the e-intervention included customized reminders, tailored content, and community features such as blogs and resources. Usage was comparable to those in other weight studies with young adults and higher than reported in a published study with pregnant women. This e-intervention specifically designed for pregnant women was used by the majority of women.",2014,"To maximize and sustain potential usage of e-Moms Roc over time, the e-intervention included customized reminders, tailored content, and community features such as blogs and resources.","['socioeconomically diverse sample of pregnant women', 'pregnant women was used by the majority of women']",['electronic intervention (e-intervention'],"['weight gain tracker', 'weight gain tracker and diet and physical activity goal-setting tools']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",,0.0394633,"To maximize and sustain potential usage of e-Moms Roc over time, the e-intervention included customized reminders, tailored content, and community features such as blogs and resources.","[{'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Graham', 'Affiliation': '1 Division of Nutritional Sciences, Cornell University , Ithaca, New York.'}, {'ForeName': 'Keriann H', 'Initials': 'KH', 'LastName': 'Uesugi', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Niederdeppe', 'Affiliation': ''}, {'ForeName': 'Geri K', 'Initials': 'GK', 'LastName': 'Gay', 'Affiliation': ''}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Olson', 'Affiliation': ''}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2013.0354']
26,32139204,A randomized controlled trial of adding intravenous corticosteroids to H1 antihistamines in patients with acute urticaria.,"BACKGROUND


Acute urticaria is a common dermatological condition in emergency departments (EDs). The main therapy involves controlling pruritus with antihistamines. Although guidelines have promoted the use of corticosteroids in addition to H1 antihistamines, well-designed clinical trials evaluating this approach are scarce.
METHODS


Adult ED patients with acute urticaria and a pruritus score > 5 on a visual analog scale (VAS) were randomized into three groups: (i) IV chlorpheniramine (CPM) treatment, (ii) IV CPM and IV dexamethasone (CPM/Dex) and (iii) IV CPM and IV dexamethasone with oral prednisolone as discharge medication for 5 days (CPM/Dex/Pred). The primary outcomes were self-reported pruritus VAS scores at 60 min after treatment. We also evaluated 1-week and 1-month urticaria activity scores for 7 days and adverse events.
RESULTS


Seventy-five patients (25 per group) were enrolled. The VAS scores of all groups decreased, but no significant difference was found in the VAS scores at 60 min after treatment between patients in the CPM group (n = 25) and those who received both CPM and dexamethasone (n = 50). At the 1-week and 1-month follow-ups, active urticaria (indicated by the urticaria activity score at 7 days) was more prevalent in the CPM/Dex/Pred group (n = 25) than in the control group.
CONCLUSIONS


The present study did not find evidence that adding IV dexamethasone improves the treatment of severe pruritus from uncomplicated acute urticaria. Oral corticosteroid therapy may be associated with persistent urticaria activity. Due to the lack of clinical benefits and the potential for side effects, using corticosteroids as an adjunctive treatment is discouraged.",2021,"The VAS scores of all groups decreased, but no significant difference was found in the VAS scores at 60 min after treatment between patients in the CPM group (n = 25) and those who received both CPM and dexamethasone (n = 50).","['Seventy-five patients (25 per group) were enrolled', 'patients with acute urticaria', 'Adult ED patients with acute urticaria and a pruritus score\u202f>\u202f5 on a visual analog scale (VAS']","['antihistamines', 'dexamethasone', 'H1 antihistamines', 'Oral corticosteroid therapy', 'intravenous corticosteroids', 'chlorpheniramine (CPM) treatment, (ii) IV CPM and IV dexamethasone (CPM/Dex) and (iii) IV CPM and IV dexamethasone with oral prednisolone']","['VAS scores', 'severe pruritus', 'urticaria activity score', 'urticaria activity scores', 'self-reported pruritus VAS scores']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0234935', 'cui_str': 'Acute urticaria (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]","[{'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0008281', 'cui_str': 'Chlorpheniramine'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0042109', 'cui_str': 'Hives'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",75.0,0.0510462,"The VAS scores of all groups decreased, but no significant difference was found in the VAS scores at 60 min after treatment between patients in the CPM group (n = 25) and those who received both CPM and dexamethasone (n = 50).","[{'ForeName': 'Pakhawadee', 'Initials': 'P', 'LastName': 'Palungwachira', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok 10330, Thailand. Electronic address: pakhawadee.p@chula.ac.th.'}, {'ForeName': 'Ketsara', 'Initials': 'K', 'LastName': 'Vilaisri', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok 10330, Thailand.'}, {'ForeName': 'Khrongwong', 'Initials': 'K', 'LastName': 'Musikatavorn', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok 10330, Thailand. Electronic address: khrongwong.m@chulahospital.org.'}, {'ForeName': 'Jongkonnee', 'Initials': 'J', 'LastName': 'Wongpiyabovorn', 'Affiliation': 'Immunology Unit, Department of Microbiology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok 10330, Thailand. Electronic address: jongkonnee.w@chula.ac.th.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.02.025']
27,32576049,MENSTRUAL DISORDERS AND ANDROGEN-RELATED TRAITS IN YOUNG WOMEN WITH TYPE 1 DIABETES MELLITUS: A CLINICAL STUDY.,"Objective.  To investigate possible causes of menstrual disorders and androgen-related traits in young women with T1DM.  Patients and Methods.  Fifty-three women with T1DM (duration 8.0±5.6 years), 41 women with PCOS and 51 controls matched for age (19.4±4.3 vs. 21.2±2.7 vs. 20.8±3.1 years, p>0.05) and BMI (22.2±2.7 vs. 21.9±2.0 vs. 21.4±1.9 kg/m2, p>0.05) were prospectively recruited.  Results.  Two women (3.8%) in the T1DM group had not experienced menarche (at 15.5 and 16.6 years); of the rest, 23.5% had oligomenorrhea, 32.1% hirsutism, 45.3% acne. The age at menarche was delayed in the T1DM group compared to controls (12.7±1.3 vs. 12.0±1.0 years, p=0.004), while no difference was observed with the PCOS group (12.4±1.2 years). There were no differences in total testosterone (0.43±0.14 vs. 0.39±0.14 ng/ml, p>0.05), DHEA-S (269±112 vs. 238±106 μg/dl, p>0.05) or Δ4-androstenedione (2.4±1.3 vs. 1.9±0.5 ng/ml, p>0.05) concentrations between T1DM and controls. However, patients with T1DM had lower SHBG concentrations than controls (61±17 vs. 83±18.1 nmol/l, p=0.001), which were even lower in the PCOS group (39.5±12.9 nmol/, p=0.001 compared with T1DM). FAI (free androgen index) was higher in the PCOS group compared with both other groups (T1DM vs. PCOS vs. controls: 2.53±0.54 vs 7.88±1.21 vs. 1.6±0.68, p<0.001). FAI was higher in patients with T1DM compared to controls, too (p=0.038). There was no difference in DHEA-S concentrations between T1DM and PCOS patients (269±112 vs. 297±100 μg/dl, p>0.05).  Conclusions.  Menstrual disorders and androgen-related traits in young women with T1DM may be attributed to an increase in androgen bioavailability due to decreased SHBG concentrations.",2020,"FAI was higher in patients with T1DM compared to controls, too (p=0.038).","['TRAITS IN YOUNG WOMEN WITH TYPE 1 DIABETES MELLITUS', 'Fifty-three women with T1DM (duration 8.0±5.6 years), 41 women with PCOS and 51 controls matched for age (19.4±4.3 vs. 21.2±2.7 vs. 20.8±3.1 years, p>0.05) and BMI (22.2±2.7 vs. 21.9±2.0 vs. 21.4±1.9 kg/m2, p>0.05) were prospectively recruited', 'young women with T1DM']",[],"['lower SHBG concentrations', 'FAI (free androgen index', 'total testosterone', 'DHEA-S concentrations', 'FAI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0057277', 'cui_str': 'Dehydroepiandrosterone sulfate'}]",53.0,0.0903609,"FAI was higher in patients with T1DM compared to controls, too (p=0.038).","[{'ForeName': 'Stavroula A', 'Initials': 'SA', 'LastName': 'Paschou', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Andromachi', 'Initials': 'A', 'LastName': 'Vryonidou', 'Affiliation': 'Department of Diabetes and Endocrinology, Hellenic Red Cross Hospital, Athens, Greece.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Melissourgou', 'Affiliation': 'Department of Diabetes and Endocrinology, Hellenic Red Cross Hospital, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosteria', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios G', 'Initials': 'DG', 'LastName': 'Goulis', 'Affiliation': 'Unit of Reproductive Endocrinology, First Department of Obstetrics and Gynecology, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Chrousos', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kanaka-Gantenbein', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2020-0153']
28,32569102,Effects of Massage on Post-Operative Pain in Infants with Complex Congenital Heart Disease.,"BACKGROUND


Pain management is an essential component of care for pediatric patients following surgery. Massage reduces self-reported post-operative pain in adults with heart disease but has received little attention in post-operative pediatric patients with congenital heart disease (CCHD).
OBJECTIVES


To evaluate the effectiveness of massage compared to a rest period on post-operative pain scores and physiologic responses in infants with CCHD.
METHODS


We used a two-group randomized clinical trial design with a sample of 60 infants with CCHD between 1 day and 12 months of age following their first cardiothoracic surgery. Both groups received standard post-operative care. Group 1 received a daily 30-minute restriction of non-essential caregiving (Quiet Time), and Group 2 received a daily 30-minute massage. Interventions continued for seven consecutive days. Pain was measured 6 times daily using the Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC). Average daily doses of analgesics were recorded. Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2) were recorded continuously. Daily averages and pre- and post- intervention FLACC scores and physiologic responses were analyzed using descriptive statistics, GLMM repeated measures, latent growth models, and/or regression discontinuity analysis. Fentanyl-equivalent narcotic values were used as a time-varying covariate.
RESULTS


Adjusted pain scores were lower for the massage group on all days except day 7. Overall there were no group effects on level of pain or differential rate of change in pain. However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR. There was little difference between groups in SpO2. Infants demonstrated immediate effects of massage, with HR and RR decreasing and oxygen saturations increasing.
DISCUSSION


This study provides beginning evidence that post-operative massage may reduce pain and improve physiologic parameters in infants with congenital heart disease. This non-pharmacological adjunct to pain management may provide a particular benefit for this population by reducing demand on the cardiorespiratory system.",2020,"However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR.","['infants with CCHD', 'adults with heart disease', 'pediatric patients with congenital heart disease (CCHD', 'infants with congenital heart disease', 'pediatric patients following surgery', '60 infants with CCHD between 1 day and 12 months of age following their first cardiothoracic surgery', 'Infants with Complex Congenital Heart Disease']","['standard post-operative care', 'daily 30-minute restriction of non-essential caregiving (Quiet Time), and Group 2 received a daily 30-minute massage', 'Fentanyl-equivalent narcotic values', 'Massage']","['Daily averages and pre- and post- intervention FLACC scores and physiologic responses', 'Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2', 'Pain', 'Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC', 'immediate effects of massage, with HR and RR decreasing and oxygen saturations increasing', 'daily pain scores', 'Adjusted pain scores', 'level of pain or differential rate of change in pain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration'}, {'cui': 'C0852710', 'cui_str': 'Oxygen saturation increased'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",60.0,0.174636,"However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR.","[{'ForeName': 'Tondi M', 'Initials': 'TM', 'LastName': 'Harrison', 'Affiliation': ""The Ohio State University College of Nursing, Columbus, Ohio University of Wisconsin-Madison School of Nursing, Madison, Wisconsin Nationwide Children's Hospital, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio COPC Ohio Center for Pediatrics, Dublin, Ohio The Ohio State University College of Nursing, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Duffey', 'Affiliation': ''}, {'ForeName': 'Corrie', 'Initials': 'C', 'LastName': 'Frey', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'Marliese Dion', 'Initials': 'MD', 'LastName': 'Nist', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Renner', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Fitch', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000459']
29,32542068,Improving Language Comprehension to Enhance Word-Problem Solving.,"The focus of this article is the role of language comprehension within word-problem solving (WPS). The role of the language comprehension in WPS is explained, and an overview of research illustrating language comprehension's contribution to WPS is described. Next, an innovative intervention that embeds WP-specific language comprehension instruction within a validated form of schema-based WP intervention is described, and the methods and results of a randomized controlled trial assessing the added value of embedding WP-specific language comprehension instruction are outlined. Implications for practice and future research are drawn.",2020,"Next, an innovative intervention that embeds WP-specific language comprehension instruction within a validated form of schema-based WP intervention is described, and the methods and results of a randomized controlled trial assessing the added value of embedding WP-specific language comprehension instruction are outlined.",[],['language comprehension within word-problem solving (WPS'],[],[],"[{'cui': 'C0233733', 'cui_str': 'Language comprehension'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}]",[],,0.0258129,"Next, an innovative intervention that embeds WP-specific language comprehension instruction within a validated form of schema-based WP intervention is described, and the methods and results of a randomized controlled trial assessing the added value of embedding WP-specific language comprehension instruction are outlined.","[{'ForeName': 'Lynn S', 'Initials': 'LS', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Seethaler', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Craddock', 'Affiliation': 'Vanderbilt University.'}]",Reading & writing quarterly : overcoming learning difficulties,[]
30,32542879,The Adjunctive Effect of Intravenous Magnesium Sulfate in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Clinical Trial.,,2021,It relaxes bronchial smooth muscles through its calcium channel blocking properties and inhibitory effects on the release of acetylcholine from neuromuscular junctions.,"['Chronic Obstructive Pulmonary Disease (COPD', 'Acute Exacerbation of COPD']","['Magnesium', 'Intravenous Magnesium Sulfate', 'Intravenous (IV) magnesium sulfate (MgS04']",['Acute exacerbation of COPD (AECOPD'],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]",,0.0879475,It relaxes bronchial smooth muscles through its calcium channel blocking properties and inhibitory effects on the release of acetylcholine from neuromuscular junctions.,"[{'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Vafadar Moradi', 'Affiliation': 'From the, Faculty of Medicine, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Pishbin', 'Affiliation': 'From the, Faculty of Medicine, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Habibzadeh', 'Affiliation': 'From the, Faculty of Medicine, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Talebi Doluee', 'Affiliation': 'From the, Faculty of Medicine, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Soltanifar', 'Affiliation': 'and the, Faculty of Medicine, Tehran University of Medical Sciences, Tahran, Iran.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14050']
31,32584168,"The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study. A Randomized, Double-Blind, Multicenter Clinical Trial.","Rationale:  In the IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial, fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) significantly reduced exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations. Objectives:  To understand whether inhaled corticosteroid (ICS) withdrawal affected IMPACT results, given direct transition from prior maintenance medication to study medication at randomization. Methods:  Exacerbations and change from baseline in trough FEV 1  and St. George's Respiratory Questionnaire results were analyzed by prior ICS use. Exacerbations were also analyzed while excluding data from the first 30 days. Measurements and Main Results:  FF/UMEC/VI significantly reduced the annual moderate/severe exacerbation rate compared with UMEC/VI in prior ICS users (29% reduction;  P  < 0.001), but only a numerical reduction was seen among prior ICS nonusers (12% reduction;  P  = 0.115). To minimize impact from ICS withdrawal, in an analysis excluding the first 30 days, FF/UMEC/VI continued to significantly reduce the annual on-treatment moderate/severe exacerbation rate (19%;  P  < 0.001) compared with UMEC/VI. The benefit of FF/UMEC/VI compared with UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users, 35% reduction;  P  < 0.001; non-ICS users, 35% reduction;  P  = 0.018), and overall when excluding the first 30 days (29%;  P  < 0.001). Improvements from baseline with FF/UMEC/VI compared with UMEC/VI were also maintained throughout the study for both trough FEV 1  and St. George's Respiratory Questionnaire, regardless of prior ICS use. Conclusions:  These data support the important treatment effects of FF/UMEC/VI combination therapy on exacerbation reduction, lung function, and quality of life that do not appear to be related to abrupt ICS withdrawal.Clinical trial registered with www.clinicaltrials.gov (NCT02164513).",2020,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).",['patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations'],"['inhaled corticosteroid (ICS', 'FF/UMEC/VI versus UMEC', 'fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI', 'ICS Withdrawal and Baseline Inhaled Treatment']","['severe exacerbation rates', ""trough forced expiratory volume in 1 second (FEV 1 ) and St George's Respiratory Questionnaire (SGRQ"", 'annual moderate/severe exacerbation rate', 'exacerbation reduction, lung function and quality of life', 'severe exacerbation rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.74081,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).","[{'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'Development, Research and Development, and.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Medical Department, Pulmonary Section, Herlev-Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Global Medical Affairs, GlaxoSmithKline, Brentford, Middlesex, United Kingdom.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom; and.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201912-2478OC']
32,32259588,Rationale and design of a randomized study comparing Motivational Interviewing to Support Oral Anticoagulation adherence versus usual care in patients with nonvalvular atrial fibrillation: The MISOAC-AF trial.,,2020,,['patients with non-valvular Atrial Fibrillation'],['Motivational Interviewing to Support Oral AntiCoagulation adherence versus usual care'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",[],,0.0232585,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Samaras', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kartas', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Vasdeki', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dividis', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Forozidou', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fotos', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kotsi', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Paschou', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Tsoukra', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Goulas', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Karvounis', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Giannakoulas', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tzikas', 'Affiliation': 'First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece; Interbalkan European Medical Center, Asklipiou 10, Pylaia, Thessaloniki, Greece. Electronic address: aptzikas@yahoo.com.'}]",Hellenic journal of cardiology : HJC = Hellenike kardiologike epitheorese,['10.1016/j.hjc.2020.02.007']
33,32576042,SHORT-TERM VERSUS 6-WEEK PREDNISONE IN THE TREATMENT OF SUBACUTE THYROIDITIS: A RANDOMIZED CONTROLLED TRIAL.,"Objective : Moderate-to-severe subacute thyroiditis is clinically managed with 6-8 weeks of glucocorticoid therapy. However, no studies have evaluated short-term prednisone treatment for subacute thyroiditis.  Methods : This 24-week, prospective, single-blind, randomized controlled study enrolled patients (aged 18-70) with subacute thyroiditis who were hospitalized between August 2013 and December 2014. Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mg/d prednisone for 1 week, followed by 1 week of nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy. The primary endpoint was intergroup differences in treatment efficacy at the end of treatment course. Secondary endpoints included between-group differences in post-withdrawal adverse effect parameters and thyroid function at weeks 6, 12, and 24.  Results : We screened 96 patients, randomized 52 participants, and 50 completed the study. Efficacy and recurrence rates were not significantly different at withdrawal in both groups ( P=0.65 ). At treatment discontinuation, parathyroid hormone (28.8 vs 38.9 pg/mL,  p=0.011 ) and systolic blood pressure (113.9 vs 122.4 mmHg,  p=0.023 ) were significantly lower in the experimental group than in the control group. There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24.  Conclusions : Fewer side effects of glucocorticoids and similar efficacy and recurrence rates were observed with short-term prednisone compared with in the 6-week treatment for subacute thyroiditis. Short-term prednisone with a better safety profile may be an alternative strategy for ameliorating moderate-to-severe symptoms of subacute thyroiditis.",2020,"There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24.  ","['Patients with moderate-to-severe symptoms', '96 patients, randomized 52 participants, and 50 completed the study', 'enrolled patients (aged 18-70) with subacute thyroiditis who were hospitalized between August 2013 and December 2014']","['30 mg/d prednisone', 'prednisone', 'nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy', 'glucocorticoid therapy', 'glucocorticoids']","['Efficacy and recurrence rates', 'treatment efficacy', 'post-withdrawal adverse effect parameters and thyroid function', 'systolic blood pressure', 'efficacy and recurrence rates', 'parathyroid hormone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040149', 'cui_str': 'Subacute thyroiditis'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}]",52.0,0.0775229,"There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24.  ","[{'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Duan', 'Affiliation': 'From: Department of Endocrinology, The Third Affiliated Hospital of Chongqing Medical University (Jie er Hospital), Chongqing, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Rufei', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Hongting', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2020-0096']
34,32564058,Pregnancy outcomes of women conceiving on antiretroviral therapy (ART) compared to those commenced on ART during pregnancy.,"BACKGROUND


Globally, the number of HIV-infected women of child-bearing age conceiving on ART is increasing. Evidence of ART safety at conception and during pregnancy and adverse pregnancy outcomes remains conflicting. The PROMISE 1077 breastfeeding (BF) and formula feeding (FF) international multisite trials provide an opportunity to examine the impact of ART at conception on pregnancy outcomes with subsequent pregnancies.
METHODS


The PROMISE 1077BF/1077FF trials were designed to address key questions in the management of HIV-infected women who did not meet clinical guidelines for ART treatment during the time of the trials. After the period of risk of mother-to-child transmission was over, women were randomized to either continue or discontinue ART. We compared subsequent pregnancy outcomes of non-breastfeeding women randomized to continue ART following delivery, or breastfeeding women randomized to continue ART following breastfeeding cessation who conceived while on ART to women randomized to discontinue ART, who re-started ART after pregnancy was diagnosed.
RESULTS


Pregnancy outcomes of 939 subsequent pregnancies of 826 mothers were recorded. The intention-to-treat analyses showed increased incidence of low birth weight (<2500gm) for women who conceived while on ART {relative risk 2.65 (95% CI 1.20, 5.81)}, and also a higher risk of spontaneous abortion, stillbirth, or neonatal death {hazard ratio 1.40 (0.99, 1.98)} compared to women who re-started ART after they were found to be pregnant during trial follow up.
CONCLUSIONS


We found an increased risk for adverse pregnancy outcomes in women conceiving on ART emphasising the need for improved obstetric and neonatal care for this group.",2020,"The intention-to-treat analyses showed increased incidence of low birth weight (<2500gm) for women who conceived while on ART {relative risk 2.65 (95% CI 1.20, 5.81)}, and also a higher risk of spontaneous abortion, stillbirth, or neonatal death {hazard ratio 1.40 (0.99, 1.98)} compared to women who re-started ART after they were found to be pregnant during trial follow up.
",['939 subsequent pregnancies of 826 mothers'],"['discontinue ART', 'women conceiving on antiretroviral therapy (ART']","['incidence of low birth weight', 'risk of spontaneous abortion, stillbirth, or neonatal death {hazard ratio']","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",826.0,0.235655,"The intention-to-treat analyses showed increased incidence of low birth weight (<2500gm) for women who conceived while on ART {relative risk 2.65 (95% CI 1.20, 5.81)}, and also a higher risk of spontaneous abortion, stillbirth, or neonatal death {hazard ratio 1.40 (0.99, 1.98)} compared to women who re-started ART after they were found to be pregnant during trial follow up.
","[{'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'Department of Obstetrics and Gynaecology, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Brummel', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Pinilla', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'McCarthy', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Maxensia', 'Initials': 'M', 'LastName': 'Owor', 'Affiliation': 'MUJHU Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Lameck', 'Initials': 'L', 'LastName': 'Chinula', 'Affiliation': 'UNC Project-Malawi CRS; University of North Carolina at Chapel Hill, Department of Obstetrics and Gynaecology, Division of Global Women Health, Lilongwe, Malawi.'}, {'ForeName': 'Bonus', 'Initials': 'B', 'LastName': 'Makanani', 'Affiliation': 'College of Medicine-Johns Hopkins Research Project, Blantyre, Malawi.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Centre for AIDS Research in South Africa and Department of Obstetrics and Gynecology, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Browning', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases , David Geffer School of Medicine at the University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Johns Hopkins University, Department of Pathology, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa805']
35,32449152,Long-term effectiveness of web-based cognitive behavioral therapy for patients with eating disorders.,"PURPOSE


To evaluate the long-term effectiveness of a web-based therapist-delivered cognitive behavioral therapy (CBT) for patients with eating disorders (ED).
METHODS


We used follow-up data from a randomized controlled trial that evaluated a web-based CBT on ED psychopathology and related health, compared to a waiting list control (WL) condition. As participants of the WL condition started the intervention after their waiting period, follow-up data included participants from both groups. The primary outcome was change from baseline, at 3, 6, and 12-month intervals in ED psychopathology, analyzed using mixed models for repeated measures. Secondary outcomes included body dissatisfaction, BMI, physical health, mental health, self-esteem, quality of life, and social functioning.
RESULTS


The population comprised 212 participants in total, in three subgroups: bulimia nervosa (BN; n = 44), binge eating disorder (BED; n = 83), and ED not otherwise specified (EDNOS; n = 85). Treatment effects were sustained during follow-up, with generally large effect sizes for the reduction of ED psychopathology and body dissatisfaction, and small to moderate effect sizes for physical and mental health, self-esteem, social functioning, and quality of life. Most effects were found for all three subgroups, except for long-term improvements in self-esteem and quality of life among participants with BN and EDNOS.
CONCLUSION


This study showed long-term sustainability of treatment effects up to 1-year post-treatment of a web-based therapist-delivered CBT for patients with various ED.
LEVEL OF EVIDENCE


Level IV, evidence obtained from multiple time series analysis, with intervention.
UNIQUE CLINICAL TRIAL NUMBER


NTR2415-Dutch Trial Registry ( http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2415 ).",2021,"Treatment effects were sustained during follow-up, with generally large effect sizes for the reduction of ED psychopathology and body dissatisfaction, and small to moderate effect sizes for physical and mental health, self-esteem, social functioning, and quality of life.","['patients with eating disorders', 'patients with various ED', '212 participants in total, in three subgroups: bulimia nervosa (BN; n\u2009=\u200944), binge eating disorder (BED; n\u2009=\u200983), and ED not otherwise specified (EDNOS; n\u2009=\u200985', 'patients with eating disorders (ED']","['web-based cognitive behavioral therapy', 'web-based therapist-delivered cognitive behavioral therapy (CBT']","['self-esteem and quality of life', 'body dissatisfaction, BMI, physical health, mental health, self-esteem, quality of life, and social functioning', 'ED psychopathology and body dissatisfaction, and small to moderate effect sizes for physical and mental health, self-esteem, social functioning, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2267227', 'cui_str': 'Bulimia nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.123607,"Treatment effects were sustained during follow-up, with generally large effect sizes for the reduction of ED psychopathology and body dissatisfaction, and small to moderate effect sizes for physical and mental health, self-esteem, social functioning, and quality of life.","[{'ForeName': 'Elke D', 'Initials': 'ED', 'LastName': 'Ter Huurne', 'Affiliation': 'Tactus Addiction Treatment, Enschede, The Netherlands. e.terhuurne@gmail.com.'}, {'ForeName': 'Hein A', 'Initials': 'HA', 'LastName': 'de Haan', 'Affiliation': 'Tactus Addiction Treatment, Enschede, The Netherlands.'}, {'ForeName': 'Marloes G', 'Initials': 'MG', 'LastName': 'Postel', 'Affiliation': 'Tactus Addiction Treatment, Enschede, The Netherlands.'}, {'ForeName': 'Cor A J', 'Initials': 'CAJ', 'LastName': 'DeJong', 'Affiliation': 'Nijmegen Institute for Scientist-Practitioners in Addiction, Nijmegen, The Netherlands.'}, {'ForeName': 'Joanne E L', 'Initials': 'JEL', 'LastName': 'VanDerNagel', 'Affiliation': 'Tactus Addiction Treatment, Enschede, The Netherlands.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Medical School Twente, Medisch Spectrum Twente, Enschede, The Netherlands.'}]",Eating and weight disorders : EWD,['10.1007/s40519-020-00929-0']
36,32445975,Wii training versus non-Wii task-specific training on motor learning in children with developmental coordination disorder: A randomized controlled trial.,"BACKGROUND


Wii-based interventions have shown significant benefits in motor learning for children with developmental coordination disorder (DCD); however, studies comparing the effects of Wii interventions versus matched non-Wii interventions, such as task-specific training (TST), are scarce.
OBJECTIVE


We compared motor learning in children with DCD who participated in 12 sessions of Wii-based training and those participating in 12 closely matched non-Wii TST sessions as well as when the highest improvements in performance occurred.
METHODS


In total, 32 children with DCD (16 per group) were randomly allocated to receive the Wii intervention or TST during 12 sessions. Motor learning was assessed in 3 consecutive phases during the intervention and was determined by the mean of the games scores obtained in the: (1) first 4 sessions, (2) intermediate 4 sessions, and (3) last 4 sessions. Six different tasks (table tennis, frisbee, archery, bowling, tightrope walking/balance beam, and marble balance/balance disc) were performed in every session. Each session lasted 42min (time on task).
RESULTS


Wii training and TST elicited improvements in motor learning, as assessed by increased scores with the frisbee and marble balance/balance disc tasks. However, Wii training elicited better performance in the archery and bowling tasks, whereas only TST elicited improvements in the balance beam and table tennis tasks.
CONCLUSION


Wii training is not always superior to non-Wii training, and improvements are based on the type of task trained. Thus, each type of intervention benefits a certain skill.",2021,"Wii training is not always superior to non-Wii training, and improvements are based on the type of task trained.","['children with developmental coordination disorder (DCD', 'children with DCD who participated in 12 sessions of Wii-based training and those participating in 12 closely matched non', 'children with developmental coordination disorder', '32 children with DCD (16 per group']","['Wii training versus non-Wii task-specific training', 'motor learning', 'Wii training', 'Wii TST sessions', 'Wii intervention or TST']","['scores with the frisbee and marble balance/balance disc tasks', 'motor learning', 'Motor learning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205689', 'cui_str': 'Marble'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",32.0,0.0193506,"Wii training is not always superior to non-Wii training, and improvements are based on the type of task trained.","[{'ForeName': 'Jorge Lopes', 'Initials': 'JL', 'LastName': 'Cavalcante Neto', 'Affiliation': 'Department of physical therapy, universidade Federal de São Carlos, São Carlos, São Paulo, Brazil; Department of human sciences, universidade do Estado da Bahia, Jacobina, Bahia, Brazil. Electronic address: jorgelcneto@hotmail.com.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Steenbergen', 'Affiliation': 'Behavioural Science Institute, Radboud university, Nijmegen, The Netherlands.'}, {'ForeName': 'Antonio Roberto', 'Initials': 'AR', 'LastName': 'Zamunér', 'Affiliation': 'Departamento kinesiologia, universidad Católica del Maule, Talca, Maule, Chile.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Tudella', 'Affiliation': 'Department of physical therapy, universidade Federal de São Carlos, São Carlos, São Paulo, Brazil.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.03.013']
37,32451933,"Design and rationale of a randomized, placebo-controlled trial on the efficacy and safety of sulodexide for extended treatment in elderly patients after a first venous thromboembolism.","How to prevent recurrences after a first venous thromboembolic (VTE) event in elderly patients is still an open issue, especially because of the high bleeding risk of anticoagulation in these patients. The placebo-controlled ""Jason"" study aims at assessing the efficacy and safety for secondary VTE prevention in elderly patients of oral Sulodexide (Vessel ® ) administration, a mixture of glycosaminoglycans (Alfasigma, Bologna, Italy) which proved effective against recurrences in a general population (SURVET study) without major bleeding (MB) complications. 1450 patients, aged ≥ 75 years, after at least 3 months of anticoagulation treatment for a first VTE episode, are double-blind randomized to receive for 12 months either sulodexide 500 lipasemic units (LSUs) twice daily, or sulodexide 250 LSU twice daily + indistinguishable placebo, or indistinguishable placebo. Primary outcomes for efficacy are the composite of death for VTE and recurrent VTE, and occurrence of MB for safety. Secondary outcomes include stroke, cardiovascular death and other thromboembolic events, and MB + clinically relevant non-MB. The first patient is scheduled to be randomized in May 2020. The study protocol has been approved by AIFA (Agenzia Italiana del Farmaco) and the Ethics Committee of the coordinating center. Written informed consent will be obtained from all patients prior to study participation. Jason study is an investigator-initiated trial, promoted by ""Arianna Anticoagulazione"" Foundation, Bologna, Italy, and supported by Alfasigma, Bologna, Italy. Study findings will be disseminated to participant centers, at research conferences and in peer-reviewed journals. Trial registration numbers NCT04257487; EudraCT (2019-000570-33).",2021,"The placebo-controlled ""Jason"" study aims at assessing the efficacy and safety for secondary VTE prevention in elderly patients of oral Sulodexide (Vessel ® ) administration, a mixture of glycosaminoglycans (Alfasigma, Bologna, Italy) which proved effective against recurrences in a general population (SURVET study) without major bleeding (MB) complications.","['elderly patients', '1450 patients, aged\u2009≥\u200975\xa0years, after at least 3\xa0months of anticoagulation treatment for a first VTE episode', 'elderly patients of oral Sulodexide (Vessel ® ) administration, a mixture of glycosaminoglycans (Alfasigma, Bologna, Italy', 'elderly patients after a first venous thromboembolism']","['sulodexide 500 lipasemic units (LSUs) twice daily, or sulodexide 250 LSU twice daily\u2009+\u2009indistinguishable placebo, or indistinguishable placebo', 'sulodexide', 'placebo']","['stroke, cardiovascular death and other thromboembolic events, and MB\u2009+\u2009clinically relevant non-MB', 'efficacy and safety', 'composite of death for VTE and recurrent VTE, and occurrence of MB for safety']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0061450', 'cui_str': 'sulodexide'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0017973', 'cui_str': 'Mucopolysaccharide'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]","[{'cui': 'C0061450', 'cui_str': 'sulodexide'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",,0.393018,"The placebo-controlled ""Jason"" study aims at assessing the efficacy and safety for secondary VTE prevention in elderly patients of oral Sulodexide (Vessel ® ) administration, a mixture of glycosaminoglycans (Alfasigma, Bologna, Italy) which proved effective against recurrences in a general population (SURVET study) without major bleeding (MB) complications.","[{'ForeName': 'Gualtiero', 'Initials': 'G', 'LastName': 'Palareti', 'Affiliation': 'Arianna Anticoagulazione"" Foundation, Via Paolo Fabbri 1/3, 40138, Bologna, Italy. gualtiero.palareti@unibo.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Legnani', 'Affiliation': 'Arianna Anticoagulazione"" Foundation, Via Paolo Fabbri 1/3, 40138, Bologna, Italy.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Antonucci', 'Affiliation': 'Arianna Anticoagulazione"" Foundation, Via Paolo Fabbri 1/3, 40138, Bologna, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Zorzi', 'Affiliation': 'Arianna Anticoagulazione"" Foundation, Via Paolo Fabbri 1/3, 40138, Bologna, Italy.'}, {'ForeName': 'Angelo A', 'Initials': 'AA', 'LastName': 'Bignamini', 'Affiliation': 'Department of Pharmaceutical Sciences, School of Specialization in Hospital Pharmacy, University of Milan, Milan, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Lodigiani', 'Affiliation': 'Thrombosis and Hemorrhagic Diseases Unit, Humanitas Research Hospital and Humanitas University, Rozzano (Milan), Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Tosetto', 'Affiliation': 'Divisione Di Ematologia, Centro Malattie Emorragiche E Trombotiche, AULSS8 Berica, Vicenza, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Bertù', 'Affiliation': ""Centro Di Ricerca Sulle Malattie Tromboemboliche E Le Terapie Antitrombotiche, Università Degli Studi dell'Insubria, Varese, Italy.""}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Pengo', 'Affiliation': 'Thrombosis Research Laboratory, Department of Cardiac-Thoracic-Vascular Sciences and Public Health, University of Padua, Padua, Italy.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Testa', 'Affiliation': 'Department of Laboratory Medicine, Haemostasis and Thrombosis Center, AO Istituti Ospitalieri, Cremona, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ageno', 'Affiliation': ""Dipartimento Di Medicina E Chirurgia, Università Degli Studi Dell'Insubria, Varese, Italy.""}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Prisco', 'Affiliation': 'DMSC Università Di Firenze, SOD Medicina Interna Interdisciplinare, AOU Careggi, Florence, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Prandoni', 'Affiliation': 'Arianna Anticoagulazione"" Foundation, Via Paolo Fabbri 1/3, 40138, Bologna, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Poli', 'Affiliation': 'Centro Trombosi, Azienda Ospedaliera Careggi, Florence, Italy.'}]",Internal and emergency medicine,['10.1007/s11739-020-02381-5']
38,32450273,Effect of postural training using a whole-body tilt apparatus in subacute stroke patients with lateropulsion: A single-blinded randomized controlled trial.,"BACKGROUND


Lateropulsion after stroke is defined as a postural bias toward the paretic side and push away from the non-paretic side. New rehabilitation techniques and programs should be designed to attenuate lateropulsion and improve functions of balance and gait.
OBJECTIVE


This study aimed to determine the effects of whole-body tilting postural training (WTPT) using a Spine Balance 3D on lateropulsion and postural control as compared with general postural training (GPT). Postural training was performed and involved a whole-body tilt apparatus that enables postural training in the tilted position, in multiple directions.
METHODS


This was a pragmatic, single-blind, randomized controlled trial conducted between June 2018 and May 2019. We randomly allocated 30 patients with subacute stroke and lateropulsion based on the Scale of Contraversive Pushing (SCP score>0) to experimental (n=15) and control (n=15) groups. The experimental group received WTPT with a whole-body tilt apparatus, and the control group GPT. WTPT was performed with the Spine Balance 3D and GPT with postural training commonly applied in the clinic. All participants received treatment for 30min/session, 2 times/day, 5 days/week for 3 weeks. The primary outcome measure was lateropulsion assessed with the Burke Lateropulsion Scale (BLS). Secondary outcome measures were postural control ability, activities of daily living, Postural Assessment Scale for Stroke (PASS) score, Berg Balance Scale (BBS) score, Korea-modified Barthel index (K-MBI), and Fugl-Meyer Motor Assessment-Lower Extremity (FMA-L) score.
RESULTS


For the primary outcome, after training, BLS scores were decreased more for the experimental than control group (Δ=-5.8 vs. Δ=-4.2, P=0.002). For secondary outcomes, scores were improved more for the experimental than control group: PASS (Δ=13.8 vs. Δ=8.5, P<0.001), BBS (Δ=20.1 vs. Δ=11.1, P=0.001), K-MBI (Δ=27.0 vs. Δ=20.1, P=0.005), and FMA-L (Δ=10.2 vs. Δ=6.3, P=0.002).
CONCLUSIONS


WTPT is a potentially effective therapeutic intervention for lateropulsion recovery in patients with subacute stroke. It may be useful for improving postural control and activities of daily living.",2021,"For secondary outcomes, scores were improved more for the experimental than control group: PASS (Δ = 13.8 vs Δ = 8.5, P <0.001), BBS (Δ = 20.1 vs Δ = 11.1, P=0.001), K-MBI (Δ = 27.0 vs Δ = 20.1, P = 0.005), and FMA-L (Δ = 10.2 vs Δ = 6.3, P = 0.002).
","['patients with subacute stroke', 'June 2018 and May 2019', '30 patients with subacute stroke and lateropulsion based on the Scale of Contraversive Pushing (SCP score >0) to experimental (n=15) and control (n=15) groups', 'subacute stroke patients with lateropulsion']","['WTPT with a whole-body tilt apparatus, and the control group GPT', 'whole-body tilting postural training (WTPT', 'general postural training (GPT', 'WTPT', 'postural training', 'Postural training was performed and involved a whole-body tilt apparatus that enables postural training']","['postural control ability, activities of daily living, Postural Assessment Scale for Stroke (PASS) score, Berg Balance Scale (BBS) score, Korea-modified Barthel index (K-MBI), and Fugl-Meyer Motor Assessment-Lower Extremity (FMA-L) score', 'lateropulsion assessed with the Burke Lateropulsion Scale (BLS', 'BBS', 'BLS scores', 'K-MBI', 'postural control and activities of daily living']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4728026', 'cui_str': 'Lateropulsion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1145610', 'cui_str': 'sodium cellulose phosphate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}]","[{'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C4728026', 'cui_str': 'Lateropulsion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",30.0,0.0509118,"For secondary outcomes, scores were improved more for the experimental than control group: PASS (Δ = 13.8 vs Δ = 8.5, P <0.001), BBS (Δ = 20.1 vs Δ = 11.1, P=0.001), K-MBI (Δ = 27.0 vs Δ = 20.1, P = 0.005), and FMA-L (Δ = 10.2 vs Δ = 6.3, P = 0.002).
","[{'ForeName': 'Chang-Man', 'Initials': 'CM', 'LastName': 'An', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Jeonbuk National University Medical School, 20, Geonjiro, Deokjin-gu, Jeonju, Jeonbuk, 54907, Republic of Korea.'}, {'ForeName': 'Myoung-Hwan', 'Initials': 'MH', 'LastName': 'Ko', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Jeonbuk National University Medical School, 20, Geonjiro, Deokjin-gu, Jeonju, Jeonbuk, 54907, Republic of Korea; Research Institute of Clinical Medicine of Jeonbuk National University - Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, 54907, Republic of Korea; Translational Research & Clinical Trial Center for Medical Device, Jeonbuk National University Hospital, Jeonju, 54907, Republic of Korea.'}, {'ForeName': 'Dae-Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Jeonbuk National University Medical School, 20, Geonjiro, Deokjin-gu, Jeonju, Jeonbuk, 54907, Republic of Korea.'}, {'ForeName': 'Gi-Wook', 'Initials': 'GW', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Jeonbuk National University Medical School, 20, Geonjiro, Deokjin-gu, Jeonju, Jeonbuk, 54907, Republic of Korea; Research Institute of Clinical Medicine of Jeonbuk National University - Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, 54907, Republic of Korea; Translational Research & Clinical Trial Center for Medical Device, Jeonbuk National University Hospital, Jeonju, 54907, Republic of Korea. Electronic address: k26@jbnu.ac.kr.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.05.001']
39,32461125,Intradiscal glucocorticoids injection in chronic low back pain with active discopathy: A randomized controlled study.,"BACKGROUND


The benefit of an intradiscal injection of corticosteroids for low back pain with active discopathy is not totally resolved.
OBJECTIVE


The objective of this study was to estimate the clinical efficacy of an intradiscal injection of glucocorticoids versus lidocaine in patients with low back pain and active discopathy (Modic 1 changes).
METHODS


A prospective, single-blind, randomized controlled study was conducted in 2 tertiary care centers with spine units. We enrolled 50 patients (mean age 50 years; 46% women) with lumbar active discopathy on MRI and failure of medical treatment for more than 6 weeks. Participants were randomly assigned to receive an intradiscal injection of glucocorticoids [50mg prednisolone acetate (GC group), n=24] or lidocaine [40mg (L group), n=26] by senior radiologists. Outcome measures were low back pain in the previous 8 days (10-point visual analog scale), Dallas Pain Questionnaire, Oswestry Disability Index, analgesic treatment and work status at 1, 3 and 6 months as well as pain at 1, 2 and 3 weeks. The primary outcome was change in pain between baseline and 1 month.
RESULTS


Data for 39 patients (78%; 17 in the GC group, 22 in the L group) were analyzed for the primary outcome. Pain intensity was significantly reduced at 1 month in the GC versus L group [mean (SD) -2.7 (2.3) and +0.1 (2.0), P<0.001] but not at 3 and 6 months. At 1 and 3 months, the groups significantly differed in daily activities of the Dallas Pain Questionnaire in favour of the GC group. The groups did not differ in consumption of analgesics or professional condition at any time. No serious intervention-related adverse events occurred. Study limitations included patients lost to the study because of injection-related technical issues in the L5/S1 disc and short time of follow-up.
CONCLUSION


As compared with intradiscal injection of lidocaine, intradiscal injection of prednisolone acetate for low back pain with active discopathy may reduce pain intensity at 1 month but not at 3 and 6 months.",2021,"Pain intensity was significantly reduced at 1 month in the GC versus L group (mean [SD] -2.7 [2.3] and +0.1 [2.0], p<0.001) but not at 3 and 6 months.","['50 patients (mean age 50 years; 46% women) with lumbar active discopathy on MRI and failure of medical treatment for more than 6 weeks', 'chronic low back pain with active discopathy', 'patients with low back pain and active discopathy (Modic 1 changes', '2 tertiary care centers with spine units']","['intradiscal injection of glucocorticoids', 'glucocorticoids versus lidocaine', 'prednisolone acetate [GC', 'corticosteroids', 'lidocaine', 'lidocaine, intradiscal injection of prednisolone acetate', 'Intradiscal glucocorticoids injection']","['low back pain in the previous 8 days (10-point visual analog scale), Dallas Pain Questionnaire, Oswestry Disability Index, analgesic treatment and work status at 1, 3 and 6 months as well as pain', 'pain intensity', 'Pain intensity', 'change in pain', 'daily activities of the Dallas Pain Questionnaire', 'consumption of analgesics or professional condition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2747858', 'cui_str': 'Discopathy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C1512934', 'cui_str': 'Intradiscal route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",50.0,0.189884,"Pain intensity was significantly reduced at 1 month in the GC versus L group (mean [SD] -2.7 [2.3] and +0.1 [2.0], p<0.001) but not at 3 and 6 months.","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Tavares', 'Affiliation': 'Département de médecine physique et de réadaptation, CHU Lapeyronie, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'Département de rhumatologie, CHU Lapeyronie, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cyteval', 'Affiliation': 'Département de radiologie, CHU Lapeyronie, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Picot', 'Affiliation': 'Unité de recherche clinique et epidémiologique (URCE), CHU Montpellier, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Manna', 'Affiliation': 'Unité de recherche clinique et epidémiologique (URCE), CHU Montpellier, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Macioce', 'Affiliation': 'Unité de recherche clinique et epidémiologique (URCE), CHU Montpellier, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Laffont', 'Affiliation': 'Département de médecine physique et de réadaptation, CHU Lapeyronie, Univ Montpellier, Montpellier, France; Euromov, Montpellier university, Montpellier, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Thouvenin', 'Affiliation': 'Département de radiologie, CHU Lapeyronie, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Viala', 'Affiliation': 'Service de radiologie, CHU Nîmes, Univ Montpellier, Nimes, France.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Larbi', 'Affiliation': 'Service de radiologie, CHU Nîmes, Univ Montpellier, Nimes, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gélis', 'Affiliation': 'Département de médecine physique et de réadaptation, CHU Lapeyronie, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Dupeyron', 'Affiliation': 'Euromov, Montpellier university, Montpellier, France; Service de médecine physique et de réadaptation, CHU Nimes, Univ Montpellier, Nimes, France. Electronic address: arnaud.dupeyron@umontpellier.fr.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.05.003']
40,32647328,Changes in cardiorespiratory fitness and activity levels over the first year after discharge in ambulatory persons with recent incomplete spinal cord injury.,"STUDY DESIGN


Secondary analysis of a clinical trial.
OBJECTIVES


To investigate changes in cardiorespiratory fitness (CRF) and activity level in ambulatory persons with SCI during the first year after discharge from inpatient rehabilitation.
SETTING


Sunnaas Rehabilitation Hospital, Nesoddtangen, Norway.
METHODS


Thirty persons with incomplete SCI, all community walkers (25 males and 5 females, 18-69 years old) were recruited to a clinical trial of a 12 weeks home-based aerobic exercise program of either high or moderate intensity. During the last week of inpatient rehabilitation (baseline), participants performed a maximal exercise test on a treadmill (peak oxygen uptake; peak VO 2 ) and a 6-min walking test (6MWT). Also, total daily energy expenditure (TDEE) and daily amount of steps were measured continuously during 7 days in the participants' homes. All tests were repeated after 3 and 12 months (post tests).
RESULTS


Twenty of the 30 clinical trial participants performed baseline and both posttests and are included in this secondary analysis. We found no statistically significant between-group differences in the time course over the first year of either peak VO 2 , 6MWT, or physical activity outcomes. Therefore, data from both exercise groups and the control group were merged for secondary analyses, revealing statistically significant increase over time in peak VO 2 , 6MWT, and TDEE. The increase over time in the average daily steps did not reach statistical significance.
CONCLUSIONS


Ambulatory persons with SCI were able to increase their CRF levels over the first year after discharge from inpatient rehabilitation, despite a minimal increase in activity levels.",2021,"We found no statistically significant between-group differences in the time course over the first year of either peak VO 2 , 6MWT, or physical activity outcomes.","['Sunnaas Rehabilitation Hospital, Nesoddtangen, Norway', 'ambulatory persons with recent incomplete spinal cord injury', 'Ambulatory persons with SCI', 'Thirty persons with incomplete SCI, all community walkers (25 males and 5 females, 18-69 years old', 'ambulatory persons with SCI during the first year after discharge from inpatient rehabilitation']","['aerobic exercise program of either high or moderate intensity', 'maximal exercise test on a treadmill (peak oxygen uptake; peak VO 2 ) and a 6-min walking test (6MWT']","['cardiorespiratory fitness (CRF) and activity level', 'cardiorespiratory fitness and activity levels', 'total daily energy expenditure (TDEE) and daily amount of steps', 'time in peak VO 2 , 6MWT, and TDEE', 'time course over the first year of either peak VO 2 , 6MWT, or physical activity outcomes', 'activity levels', 'CRF levels']","[{'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",30.0,0.028803,"We found no statistically significant between-group differences in the time course over the first year of either peak VO 2 , 6MWT, or physical activity outcomes.","[{'ForeName': 'Matthijs F', 'Initials': 'MF', 'LastName': 'Wouda', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway. Matthijs.wouda@sunnaas.no.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Lundgaard', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Becker', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway.'}, {'ForeName': 'Vegard', 'Initials': 'V', 'LastName': 'Strøm', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway.'}]",Spinal cord,['10.1038/s41393-020-0514-7']
41,32617960,"Modeling the Effect of DAV132, a Novel Colon-Targeted Adsorbent, on Fecal Concentrations of Moxifloxacin and Gut Microbiota Diversity in Healthy Volunteers.","To prevent antibiotic-induced perturbations on gut microbiota, DAV132, a novel colon-targeted adsorbent, which sequesters antibiotic residues in the lower gastrointestinal tract, was developed. We built an integrated pharmacological model of how DAV132 reduces fecal free moxifloxacin and preserves gut microbiota. We used plasma and fecal free moxifloxacin concentrations, and Shannon diversity index from 16S ribosomal RNA gene metagenomics analysis of fecal microbiota, of 143 healthy volunteers assigned randomly to receive moxifloxacin only, or with 10 DAV132 dose regimens, or to a control group. We modeled reduced fecal moxifloxacin concentrations using a transit model for DAV132 kinetics and a Michaelis-Menten model with an effect of the amount of activated charcoal on adsorption efficacy. Changes in moxifloxacin-induced perturbations on gut microbiota diversity were then quantified through a turnover model with the Emax model. With the developed model, the efficiency of pharmacokinetic antagonism and its consequences on gut microbiota diversity were quantified.",2021,We built an integrated pharmacological model of how DAV132 reduces fecal free moxifloxacin (MXF) and preserves gut microbiota.,"['healthy volunteers', '143 healthy volunteers assigned randomly to receive']","['DAV132', 'moxifloxacin (MXF', 'moxifloxacin', 'MXF']","['fecal MXF concentrations', 'gut microbiota diversity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",143.0,0.0162659,We built an integrated pharmacological model of how DAV132 reduces fecal free moxifloxacin (MXF) and preserves gut microbiota.,"[{'ForeName': 'Jinju', 'Initials': 'J', 'LastName': 'Guk', 'Affiliation': 'Université de Paris, IAME, INSERM, Paris, France.'}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Guedj', 'Affiliation': 'Université de Paris, IAME, INSERM, Paris, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Burdet', 'Affiliation': 'Université de Paris, IAME, INSERM, Paris, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Andremont', 'Affiliation': 'Université de Paris, IAME, INSERM, Paris, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'de Gunzburg', 'Affiliation': 'Da Volterra, Paris, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Ducher', 'Affiliation': 'Da Volterra, Paris, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Mentré', 'Affiliation': 'Université de Paris, IAME, INSERM, Paris, France.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1977']
42,32586736,Tezacaftor/ivacaftor in people with cystic fibrosis who stopped lumacaftor/ivacaftor due to respiratory adverse events.,"BACKGROUND


Increased rates of respiratory adverse events have been observed in people ≥12 years of age with cystic fibrosis homozygous for the Phe508del-CFTR mutation treated with lumacaftor/ivacaftor, particularly in those with percent predicted forced expiratory volume in 1 s (ppFEV 1 ) of <40%. We evaluated the safety, tolerability, and efficacy of tezacaftor/ivacaftor in people with cystic fibrosis homozygous for Phe508del-CFTR who discontinued lumacaftor/ivacaftor due to treatment-related respiratory signs or symptoms.
METHODS


Participants ≥12 years of age with cystic fibrosis homozygous for Phe508del-CFTR with ppFEV 1  of ≥25% and ≤90% were randomized 1:1 and treated with tezacaftor/ivacaftor or placebo for 56 days.
RESULTS


Of 97 participants, 94 (96.9%) completed the study. The primary endpoint was incidence of predefined respiratory adverse events of special interest (chest discomfort, dyspnea, respiration abnormal, asthma, bronchial hyperreactivity, bronchospasm, and wheezing): tezacaftor/ivacaftor, 14.0%; placebo, 21.3%. The adverse events were mild or moderate in severity. None were serious or led to treatment interruption or discontinuation. Overall, the discontinuation rate was similar between groups. The mean (SD) ppFEV 1  at baseline was 44.6% (16.1%) with tezacaftor/ivacaftor and 48.0% (18.1%) with placebo. The posterior mean difference in absolute change in ppFEV 1  from baseline to the average value of days 28 and 56 was 2.7 percentage points with tezacaftor/ivacaftor vs placebo.
CONCLUSIONS


Tezacaftor/ivacaftor was generally safe, well tolerated, and efficacious in people ≥12 years of age with cystic fibrosis homozygous for Phe508del-CFTR with ppFEV 1  of ≥25% and ≤90% who previously discontinued lumacaftor/ivacaftor due to treatment-related respiratory signs or symptoms.",2021,ppFEV 1  at baseline was 44.6% (16.1%) with tezacaftor/ivacaftor and 48.0% (18.1%) with placebo.,"['Of 97 participants, 94 (96.9%) completed the study', 'people with cystic fibrosis who stopped lumacaftor/ivacaftor due to respiratory adverse events', 'people ≥12 years of age with cystic fibrosis homozygous for the Phe508del-CFTR mutation treated with', 'people ≥12 years of age with cystic fibrosis homozygous', 'people with cystic fibrosis homozygous for Phe508del-CFTR who discontinued lumacaftor/ivacaftor due to treatment-related respiratory signs or symptoms', 'Participants ≥12 years of age with cystic fibrosis homozygous for Phe508del-CFTR with ppFEV 1  of ≥25% and ≤90']","['tezacaftor/ivacaftor or placebo', 'tezacaftor/ivacaftor', 'Tezacaftor/ivacaftor', 'lumacaftor/ivacaftor', 'placebo']","['safe, well tolerated, and efficacious', 'discontinuation rate', 'mean (SD', 'adverse events', 'incidence of predefined respiratory adverse events of special interest (chest discomfort, dyspnea, respiration abnormal, asthma, bronchial hyperreactivity, bronchospasm, and wheezing): tezacaftor/ivacaftor', 'safety, tolerability, and efficacy']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C3852684', 'cui_str': 'lumacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]","[{'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3852684', 'cui_str': 'lumacaftor'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0235710', 'cui_str': 'Chest discomfort'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C1260922', 'cui_str': 'Abnormal breathing'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0085129', 'cui_str': 'Bronchial hyperreactivity'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",97.0,0.134808,ppFEV 1  at baseline was 44.6% (16.1%) with tezacaftor/ivacaftor and 48.0% (18.1%) with placebo.,"[{'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwarz', 'Affiliation': 'Christiane Herzog Zentrum Berlin/Charité-Universitätsmedizin Berlin, Berlin, Germany. Electronic address: carsten.schwarz@charite.de.'}, {'ForeName': 'Sivagurunathan', 'Initials': 'S', 'LastName': 'Sutharsan', 'Affiliation': 'Division of Cystic Fibrosis, Department of Pulmonary Medicine, Faculty of Medicine, Universitat Duisburg Essen-Ruhrlandklinik, Essen, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Epaud', 'Affiliation': 'Cystic Fibrosis and Rare Lung Disease Centre, Centre Hospitalier Intercommunal de Créteil, Créteil, France.'}, {'ForeName': 'Ross C', 'Initials': 'RC', 'LastName': 'Klingsberg', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Rainald', 'Initials': 'R', 'LastName': 'Fischer', 'Affiliation': 'Pneumologische Praxis München-Pasing, Munich, Germany.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rowe', 'Affiliation': 'The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Audhya', 'Affiliation': 'Formerly of Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ahluwalia', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'You', 'Affiliation': 'Formerly of Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ferro', 'Affiliation': 'Formerly of Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Duncan', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Bote G', 'Initials': 'BG', 'LastName': 'Bruinsma', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.06.001']
43,32616866,Controlled blood sugar improves the eye's accommodative ability in type-1 diabetes.,"PURPOSE


To evaluate the impact of blood sugar level on ocular measures, including refractive error (RE), amplitude of accommodation (AoA), and lag of accommodation (LoA), in pre-presbyopes with type-1 diabetes.
METHOD


The fasting blood sugar (FBS) and ocular measures of type-1 diabetes patients (age: 14-39 years; n = 30) on insulin treatment was recorded while they fasted on two separate visits, at baseline and 3 months later. The AoA and LoA was measured with the appropriate spectacle correction worn. The Welch's t-test was used for comparison of the baseline measures between the normal FBS ≤ 7 (n = 10) and higher FBS > 7 (n = 20) patients, and the paired t-test used to investigate for differences between the baseline and follow-up data in patients with changes in FBS.
RESULTS


On average, the spectacle correction for the normal FBS group was marginally more myopic (RE: -0.30 ± 0.67 D vs. +0.18 ± 1.00 D, p = 0.032), and they showed greater AoA (5.38 ± 1.08 D vs. 3.68 ± 1.43 D, p < 0.001) and lower LoA (1.00 ± 0.30 D vs. 1.30 ± 0.38 D, p = 0.004) compared with the higher FBS group at baseline. On the follow-up visit attended by 25 patients, the FBS of 15 patients was reduced by an average of 7.0 mmol/L, 8 patients had an average increase of 5.2 mmol/L, while 2 patients recorded no changes relative to the baseline. The patients whose FBS was reduced showed improvement in the mean AoA from 3.78 ± 1.58 D to 4.88 ± 1.61 D (p < 0.001) and a reduction in the mean LoA from 1.37 ± 0.40D to 0.87 ± 0.19D (p < 0.001), whereas those with deteriorated control of the FBS showed an opposite trend.
CONCLUSIONS


Controlling hyperglycemia improves ocular accommodation in type-1 diabetes.",2021,"D vs. 3.68 ± 1.43 D, p < 0.001) and lower LoA (1.00 ± 0.30 D vs. 1.30 ± 0.38 D, p = 0.004) compared with the higher FBS group at baseline.","['type-1 diabetes', 'type-1 diabetes patients (age: 14-39 years; n\u2009=\u200930) on']","['Controlled blood sugar', 'Controlling hyperglycemia', 'insulin treatment']","['ocular accommodation', 'fasting blood sugar (FBS) and ocular measures', 'refractive error (RE), amplitude of accommodation (AoA), and lag of accommodation (LoA), in pre-presbyopes with type-1 diabetes']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C1627880', 'cui_str': 'Accommodative amplitude'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",,0.0327062,"D vs. 3.68 ± 1.43 D, p < 0.001) and lower LoA (1.00 ± 0.30 D vs. 1.30 ± 0.38 D, p = 0.004) compared with the higher FBS group at baseline.","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Abokyi', 'Affiliation': 'Department of Optometry and Vision Science, School of Allied Health Sciences, College of Health and Allied Sciences, University of Cape Coast, Cape Coast, Ghana. sabokyi@ucc.edu.gh.'}, {'ForeName': 'Patience Ansomah', 'Initials': 'PA', 'LastName': 'Ayerakwah', 'Affiliation': 'Department of Optometry and Vision Science, School of Allied Health Sciences, College of Health and Allied Sciences, University of Cape Coast, Cape Coast, Ghana.'}, {'ForeName': 'Sampson Listowell', 'Initials': 'SL', 'LastName': 'Abu', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Emmanuel Kwasi', 'Initials': 'EK', 'LastName': 'Abu', 'Affiliation': 'Department of Optometry and Vision Science, School of Allied Health Sciences, College of Health and Allied Sciences, University of Cape Coast, Cape Coast, Ghana.'}]","Eye (London, England)",['10.1038/s41433-020-1058-y']
44,32645162,Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial.,"BACKGROUND


Patterns of antiretroviral therapy (ART) use and immunologic correlates vary globally, and contemporary trends are not well described.
METHODS


The REPRIEVE trial (Randomized Trial to Prevent Vascular Events in HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk. ART use was summarized within Global Burden of Disease (GBD) super-regions, with adjusted linear and logistic regression analyses examining associations with immune parameters and key demographics.
RESULTS


A total of 7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers. The median CD4 T-cell count was 620/µL (interquartile range, 447-826/ µ L), and the median duration of prior ART use, 9.5 years (5.3-14.8) years. The most common ART regimens were nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI) plus nonnucleoside reverse-transcriptase inhibitor (43%), NRTI plus integrase strand transfer inhibitor (25%), and NRTI plus protease inhibitor (19%). Entry ART varied by GBD region, with shifts during the trial enrollment period. In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
CONCLUSIONS


There were substantial variations in ART use by geographic region and over time, likely reflecting the local availability of specific medications, changes in treatment guidelines and provider/patient preferences. The analyses of CD4 cell counts and CD4/CD8 ratios may provide valuable insights regarding immune correlates and outcomes in people living with HIV.
CLINICAL TRIALS REGISTRATION


NCT02344290.",2020,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","['HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk', 'people living with HIV', '7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers']",['nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI)\u2005plus nonnucleoside reverse-transcriptase inhibitor'],"['GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts', 'entry CD4 cell count and CD4/CD8 ratio', 'median CD4 T-cell count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}]","[{'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C4277729', 'cui_str': 'Global Burden of Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",7770.0,0.18883,"In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
","[{'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Fichtenbaum', 'Affiliation': 'Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Leon-Cruz', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Carlos D', 'Initials': 'CD', 'LastName': 'Malvestutto', 'Affiliation': 'Division of Infectious Diseases, Ohio State University Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Kileel', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Van Schalkwyk', 'Affiliation': 'Family Centre for Research with Ubuntu, Division of Adult Infectious Diseases, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Nagalingeswaran', 'Initials': 'N', 'LastName': 'Kumarasamy', 'Affiliation': 'Infectious Diseases Medical Centre, Voluntary Health Services, Chennai, India.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Hospital Clinic and University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Breno Riegel', 'Initials': 'BR', 'LastName': 'Santos', 'Affiliation': 'Infectious Diseases Service, Hospital Nossa, Senhora da Conceição/GHC, Porto Alegre, Brazil.'}, {'ForeName': 'Yvetot', 'Initials': 'Y', 'LastName': 'Joseph', 'Affiliation': 'Les Centres GHESKIO, Port-au-Prince, Haiti.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Siminski', 'Affiliation': 'Frontier Science and Technology Foundation, Amherst, Massachusetts, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Melbourne', 'Affiliation': 'HIV Medical Sciences, Gilead Sciences, Foster City, California, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sponseller', 'Affiliation': 'Kowa Pharmaceuticals America, Montgomery, Alabama, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung and Blood Institute, Baltimore, Maryland, USA.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Department of Medicine, Duke Global Health Institute and Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, University of California-Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiaa259']
45,32645164,An Evaluation of Baseline Kidney Function in the REPRIEVE Trial of Pitavastatin in Human Immunodeficiency Virus.,"BACKGROUND


Chronic kidney disease is a common comorbid condition among persons living with human immunodeficiency virus (PWH). We characterized baseline kidney function in the REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) trial cohort.
METHODS


REPRIEVE enrolled PWH with low to moderate cardiovascular risk based on traditional risk factors to evaluate the effect of statin therapy on cardiovascular events. We determined baseline estimated glomerular filtration rate (eGFR) with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Modification of Diet in Renal Disease, and Cockcroft-Gault equations, and we evaluated baseline factors associated with eGFR <90 mL/min/1.73 m2 by logistic regression. We performed Bland-Altman plots and scatterplots to assess agreement between equations.
RESULTS


Among 7770 participants enrolled, the median age was 50 years, 31% were female (natal sex), 43% black or African American and 15% Asian, the median body mass index (calculated as calculated as weight in kilograms divided by height in meters squared) was 25.8, and the median CD4 cell count 620/µL. The median CKD-EPI eGFR was 97 mL/min/1.73 m2, and 38% had an eGFR <90 mL/min/1.73 m2. In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate. The CKD-EPI and Modification of Diet in Renal Disease equations demonstrated strong agreement, particularly at lower eGFR values. Overall, there was 56% concordance between the 3 equations (categories <60, 60 to <90, ≥90 mL/min), improving to 73% after accounting for individual body surface area.
CONCLUSIONS


REPRIEVE enrolled a diverse cohort including a substantial number of PWH with reduced kidney function. Factors associated with reduced eGFR included traditional risk factors and tenofovir disoproxil fumarate exposure. Three commonly used equations have only fair agreement, with potential implications for both clinical care and epidemiologic studies.
CLINICAL TRIALS REGISTRATION


NCT02344290.",2020,"In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate.","['7770 participants enrolled, the median age was 50 years, 31% were female (natal sex), 43% black or African American and 15% Asian, the', 'Human Immunodeficiency Virus', 'persons living with human immunodeficiency virus (PWH']","['tenofovir disoproxil fumarate exposure', 'statin therapy', 'eGFR', 'tenofovir disoproxil fumarate', 'Pitavastatin']","['median CKD-EPI eGFR', 'median CD4 cell count', 'median body mass index', 'glomerular filtration rate (eGFR) with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Modification of Diet in Renal Disease, and Cockcroft-Gault equations', 'cardiovascular events']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",7770.0,0.0804019,"In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate.","[{'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'HIV Treatment Clinical Research Site, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Mosepele', 'Initials': 'M', 'LastName': 'Mosepele', 'Affiliation': 'University of Botswana and Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Lerato', 'Initials': 'L', 'LastName': 'Mohapi', 'Affiliation': 'Soweto Clinical Research Site, Chris Hani Baragwanath Hospital, Johannesburg, Gauteng, South Africa.'}, {'ForeName': 'Sandra Wagner', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': 'Fiocruz Therapeutic and Prevention HIV/AIDS Clinical Trials Unit, Rio de Janeiro, Brazil.'}, {'ForeName': 'Sandesh', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Marcus V G', 'Initials': 'MVG', 'LastName': 'de Lacerda', 'Affiliation': 'Fundação de Medicina Tropical Doutor Heitor Viera Dourado, Manaus, Amazonas, Brazil.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'McComsey', 'Affiliation': 'Division of Pediatric Infectious Diseases and Rheumatology, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Wyatt', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa222']
46,32651338,"A double-blind, randomized, controlled study of two dose strengths of dalfampridine extended release on walking deficits in ischemic stroke.","BACKGROUND


Stroke-induced ischemia affects both cortex and underlying white matter. Dalfampridine extended release tablets (D-ER) enhance action potential conduction in demyelinated axons, which may positively affect post-stroke recovery.
OBJECTIVE


Based on promising preliminary data, we compared efficacy of D-ER administered at 7.5 mg or 10 mg with placebo on post-stroke ambulation. Primary study outcome (response) was a ≥20% increase on the 2-minute walk test (2 MinWT) at 12 weeks after first drug administration.
METHODS


This was a multicenter, randomized, placebo-controlled, 3-arm, parallel-group, safety and efficacy trial. After obtaining baseline measures of 2 MinWT, Walk-12, and Timed Up and Go, subjects entered a 2-week, single-blind placebo run-in period and were randomized 1:1:1 to receive 7.5 mg D-ER, 10 mg D-ER, or placebo, dosed twice-daily for 12 weeks. Follow-up evaluations occurred at weeks 14 and 16 when subjects were off study drug.
RESULTS


The study was terminated early with 377 of planned 540 patients enrolled, due to no treatment effect. At week 12, mean increase in distances walked in 2 minutes were similar among the 3 study groups (14.9±40.0 feet; 19.4±39.6 feet; and 20.4±38.3 feet for placebo, 7.5 mg D-ER, and 10 mg D-ER, respectively). The proportion of subjects who showed ≥20% improvement on 2 MinWT at week 12 was 13.5%, 14.0%, and 19.0%, for placebo, 7.5 mg D-ER, and 10 mg D-ER, respectively; these were nonsignificant changes from baseline for all groups.
CONCLUSIONS


D-ER at either a 7.5-mg or 10-mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment. (Clinical Trial # NCT02271217).",2020,"CONCLUSIONS


D-ER at either a 7.5 mg or 10 mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment.","['stroke survivors with gait impairment', '377 of planned 540 patients enrolled, due to no treatment effect', 'ischemic stroke']","['Dalfampridine extended release tablets (D-ER', '7.5\u200amg D-ER, 10\u200amg D-ER, or placebo', 'D-ER', 'dalfampridine', 'placebo']","['distances walked', '2-minute walk test (2\u200aMinWT', 'walking deficits']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0991507', 'cui_str': 'Prolonged-release oral tablet'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",540.0,0.674871,"CONCLUSIONS


D-ER at either a 7.5 mg or 10 mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment.","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Page', 'Affiliation': 'RehabLab™, Neurorecovery Unlimited, LLC, Columbus, OH, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Bockbrader', 'Affiliation': 'Ohio State University Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'JEM Research Institute, Atlantis, FL, USA.'}, {'ForeName': 'Seth P', 'Initials': 'SP', 'LastName': 'Finklestein', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'MingMing', 'Initials': 'M', 'LastName': 'Ning', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Waleed H', 'Initials': 'WH', 'LastName': 'El-Feky', 'Affiliation': 'Texas Neurology, Dallas, TX, USA.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Wilson', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Roberts', 'Affiliation': 'Acorda Therapeutics, Inc., Ardsley, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Restorative neurology and neuroscience,['10.3233/RNN-201009']
47,32645158,Myocardial Steatosis Among Antiretroviral Therapy-Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial.,"BACKGROUND


People with human immunodeficiency virus (PWH) face increased risks for heart failure and adverse heart failure outcomes. Myocardial steatosis predisposes to diastolic dysfunction, a heart failure precursor. We aimed to characterize myocardial steatosis and associated potential risk factors among a subset of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) participants.
METHODS


Eighty-two PWH without known heart failure successfully underwent cardiovascular magnetic resonance spectroscopy, yielding data on intramyocardial triglyceride (IMTG) content (a continuous marker for myocardial steatosis extent). Logistic regression models were applied to investigate associations between select clinical characteristics and odds of increased or markedly increased IMTG content.
RESULTS


Median (Q1, Q3) IMTG content was 0.59% (0.28%, 1.15%). IMTG content was increased (> 0.5%) among 52% and markedly increased (> 1.5%) among 22% of participants. Parameters associated with increased IMTG content included age (P = .013), body mass index (BMI) ≥ 25 kg/m2 (P = .055), history of intravenous drug use (IVDU) (P = .033), and nadir CD4 count < 350 cells/mm³ (P = .055). Age and BMI ≥ 25 kg/m2 were additionally associated with increased odds of markedly increased IMTG content (P = .049 and P = .046, respectively).
CONCLUSIONS


A substantial proportion of antiretroviral therapy-treated PWH exhibited myocardial steatosis. Age, BMI ≥ 25 kg/m2, low nadir CD4 count, and history of IVDU emerged as possible risk factors for myocardial steatosis in this group.
CLINICAL TRIALS REGISTRATION


NCT02344290; NCT03238755.",2020,IMTG content was increased (> 0.5%) among 52% and markedly increased (> 1.5%) among 22% of participants.,"['Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial', '25 kg/m2 ', 'HIV (REPRIEVE) participants', 'People with human immunodeficiency virus (PWH', 'Eighty-two PWH without known heart failure successfully underwent']","['cardiovascular magnetic resonance spectroscopy, yielding data on intramyocardial triglyceride (IMTG) content', 'Antiretroviral Therapy']","['Median (Q1, Q3', 'Age and BMI ≥', 'myocardial steatosis', 'body mass index (BMI) ≥', 'Myocardial Steatosis', 'IMTG content', 'nadir CD4 count', 'history of intravenous drug use (IVDU']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0242566', 'cui_str': 'Intravenous drug user'}]",,0.0838812,IMTG content was increased (> 0.5%) among 52% and markedly increased (> 1.5%) among 22% of participants.,"[{'ForeName': 'Tomas G', 'Initials': 'TG', 'LastName': 'Neilan', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kim-Lien', 'Initials': 'KL', 'LastName': 'Nguyen', 'Affiliation': 'Division of Cardiology, David Geffen School of Medicine at the University of California, Los Angeles and the Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, USA.'}, {'ForeName': 'Vlad G', 'Initials': 'VG', 'LastName': 'Zaha', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Advanced Imaging Research Center, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Kara W', 'Initials': 'KW', 'LastName': 'Chew', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Leavitt', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Ntobeko A B', 'Initials': 'NAB', 'LastName': 'Ntusi', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa.'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Toribio', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Magid', 'Initials': 'M', 'LastName': 'Awadalla', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Zsofia D', 'Initials': 'ZD', 'LastName': 'Drobni', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Nelson', 'Affiliation': 'Applied Physiology and Advanced Imaging Laboratory, Department of Kinesiology, University of Texas at Arlington, Arlington, Texas, USA.'}, {'ForeName': 'Tricia H', 'Initials': 'TH', 'LastName': 'Burdo', 'Affiliation': 'Department of Neuroscience, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Van Schalkwyk', 'Affiliation': 'Family Clinical Research Unit, Division of Adult Infectious Diseases, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Skiest', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School-Baystate, Springfield, Massachusetts, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Tashima', 'Affiliation': 'Division of Infectious Diseases, The Miriam Hospital and Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Landovitz', 'Affiliation': 'Center for Clinical AIDS Research and Education, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Daar', 'Affiliation': 'Lundquist Institute at Harbor-University of California, Los Angeles Medical Center and David Geffen School of Medicine at the University of Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Alysse G', 'Initials': 'AG', 'LastName': 'Wurcel', 'Affiliation': 'Division of Geographic Medicine and Infectious Diseases, Department of Medicine, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Robbins', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Bolan', 'Affiliation': 'Los Angeles Lesbian Gay Bisexual Transgender Center, Los Angeles, California, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Duke Clinical Research Institute, Duke Global Health Institute, Department of Medicine, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology and Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Dawson', 'Affiliation': 'Division of Pulmonology and Department of Medicine, University of Cape Town Lung Institute, Mowbray, Cape Town, South Africa.'}, {'ForeName': 'Matthew Bidwell', 'Initials': 'MB', 'LastName': 'Goetz', 'Affiliation': 'Infectious Diseases Section, Department of Medicine, Veterans Affairs Greater Los Angeles Healthcare System and David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Alberta', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Division of Cardiology, David Geffen School of Medicine at the University of California, Los Angeles and the Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, USA.'}, {'ForeName': 'Lidia S', 'Initials': 'LS', 'LastName': 'Szczepaniak', 'Affiliation': 'Biomedical Research Consulting in Magnetic Resonance Spectroscopy, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa245']
48,32645161,Leveraging a Landmark Trial of Primary Cardiovascular Disease Prevention in Human Immunodeficiency Virus: Introduction From the REPRIEVE Coprincipal Investigators.,"The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is the largest study of cardiovascular disease in human immunodeficiency virus. Enrolling 7770 participants from 2015 to 2019 with sites across 5 continents, REPRIEVE will assess the effects of a statin as a cardiovascular disease prevention strategy in people with HIV (PWH) receiving antiretroviral therapy (ART). Although the primary purpose of REPRIEVE, and its substudy assessing coronary plaque, is to assess cardiovascular outcomes, the trial is a rich source of data on population characteristics and critical comorbidities in PWH, particularly across Global Burden of Disease (GBD) regions, reflective of the ethnic, racial, and gender diversity in this global epidemic. The purpose of this Supplement is to leverage the rich phenotyping in REPRIEVE, to provide data on detailed patterns of baseline ART and immune function by GBD region, reproductive aging among cisgender women, and data on the participation and clinical characteristics of transgender participants. We also leveraged REPRIEVE to assess critical comorbidities, including renal dysfunction, muscle function and frailty, and myocardial steatosis. REPRIEVE is a remarkable collaboration between funders, trial networks, clinical research sites, clinical and data coordinating centers, and willing participants who devoted their time to make the trial possible.",2020,The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is the largest study of cardiovascular disease in human immunodeficiency virus.,"['Human Immunodeficiency Virus', 'human immunodeficiency virus', 'Enrolling 7770 participants from 2015 to 2019 with sites across 5 continents', 'people with HIV (PWH) receiving antiretroviral therapy (ART']",[],"['renal dysfunction, muscle function and frailty, and myocardial steatosis']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]",[],"[{'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}]",7770.0,0.113634,The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is the largest study of cardiovascular disease in human immunodeficiency virus.,"[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Center, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa098']
49,32631142,Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: An overview.,"The stepped wedge cluster randomized design has received increasing attention in pragmatic clinical trials and implementation science research. The key feature of the design is the unidirectional crossover of clusters from the control to intervention conditions on a staggered schedule, which induces confounding of the intervention effect by time. The stepped wedge design first appeared in the Gambia hepatitis study in the 1980s. However, the statistical model used for the design and analysis was not formally introduced until 2007 in an article by Hussey and Hughes. Since then, a variety of mixed-effects model extensions have been proposed for the design and analysis of these trials. In this article, we explore these extensions under a unified perspective. We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity. We review the key model ingredients and clarify their implications for the design and analysis. The article serves as an entry point to the evolving statistical literatures on stepped wedge designs.",2021,"We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity.",[],[],[],[],[],[],,0.0502379,"We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Melnick', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, WA, USA.'}]",Statistical methods in medical research,['10.1177/0962280220932962']
50,33141785,Single-Session Dance/Movement Therapy for Thought and Behavioral Dysfunction Associated With Schizophrenia: A Mixed Methods Feasibility Study.,"ABSTRACT


This purposes of this mixed methods feasibility study were to determine whether people with schizophrenia in an inpatient psychiatric facility were able to complete the research protocol, and to obtain preliminary treatment effects of a single-session dance/movement therapy (DMT) intervention versus verbal treatment as usual (TAU). Thirty-two participants were randomized to a 45-minute DMT or verbal TAU session. Data were collected quantitatively using the Brief Psychiatric Rating Scale (BPRS) and qualitatively through open-ended interviews. Results indicated that participants in the DMT group had statistically significant symptom reduction compared with those in the TAU group in overall BPRS scores (effect size [ES] = 0.67), psychological discomfort (ES = 0.64), negative symptoms (ES = 0.67), and positive symptoms (ES = 0.55). No statistical significance was shown for resistance. Qualitative findings substantiate the quantitative findings, however, show divergence regarding resistance. Participants in the DMT group expressed feeling in control, less angry, and motivated for treatment.",2021,"Results indicated that participants in the DMT group had statistically significant symptom reduction compared with those in the TAU group in overall BPRS scores (effect size [ES] = 0.67), psychological discomfort (ES = 0.64), negative symptoms (ES = 0.67), and positive symptoms (ES = 0.55).","['people with schizophrenia in an inpatient psychiatric facility', 'Schizophrenia']","['single-session dance/movement therapy (DMT) intervention versus verbal treatment as usual (TAU', 'Single-Session Dance/Movement Therapy', '45-minute DMT or verbal TAU session', 'DMT', 'TAU']","['psychological discomfort', 'Brief Psychiatric Rating Scale (BPRS', 'overall BPRS scores', 'symptom reduction', 'negative symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",32.0,0.0627788,"Results indicated that participants in the DMT group had statistically significant symptom reduction compared with those in the TAU group in overall BPRS scores (effect size [ES] = 0.67), psychological discomfort (ES = 0.64), negative symptoms (ES = 0.67), and positive symptoms (ES = 0.55).","[{'ForeName': 'Jacelyn', 'Initials': 'J', 'LastName': 'Biondo', 'Affiliation': 'Department of Creative Arts Therapies, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Gerber', 'Affiliation': 'Art Therapy Program, Department of Education, Florida State University, Tallahassee, Florida.'}, {'ForeName': 'Joke', 'Initials': 'J', 'LastName': 'Bradt', 'Affiliation': 'Department of Creative Arts Therapies, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'Department of Psychiatry, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Goodill', 'Affiliation': 'Department of Creative Arts Therapies, Drexel University, Philadelphia, Pennsylvania.'}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001263']
51,33071273,Effects of resistance training using elastic bands on muscle strength with or without a leucine supplement for 48 weeks in elderly patients with type 2 diabetes.,"Type 2 diabetes is associated with sarcopenia. Resistance training and appropriate nutritional therapy are reported to be effective for muscle strength and mass. This study aimed to evaluate the effect of resistance training using elastic bands at home combined with a leucine-rich amino acid supplement on muscle strength, physical function, and muscle mass in elderly type 2 diabetes. We conducted a 48-week prospective single-center randomized controlled trial in 60 patients who were randomly allocated to one of three groups: control (C), resistance exercise (R), and resistance exercise plus supplement (RL). R and RL groups performed daily bodyweight resistance training with elastic bands exercises at home, and the RL group also took 6 g of a leucine-rich amino acid supplement daily. Knee extension strength (muscle strength), grip strength, usual gait speed (physical function), muscle mass, and cognitive function were assessed at 0 and 48 weeks. Although the change in knee extension strength from baseline was significantly increased by 6.4 Nm (95% CI 1.0, 11.7) in the RL group (p = 0.036), no significant difference was observed among the three groups (p = 0.090). Physical function, muscle mass, and cognitive function also had no changes during the study period among the three groups. No additive effect of a leucine-rich amino acid supplement on muscle strength or mass was observed. Although a post hoc analysis comparing with or without resistance training (C group vs. R + RL group) found that knee extension strength was significantly increased (p = 0.028), and cognitive decline was less (p = 0.046) than in the C group.",2021,"Although the change in knee extension strength from baseline was significantly increased by 6.4 Nm (95% CI 1.0, 11.7) in the RL group (p = 0.036), no significant difference was observed among the three groups (p = 0.090).","['60 patients who were randomly allocated to one of three groups', 'elderly patients with type 2 diabetes', 'elderly type 2 diabetes']","['resistance training', 'control (C), resistance exercise (R), and resistance exercise plus supplement (RL', 'leucine supplement', 'leucine-rich amino acid supplement', 'Resistance training and appropriate nutritional therapy']","['muscle strength, physical function, and muscle mass', 'Physical function, muscle mass, and cognitive function', 'cognitive decline', 'Knee extension strength (muscle strength), grip strength, usual gait speed (physical function), muscle mass, and cognitive function', 'knee extension strength', 'muscle strength or mass']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0556082', 'cui_str': 'Amino acid supplement'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",60.0,0.0260347,"Although the change in knee extension strength from baseline was significantly increased by 6.4 Nm (95% CI 1.0, 11.7) in the RL group (p = 0.036), no significant difference was observed among the three groups (p = 0.090).","[{'ForeName': 'Yutaro', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nagai', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Kawanabe', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Hishida', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Hiraki', 'Affiliation': 'Department of Rehabilitation Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Sone', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.'}]",Endocrine journal,['10.1507/endocrj.EJ20-0550']
52,33099752,Ropeginterferon alfa-2b every 2 weeks as a novel pegylated interferon for patients with chronic hepatitis B.,"BACKGROUND


Ropeginterferon alfa-2b is a novel mono-pegylated interferon that has only one major form as opposed to 8-14 isomers of other on-market pegylated interferon, allowing injection every two or more weeks with higher tolerability. It received European Medicines Agency and Taiwan marketing authorization in 2019 and 2020, for treatment of polycythemia vera. This phase I/II study aimed to have preliminary evaluation of safety and efficacy in chronic hepatitis B.
METHODS


Thirty-one HBeAg-positive and 31 HBeAg-negative were stratified by HBeAg status and randomized at 1:1:1 ratio to q2w ropeginterferon alfa-2b 350 μg (group 1), q2w 450 μg (group 2) or q1w PEG-IFN alfa-2a 180 μg (group 3). Each patient received 48-week treatment (TW48) and 24-week post-treatment follow-up (FW24).
RESULTS


The baseline demographics were comparable among the three groups, except for mean HBeAg in HBeAg-positive patients (2.90, 2.23, 2.99 log 10  S/CO, respectively). Cumulative HBeAg seroconversion rate at follow-up period was 27.3% (3/11), 36.4% (4/11), and 11.1% (1/9) with time to HBeAg seroconversion starting from TW24, TW16, and TW48 in group 1, 2, and 3, respectively. The rate of HBV DNA < 2000 IU/mL and HBsAg levels < 1500 IU/mL at FW24 were comparable in all groups. Ropeginterferon alfa-2b (group 1 & 2) had numerically lower incidence of rash (9.5% and 4.5%) as compared to PEG-IFN alfa-2a (36.8%). Ropeginterferon alfa-2b 350 μg (group 1) had more ALT elevation (38.1%), however the rate was comparable in group 2 (9.1%) and group 3 (10.5%).
CONCLUSION


In this preliminary study, ropeginterferon alfa-2b, although in only half the number of injections, is as safe and effective as pegylated interferon alfa-2a for chronic hepatitis B.",2020,The rate of HBV DNA < 2000 IU/mL and HBsAg levels < 1500 IU/mL at FW24 were comparable in all groups.,"['Thirty-one HBeAg-positive and 31 HBeAg-negative were stratified by HBeAg status', 'patients with chronic hepatitis B', 'chronic hepatitis B']","['Ropeginterferon alfa-2b', 'q2w ropeginterferon alfa-2b 350\xa0μg (group 1), q2w 450\xa0μg (group 2) or q1w PEG-IFN alfa-2a 180\xa0μg', 'interferon alfa-2a', '48-week treatment (TW48) and 24-week post-treatment follow-up (FW24']","['Cumulative HBeAg seroconversion rate', 'ALT elevation', 'safety and efficacy', 'rate of HBV DNA', 'incidence of rash']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}]","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0391001', 'cui_str': 'peginterferon alfa-2a'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0021734', 'cui_str': 'Interferon Alfa-2a'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",,0.108808,The rate of HBV DNA < 2000 IU/mL and HBsAg levels < 1500 IU/mL at FW24 were comparable in all groups.,"[{'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Huang', 'Affiliation': 'Liver Center, Cathay General Hospital Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Chao-Wei', 'Initials': 'CW', 'LastName': 'Hsu', 'Affiliation': 'Division of Hepatogastroenterology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan.'}, {'ForeName': 'Sheng-Nan', 'Initials': 'SN', 'LastName': 'Lu', 'Affiliation': 'Division of Hepatogastroenterology, Department of Internal Medicine, Chia-Yi Chang Gung Memorial Hospital, Chia-Yi, Taiwan.'}, {'ForeName': 'Ming-Lung', 'Initials': 'ML', 'LastName': 'Yu', 'Affiliation': 'Hepatobiliary Section, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Chien-Wei', 'Initials': 'CW', 'LastName': 'Su', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Wen', 'Initials': 'WW', 'LastName': 'Su', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan.'}, {'ForeName': 'Rong-Nan', 'Initials': 'RN', 'LastName': 'Chien', 'Affiliation': 'Division of Hepatogastroenterology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan.'}, {'ForeName': 'Ching-Sheng', 'Initials': 'CS', 'LastName': 'Hsu', 'Affiliation': 'Liver Diseases Research Center, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jer', 'Initials': 'SJ', 'LastName': 'Hsu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital Yun-Lin Branch, Yunlin, Taiwan.'}, {'ForeName': 'Hsueh-Chou', 'Initials': 'HC', 'LastName': 'Lai', 'Affiliation': 'Division of Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Qin', 'Affiliation': 'PharmaEssentia Corp, Taipei, Taiwan.'}, {'ForeName': 'Kuan-Chiao', 'Initials': 'KC', 'LastName': 'Tseng', 'Affiliation': 'PharmaEssentia Corp, Taipei, Taiwan.'}, {'ForeName': 'Pei-Jer', 'Initials': 'PJ', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, No. 7, Chung-Shan South Rd., Taipei, Taiwan. peijerchen@ntu.edu.tw.'}]",Hepatology international,['10.1007/s12072-020-10098-y']
53,33068751,Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder: Cognitive and Electroencephalographic Predictors of Treatment Response.,"OBJECTIVE


The current study applies a precision medicine approach to trigeminal nerve simulation (TNS), a Food and Drug Administration-approved neuromodulation treatment for attention-deficit/hyperactivity disorder (ADHD), by testing secondary outcomes of cognitive and electroencephalographic [EEG] predictors of treatment response among subjects from the original randomized controlled trial.
METHOD


Children aged 8 to 12 years with ADHD, were randomized to 4 weeks of active or sham TNS treatment, after which the sham group crossed over into 4 weeks of open-label treatment. TNS treatment responders (RESP) had an ADHD Rating Scale (ADHD-RS) Total score reduction of ≥25%, whereas nonresponders (NR) had <25% reduction posttreatment. Assessments included weekly behavioral ratings and pre-/posttreatment cognitive EEG measures.
RESULTS


The final sample was 25 RESP and 26 NR comprising 34 male and 17 female children, with a mean (SD) age of 10.3 (1.4) years. Baseline measures that significantly differentiated RESP from NR included: lower working memory, lower spelling and mathematics achievement, deficits on behavioral ratings of executive function (BRIEF), and lower resting state EEG power in the right frontal (F4) region (all p values <.05). Compared to NRs, responders showed significantly increased right frontal EEG power with TNS treatment, which was predictive of improved executive functions and ADHD symptomatology (β = 0.65, p < .001). When EEG findings and behavior were modeled together, the area under the curve (AUC) for BRIEF Working Memory scale was 0.83 (p = .003), indicating moderate prediction of treatment response.
CONCLUSION


Children with ADHD who have executive dysfunction are more likely to be TNS responders and show modulation of right frontal brain activity, improved/normalized executive functions, and ADHD symptom reduction.
CLINICAL TRIAL REGISTRATION INFORMATION


Developmental Pilot Study of External Trigeminal Nerve Stimulation for ADHD; http://clinicaltrials.gov; NCT02155608.",2020,"Baseline measures that significantly differentiated RESP from NR include: lower working memory, lower spelling and math achievement, deficits on behavioral ratings of executive function (BRIEF), and lower resting state EEG power in the right frontal (F4) region (all p's <.05).","['subjects from the original randomized controlled trial', 'The final sample was 25 RESP and 26 NR (34 male children, mean age 10.3 (1.4) years', 'Children aged 8-12 years with ADHD']","['active or sham TNS', 'Trigeminal Nerve Simulation (TNS']","['right frontal EEG power', 'ADHD Rating Scale (ADHD-RS', 'normalized executive functions, and ADHD symptom reduction', 'weekly behavioral ratings and pre-/post-treatment cognitive and EEG measures', 'working memory, lower spelling and math achievement, deficits on behavioral ratings of executive function (BRIEF), and lower resting state EEG power in the right frontal (F4) region', 'area under the curve (AUC) for BRIEF Working Memory scale', 'executive functions and ADHD symptomatology', 'Total score reduction']","[{'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",34.0,0.0251203,"Baseline measures that significantly differentiated RESP from NR include: lower working memory, lower spelling and math achievement, deficits on behavioral ratings of executive function (BRIEF), and lower resting state EEG power in the right frontal (F4) region (all p's <.05).","[{'ForeName': 'Sandra K', 'Initials': 'SK', 'LastName': 'Loo', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: sloo@mednet.ucla.edu.'}, {'ForeName': 'Giulia C', 'Initials': 'GC', 'LastName': 'Salgari', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Ellis', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cowen', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Dillon', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'McGough', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, Los Angeles, California.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.09.021']
54,33103925,Effectiveness of brief schema group therapy for borderline personality disorder symptoms: a randomized pilot study.,"BACKGROUND AND OBJECTIVES


Schema group therapy is a potentially cost-effective treatment for borderline personality disorder (BPD). We piloted the feasibility and effectiveness of a 20-session schema group therapy without individual therapy among psychiatric BPD outpatients in a randomized pilot study registered as a clinical trial (ISRCTN76381242).
METHODS


Altogether 42 psychiatric outpatients diagnosed with BPD were randomized 2:1 to a 20-session weekly schema group therapy plus treatment as usual (TAU) ( n  = 28) vs. a control group with TAU alone ( n  = 14). The primary outcome was decline of BPD symptoms in the short Borderline Symptom List (BSL-23) score. Secondary outcomes were decline in symptoms of anxiety, depression, alcohol use, and improvement in functioning and schema modes. Two external experts evaluated validity of the intervention based on videotaped sessions.
RESULTS


Overall, 23 schema group therapy patients (82%) and 12 controls (86%) completed their treatment. Treatment validity good or very good. However, no significant differences emerged in the primary outcome mean BSL-23 decline (6.95 [SE 5.91] in group schema therapy vs. 12.55 [4.85] in TAU) or in any of the secondary outcome measures.
LIMITATIONS


Despite randomization, the TAU subgroup had non-significantly higher baseline scores in most measures. Small sample size predisposing to type II errors; reliance on self-reported outcomes.
CONCLUSIONS


Schema group therapy was feasible for psychiatric outpatients with BPD. However, in this small pilot study we did not find it more effective than TAU. Effectiveness of this short intervention remains open.",2021,"We piloted the feasibility and effectiveness of a 20-session schema group therapy without individual therapy among psychiatric BPD outpatients in a randomized pilot study registered as a clinical trial (ISRCTN76381242).
","['borderline personality disorder symptoms', 'Altogether 42 psychiatric outpatients diagnosed with BPD', 'psychiatric BPD outpatients', 'psychiatric outpatients with BPD', 'borderline personality disorder (BPD']","['20-session schema group therapy without individual therapy', 'control group with TAU alone', '20-session weekly schema group therapy plus treatment as usual (TAU', 'brief schema group therapy']","['decline in symptoms of anxiety, depression, alcohol use, and improvement in functioning and schema modes', 'decline of BPD symptoms in the short Borderline Symptom List (BSL-23) score', 'mean BSL-23 decline']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1443933', 'cui_str': 'Laboratory biosafety level'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",2.0,0.0816193,"We piloted the feasibility and effectiveness of a 20-session schema group therapy without individual therapy among psychiatric BPD outpatients in a randomized pilot study registered as a clinical trial (ISRCTN76381242).
","[{'ForeName': 'Hanna-Mari', 'Initials': 'HM', 'LastName': 'Hilden', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Rosenström', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Karila', 'Affiliation': 'KL Institute, Helsinki, Finland.'}, {'ForeName': 'Aila', 'Initials': 'A', 'LastName': 'Elokorpi', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mirka', 'Initials': 'M', 'LastName': 'Torpo', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ritva', 'Initials': 'R', 'LastName': 'Arajärvi', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Isometsä', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",Nordic journal of psychiatry,['10.1080/08039488.2020.1826050']
55,33110649,The  Bacillus  Calmette-Guérin (BCG) Vaccine: Is it a better choice for the treatment of viral warts?,"Objectives


This study aimed to compare the effectiveness of the  bacillus  Calmette-Guérin (BCG) vaccine with topical salicylic acid (SA) in the treatment of viral warts.
Methods


This non-randomised controlled trial was conducted at the Al-Sader Teaching Hospital, Basrah, Iraq, from January 2016 to April 2017. A total of 201 patients with viral warts were injected with an intradermal purified protein derivative. Subsequently, those with negative tuberculin test results received an intradermal BCG vaccination, while those with positive results underwent conventional treatment with topical SA. Patients were assessed for any signs of improvement at one, two and three months.
Results


Overall, 190 patients completed the trial; of these, 133 (70%) received the BCG vaccine and 57 (30%) were treated with topical SA. Complete response to treatment was observed in 9.8% and 5.3% of patients in the BCG and SA groups, respectively ( P  <0.001). Cure rates were significantly higher for patients with genital (22.2% versus 7.7%;  P  = 0.002) and common warts (8.5% versus 0%;  P  = 0.001) treated with the BCG vaccine; however, the reverse was true for flat warts (12.9% versus 25%;  P  = 0.041). A binary logistic regression analysis indicated that BCG therapy was the only significant independent predictor of positive treatment response (odds ratio: 7.56, 95% confidence interval: 3.72-15.36;  P  <0.001).
Conclusion


The BCG vaccine was more effective than topical SA for treating viral warts, with the best response noted in the treatment of genital warts, followed by flat warts. However,  plantar  warts demonstrated least response to this treatment.",2020,"Cure rates were significantly higher for patients with genital (22.2% versus 7.7%;  P  = 0.002) and common warts (8.5% versus 0%;  P  = 0.001) treated with the BCG vaccine; however, the reverse was true for flat warts (12.9% versus 25%;  P  = 0.041).","['Al-Sader Teaching Hospital, Basrah, Iraq, from January 2016 to April 2017', '201 patients with viral warts', '190 patients completed the trial; of these, 133 (70%) received the']","['conventional treatment with topical SA', 'BCG vaccine', 'topical SA', 'Guérin (BCG) Vaccine', 'bacillus  Calmette-Guérin (BCG) vaccine with topical salicylic acid (SA', 'intradermal BCG vaccination', 'intradermal purified protein derivative']","['Cure rates', 'positive treatment response', 'Complete response to treatment']","[{'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0022066', 'cui_str': 'Iraq'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517563', 'cui_str': '133'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3212023', 'cui_str': 'Salicylic acid-containing product in cutaneous dose form'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0199804', 'cui_str': 'BCG vaccination'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1275810', 'cui_str': 'Complete therapeutic response'}]",201.0,0.0875421,"Cure rates were significantly higher for patients with genital (22.2% versus 7.7%;  P  = 0.002) and common warts (8.5% versus 0%;  P  = 0.001) treated with the BCG vaccine; however, the reverse was true for flat warts (12.9% versus 25%;  P  = 0.041).","[{'ForeName': 'Asaad Q', 'Initials': 'AQ', 'LastName': 'Al-Yassen', 'Affiliation': 'Department of Family & Community Medicine, College of Medicine, Basrah University, Basrah, Iraq.'}, {'ForeName': 'Shukrya K', 'Initials': 'SK', 'LastName': 'Al-Maliki', 'Affiliation': 'Department of Family & Community Medicine, College of Medicine, Basrah University, Basrah, Iraq.'}, {'ForeName': 'Jasim N', 'Initials': 'JN', 'LastName': 'Al-Asadi', 'Affiliation': 'Department of Family & Community Medicine, College of Medicine, Basrah University, Basrah, Iraq.'}]",Sultan Qaboos University medical journal,['10.18295/squmj.2020.20.03.013']
56,33069871,A pilot randomized trial of contrast-rebalanced binocular treatment for deprivation amblyopia.,"BACKGROUND


Binocular neural architecture may be preserved in children with deprivation amblyopia due to unilateral cataract. The purpose of this study was to investigate whether a contrast-rebalanced binocular treatment, recently used with success to treat the interocular suppression and amblyopia in strabismic and anisometropic children, can contribute to rehabilitation of visual acuity in children with deprivation amblyopia secondary to monocular cataract.
METHODS


In a pilot randomized trial, 15 children (4-13 years of age) were enrolled and randomized to continue with their current treatment only (n = 7) or to continue with their current treatment and add contrast-rebalanced binocular iPad game play 5 hours/week for 4 weeks (n = 8). The primary outcome was change in visual acuity at 4 weeks.
RESULTS


Although 10 of 15 participants were patching, there was little change in visual acuity during the 3 months prior to enrollment. At the 4-week primary outcome visit, the mean improvement in visual acuity for the binocular game group was significantly greater than that for the current-treatment group (0.08 ± 0.10 logMAR vs -0.03 ± 0.05 logMAR [t 10.2  = 2.53, P = 0.03]). None of the children who had dense congenital cataract achieved improved visual acuity with binocular treatment.
CONCLUSIONS


In this study cohort, visual acuity improved over 8 weeks in children with unilateral deprivation amblyopia who played a binocular contrast-rebalanced binocular iPad game.",2020,"At the 4-week primary outcome visit, the mean improvement in visual acuity for the binocular game group was significantly greater than that for the current-treatment group (0.08 ± 0.10 logMAR vs -0.03 ± 0.05 logMAR [t 10.2  = 2.53, P = 0.03]).","['children with deprivation amblyopia due to unilateral cataract', 'children with unilateral deprivation amblyopia who played a binocular contrast-rebalanced binocular iPad game', 'deprivation amblyopia', 'strabismic and anisometropic children', 'children with deprivation amblyopia secondary to monocular cataract', '15 children (4-13 years of age']","['contrast-rebalanced binocular treatment', 'continue with their current treatment and add contrast-rebalanced binocular iPad game play']","['mean improvement in visual acuity', 'visual acuity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0152189', 'cui_str': 'Stimulus deprivation amblyopia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0521706', 'cui_str': 'Unilateral cataract'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",15.0,0.213266,"At the 4-week primary outcome visit, the mean improvement in visual acuity for the binocular game group was significantly greater than that for the current-treatment group (0.08 ± 0.10 logMAR vs -0.03 ± 0.05 logMAR [t 10.2  = 2.53, P = 0.03]).","[{'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Birch', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas; Department of Ophthalmology, UT Southwestern Medical Center, Dallas, Texas. Electronic address: ebirch@rfsw.org.'}, {'ForeName': 'Reed M', 'Initials': 'RM', 'LastName': 'Jost', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Serena X', 'Initials': 'SX', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Krista R', 'Initials': 'KR', 'LastName': 'Kelly', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas; Department of Ophthalmology, UT Southwestern Medical Center, Dallas, Texas.'}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2020.07.009']
57,33108574,Single-Session Cerebellar Transcranial Direct Current Stimulation Affects Postural Control Learning and Cerebellar Brain Inhibition in Healthy Individuals.,"Cerebellar transcranial direct current stimulation (ctDCS) modulates cerebellar activity and postural control. However, the effects of ctDCS on postural control learning and the mechanisms associated with these effects remain unclear. To examine the effects of single-session ctDCS on postural control learning and cerebellar brain inhibition (CBI) of the primary motor cortex in healthy individuals. In this triple-blind, sham-controlled study, 36 participants were allocated randomly to one of three groups: (1) anodal ctDCS group, (2) cathodal ctDCS group, and (3) sham ctDCS group. ctDCS (2 mA) was applied to the cerebellar brain for 20 min prior to six blocks of standing postural control training (each block consisted of five trials of a 30-s tracking task). CBI and corticospinal excitability of the tibialis anterior muscle were assessed at baseline, immediately after, 1 day after, and 7 days after training. Skill acquisition following training was significantly reduced in both the anodal and cathodal ctDCS groups compared with the sham ctDCS group. Changes in performance measured 1 day after and 7 days after training did not differ among the groups. In the anodal ctDCS group, CBI significantly increased after training, whereas corticospinal excitability decreased. Anodal ctDCS-induced CBI changes were correlated with the learning formation of postural control (r = 0.55, P = 0.04). Single-session anodal and cathodal ctDCS could suppress the skill acquisition of postural control in healthy individuals. The CBI changes induced by anodal ctDCS may affect the learning process of postural control.",2021,Skill acquisition following training was significantly reduced in both the anodal and cathodal ctDCS groups compared with the sham ctDCS group.,"['36 participants', 'Healthy Individuals', 'healthy individuals']","['ctDCS', 'standing postural control training', 'Cerebellar transcranial direct current stimulation (ctDCS', 'single-session ctDCS', 'anodal ctDCS group, (2) cathodal ctDCS group, and (3) sham ctDCS', 'Single-session anodal and cathodal ctDCS', 'anodal ctDCS', 'Single-Session Cerebellar Transcranial Direct Current Stimulation']","['postural control learning', 'CBI and corticospinal excitability of the tibialis anterior muscle', 'corticospinal excitability', 'CBI', 'learning formation of postural control', 'Anodal ctDCS-induced CBI changes', 'skill acquisition of postural control', 'postural control learning and cerebellar brain inhibition (CBI', 'Skill acquisition']","[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",36.0,0.0282038,Skill acquisition following training was significantly reduced in both the anodal and cathodal ctDCS groups compared with the sham ctDCS group.,"[{'ForeName': 'Natsuki', 'Initials': 'N', 'LastName': 'Katagiri', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kawakami', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan.'}, {'ForeName': 'Sayuri', 'Initials': 'S', 'LastName': 'Okuyama', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan.'}, {'ForeName': 'Tadaki', 'Initials': 'T', 'LastName': 'Koseki', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kudo', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan.'}, {'ForeName': 'Shigehiro', 'Initials': 'S', 'LastName': 'Namba', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Tanabe', 'Affiliation': 'Faculty of Rehabilitation, School of Health Sciences, Fujita Health University, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi, 470-1192, Japan.'}, {'ForeName': 'Tomofumi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Physical Therapy, Graduate School of Health Sciences, Yamagata Prefectural University of Health Sciences, 260 Kamiyanagi, Yamagata-shi, Yamagata, 990-2212, Japan. t.yamaguchi.ja@juntendo.ac.jp.'}]","Cerebellum (London, England)",['10.1007/s12311-020-01208-5']
58,33128725,Validation of the Ankylosing Spondylitis Quality of Life assessment tool in patients with non-radiographic axial spondyloarthritis.,"PURPOSE


To evaluate the psychometric performance of the Ankylosing Spondylitis Quality of Life (ASQoL) scale in patients with non-radiographic axial spondyloarthritis (nr-axSpA) to assess its appropriateness as an outcome measure in future clinical studies.
METHODS


Patients with active axSpA from a Phase III, randomized, double-blind, placebo-controlled trial (RAPID-axSpA, NCT01087762) were included (N = 325). Modified New York (mNY) classification criteria were used to classify patients as having ankylosing spondylitis or nr-axSpA; those with nr-axSpA were further categorized based on objective signs of inflammation. Psychometric properties of the ASQoL were assessed/documented using a mixture of modern psychometric methods and classical test theory methods. These included exploratory factor analysis and item response theory models to assess the domain structure, test the utility of a single domain relative to subdomains, assess bias, and generate statistics to guide an empirical scoring algorithm. The reliability and validity of scores were evaluated via internal consistency, test-retest reliability, concurrent validity, and known-groups validity. Score responsiveness was assessed via anchor-based clinically meaningful change, supplemented with empirical cumulative distribution function visualizations.
RESULTS


The ASQoL data were defined by four domains. However, a four-domain solution was found to be inferior to a bifactor solution in which the four domains were included within a total domain. Scoring statistics supported a unit-weighted total score. Within the nr-axSpA population with objective signs of inflammation, the ASQoL mean score had adequate reliability, validity, and ability to detect clinically meaningful change.
CONCLUSIONS


Our findings suggest that the ASQoL is an appropriate outcome measure in interventional clinical trials in patients with nr-axSpA.",2021,"Within the nr-axSpA population with objective signs of inflammation, the ASQoL mean score had adequate reliability, validity, and ability to detect clinically meaningful change.
","['patients with non-radiographic axial spondyloarthritis (nr-axSpA', 'patients with nr-axSpA', 'Patients with active axSpA from a Phase III', 'patients with non-radiographic axial spondyloarthritis']","['Modified New York (mNY', 'placebo', 'ASQoL']","['psychometric performance of the Ankylosing Spondylitis Quality of Life (ASQoL) scale', 'Score responsiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3889038', 'cui_str': 'Non-radiographic axial spondyloarthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.181763,"Within the nr-axSpA population with objective signs of inflammation, the ASQoL mean score had adequate reliability, validity, and ability to detect clinically meaningful change.
","[{'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hoepken', 'Affiliation': 'UCB Pharma, Alfred-Nobel-Strasse 10, 40789, Monheim am Rhein, Germany. Bengt.Hoepken@ucb.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Serrano', 'Affiliation': 'Pharmerit International, Bethesda, MD, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Harris', 'Affiliation': 'UCB Pharma, Hong Kong, China.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Hwang', 'Affiliation': 'McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Reveille', 'Affiliation': 'McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02686-0']
59,33111239,Substance Use Disorder Detection Rates Among Providers of General Medical Inpatients.,"BACKGROUND


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


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


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


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


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


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


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


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


Provider detection rates were highest for nicotine use disorder (72.2%) and lowest for cannabis use disorder (26.4%).","[{'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Serowik', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA. kristin.serowik@yale.edu.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Forray', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zimbrean', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06319-7']
60,33142016,"Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Further Analyses of a Randomized, Double-Blind, Placebo-Controlled Trial.","OBJECTIVE


In the SENSCIS trial in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks by 44% versus placebo. This study was undertaken to investigate the effects of nintedanib on categorical changes in FVC and other measures of ILD progression.
METHODS


In post hoc analyses, we assessed the proportions of subjects with categorical changes in FVC % predicted at week 52 and the time to absolute decline in FVC of ≥5% predicted or death and absolute decline in FVC of ≥10% predicted or death.
RESULTS


A total of 288 subjects received nintedanib and 288 subjects received placebo. At week 52, in subjects treated with nintedanib and placebo, respectively, 55.7% and 66.3% had any decline in FVC % predicted, 13.6% and 20.1% had a decline in FVC of >5% to ≤10% predicted, and 3.5% and 5.2% had a decline in FVC of >10% to ≤15% predicted; 34.5% and 43.8% had a decrease in FVC of ≥3.3% predicted (proposed minimal clinically important difference [MCID] for worsening of FVC), while 23.0% and 14.9% had an increase in FVC of ≥3.0% predicted (proposed MCID for improvement in FVC). Over 52 weeks, the hazard ratio (HR) for an absolute decline in FVC of ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% confidence interval [95% CI] 0.66-1.06) (P = 0.14), and the HR for an absolute decline in FVC of ≥10% predicted was 0.64 (95% CI 0.43-0.95) (P = 0.029).
CONCLUSION


These results suggest that nintedanib has a clinically relevant benefit on the progression of SSc-ILD.",2021,"Over 52 weeks, the hazard ratio for an absolute decline in FVC ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% CI: 0.66, 1.06) (P=0.14) and the hazard ratio for an absolute decline in FVC ≥10% predicted was 0.64 (95% CI: 0.43, 0.95); P=0.029.
","['subjects with systemic sclerosis-associated ILD (SSc-ILD', 'patients with systemic sclerosis-associated interstitial lung disease', '288 subjects received nintedanib and 288 received']","['nintedanib and placebo', 'placebo', 'nintedanib']","['lung function', 'FVC decline']","[{'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",288.0,0.283625,"Over 52 weeks, the hazard ratio for an absolute decline in FVC ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% CI: 0.66, 1.06) (P=0.14) and the hazard ratio for an absolute decline in FVC ≥10% predicted was 0.64 (95% CI: 0.43, 0.95); P=0.029.
","[{'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'National Heart and Lung Institute, Imperial College London and NIHR Clinical Research Facility, Royal Brompton Hospital, London, UK, and Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Maureen D', 'Initials': 'MD', 'LastName': 'Mayes', 'Affiliation': 'University of Texas McGovern Medical School, Houston.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Thoraxklinik, University of Heidelberg, and the German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'University of California, David Geffen School of Medicine, Los Angeles.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Aringer', 'Affiliation': 'University Medical Center and Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Castellvi', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cutolo', 'Affiliation': 'University of Genova, IRCCS San Martino Polyclinic Hospital, Genova, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stock', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Schoof', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Alves', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41576']
61,33152697,Lessons From Adaptive Randomization: Spying the I-SPY2 Trial in Breast Cancer.,,2020,,['Breast Cancer'],[],[],"[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",[],[],,0.037732,,"[{'ForeName': 'Bishal', 'Initials': 'B', 'LastName': 'Gyawali', 'Affiliation': ''}, {'ForeName': 'Saroj', 'Initials': 'S', 'LastName': 'Niraula', 'Affiliation': ''}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2020.7648']
62,33152708,Cost-Effectiveness of Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer.,"BACKGROUND


Maintenance therapy with the PARP inhibitor olaparib for metastatic pancreatic cancer (MPC) with a germline BRCA1 or BRCA2 mutation has been shown to be effective. We aimed to evaluate the cost-effectiveness of maintenance olaparib for MPC from the US payer perspective.
MATERIALS AND METHODS


A partitioned survival model was adopted to project the disease course of MPC. Efficacy and toxicity data were gathered from the Pancreas Cancer Olaparib Ongoing (POLO) trial. Transition probabilities were estimated from the reported survival probabilities in each POLO group. Cost and health preference data were derived from the literature. The incremental cost-utility ratio, incremental net-health benefit, and incremental monetary benefit were measured. Subgroup analysis, one-way analysis, and probabilistic sensitivity analysis were performed to explore the model uncertainties.
RESULTS


Maintenance olaparib had an incremental cost-utility ratio of $191,596 per additional progression-free survival (PFS) quality-adjusted life-year (QALY) gained, with a high cost of $132,287 and 0.691 PFS QALY gained, compared with results for a placebo. Subgroup analysis indicated that maintenance olaparib achieved at least a 16.8% probability of cost-effectiveness at the threshold of $200,000/QALY. One-way sensitivity analyses revealed that the results were sensitive to the hazard ratio of PFS and the cost of olaparib. When overall survival was considered, maintenance olaparib had an incremental cost-utility ratio of $265,290 per additional QALY gained, with a high cost of $128,266 and 0.483 QALY gained, compared with results for a placebo.
CONCLUSIONS


Maintenance olaparib is potentially cost-effective compared with placebo for patients with a germline BRCA mutation and MPC. Economic outcomes could be improved by tailoring treatment based on individual patient factors.",2020,"Subgroup analysis indicated that maintenance olaparib achieved at least a 16.8% probability of cost-effectiveness at the threshold of $200,000/QALY.","['patients with a germline BRCA mutation and MPC', 'metastatic pancreatic cancer (MPC', 'Germline BRCA-Mutated Metastatic Pancreatic Cancer']","['PARP inhibitor olaparib', 'placebo', 'Maintenance Olaparib']","['cost-effectiveness', 'incremental cost-utility ratio of $191,596 per additional progression-free survival (PFS) quality-adjusted life-year (QALY', 'incremental cost-utility ratio, incremental net-health benefit, and incremental monetary benefit', 'Transition probabilities', 'survival probabilities', 'hazard ratio of PFS and the cost of olaparib', 'Efficacy and toxicity data', 'incremental cost-utility ratio', 'Cost and health preference data', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}]","[{'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.129863,"Subgroup analysis indicated that maintenance olaparib achieved at least a 16.8% probability of cost-effectiveness at the threshold of $200,000/QALY.","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': '1Medical Decision and Economic Group, Department of Pharmacy, Ren Ji Hospital, South Campus, School of Medicine, Shanghai Jiaotong University, Shanghai, China; and.'}, {'ForeName': 'Lizheng', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': '2Department of Global Health Management and Policy, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2020.7587']
63,33154429,Electronic health record alerts enhance mass screening for chronic hepatitis B.,"To measure the effect of an electronic health record (EHR) alert on chronic hepatitis B (CHB) screening among at-risk Asian and Pacific Islanders (API). API patients who had not yet completed hepatitis B surface antigen (HBsAg) testing were identified by a novel EHR-based population health tool. At-risk API patients in Cohort 1 (primarily privately insured) and Cohort 2 (includes Medicare and/or Medicaid) were randomized to alert activation in their electronic medical charts or not. In total, 8299 API were found to be deficient in HBsAg completion at baseline within our health system. In Cohort 1, 1542 patients and 1568 patients were randomized to the alert and control respectively. In Cohort 2, 2599 patients and 2590 patients were randomized to the alert and control respectively. For both cohorts combined, 389 HBsAg tests were completed in the alert group compared to 177 HBsAg tests in the control group (p < 0.0001; OR = 2.3; 95% CI 1.94-2.80), but there was no increased detection of HBsAg positivity from the alert (15 versus 13 respectively, p = 0.09; OR = 0.5; 95% CI 0.24-1.09). Our results demonstrate that personalized, automated electronic alerts increase screening for CHB, but more comprehensive measures are needed to detect HBsAg positive patients.NIH Trial Registry Number: NCT04240678.",2020,"For both cohorts combined, 389 HBsAg tests were completed in the alert group compared to 177 HBsAg tests in the control group (p < 0.0001; OR = 2.3; 95% CI 1.94-2.80), but there was no increased detection of HBsAg positivity from the alert (15 versus 13 respectively, p = 0.09; OR = 0.5; 95% CI 0.24-1.09).","['At-risk API patients in Cohort 1 (primarily privately insured) and Cohort 2 (includes Medicare and/or Medicaid', '2599 patients and 2590 patients', 'chronic hepatitis B', 'chronic hepatitis B (CHB) screening among at-risk Asian and Pacific Islanders (API', 'API patients who had not yet completed hepatitis B surface antigen ', '1542 patients and 1568 patients']","['electronic health record (EHR) alert', 'Electronic health record alerts enhance mass screening']","['detection of HBsAg positivity', 'HBsAg completion']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0242191', 'cui_str': 'Pacific Island Americans'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}]","[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0024870', 'cui_str': 'Mass Screening'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",8299.0,0.0903795,"For both cohorts combined, 389 HBsAg tests were completed in the alert group compared to 177 HBsAg tests in the control group (p < 0.0001; OR = 2.3; 95% CI 1.94-2.80), but there was no increased detection of HBsAg positivity from the alert (15 versus 13 respectively, p = 0.09; OR = 0.5; 95% CI 0.24-1.09).","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Chak', 'Affiliation': 'Division of Gastroenterology and Hepatology, UC Davis School of Medicine, 4150 V Street, PSSB 3500, Sacramento, CA, USA. echak@ucdavis.edu.'}, {'ForeName': 'Chin-Shang', 'Initials': 'CS', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The State University of New York, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Moon S', 'Initials': 'MS', 'LastName': 'Chen', 'Affiliation': 'Division of Hematology and Oncology, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'MacDonald', 'Affiliation': 'Division of Clinical Informatics, UC Davis Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bowlus', 'Affiliation': 'Division of Gastroenterology and Hepatology, UC Davis School of Medicine, 4150 V Street, PSSB 3500, Sacramento, CA, USA.'}]",Scientific reports,['10.1038/s41598-020-75842-8']
64,33148701,Switching between Janus kinase inhibitor upadacitinib and adalimumab following insufficient response: efficacy and safety in patients with rheumatoid arthritis.,"OBJECTIVES


To evaluate efficacy and safety of immediate switch from upadacitinib to adalimumab, or vice versa, in patients with rheumatoid arthritis with non-response or incomplete-response to the initial therapy.
METHODS


SELECT-COMPARE randomised patients to upadacitinib 15 mg once daily (n=651), placebo (n=651) or adalimumab 40 mg every other week (n=327). A treat-to-target study design was implemented, with blinded rescue occurring prior to week 26 for patients who did not achieve at least 20% improvement in both tender and swollen joint counts ('non-responders') and at week 26 based on Clinical Disease Activity Index (CDAI) >10 ('incomplete-responders') without washout.
RESULTS


A total of 39% (252/651) and 49% (159/327) of patients originally randomised to upadacitinib and adalimumab were rescued to the alternate therapy. In both switch groups (adalimumab to upadacitinib and vice versa) and in non-responders and incomplete-responders, improvements in disease activity were observed at 3 and 6 months following rescue. CDAI low disease activity was achieved by 36% and 47% of non-responders and 45% and 58% of incomplete-responders switched to adalimumab and upadacitinib, respectively, 6 months following switch. Overall, approximately 5% of rescued patients experienced worsening in disease activity at 6 months postswitch. The frequency of adverse events was similar between switch groups.
CONCLUSIONS


These observations support a treat-to-target strategy, in which patients who fail to respond initially (or do not achieve sufficient response) are switched to a therapy with an alternate mechanism of action and experience improved outcomes. No new safety findings were observed despite immediate switch without washout.",2020,"CDAI low disease activity was achieved by 36% and 47% of non-responders and 45% and 58% of incomplete-responders switched to adalimumab and upadacitinib, respectively, 6 months following switch.","['patients with rheumatoid arthritis with non-response or incomplete-response to the initial therapy', 'patients with rheumatoid arthritis']","['adalimumab', 'placebo']","['disease activity', 'CDAI low disease activity', 'Clinical Disease Activity Index (CDAI', 'frequency of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0449819,"CDAI low disease activity was achieved by 36% and 47% of non-responders and 45% and 58% of incomplete-responders switched to adalimumab and upadacitinib, respectively, 6 months following switch.","[{'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Medicine, The University of Texas Southwestern Medical Center and Metroplex Clinical Research Center, Dallas, Texas, USA rfleischmann@arthdocs.com.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Division of Rheumatology, Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Department of Medicine, Monash University, Cabrini Health and Emeritus Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Glen T D', 'Initials': 'GTD', 'LastName': 'Thomson', 'Affiliation': 'CIADS Research, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Filip E', 'Initials': 'FE', 'LastName': 'Van den Bosch', 'Affiliation': 'Department of Rheumatology, University Hospital Ghent, Gent, Oost-Vlaanderen, Belgium.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Zerbini', 'Affiliation': 'Centro Paulista de Investigação Clinica, São Paulo, Brazil.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bessette', 'Affiliation': 'Université Laval Faculté de médecine, Quebec City, Québec, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Enejosa', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Yihan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Yanna', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'DeMasi', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218412']
65,33190420,The effects of foot reflexology on blood pressure and heart rate: A randomized clinical trial in stage-2 hypertensive patients.,"Hypertension (HT) is a prominent cardiovascular risk factor. Although there are various pharmacological treatment choices for this condition, many patients fail to adhere to them, making non-pharmacological options attractive alternatives. Foot reflexology has been proven to decrease blood pressure (BP), but data are limited in patients with stage-2 HT. We conducted a randomized clinical trial to examine the effectiveness of foot reflexology in reducing BP and heart rate (HR). Stage-2 HT patients were enrolled and randomized into the intervention and the control groups (n = 47, each), the former of which underwent foot reflexology during a follow-up visit. Office BP and HR were measured before and at 15 and 30 min after the procedure in the intervention group and after resting in the control group. In the intervention group, systolic BP (SBP), diastolic BP (DBP), and HR at 15 min were significantly lower than at baseline: -3.29 mm Hg (95%CI; -5.64 to -0.93), -1.71 mm Hg (95%CI; -3.11 to -0.32), and -1.71 beats per min (bpm; 95%CI; -2.88 to -0.54), respectively. Similar trends were also observed at 30 min. However, when compared with the control group, only the reduction in HR was significant (-4.96 bpm; 95%CI, -9.63 to -0.28). We conclude that foot reflexology was effective in reducing HR in stage-2 HT patients and partially effective in reducing BP.",2021,"However, when compared with the control group, only the reduction in HR was significant (-4.96 bpm; 95%CI, -9.63 to -0.28).","['HT patients', 'patients with stage-2 HT', 'stage-2 HT patients', 'stage-2 hypertensive patients']",['foot reflexology'],"['Office BP and HR', 'blood pressure and heart rate', 'blood pressure (BP', 'reduction in HR', 'BP and heart rate (HR', 'systolic BP (SBP), diastolic BP (DBP), and HR at 15\xa0min', 'BP']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0676557,"However, when compared with the control group, only the reduction in HR was significant (-4.96 bpm; 95%CI, -9.63 to -0.28).","[{'ForeName': 'Praew', 'Initials': 'P', 'LastName': 'Kotruchin', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Supap', 'Initials': 'S', 'LastName': 'Imoun', 'Affiliation': 'Accident and Emergency Nursing Unit, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Thapanawong', 'Initials': 'T', 'LastName': 'Mitsungnern', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Patcharin', 'Initials': 'P', 'LastName': 'Aountrai', 'Affiliation': 'Accident and Emergency Nursing Unit, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Maneenuch', 'Initials': 'M', 'LastName': 'Domthaisong', 'Affiliation': 'Accident and Emergency Nursing Unit, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.14103']
66,33158554,"Functional connectivity changes and symptoms improvement after personalized, double-daily dosing, repetitive transcranial magnetic stimulation in obsessive-compulsive disorder: A pilot study.","BACKGROUND


intrusive thoughts and compulsive behaviors that characterize obsessive compulsive disorder (OCD) are associated to aberrant resting state functional connectivity (rsFC) patterns within the cortico-striatal-thalamo-cortical (CSTC) circuits. A high percentage of OCD patients do not respond to conventional pharmacological treatments or psychotherapy. In these patients, inhibitory repetitive transcranial magnetic stimulation (rTMS) of the Supplementary Motor Area (SMA) resulted in a significant clinical benefit.
METHODS


In the current study, we applied a novel protocol of 1-week MRI-guided individualized double-daily sessions of rTMS treatment (1-Hz; 110% of resting Motor Threshold/7200 pulses/day), to bilateral SMA in 9 OCD patients. We tested its (i) feasibility-safety, (ii) clinical efficacy and (iii) rsFC related changes.
RESULTS


Patients reported no side effects during and after rTMS. Personalized rTMS treatment led to a significant improvement of OCD symptoms (average 25%; p = .005) and persistence of benefit up to 3-month follow-up. rsFC analysis revealed a significant reduction of connectivity patterns between bilateral SMA and subcortical regions, specifically in the basal ganglia and thalamus. Additional analysis showed that OCD symptoms severity correlates with a higher connectivity pattern between bilateral SMA and subcortical regions.
CONCLUSIONS


rTMS double-daily sessions are safe, feasible and effective in OCD. The clinical outcomes, that are consistent with those found in our previous RCT, are linked to a decreased connectivity between SMA and subcortical brain areas implicated in control over obsessions and maladaptive compulsive behavior.",2021,Personalized rTMS treatment led to a significant improvement of OCD symptoms (average 25%; p = .005) and persistence of benefit up to 3-month follow-up.,"['9 OCD patients', 'obsessive-compulsive disorder']","['Personalized rTMS', 'inhibitory repetitive transcranial magnetic stimulation (rTMS) of the Supplementary Motor Area (SMA', 'rTMS', 'repetitive transcranial magnetic stimulation']","['safe, feasible and effective in OCD', 'connectivity patterns', 'feasibility-safety, (ii) clinical efficacy and (iii) rsFC related changes', 'OCD symptoms']","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",9.0,0.043163,Personalized rTMS treatment led to a significant improvement of OCD symptoms (average 25%; p = .005) and persistence of benefit up to 3-month follow-up.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Mantovani', 'Affiliation': 'Department of Molecular, Cellular and Biomedical Sciences, CUNY, School of Medicine, New York, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Neri', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy. Electronic address: f.neri@unifi.it.'}, {'ForeName': 'Giordano', 'Initials': 'G', 'LastName': ""D'Urso"", 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mencarelli', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy; Berenson-Allen Center for Non-Invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Tatti', 'Affiliation': 'Department of Molecular, Cellular and Biomedical Sciences, CUNY, School of Medicine, New York, USA.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Momi', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy; Berenson-Allen Center for Non-Invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Menardi', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy; Berenson-Allen Center for Non-Invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Sprugnoli', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Santarnecchi', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy; Berenson-Allen Center for Non-Invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rossi', 'Affiliation': 'Siena Brain Investigation and Neuromodulation Lab (Si-BIN Lab), Unit of Neurology and Clinical Neurophysiology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy; Department of Medicine, Surgery and Neuroscience, University of Siena School of Medicine, Siena, Italy.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.030']
67,33186516,"Safety and immunogenicity of a synthetic carbohydrate conjugate vaccine against Shigella flexneri 2a in healthy adult volunteers: a phase 1, dose-escalating, single-blind, randomised, placebo-controlled study.","BACKGROUND


Shigella remains in the top four pathogens responsible for moderate to severe diarrhoea in children below 5 years of age. The shigella O-specific polysaccharide (O-SP) is a promising vaccine target. We developed a conjugate vaccine prototype incorporating a unique well defined synthetic oligosaccharide hapten, chemically designed for optimal antigenic, conformational, structural, and functional mimicry of the O-SP from Shigella flexneri 2a (SF2a). We aimed to assess the safety, tolerability, and immunogenicity of this original synthetic oligosaccharide-based vaccine candidate, SF2a-TT15, conceived to drive the antibody response towards the key protective determinants of the native lipopolysaccharide antigen, in a first-in-human phase 1 study.
METHODS


We did a first-in-human, dose-escalating, single-blind, observer-masked, randomised, placebo-controlled study at the Clinical Research Center of Tel Aviv Sourasky Medical Center (Israel). Participants were healthy adults aged 18-45 years with low titres of serum SF2a-specific IgG antibodies. 64 eligible participants were assigned to one of two cohorts. 32 participants in each of the two cohorts were randomly assigned via computer-generated algorithm in a stepwise manner to receive the 2 μg (cohort 1) and 10 μg oligosaccharide dose (cohort 2) of the SF2a-TT15 vaccine candidate non-adjuvanted or adjuvanted with aluminium hydroxide (alum) or matching placebos. The vaccine was administered as three single intramuscular injections into the arm, 28 days apart. The primary outcome was the incidence and severity of adverse events, which were assessed in the intention-to-treat safety population analysis including all participants who were randomly assigned and received at least one vaccine or placebo injection. The immunogenicity endpoints were secondary outcomes and were analysed in all participants who were randomly assigned, received all of the assigned injections before the time of the immunogenicity assessment, and provided blood samples for immunological follow-up (per-protocol immunogenicity analysis). The study is registered with ClinicalStudies.gov, NCT02797236 and is completed.
FINDINGS


Of 203 volunteers initially screened, 64 participants were enrolled between Sept 20, 2016, and Sept 26, 2017. In each of the two cohorts, 12 participants received the adjuvanted vaccine, 12 received the non-adjuvanted vaccine and eight received the matching placebo (four each). The SF2a-TT15 glycoconjugate was well tolerated at both doses. No serious or severe adverse events occurred. Overall, seven (88%) of eight to 12 (100%) of 12 in each group of volunteers had one adverse event or more after receiving the study agents with the majority of adverse events, 300 (98%) of 307, considered mild in intensity. Of the seven adverse events defined as moderate in severity, one (nausea) was suspected to be related to the vaccine candidate. At all post-immunisation days and for both oligosaccharide doses, whether adjuvanted or not, SF2a-TT15 induced significantly higher serum IgG anti-SF2a lipopolysaccharide geometric mean titres (GMTs) as compared with baseline or with the corresponding GMTs in placebo recipients (p<0·01). After one injection, the non-adjuvanted 10 μg oligosaccharide dose induced a 27-times increase in IgG GMT (5080 vs 189) and the non-adjuvanted 2 μg oligosaccharide dose induced a five-times increase (1411 vs 283), compared with baseline. Alum enhanced the specific IgG response at 2 μg oligosaccharide dose after the third injection (GMTs 3200 vs 1176, p=0.045).
INTERPRETATION


SF2a-TT15 was safe and well tolerated and induced high titres of anti-SF2a LPS IgG antibodies. These results support further evaluation of this original synthetic oligosaccharide-protein conjugate vaccine candidate for safety, immunogenicity, and protective efficacy in target populations.
FUNDING


The European Union Seventh Framework Programme.",2021,"INTERPRETATION


SF2a-TT15 was safe and well tolerated and induced high titres of anti-SF2a LPS IgG antibodies.","['healthy adult volunteers', '203 volunteers initially screened, 64 participants were enrolled between Sept 20, 2016, and Sept 26, 2017', '64 eligible participants', 'children below 5 years of age', '32 participants in each of the two cohorts were', 'Participants were healthy adults aged 18-45 years with low titres of serum SF2a-specific IgG antibodies']","['adjuvanted vaccine, 12 received the non-adjuvanted vaccine and eight received the matching placebo', 'synthetic carbohydrate conjugate vaccine', 'randomly assigned via computer-generated algorithm in a stepwise manner to receive the 2 μg (cohort 1) and 10 μg oligosaccharide dose (cohort 2) of the SF2a-TT15 vaccine candidate non-adjuvanted or adjuvanted with aluminium hydroxide (alum) or matching placebos', 'placebo', 'vaccine or placebo injection']","['serum IgG anti-SF2a lipopolysaccharide geometric mean titres (GMTs', '27-times increase in IgG GMT', 'Safety and immunogenicity', 'incidence and severity of adverse events', 'specific IgG response', 'safety, tolerability, and immunogenicity', 'No serious or severe adverse events']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1265139', 'cui_str': 'Shigella flexneri, serovar 2a'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1265139', 'cui_str': 'Shigella flexneri, serovar 2a'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0051979', 'cui_str': 'Anti-Immunoglobulin G antibody'}, {'cui': 'C1265139', 'cui_str': 'Shigella flexneri, serovar 2a'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",64.0,0.493768,"INTERPRETATION


SF2a-TT15 was safe and well tolerated and induced high titres of anti-SF2a LPS IgG antibodies.","[{'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: dancohen@tauex.tau.ac.il.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Atsmon', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Clinical Research Center, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Artaud', 'Affiliation': 'Centre de Recherche Translationnelle-Coordination Clinique Institut Pasteur, Paris, France.'}, {'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Meron-Sudai', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Marie-Lise', 'Initials': 'ML', 'LastName': 'Gougeon', 'Affiliation': 'Unité Immunité Innée et Virus, Institut Pasteur, Paris, France.'}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Bialik', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Sophy', 'Initials': 'S', 'LastName': 'Goren', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Asato', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Ortal', 'Initials': 'O', 'LastName': 'Ariel-Cohen', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Arava', 'Initials': 'A', 'LastName': 'Reizis', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Dorman', 'Affiliation': 'School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Carla W G', 'Initials': 'CWG', 'LastName': 'Hoitink', 'Affiliation': 'Intravacc, Bilthoven, Netherlands.'}, {'ForeName': 'Janny', 'Initials': 'J', 'LastName': 'Westdijk', 'Affiliation': 'Intravacc, Bilthoven, Netherlands.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Ashkenazi', 'Affiliation': ""Adelson School of Medicine, Ariel University and Schneider Children's Hospital, Petah Tikva, Israel.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Sansonetti', 'Affiliation': 'Unité de Pathogénie Microbienne Moléculaire, Institut Pasteur, INSERM U1202, Paris, France.'}, {'ForeName': 'Laurence A', 'Initials': 'LA', 'LastName': 'Mulard', 'Affiliation': 'Unité de Chimie des Biomolécules, Institut Pasteur, UMR3523, CNRS, Paris, France.'}, {'ForeName': 'Armelle', 'Initials': 'A', 'LastName': 'Phalipon', 'Affiliation': 'Unité de Pathogénie Microbienne Moléculaire, Institut Pasteur, INSERM U1202, Paris, France.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30488-6']
68,33199274,Efficacy and safety of fasinumab in patients with chronic low back pain: a phase II/III randomised clinical trial.,"OBJECTIVES


To study the efficacy and safety of fasinumab in moderate-to-severe, chronic low back pain (CLBP).
METHODS


In this phase II/III, double-blind, placebo-controlled study, patients with CLBP aged ≥35 years with inadequate pain relief/intolerance to acetaminophen, non-steroidal anti-inflammatory drugs and opioids were randomised to fasinumab 6 or 9 mg subcutaneous every 4 weeks (Q4W), 9 mg intravenous every 8 weeks (Q8W) or placebo. Primary endpoint was change from baseline to week 16 in average daily low back pain intensity (LBPI) numeric rating score. Key secondary efficacy variables included Roland-Morris Disability Questionnaire (RMDQ) and Patient Global Assessment (PGA). The results are based on a modified intent-to-treat analysis of 563/800 planned patients when enrolment was stopped early given emerging signals of joint risk in other osteoarthritis (OA) studies at doses being tested here.
RESULTS


Significant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg Q4W and Q8W (least squares mean (standard error) -0.7 (0.3); both nominal p<0.05), but not 6 mg (-0.3 (0.3); p=0.39). RMDQ and PGA improvements to week 16 were greatest for fasinumab 9 mg intravenous. Numerically greater efficacy occurred in patients with, versus those without, peripheral OA (pOA) over 16 weeks. Treatment-emergent adverse events (AEs) occurred in 274/418 (65.6%) patients in the combined fasinumab groups and 94/140 (67.1%) placebo patients. Joint AEs, mostly rapid progressive OA type 1, were more frequent in the combined fasinumab groups (19 events in 16 patients (3.8%) vs 1 event in 1 patient (0.7%) for placebo); all except one occurred in pOA patients.
CONCLUSIONS


Fasinumab highest doses, but not lower dose, improved both CLBP pain and function. Most joint AEs occurred in pOA patients, consistent with earlier findings in symptomatic OA. Further study is needed of patients with CLBP with and without pOA to determine optimal benefit-risk.",2020,"RESULTS


Significant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg Q4W and Q8W (least squares mean (standard error) -0.7 (0.3); both nominal p<0.05), but not 6 mg (-0.3 (0.3); p=0.39).","['patients with CLBP with and without pOA', 'patients with CLBP aged ≥35 years with inadequate pain relief/intolerance to acetaminophen, non-steroidal anti-inflammatory drugs and opioids', 'patients with chronic low back pain', 'moderate-to-severe, chronic low back pain (CLBP']","['placebo', 'fasinumab']","['efficacy', 'CLBP pain and function', 'average daily low back pain intensity (LBPI) numeric rating score', 'RMDQ and PGA improvements', 'efficacy and safety', 'Roland-Morris Disability Questionnaire (RMDQ) and Patient Global Assessment (PGA', 'LBPI reductions', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C1135862', 'cui_str': 'Genus Poa'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1708484', 'cui_str': 'Inadequate pain relief'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4519593', 'cui_str': 'fasinumab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.198965,"RESULTS


Significant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg Q4W and Q8W (least squares mean (standard error) -0.7 (0.3); both nominal p<0.05), but not 6 mg (-0.3 (0.3); p=0.39).","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Dakin', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Department of Rheumatology, Altoona Center for Research, Duncansville, Pennsylvania, USA.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Gimbel', 'Affiliation': 'Arizona Research Center, Phoenix, Arizona, USA.'}, {'ForeName': 'Nebojsa', 'Initials': 'N', 'LastName': 'Skrepnik', 'Affiliation': 'Research Center, Tucson Orthopedic Institute, Tucson, Arizona, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'DiMartino', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Chetachi A', 'Initials': 'CA', 'LastName': 'Emeremni', 'Affiliation': 'R&D, Regeneron Pharmaceuticals Inc, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'R&D, Regeneron Pharmaceuticals Inc, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Stahl', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Geba', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA gregory.geba@regeneron.com.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217259']
69,33156757,The effect of TB treatment on health-related quality of life for people with advanced HIV.,"BACKGROUND:  Study A5274 was an open-label trial of people with HIV (PLHIV) with CD4 cell count <50 cells/µL who were randomized to empirical TB treatment vs. isoniazid preventive therapy (IPT) in addition to antiretroviral therapy (ART). We evaluated health-related quality of life (HRQoL) by study arm, changes over time, and association with sociodemographic and clinical factors. METHODS:  Participants aged >13 years were enrolled from outpatient clinics in 10 countries. HRQoL was assessed at Weeks 0, 8, 24 and 96 with questions about daily activity, hospital or emergency room visits, and general health status. We used logistic regression to examine HRQoL by arm and association with sociodemographic and clinical factors. RESULTS:  Among 850 participants (424 empiric arm, 426 IPT arm), HRQoL improved over time with no difference between arms. At baseline and Week 24, participants with WHO Stage 3 or 4 events, or those who had Grade 3 or 4 signs/symptoms, were significantly more likely to report poor HRQoL using the composite of four HRQoL measures. CONCLUSION:  HRQoL improved substantially in both arms during the study period. These findings show that ART, TB screening, and IPT can not only reduce mortality, but also improve HRQoL in PLHIV with advanced disease.",2020,"HRQoL was assessed at Weeks 0, 8, 24 and 96 with questions about daily activity, hospital or emergency room visits, and general health status.","['850 participants (424 empiric arm, 426 IPT arm', 'people with advanced HIV', 'people with HIV (PLHIV) with CD4 cell count <50 cells/µL', 'Participants aged >13 years were enrolled from outpatient clinics in 10 countries']","['HRQoL', 'isoniazid preventive therapy (IPT) in addition to antiretroviral therapy (ART', 'TB']","['health-related quality of life', 'health-related quality of life (HRQoL', 'HRQoL']","[{'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",850.0,0.18047,"HRQoL was assessed at Weeks 0, 8, 24 and 96 with questions about daily activity, hospital or emergency room visits, and general health status.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Opollo', 'Affiliation': 'Kenya Medical Research Institute, HIV-Research Branch, Kisumu, Kenya.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lando', 'Affiliation': 'Kenya Medical Research Institute, HIV-Research Branch, Kisumu, Kenya.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Miyahara', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Torres', 'Affiliation': 'Instituto Nacional de Infectologia Evandro Chagas (INI-FIOCRUZ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC, USA, University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Bisson', 'Affiliation': 'Perlman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kumwenda', 'Affiliation': 'Johns Hopkins Project, Blantyre, Malawi.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Johns Hopkins Project, Blantyre, Malawi.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Katende', 'Affiliation': 'Joint Clinical Research Centre Clinical Research Site, Kampala, Uganda.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Suryavanshi', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College Clinical Trials Unit, Pune, India.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Beulah', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education, Chennai Antiviral Research and Treatment Clinical Research Site, Chennai, India.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Shah', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}]",The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease,['10.5588/ijtld.19.0716']
70,33199051,Effect of mindfulness intervention versus health education program on salivary Aβ-42 levels in community-dwelling older adults with mild cognitive impairment: A randomized controlled trial.,"BACKGROUND


Few randomized controlled trials have investigated the effects of mindfulness intervention on older adults diagnosed with mild cognitive impairment (MCI). Specifically, scarce literature exists on the potential benefits of mindfulness intervention on biomarkers representing AD hallmarks. Our previous studies showed the potential of Mindful Awareness Practice (MAP) in improving multiple biomarkers of gut microbiota, systemic inflammation, and synaptic functions. Extending these findings, in this study, we conducted analysis on bio-banked saliva samples, examining whether MAP improved salivary amyloid beta-42 (Aβ-42) levels in community-dwelling older adults diagnosed with MCI. We also explored the moderating role of education level, an indicator of cognitive reserve, on intervention effect.
METHODS


A total of 55 community-dwelling older adults diagnosed with MCI were randomized into either the treatment arm, MAP, or the active control arm, the health education program (HEP). Interventions were performed for a total of nine months. Field and laboratory investigators who were blinded to the treatment allocations collected saliva samples at baseline, 3-month, and 9-month follow-ups. Salivary Aβ-42 levels were quantified using a commercial assay. Linear-mixed models were used to examine the effect of MAP on salivary Aβ-42 levels.
RESULTS


Compared to the HEP arm, MAP participants had no significantly modified Aβ-42 levels throughout the 9-month intervention period, regardless of subgroup analyses stratified by either sex or MCI-subtypes (amnestic and non-amnestic). Exploring the moderating effect of education, participants in the HEP arm with higher education levels had significantly lower salivary Aβ-42 at 3-month time-point.
DISCUSSION


Taken together with our previous findings and other mindfulness interventional studies failing to find a significant effect on peripheral Aβ-42, we conclude the non-significant effects of mindfulness intervention on ameliorating peripheral Aβ-42 levels. Conversely, participants in the HEP arm with higher cognitive reserve had significantly improved salivary Aβ-42, highlighting the role of cognitive reserve in moderating treatment response in MCI.",2021,"Compared to the HEP arm, MAP participants had no significantly modified Aβ-42 levels throughout the 9-month intervention period, regardless of subgroup analyses stratified by either sex or MCI-subtypes (amnestic and non-amnestic).","['older adults diagnosed with mild cognitive impairment (MCI', 'community-dwelling older adults diagnosed with MCI', 'community-dwelling older adults with mild cognitive impairment', '55 community-dwelling older adults diagnosed with MCI']","['mindfulness intervention', 'mindfulness intervention versus health education program', 'MAP, or the active control arm, the health education program (HEP']","['ameliorating peripheral Aβ-42 levels', 'salivary amyloid beta-42 (Aβ-42) levels', 'salivary Aβ-42 levels', 'salivary Aβ-42', 'modified Aβ-42 levels', 'Salivary Aβ-42 levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",55.0,0.033167,"Compared to the HEP arm, MAP participants had no significantly modified Aβ-42 levels throughout the 9-month intervention period, regardless of subgroup analyses stratified by either sex or MCI-subtypes (amnestic and non-amnestic).","[{'ForeName': 'Ted Kheng Siang', 'Initials': 'TKS', 'LastName': 'Ng', 'Affiliation': 'Department of Psychological Medicine, National University of Singapore, Singapore. Electronic address: a0047115@u.nus.edu.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Slowey', 'Affiliation': 'Oasis Diagnostics® Corporation, Vancouver, WA, USA; Central South University, Changsha, China.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Beltran', 'Affiliation': 'Oasis Diagnostics® Corporation, Vancouver, WA, USA.'}, {'ForeName': 'Roger C M', 'Initials': 'RCM', 'LastName': 'Ho', 'Affiliation': 'Department of Psychological Medicine, National University Hospital, Singapore; Biomedical Global Institute of Healthcare Research & Technology (BIGHEART), National University of Singapore, Singapore; Center of Excellence in Behavioral Medicine, Nguyen Tat Thanh University, Faculty of Education, Huaibei Normal University, Vietnam, China.'}, {'ForeName': 'Ee Heok', 'Initials': 'EH', 'LastName': 'Kua', 'Affiliation': 'Department of Psychological Medicine, National University of Singapore, Singapore; Department of Psychological Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Rathi', 'Initials': 'R', 'LastName': 'Mahendran', 'Affiliation': 'Department of Psychological Medicine, National University of Singapore, Singapore; Department of Psychological Medicine, National University Hospital, Singapore; Academic Development Department, Duke-NUS Medical School, 8 College Road, Singapore.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.038']
71,33206462,"Greater dapivirine release from the dapivirine vaginal ring is correlated with lower risk of HIV-1 acquisition: a secondary analysis from a randomized, placebo-controlled trial.","INTRODUCTION


A vaginal ring containing 25 mg of the antiretroviral dapivirine has demonstrated efficacy in reducing women's risk of sexually acquiring HIV-1; however, imperfect ring use likely diluted efficacy estimates in clinical trials. The amount of dapivirine remaining in returned rings may reflect the extent of product use, permitting estimation of HIV protection in the context of consistent use.
METHODS


We measured the amount of dapivirine in returned rings from a placebo-controlled trial of the dapivirine vaginal ring conducted between August 2012 and June 2015 among 2629 African women. Phase I/II studies established that greater than 4 mg of dapivirine on average is released from the ring when used consistently over 28 days and ≤0.9 mg released suggested non-use. We assessed the relative risk reduction associated with levels of ring use using residual dapivirine in returned rings as a time-dependent covariate for HIV-1 infection in multivariable Cox models, including multiple exploratory analyses designed to estimate upper limits of efficacy given uncertainty in timing of HIV-1 acquisition. All models were adjusted for baseline covariates associated with HIV risk and adherence.
RESULTS


Residual dapivirine levels indicating at least some use (>0.9 mg released over a month) were associated with a 48% relative reduction in HIV-1 acquisition risk (95% confidence interval (CI): 21% to 66%; p = 0.002) compared to the placebo. Exploratory analyses accounting for potential misclassification in timing of HIV-1 acquisition estimated 75% to 91% HIV-1 risk reduction with> 4 mg released when compared to placebo. Results limited to the subgroup of women <25 years of age, who tended to have lower adherence, were generally consistent to those overall.
CONCLUSIONS


Residual dapivirine levels, an objective measure of adherence, were correlated with HIV-1 protection in a secondary analysis of a randomized trial. Periods of ring use were associated with approximately 50% protection, with exploratory analyses suggesting higher protection with more consistent use. The dapivirine vaginal ring is the first method to fulfil the promise of a fully reversible, long-acting, woman-initiated approach for discreet HIV-1 prevention.",2020,"Results limited to the subgroup of women <25 years of age, who tended to have lower adherence, were generally consistent to those overall.
",['controlled trial of the dapivirine vaginal ring conducted between August 2012 and June 2015 among 2629 African women'],"['placebo', 'antiretroviral dapivirine', 'dapivirine']","['HIV risk and adherence', 'risk of HIV-1 acquisition', 'HIV-1 acquisition risk']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1434916', 'cui_str': 'dapivirine'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C1434916', 'cui_str': 'dapivirine'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}]",2629.0,0.25361,"Results limited to the subgroup of women <25 years of age, who tended to have lower adherence, were generally consistent to those overall.
","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Brown', 'Affiliation': 'Vaccine and Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA, USA.""}, {'ForeName': 'Flavia M', 'Initials': 'FM', 'LastName': 'Kiweewa', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Nyaradzo M', 'Initials': 'NM', 'LastName': 'Mgodi', 'Affiliation': 'University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Philips', 'Affiliation': 'Wits Reproductive Health and HIV Research Institute, School of Clinical Medicine, University of the Witswatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Foundation Clinical Research Site, Cape Town, South Africa.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Soto-Torres', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine and Magee-Womens Research Institute, Pittsburgh, PA, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Departments of Medicine, Epidemiology, and Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25634']
72,33205372,Clinical efficacy of 0.01% atropine in retarding the progression of myopia in children.,"PURPOSE


To investigate the clinical efficacy of 0.01% atropine in slowing the progression of myopia in children and to evaluate the influence of 0.01% atropine on secretion of basal tear and stability of tear film.
METHODS


Eighty children aged 5-14 years with myopia, 40 were randomly divided into two groups consisting of those who received spectacles in addition to 0.01% atropine (SA group) and those who received only spectacles (S group). The remaining 40 children who were wearing orthokeratology (OK) lenses for 3 months were randomly divided into two groups comprising those who received OK lenses in addition to 0.01% atropine (OKA group) and those who received only OK lenses (OK group). Comprehensive ophthalmologic examinations, including slit-lamp examination, visual acuity testing, autorefraction, intraocular pressure, axial length (AL), corneal topography, Schirmer's test, and tear film break-up time (TBuT), were performed before treatment and after every 3 months treatment.
RESULTS


During the follow-up visits, evidently better spherical equivalent (SE) control over 3, 6 and 12 months was observed in the SA and OKA groups compared with the S and OK groups. The AL over 3, 6, and 12 months was evidently inhibited in the SA and OKA groups compared with the S and OK groups. No statistically significant differences in Schirmer's test and TBuT results were observed between the S and SA groups and between the OK and OKA groups. However, statistically significant differences were found in TBuT results between before treatment and after 3 months treatment in the OK group (P < 0.05, paired t test) and the OKA group (P < 0.05, paired t test).
CONCLUSIONS


0.01% atropine can effectively control myopia progression and axial elongation regardless of combined treatment with spectacles or OK lenses. And 0.01% atropine has no evident effect on Schirmer's test and TBuT results; however, researchers also found that Schirmer's test and TBuT results showed a tendency to reduce after treatment with 0.01% atropine.",2021,No statistically significant differences in Schirmer's test and TBuT results were observed between the S and SA groups and between the OK and OKA groups.,"['40 children who were wearing orthokeratology (OK) lenses for 3\xa0months', 'Eighty children aged 5-14\xa0years with myopia, 40', 'myopia in children']","['atropine (SA group) and those who received only spectacles', 'OK lenses in addition to 0.01% atropine (OKA group) and those who received only OK lenses', 'atropine']","[""Schirmer's test and TBuT results"", 'TBuT results', 'secretion of basal tear and stability of tear film', ""slit-lamp examination, visual acuity testing, autorefraction, intraocular pressure, axial length (AL), corneal topography, Schirmer's test, and tear film break-up time (TBuT""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0069389', 'cui_str': 'Okadaic acid'}]","[{'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0200150', 'cui_str': 'Visual acuity testing'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0524957', 'cui_str': 'Corneal topography'}]",80.0,0.0182668,No statistically significant differences in Schirmer's test and TBuT results were observed between the S and SA groups and between the OK and OKA groups.,"[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': ""Department of Ophthalmology, The Second Hospital of Dalian Medical University, 467 Zhongshan Road, Shahekou District, Dalian, People's Republic of China. zhaoqidyey@126.com.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Hao', 'Affiliation': ""Department of Ophthalmology, The Second Hospital of Dalian Medical University, 467 Zhongshan Road, Shahekou District, Dalian, People's Republic of China.""}]",International ophthalmology,['10.1007/s10792-020-01658-0']
73,33217600,Application of thrombin gel matrix for the prevention of lymphocele in patients with endometrial cancer: A prospective randomized trial.,"OBJECTIVE


To evaluate a thrombin gel matrix (TGM), Floseal, for the prevention of lymphocele in patients with endometrial cancer who underwent pelvic lymphadenectomy.
METHODS


A total of 79 consecutive patients with endometrial cancer were randomly allocated to one of two groups: the TGM group and control group. After completion of the lymphadenectomy, 5 mL of Floseal was applied to the bilateral pelvic sidewalls, especially the femoral canal, obturator, and common iliac vessels areas. Computed tomography scans were obtained for lymphocele evaluation 2 months after the surgery.
RESULTS


Three patients from the TGM group, and four patients from the control group were lost during follow-up, and data from 36 participants from each group were analyzed. As the primary outcome, lymphocele developed in 12 patients in both groups (33 %). There was no significant difference between the groups in terms of lymphocele and symptomatic lymphocele development. Lymphocele localization was also not different between the two groups, but the diameter of the lymphoceles detected in the TGM group was significantly greater (p = 0.021). The mean drainage days was significantly shorter in the TGM group (p = 0.015). The amount of drainage was also less in the TGM group, but the difference was not statistically significant.
CONCLUSION


Thrombin gel matrix applied to the pelvic sidewalls does not reduce the incidence of symptomatic or asymptomatic lymphoceles after pelvic lymphadenectomy in endometrial cancer. However, it can reduce the amount of drainage and the number of drainage days so it can help to shorten hospitalization.",2020,"CONCLUSION


Thrombin gel matrix applied to the pelvic sidewalls does not reduce the incidence of symptomatic or asymptomatic lymphoceles after pelvic lymphadenectomy in endometrial cancer.","['patients with endometrial cancer who underwent pelvic lymphadenectomy', '79 consecutive patients with endometrial cancer', 'patients with endometrial cancer']","['TGM group and control group', 'thrombin gel matrix', 'Thrombin gel matrix', 'TGM', 'thrombin gel matrix (TGM), Floseal', 'lymphadenectomy, 5\u2009mL of Floseal']","['mean drainage days', 'Lymphocele localization', 'incidence of symptomatic or asymptomatic lymphoceles', 'amount of drainage', 'lymphocele and symptomatic lymphocele development', 'lymphocele']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}]","[{'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",79.0,0.0301364,"CONCLUSION


Thrombin gel matrix applied to the pelvic sidewalls does not reduce the incidence of symptomatic or asymptomatic lymphoceles after pelvic lymphadenectomy in endometrial cancer.","[{'ForeName': 'Şener', 'Initials': 'Ş', 'LastName': 'Gezer', 'Affiliation': 'Kocaeli University School of Medicine, Department of Gynecologic Oncology, Turkey. Electronic address: dr.senergezer@gmail.com.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Pulur', 'Affiliation': 'Kocaeli University School of Medicine, Department of Gynecologic Oncology, Turkey.'}, {'ForeName': 'İzzet', 'Initials': 'İ', 'LastName': 'Yücesoy', 'Affiliation': 'Kocaeli University School of Medicine, Department of Gynecologic Oncology, Turkey.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101994']
74,33212067,"Immunogenicity and safety of simplified vaccination schedules for the CYD-TDV dengue vaccine in healthy individuals aged 9-50 years (CYD65): a randomised, controlled, phase 2, non-inferiority study.","BACKGROUND


Three doses of the licensed tetravalent dengue vaccine CYD-TDV (Dengvaxia, Sanofi Pasteur, Lyon France) are immunogenic and effective against symptomatic dengue in individuals aged 9 years and older who are dengue seropositive. Previous trials have provided some evidence that antibody responses elicited after just one dose or two doses of CYD-TDV might be similar to those elicited after three doses. We compared antibody responses following one-dose, two-dose, and three-dose vaccination regimens in individuals who were dengue seropositive at baseline up to 1 year after the last injection.
METHODS


In this randomised, controlled, phase 2, non-inferiority study (CYD65), healthy individuals aged 9-50 years were recruited from the community in three sites in Colombia and three sites in the Philippines. Participants were randomly assigned (1:1:1), using a permuted block method with stratification by site and age group, to receive, at 6-month intervals (on day 0, month 6, and month 12), three doses of CYD-TDV (three-dose group), one dose of placebo (on day 0) and two doses of CYD-TDV (at months 6 and 12; two-dose group), or two doses of placebo (on day 0 and month 6) and one dose of CYD-TDV (at month 12; one-dose group). Each dose of CYD-TDV was 0·5 mL, administered subcutaneously into the deltoid of the upper arm. Participants, study staff, investigators, and the funder were masked to group assignment. The co-primary endpoints were geometric mean titres (GMTs) of neutralising antibodies against each dengue virus serotype at 28 days and 1 year after the last vaccine injection. After a protocol amendment during the conduct of the study, the original co-primary objectives of non-inferiority of the one-dose and two-dose groups to the three-dose group were altered to include non-inferiority of the two-dose group to the three-dose group only, to be assessed in individuals who were dengue seropositive at baseline. Non-inferiority was shown if the lower limit of the 95% CI for the ratio of GMTs (GMR) at 28 days and 1 year between groups was more than 0·5 for each serotype. The analysis of the coprimary objectives was done in the per-protocol analysis dataset, which included all participants who had been vaccinated, had no protocol deviations, and had a valid serology test result for at least one dengue serotype at 28 days after the third injection. Safety was assessed throughout in all participants who received at least one injection of study drug, regardless of serostatus. This trial is registered with ClinicalTrials.gov, NCT02628444, and is closed to accrual.
FINDINGS


Between May 2, 2016, and Sept 16, 2016, we recruited and enrolled 1050 individuals, of whom 1048 received at least one injection and 993 had at least one blood sample taken (full-analysis dataset; 333 in three-dose group, 328 in two-dose group, and 332 in one-dose group). 860 (86·6%) of 993 participants in the full-analysis dataset were dengue seropositive at baseline. Non-inferiority (two dose vs three dose) was shown for each serotype at both 28 days and 1 year among dengue-seropositive participants (number of participants assessed: 272 [two-dose group], 265 [three-dose group] at 28 days; and 190 [two-dose group], 185 [three-dose group] at 1 year). At 28 days after the last injection, neutralising antibody GMTs were 899 (95% CI 752-1075) in the two-dose group versus 822 (700-964) in the three dose group against dengue serotype 1 (GMR 1·09 [95% CI 0·86-1·39]); 869 (754-1002) versus 875 (770-995) against serotype 2 (GMR 0·99 [0·82-1·20]); 599 (524-685) versus 610 (535-694) against serotype 3 (GMR 0·98 [0·82-1·18]); and 510 (453-575) versus 531 (470-601) against serotype 4 (GMR 0·96 [0·81-1·14]). At year 1, GMTs had decreased but remained above baseline for all serotypes: 504 (95% CI 403-630) in the two-dose group versus 490 (398-604) in the three-dose group against serotype 1 (GMR 1·03 [0·76-1·40]); 737 (611-888) versus 821 (704-957) against serotype 2 (GMR 0·90 [0·71-1·14]); 437 (368-519) versus 477 (405-561) against serotype 3 (GMR 0·92 [0·72-1·16]); and 238 (205-277) versus 270 (235-310) against serotype 4 (GMR 0·88 [0·72-1·09]). Reactogenicity profiles were similar across treatment groups. Most unsolicited adverse events after any injection were non-serious and systemic in nature. During the study, 60 serious adverse events were reported in 58 participants (14 in three-dose group, 26 in two-dose group, 18 in one-dose group), mostly infection and infestations or injury, poisoning, and procedural complications. No serious adverse events of special interest or admissions to hospital for dengue occurred. Two deaths occurred, unrelated to study treatment.
INTERPRETATION


A two-dose CYD-TDV regimen might be an alternative to the licensed three-dose regimen in individuals who are dengue seropositive at baseline and aged 9 years and older. Vaccination with a reduced number of doses could lead to improved vaccine compliance and coverage, especially in low-resource settings.
FUNDING


Sanofi Pasteur.",2021,Non-inferiority (two dose vs three dose) was shown for each serotype at both 28 days and 1 year among dengue-seropositive participants (number of participants assessed:,"['Between May 2, 2016, and Sept 16, 2016, we recruited and enrolled 1050 individuals, of whom 1048 received at least one injection and 993 had at least one blood sample taken (full-analysis dataset; 333 in three-dose group, 328 in two-dose group, and 332 in one-dose group', 'healthy individuals aged 9-50 years were recruited from the community in three sites in Colombia and three sites in the Philippines', 'individuals who are dengue seropositive at baseline and aged 9 years and older', 'participants who had been vaccinated, had no protocol deviations, and had a valid serology test result for at least one dengue serotype at 28 days after the third injection', 'individuals aged 9 years and older who are dengue seropositive', 'healthy individuals aged 9-50 years (CYD65', '860 (86·6%) of 993 participants in the full-analysis dataset were dengue seropositive at baseline']","['CYD-TDV', 'placebo']","['Immunogenicity and safety', 'geometric mean titres (GMTs) of neutralising antibodies against each dengue virus serotype', 'Safety', 'neutralising antibody GMTs', 'mostly infection and infestations or injury, poisoning, and procedural complications', 'Reactogenicity profiles']","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0443225', 'cui_str': 'Full'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0011315', 'cui_str': 'Dengue virus'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}]",,0.361198,Non-inferiority (two dose vs three dose) was shown for each serotype at both 28 days and 1 year among dengue-seropositive participants (number of participants assessed:,"[{'ForeName': 'Diana Leticia', 'Initials': 'DL', 'LastName': 'Coronel-MartÍnez', 'Affiliation': 'Sanofi Pasteur, Santa Catarina, Coyoacán, Mexico City, Mexico. Electronic address: dianaLeticia.coronel@sanofi.com.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Sanofi Pasteur, Singapore.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'López-Medina', 'Affiliation': 'Centro de Estudios en Infectología Pediátrica, Universidad del Valle and Centro Médico Imbanaco, Cali, Valle del Cauca, Colombia.'}, {'ForeName': 'María Rosario', 'Initials': 'MR', 'LastName': 'Capeding', 'Affiliation': 'Research Institute for Tropical Medicine, Filinvest Corporate City, Alabang, Muntinlupa, Metro Manila, Philippines.'}, {'ForeName': 'Andrés Angelo', 'Initials': 'AA', 'LastName': 'Cadena Bonfanti', 'Affiliation': 'Clinica de la Costa, Barranquilla, Atlántico, Colombia.'}, {'ForeName': 'María Cecilia', 'Initials': 'MC', 'LastName': 'Montalbán', 'Affiliation': 'Manila Doctors Hospital, Ermita, Metro Manila, Philippines.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Ramírez', 'Affiliation': 'Infectious Diseases, Internal Medicine, Hospital Pablo Tobón Uribe, Universidad de Antioquia, Medellín, Antioquia, Colombia.'}, {'ForeName': 'María Liza Antoinette', 'Initials': 'MLA', 'LastName': 'Gonzales', 'Affiliation': 'University of the Philippines Manila-Philippine General Hospital, Ermita, Metro Manila, Philippines.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': ""Sanofi Pasteur, Swiftwater, PA, USA; Sanofi Pasteur, Marcy L'Etoile, France.""}, {'ForeName': 'Betzana', 'Initials': 'B', 'LastName': 'Zambrano', 'Affiliation': 'Sanofi Pasteur, Montevideo, Uruguay.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Dayan', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Savarino', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Zhenghong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Sanofi Pasteur, Chaoyang, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Sanofi Pasteur, Chaoyang, Beijing, China.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Sanofi Pasteur, Chaoyang, Beijing, China.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bonaparte', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Rojas', 'Affiliation': 'Sanofi Pasteur, Bogotá, Colombia.'}, {'ForeName': 'Jenny Carolina', 'Initials': 'JC', 'LastName': 'Ramírez', 'Affiliation': 'Sanofi Pasteur, Bogotá, Colombia.'}, {'ForeName': 'Mae Ann', 'Initials': 'MA', 'LastName': 'Verdan', 'Affiliation': 'Sanofi Pasteur, Taguig, Metro Manila, Philippines.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Noriega', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30767-2']
75,33217361,"Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial.","BACKGROUND


To address the unmet medical need for an effective prophylactic vaccine against Ebola virus we assessed the safety and immunogenicity of three different two-dose heterologous vaccination regimens with a replication-deficient adenovirus type 26 vector-based vaccine (Ad26.ZEBOV), expressing Zaire Ebola virus glycoprotein, and a non-replicating, recombinant, modified vaccinia Ankara (MVA) vector-based vaccine, encoding glycoproteins from Zaire Ebola virus, Sudan virus, and Marburg virus, and nucleoprotein from the Tai Forest virus.
METHODS


This randomised, observer-blind, placebo-controlled, phase 2 trial was done at seven hospitals in France and two research centres in the UK. Healthy adults (aged 18-65 years) with no history of Ebola vaccination were enrolled into four cohorts. Participants in cohorts I-III were randomly assigned (1:1:1) using computer-generated randomisation codes into three parallel groups (randomisation for cohorts II and III was stratified by country and age), in which participants were to receive an intramuscular injection of Ad26.ZEBOV on day 1, followed by intramuscular injection of MVA-BN-Filo at either 28 days (28-day interval group), 56 days (56-day interval group), or 84 days (84-day interval group) after the first vaccine. Within these three groups, participants in cohort II (14:1) and cohort III (10:3) were further randomly assigned to receive either Ad26.ZEBOV or placebo on day 1, followed by either MVA-BN-Filo or placebo on days 28, 56, or 84. Participants in cohort IV were randomly assigned (5:1) to receive one dose of either Ad26.ZEBOV or placebo on day 1 for vector shedding assessments. For cohorts II and III, study site personnel, sponsor personnel, and participants were masked to vaccine allocation until all participants in these cohorts had completed the post-MVA-BN-Filo vaccination visit at 6 months or had discontinued the trial, whereas cohort I was open-label. For cohort IV, study site personnel and participants were masked to vaccine allocation until all participants in this cohort had completed the post-vaccination visit at 28 days or had discontinued the trial. The primary outcome, analysed in all participants who had received at least one dose of vaccine or placebo (full analysis set), was the safety and tolerability of the three vaccination regimens, as assessed by participant-reported solicited local and systemic adverse events within 7 days of receiving both vaccines, unsolicited adverse events within 42 days of receiving the MVA-BN-Filo vaccine, and serious adverse events over 365 days of follow-up. The secondary outcome was humoral immunogenicity, as measured by the concentration of Ebola virus glycoprotein-binding antibodies at 21 days after receiving the MVA-BN-Filo vaccine. The secondary outcome was assessed in the per-protocol analysis set. This study is registered at ClinicalTrials.gov, NCT02416453, and EudraCT, 2015-000596-27.
FINDINGS


Between June 23, 2015, and April 27, 2016, 423 participants were enrolled: 408 in cohorts I-III were randomly assigned to the 28-day interval group (123 to receive Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), the 56-day interval group (124 to receive Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), and the 84-day interval group (117 to receive Ad26.ZEBOV and MVA-BN-Filo, and 18 to receive placebo), and 15 participants in cohort IV were assigned to receive Ad26.ZEBOV and MVA-BN-Filo (n=13) or to receive placebo (n=2). 421 (99·5%) participants received at least one dose of vaccine or placebo. The trial was temporarily suspended after two serious neurological adverse events were reported, one of which was considered as possibly related to vaccination, and per-protocol vaccination was disrupted for some participants. Vaccinations were generally well tolerated. Mild or moderate local adverse events (mostly pain) were reported after 206 (62%) of 332 Ad26.ZEBOV vaccinations, 136 (58%) of 236 MVA-BN-Filo vaccinations, and 11 (15%) of 72 placebo injections. Systemic adverse events were reported after 255 (77%) Ad26.ZEBOV vaccinations, 116 (49%) MVA-BN-Filo vaccinations, and 33 (46%) placebo injections, and included mostly mild or moderate fatigue, headache, or myalgia. Unsolicited adverse events occurred after 115 (35%) of 332 Ad26.ZEBOV vaccinations, 81 (34%) of 236 MVA-BN-Filo vaccinations, and 24 (33%) of 72 placebo injections. At 21 days after receiving the MVA-BN-Filo vaccine, geometric mean concentrations of Ebola virus glycoprotein-binding antibodies were 4627 ELISA units (EU)/mL (95% CI 3649-5867) in the 28-day interval group, 10 131 EU/mL (8554-11 999) in the 56-day interval group, and 11 312 mL (9072-14106) in the 84-day interval group, with antibody concentrations persisting at 1149-1205 EU/mL up to day 365.
INTERPRETATION


The two-dose heterologous regimen with Ad26.ZEBOV and MVA-BN-Filo was safe, well tolerated, and immunogenic, with humoral and cellular immune responses persisting for 1 year after vaccination. Taken together, these data support the intended prophylactic indication for the vaccine regimen.
FUNDING


Innovative Medicines Initiative and Janssen Vaccines & Prevention BV.
TRANSLATION


For the French translation of the abstract see Supplementary Materials section.",2021,"Unsolicited adverse events occurred after 115 (35%) of 332 Ad26.ZEBOV vaccinations, 81 (34%) of 236 MVA-BN-Filo vaccinations, and 24 (33%) of 72 placebo injections.","['participants in cohort II (14:1) and cohort III (10:3', 'adults in Europe (EBOVAC2', 'Participants in cohorts', 'Healthy adults (aged 18-65 years) with no history of Ebola vaccination were enrolled into four cohorts', 'seven hospitals in France and two research centres in the UK', '423 participants were enrolled: 408 in cohorts I-III', 'Between June 23, 2015, and April 27, 2016', '15 participants in cohort IV']","['heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen', 'Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), the 56-day interval group (124 to receive Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), and the 84-day interval group (117 to receive Ad26.ZEBOV and MVA-BN-Filo, and 18 to receive placebo', 'placebo', 'Ad26.ZEBOV and MVA-BN-Filo (n=13) or to receive placebo', 'MVA-BN-Filo or placebo', 'vaccine or placebo', 'Ad26.ZEBOV or placebo']","['Systemic adverse events', 'solicited local and systemic adverse events', 'safety and tolerability', 'serious adverse events', 'Mild or moderate local adverse events (mostly pain', 'Safety and immunogenicity', 'Unsolicited adverse events', 'moderate fatigue, headache, or myalgia', 'humoral immunogenicity, as measured by the concentration of Ebola virus glycoprotein-binding antibodies', 'tolerated']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0282687', 'cui_str': 'Ebola virus disease'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0439860', 'cui_str': 'Heterologous'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042214', 'cui_str': 'Vaccinia'}, {'cui': 'C1449556', 'cui_str': 'Ebolavirus Vaccines'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0949892', 'cui_str': 'Ebolavirus'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",423.0,0.596138,"Unsolicited adverse events occurred after 115 (35%) of 332 Ad26.ZEBOV vaccinations, 81 (34%) of 236 MVA-BN-Filo vaccinations, and 24 (33%) of 72 placebo injections.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Launay', 'Affiliation': 'Université de Paris, INSERM CIC 1417, F-CRIN I-REIVAC, Paris, France; Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, CIC Cochin Pasteur, Paris, France.'}, {'ForeName': 'Jean-Daniel', 'Initials': 'JD', 'LastName': 'Lelievre', 'Affiliation': 'Vaccine Research Institute, Faculté de Médecine, Université Paris-Est Créteil, INSERM U955, Créteil, France; Assistance Publique-Hôpitaux de Paris, Groupe Henri-Mondor Albert-Chenevier, Service Immunologie Clinique, Créteil, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lacabaratz', 'Affiliation': 'Vaccine Research Institute, Faculté de Médecine, Université Paris-Est Créteil, INSERM U955, Créteil, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Grande', 'Affiliation': 'Allergology and Clinical Immunology, LYREC, Lyon University Hospital, France.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Goldstein', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Auguste', 'Initials': 'A', 'LastName': 'Gaddah', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Viki', 'Initials': 'V', 'LastName': 'Bockstal', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Wiedemann', 'Affiliation': 'Vaccine Research Institute, Faculté de Médecine, Université Paris-Est Créteil, INSERM U955, Créteil, France.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Leyssen', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luhn', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Richert', 'Affiliation': 'University Bordeaux, INSERM, Bordeaux Population Health Research Center, UMR 1219, INSERM, CHU Bordeaux, Bordeaux, France; CIC, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France; Inria SISTM team, F-33405, Talence, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Bétard', 'Affiliation': 'University Bordeaux, INSERM, Bordeaux Population Health Research Center, UMR 1219, INSERM, CHU Bordeaux, Bordeaux, France; CIC, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Malick M', 'Initials': 'MM', 'LastName': 'Gibani', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Levy', 'Affiliation': 'Vaccine Research Institute, Faculté de Médecine, Université Paris-Est Créteil, INSERM U955, Créteil, France.'}, {'ForeName': 'Macaya', 'Initials': 'M', 'LastName': 'Douoguih', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiebaut', 'Affiliation': 'University Bordeaux, INSERM, Bordeaux Population Health Research Center, UMR 1219, INSERM, CHU Bordeaux, Bordeaux, France; CIC, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France; Inria SISTM team, F-33405, Talence, France. Electronic address: rodolphe.thiebaut@u-bordeaux.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30476-X']
76,32701542,Reflection Versus Rebreathing for Administration of Sevoflurane During Minor Gynecological Surgery.,"BACKGROUND


Contemporary anesthetic circle systems, when used at low fresh gas flows (FGF) to allow rebreathing of anesthetic, lack the ability for rapid dose titration. The small-scale anesthetic reflection device Anaesthetic Conserving Device (50mL Version; AnaConDa-S) permits administration of volatile anesthetics with high-flow ventilators. We compared washin, washout, and sevoflurane consumption using AnaConDa-S versus a circle system with low and minimal FGF.
METHODS


Forty patients undergoing breast surgery were randomized to receive 0.5 minimal alveolar concentration (MAC) sevoflurane with AnaConDa-S (21 patients, reflection group) or with a circle system (low flow: FGF = 0.2 minute ventilation [V'E], 9 patients; or minimal flow: 0.1 V'E, 10 patients). In the reflection group, syringe pump boluses were given for priming and washin; to simulate an open system, the FGF of the anesthesia ventilator was set to 18 L·min-1 with the soda lime removed. In the other groups, the FGF was increased for washin (1 V'E for 8 minutes) and washout (3 V'E). For all patients, tidal volume was 7 mL·kg-1 and the respiratory rate adjusted to ensure normoventilation. Analgesia was attained with remifentanil 0.3 µg·kg-1·min-1. Sevoflurane consumption was compared between the reflection group and the low- and minimal-flow groups, respectively, using a post hoc test (Fisher Least Significant Difference). To compare washin and washout (half-life), the low- and minimal-flow groups were combined.
RESULTS


Sevoflurane consumption was reduced in the reflection group (9.4 ± 2.0 vs 15.0 ± 3.5 [low flow, P < .001] vs 11.6 ± 2.3 mL·MAC h-1 [minimal flow, P = .02]); washin (33 ± 15 vs 49 ± 12 seconds, P = .001) and washout (28 ± 15 vs 55 ± 19 seconds, P < .001) times were also significantly shorter.
CONCLUSIONS


In this clinical setting with short procedures, low anesthetic requirements, and low tidal volumes, AnaConDa-S decreased anesthetic consumption, washin, and washout times compared to a circle system.",2021,"washin (33 ± 15 vs 49 ± 12 seconds, P = .001) and washout (28 ± 15 vs 55 ± 19 seconds, P < .001)",['Forty patients undergoing breast surgery'],"['sevoflurane consumption using AnaConDa-S versus a circle system with low and minimal FGF', 'remifentanil 0.3 µg·kg·min', 'Anaesthetic Conserving Device (50mL Version; AnaConDa-S', ""0.5 minimal alveolar concentration (MAC) sevoflurane with AnaConDa-S (21 patients, reflection group) or with a circle system (low flow: FGF = 0.2 minute ventilation [V'E], 9 patients; or minimal flow: 0.1 V'E"", 'Sevoflurane']","['Sevoflurane consumption', 'low anesthetic requirements, and low tidal volumes, AnaConDa-S decreased anesthetic consumption, washin, and washout times', 'Analgesia', 'FGF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0206302', 'cui_str': 'Eunectes murinus'}, {'cui': 'C1531632', 'cui_str': 'Circle system'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0428716', 'cui_str': 'Fresh gas flow'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C4517420', 'cui_str': '0.1'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0206302', 'cui_str': 'Eunectes murinus'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0428716', 'cui_str': 'Fresh gas flow'}]",40.0,0.0534774,"washin (33 ± 15 vs 49 ± 12 seconds, P = .001) and washout (28 ± 15 vs 55 ± 19 seconds, P < .001)","[{'ForeName': 'Azzeddine', 'Initials': 'A', 'LastName': 'Kermad', 'Affiliation': 'From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, Saarland University Hospital Medical Center, Homburg/Saar, Germany.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Appenzeller', 'Affiliation': 'From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, Saarland University Hospital Medical Center, Homburg/Saar, Germany.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Morinello', 'Affiliation': 'From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, Saarland University Hospital Medical Center, Homburg/Saar, Germany.'}, {'ForeName': 'Sven Oliver', 'Initials': 'SO', 'LastName': 'Schneider', 'Affiliation': 'From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, Saarland University Hospital Medical Center, Homburg/Saar, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kleinschmidt', 'Affiliation': 'From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, Saarland University Hospital Medical Center, Homburg/Saar, Germany.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': ""O'Gara"", 'Affiliation': 'Department of Anesthesiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Volk', 'Affiliation': 'From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, Saarland University Hospital Medical Center, Homburg/Saar, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Meiser', 'Affiliation': 'From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, Saarland University Hospital Medical Center, Homburg/Saar, Germany.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005074']
77,33221561,Conventional IVF revisited: Is ICSI better for non-male factor infertility? Randomized controlled double blind study.,"STUDY QUESTION


Is ICSI better than conventional IVF for non-male factor infertility?
SUMMARY ANSWER


IVF should be the choice of assisted reproductive technique in non-male factor infertility cases.
WHAT IS ALREADY KNOWN


Although total fertilization failure is a major concern for patients and professionals, the overall risk/benefit analysis favors conventional IVF in non-male factor infertility cases. However, according to the ESHRE EIM database pertaining to 1997-2012, the use of IVF has been continuously decreasing in favor of ICSI.
STUDY DESIGN, SIZE, DURATION


Randomized controlled double-blind study involving 138 women undergoing ART in a private Center.
PARTICIPANTS/MATERIALS, SETTING, METHODS


All couples with a female partner ≤42 years of age and without severe male factor (total progressive motile sperm with normal morphology >10.000) were included in the study. Exclusion criteria were: history of total fertilization failure, less than 6 cumulus oocyte complexes (COC) available for fertilization, prenatal genetic testing (PGT) cycles, unwillingness to participate and couples undergoing total cryopreservation for any indication. On the day of oocyte pick up, sibling COCs were randomly allocated to fertilization with IVF or denudation followed by ICSI to MII oocytes. The decision to transfer IVF or ICSI embryo(s) depended on embryo quality. Women receiving two embryos were given only IVF or ICSI embryos. Neither the clinician performing the transfer nor the patients were aware of the fertilization method used to generate the embryos transferred. Main outcome parameters were fertilization, clinical pregnancy, implantation and miscarriage rates.
MAIN RESULTS AND THE ROLE OF CHANCE


Demographic variables, ovarian reserve and infertility etiology, duration of stimulation, total gonadotropin consumption, peak estradiol levels were similar for IVF-ET and ICSI-ET groups. Mean number of COCs (18.95 vs 19.24), number of embryos transferred (1,81 vs 1,81), the ratio of good quality embryos/total embryos (56.89 % and 55.97 %), clinical pregnancy rates (63 % vs 49 %), implantation rates (31 % vs 28 %), and abortion rates (12,5 % vs 8,1 %) were also similar. A total of 1306 COCs were allocated for IVF while 1331 COCs were denuded for ICSI. Fertilization rate per inseminated oocyte was significantly higher in ICSI group (56,20 % vs 63,78 %). There were ten cases of total fertilization failure, all in the IVF group. Although overall fertilization rate was higher for ICSI, it was similar in both groups when cases with total fertilization failure were excluded.
LIMITATIONS, REASONS FOR CAUTION


The non-availability of live birth rates is a limitation. Randomization of sibling oocytes, not patients requires careful interpretation of pregnancy and implantation rates.
WIDER IMPLICATIONS OF THE FINDINGS


Lower cost, ease of application and similar clinical outcome makes IVF the choice of fertilization method in non-male factor infertility cases.",2020,"Although overall fertilization rate was higher for ICSI, it was similar in both groups when cases with total fertilization failure were excluded.
","['Exclusion criteria were: history of total fertilization failure, less than 6 cumulus oocyte complexes (COC) available for fertilization, prenatal genetic testing (PGT) cycles, unwillingness to participate and couples undergoing total cryopreservation for any indication', 'A total of 1306 COCs', '138 women undergoing ART in a private Center', 'All couples with a female partner ≤42 years of age and without severe male factor (total progressive motile sperm with normal morphology >10.000) were included in the study']","['conventional IVF', 'ICSI', 'Conventional IVF revisited']","['Fertilization rate per inseminated oocyte', 'embryo quality', 'clinical pregnancy rates', 'Mean number of COCs', 'Demographic variables, ovarian reserve and infertility etiology, duration of stimulation, total gonadotropin consumption, peak estradiol levels', 'abortion rates', 'ratio of good quality embryos/total embryos', 'total fertilization failure', 'number of embryos transferred', 'fertilization, clinical pregnancy, implantation and miscarriage rates', 'overall fertilization rate', 'implantation rates']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0449951', 'cui_str': 'Number of embryos transferred'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",138.0,0.437391,"Although overall fertilization rate was higher for ICSI, it was similar in both groups when cases with total fertilization failure were excluded.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Isikoglu', 'Affiliation': 'GELECEK IVF Center, Antalya, Turkey. Electronic address: misikoglu@hotmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Avci', 'Affiliation': 'GELECEK IVF Center, Antalya, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kendirci Ceviren', 'Affiliation': 'GELECEK IVF Center, Antalya, Turkey.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Aydınuraz', 'Affiliation': 'GELECEK IVF Center, Antalya, Turkey.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ata', 'Affiliation': 'Koç University School of Medicine, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101990']
78,33221027,"Silexan does not affect driving performance after single and multiple dose applications: Results from a double-blind, placebo and reference-controlled study in healthy volunteers.","Anxiolytic drugs often have sedative effects that impair the ability to drive. Our double-blind, randomized crossover trial investigated the effect of Silexan, a non-sedating, anxiolytic herbal medicinal product, on driving performance in healthy volunteers. Part 1 aimed at demonstrating equivalence between 80 mg/d Silexan and placebo. Part 2 was performed to demonstrate superiority of 160 and 320 mg Silexan over 1 mg lorazepam and included a placebo arm for assay sensitivity. Driving performance was assessed in a validated, alcohol-calibrated simulator test. The primary outcome was the standard deviation of the lane position (SDLP). Secondary outcomes included driving errors and sleepiness. Fifty and 25 subjects were randomized in Parts 1 and 2, respectively. In Part 1, Silexan 80 mg was confirmed to be equivalent to placebo after single administration (equivalence range: δ = ±2 cm). The 95% confidence interval (CI) for the SDLP marginal mean value difference Silexan-placebo for single administration was -1.43; +1.38 and thus similar to the 95% CI of -1.45; +0.79 cm for 7 days' multiple dosing. In Part 2, 95% CIs for SDLP marginal mean value differences to lorazepam were -8.58; -5.42 cm for Silexan 160 mg and -8.65; -5.45 cm for 320 mg (p < 0.001). Confirmatory results were supported by secondary outcomes, where results for Silexan were comparable to placebo and more favorable than for lorazepam. The study demonstrates that single doses of up to 320 mg Silexan and multiple doses of 80 mg/d have no adverse effect on driving performance.",2021,Part 2 was performed to demonstrate superiority of 160 and 320 ,"['Fifty and 25 subjects', '160 and 320', 'healthy volunteers']","['Silexan and placebo', 'placebo', 'Silexan', 'mg Silexan', 'Silexan, a non-sedating, anxiolytic herbal medicinal product', 'lorazepam']","['driving performance', 'standard deviation of the lane position (SDLP', 'Driving performance', 'driving errors and sleepiness']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2930445', 'cui_str': 'silexan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",,0.627834,Part 2 was performed to demonstrate superiority of 160 and 320 ,"[{'ForeName': 'Hans-Jürgen', 'Initials': 'HJ', 'LastName': 'Möller', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximilian University, Nußbaumstraße 7, 80336 Munich, Germany. Electronic address: hans-juergen.moeller@med.uni-muenchen.de.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Volz', 'Affiliation': 'Hospital for Psychiatry, Psychotherapy and Psychosomatic Medicine Schloss Werneck, Balthasar-Neumann-Platz 1, 97440 Werneck, Germany.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, 8032 Zürich, Switzerland.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Müller', 'Affiliation': 'Dr. Willmar Schwabe GmbH & Co. KG, Willmar-Schwabe-Straße 4, 76227 Karlsruhe, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Kenntner-Mabiala', 'Affiliation': 'Würzburg Institute for Traffic Sciences (WIVW), Robert-Bosch-Straße 4, 97209 Veitshöchheim, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Kaussner', 'Affiliation': 'Würzburg Institute for Traffic Sciences (WIVW), Robert-Bosch-Straße 4, 97209 Veitshöchheim, Germany; Department for General Practice, Julius-Maximilians-Universität Wurzburg, Josef-Schneider-Straße 2 / Haus D7, 97080 Wurzburg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schoch', 'Affiliation': 'Würzburg Institute for Traffic Sciences (WIVW), Robert-Bosch-Straße 4, 97209 Veitshöchheim, Germany.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.028']
79,32745598,Changes in Intrinsic Brain Connectivity in Family-Focused Therapy Versus Standard Psychoeducation Among Youths at High Risk for Bipolar Disorder.,"OBJECTIVE


We compared intrinsic network connectivity in symptomatic youths at high risk (HR) for bipolar disorder (BD) and healthy comparison (HC) youths. In HR youths, we also investigated treatment-related changes in intrinsic connectivity after family-focused therapy for high-risk youths (FFT-HR) vs standardized family psychoeducation.
METHOD


HR youths (N = 34; age 9-17 years; mean 14 years, 56% girls and 44% boys) with depressive and/or hypomanic symptoms and at least 1 first- or second-degree relative with BD I or II were randomly assigned to 4 months of FFT-HR (12 sessions of psychoeducation, communication, and problem-solving skills training) or enhanced care (EC; 3 family and 3 individual psychoeducation sessions). Before and after 4 months of treatment, participants underwent resting state functional magnetic resonance imaging (rs-fMRI). A whole-brain independent component analysis compared rs-fMRI networks in HR youths and 30 age-matched HC youths at a pretreatment baseline. Then we identified pretreatment to posttreatment (4-month) changes in network connectivity in HR youths receiving FFT-HR (n = 16) or EC (n = 18) and correlated these changes with depression improvement.
RESULTS


At baseline, HR youths had greater connectivity between the ventrolateral prefrontal cortex (VLPFC) and the anterior default mode network (aDMN) than did HCs (p = .004). Over 4 months of treatment, FFT-HR-assigned HR youths had increased VLPFC-aDMN connectivity from pre- to posttreatment (p = .003), whereas HR youths in EC showed no significant change over time (p = .11) (treatment by time interaction, t 31  = 3.33, 95% CI = 0.27-1.14, p = .002]. Reduction in depression severity over 4 months inversely correlated with enhanced anterior DMN (r = -0.71) connectivity in the FFT-HR but not in the EC (r = -0.07) group (z = -2.17, p = .015).
CONCLUSION


Compared to standard psychoeducation, FFT-HR is associated with stronger connectivity between the VLPFC and aDMN, suggesting possible enhancements of self-awareness, illness awareness, and emotion regulation.
CLINICAL TRIAL REGISTRATION INFORMATION


Early Intervention for Youth at Risk for Bipolar Disorder; https://clinicaltrials.gov/; NCT01483391.",2021,"Compared to standard psychoeducation, FFT-HR is associated with stronger connectivity between the VLPFC and aDMN, suggesting possible enhancements of self- and illness awareness and emotion regulation.","['Youth at High Risk for Bipolar Disorder', 'Family', 'HR youth (N=34; age 9-17 years; mean 14 years, 56% girls) with depressive and/or hypomanic symptoms and at least one first- or second-degree relative with BD I or II', 'symptomatic youth at high risk (HR) for bipolar disorder (BD) and healthy comparison (HC) youth, and, in HR youth']","['FFT-HR (n=16) or EC', 'Focused Therapy Versus Standard Psychoeducation', 'FFT-HR (12 sessions of psychoeducation, communication, and problem-solving skills training) or Enhanced Care (EC; 3 family and 3 individual psychoeducation sessions', 'resting state functional magnetic resonance imaging (rs-fMRI']","['VLPFC-aDMN connectivity', 'depression severity', 'depression improvement']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443298', 'cui_str': 'Second degree'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0256181,"Compared to standard psychoeducation, FFT-HR is associated with stronger connectivity between the VLPFC and aDMN, suggesting possible enhancements of self- and illness awareness and emotion regulation.","[{'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'Stanford University School of Medicine, California. Electronic address: mksingh@stanford.edu.'}, {'ForeName': 'Akua F', 'Initials': 'AF', 'LastName': 'Nimarko', 'Affiliation': 'Stanford University School of Medicine, California.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Garrett', 'Affiliation': 'University of Texas, Health Science Center at San Antonio.'}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Gorelik', 'Affiliation': 'University of California, Davis.'}, {'ForeName': 'Donna J', 'Initials': 'DJ', 'LastName': 'Roybal', 'Affiliation': 'University of Texas, Health Science Center at San Antonio.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'University of California, Los Angeles School of Medicine.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'private practice, Menlo Park, California.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'University of California, Los Angeles School of Medicine.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.07.892']
80,32726431,Risk Factors for Cytomegalovirus Viremia following Liver Transplantation With a Seropositive Donor and Seronegative Recipient Receiving Antiviral Therapy.,"BACKGROUND


The risk factors for development of viremia in high-risk donor cytomegalovirus (CMV)-seropositive and recipient CMV-seronegative (D+R-) transplant recipients are incompletely defined.
METHODS


The study population comprised patients in the preemptive therapy (PET) arm of a randomized, controlled trial of PET versus prophylaxis using valganciclovir in D+R- liver transplant recipients. Weekly surveillance monitoring for viremia for 100 days was performed using a sensitive CMV-DNA polymerase chain reaction assays. Risk factors for viremia and time to onset (≤4 vs >4 weeks) of viremia were examined using logistic regression models.
RESULTS


Viremia developed in 84% (79/94) of recipients and older donor age was the only independent factor associated with viremia (odds ratio, 2.20 for each quartile increase in donor age; 95% confidence interval [CI], 1.07-4.52; P = .031). Recipients who developed early-onset viremia (within 4 weeks) also had significantly older donors than those with later-onset viremia (difference in age 10.1 years; 95% CI, 2-19; P = .03).
CONCLUSIONS


Older donor age was an independent predictor of viremia and earlier-onset of viremia in D+R- liver transplant recipients. Future studies should assess the mechanistic links underlying this novel association.
CLINICAL TRIAL REGISTRATION


NCT01552369.",2021,"RESULTS


Viremia developed in 84% (79/94) of recipients and older donor age was the only independent factor associated with viremia (OR 2.20 for each quartile increase in donor age, 95% CI 1.07-4.52, p=0.031).","['CMV- recipient seronegative donor seropositive liver transplant recipients who receive', 'D+R- liver transplant recipients']","['PET', 'preemptive therapy (PET', 'preemptive antiviral therapy']","['Viremia', 'early-onset viremia', 'viremia']","[{'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0455647', 'cui_str': 'H/O: liver recipient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}]","[{'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",,0.0310473,"RESULTS


Viremia developed in 84% (79/94) of recipients and older donor age was the only independent factor associated with viremia (OR 2.20 for each quartile increase in donor age, 95% CI 1.07-4.52, p=0.031).","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'University of Pittsburgh and VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Drew J', 'Initials': 'DJ', 'LastName': 'Winston', 'Affiliation': 'University of California Los Angeles Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Raymund R', 'Initials': 'RR', 'LastName': 'Razonable', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'G Marshall', 'Initials': 'GM', 'LastName': 'Lyon', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Fernanda P', 'Initials': 'FP', 'LastName': 'Silveira', 'Affiliation': 'University of Pittsburgh and University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Marilyn M', 'Initials': 'MM', 'LastName': 'Wagener', 'Affiliation': 'University of Pittsburgh and VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Ajit P', 'Initials': 'AP', 'LastName': 'Limaye', 'Affiliation': 'University of Washington, Seattle, Washington, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa470']
81,32861773,Effectiveness of Motivational Interviewing-Enhanced Behavior Therapy for Adolescents With Attention-Deficit/Hyperactivity Disorder: A Randomized Community-Based Trial.,"OBJECTIVE


This study tests the effectiveness of parent-teen psychotherapy for adolescent attention-deficit hyperactivity disorder (ADHD) (Supporting Teens' Autonomy Daily [STAND]) versus usual care (UC) in 4 community clinics.
METHOD


A randomized clinical trial was conducted with double randomization of adolescents and therapists to STAND versus UC. Participants were 278 culturally diverse adolescents diagnosed with DSM-5 ADHD at baseline and 82 community therapists. Seven primary outcomes were assessed at baseline (BL), posttreatment (PT; mean = 5.11 months post-BL, SD = 2.26), and follow-up (FU; mean = 9.81 months post-BL, SD = 2.50): inattention (IN; parent/teacher-rated), academics (parent-rated/official records), family functioning (parent/adolescent-rated), and disciplinary records. Treatment engagement indicated consumer fit (eg, number or sessions received, percentage of sessions attended by parent, satisfaction). The impact of treatment on concurrent medication use was also examined. Service delivery features were examined as moderators of outcome.
RESULTS


Intent-to-treat (N = 278) analyses indicated no significant group × time effects. STAND only led to superior outcomes when therapists were licensed (22% of sample) versus unlicensed (parent-rated IN: p < .001, d = 1.08; parent-rated academic impairment: p = .010, d = 1.17). Compared to UC, STAND was associated with greater parent participation (p < .001, d = 0.88) and higher scores on certain indices of parent satisfaction. STAND also was associated with superior medication engagement over time compared to UC (odds ratio = 7.18).
CONCLUSION


Evidence-based psychosocial treatment for adolescent ADHD did not outperform UC on outcome trajectories despite improving some indices of treatment engagement. STAND requires additional adaptation for community contexts.
CLINICAL TRIAL REGISTRATION INFORMATION


STAND Community Trial (STAND); clinicaltrials.gov; NCT02694939.",2020,"Compared to UC, STAND was associated with greater parent participation (p<.001, d=.88) and higher scores on certain indices of parent satisfaction.","['four community clinics', 'Participants were 278 culturally-diverse adolescents diagnosed with DSM-5 ADHD at baseline and 82 community therapists', 'Adolescents With Attention-Deficit/Hyperactivity Disorder', 'adolescents and therapists to STAND vs. UC']","['Motivational Interviewing-Enhanced Behavior Therapy', 'Usual Care (UC', 'parent-teen psychotherapy']",[],"[{'cui': 'C0587907', 'cui_str': 'Community clinic'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]",[],278.0,0.201357,"Compared to UC, STAND was associated with greater parent participation (p<.001, d=.88) and higher scores on certain indices of parent satisfaction.","[{'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Sibley', 'Affiliation': ""University of Washington School of Medicine, Seattle Children's Research Institute, Seattle; Florida International University Herbert Wertheim College of Medicine, Miami, FL. Electronic address: margaret.sibley@seattlechildrens.org.""}, {'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Graziano', 'Affiliation': 'Florida International University, Miami.'}, {'ForeName': 'Stefany', 'Initials': 'S', 'LastName': 'Coxe', 'Affiliation': 'Florida International University, Miami.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Bickman', 'Affiliation': 'Florida International University, Miami.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Florida International University, Miami.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.07.907']
82,32763086,Randomised controlled trial of pharmacist-led patient counselling in controlling hypoglycaemic attacks in older adults with type 2 diabetes mellitus (ROSE-ADAM): A study protocol of the SUGAR intervention.,"INTRODUCTION


Hypoglycaemia is one of the most serious adverse effects of diabetes treatment. Older adults are at the highest risk to develop hypoglycaemia. Several studies have established the important positive role of educational interventions on achieving glycaemic control and other clinical outcomes, however, there is still a lack in studies that evaluate the impact of such type of interventions on hypoglycaemia risk in elderly patients with type 2 diabetes. The purpose of this research is to evaluate the effectiveness of pharmacist-led patient counselling on reducing hypoglycaemic attacks in older adults with type 2 diabetes mellitus.
METHODS


and analysis: This study is an open-label, parallel controlled randomised trial, which will be conducted in the outpatient clinics at the largest referral hospital in the north of Jordan. Participants who are elderly (age ≥ 65 years), diagnosed with type 2 diabetes mellitus, and taking insulin, sulfonylurea, or any three anti-diabetic medications will be randomly assigned to intervention (SUGAR Handshake) and control (usual care) groups. The SUGAR Handshake participants will have an interactive, individualised, medications-focused counselling session reinforced with a pictogram and a phone call at week six of enrolment. The primary outcome measure is the frequency of total hypoglycaemic events within 12 weeks of follow up. Secondary outcomes include the frequency of asymptomatic, symptomatic, and severe hypoglycaemic events, hypoglycaemia incidence, and time to the first hypoglycaemic attack. We will also conduct a nested qualitative study for process evaluation.
ETHICS AND DISSEMINATION


The Human Research Ethics Committee of the University of Lincoln and the Institutional Review Board of King Abdullah University Hospital approved this protocol. The findings of this study will be presented in international conferences and published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


The study protocol has been registered with ClinicalTrials.gov, NCT04081766.",2021,"The purpose of this research is to evaluate the effectiveness of pharmacist-led patient counselling on reducing hypoglycaemic attacks in older adults with type 2 diabetes mellitus.
","['elderly patients with type 2 diabetes', 'older adults with type 2 diabetes mellitus', 'Older adults', 'outpatient clinics at the largest referral hospital in the north of Jordan', 'older adults with type 2 diabetes mellitus (ROSE-ADAM', 'Participants who are elderly (age\xa0≥\xa065 years), diagnosed with type 2 diabetes mellitus, and taking insulin, sulfonylurea, or any three anti-diabetic medications']","['SUGAR intervention', 'pharmacist-led patient counselling']","['frequency of total hypoglycaemic events', 'frequency of asymptomatic, symptomatic, and severe hypoglycaemic events, hypoglycaemia incidence, and time to the first hypoglycaemic attack', 'hypoglycaemic attacks', 'hypoglycaemia risk', 'Hypoglycaemia']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1529905', 'cui_str': '(123I)ADAM'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0600047', 'cui_str': 'Patient counseled'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.12039,"The purpose of this research is to evaluate the effectiveness of pharmacist-led patient counselling on reducing hypoglycaemic attacks in older adults with type 2 diabetes mellitus.
","[{'ForeName': 'Huda Y', 'Initials': 'HY', 'LastName': 'Almomani', 'Affiliation': 'School of Pharmacy, University of Lincoln, LN6 7DL, Lincoln, UK. Electronic address: huda.almomani@yahoo.com.'}, {'ForeName': 'Carlos Rodriguez', 'Initials': 'CR', 'LastName': 'Pascual', 'Affiliation': 'School of Pharmacy, University of Lincoln, LN6 7DL, Lincoln, UK.'}, {'ForeName': 'Sayer I', 'Initials': 'SI', 'LastName': 'Al-Azzam', 'Affiliation': 'Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, 22110, Jordan.'}, {'ForeName': 'Keivan', 'Initials': 'K', 'LastName': 'Ahmadi', 'Affiliation': 'Lincoln Medical School, Universities of Nottingham and Lincoln, University of Lincoln, LN6 7TS, Lincoln, UK.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.07.012']
83,32820846,Efficacy of whitening toothpaste containing blue covarine: A double-blind controlled randomized clinical trial.,"OBJECTIVE


This randomized clinical trial evaluated the efficacy and safety of a blue-covarine whitening toothpaste on tooth bleaching.
SUBJECTS AND METHODS


Seventy-five subjects with shade mean C1 or darker were randomized into three groups (n = 25): CT-conventional toothpaste, WT-whitening toothpaste, and CP10-10% carbamide peroxide. Subjects from CT and WT brushed their teeth twice/day for 2 weeks. CP10 used bleaching gel for 4 hours/night for 2 weeks. Tooth shade and CIELab parameters were measured at baseline, after the first application, 2- and 4-week. ΔE* ab  and ΔE 00  were calculated. Subjects' perception about tooth color appearance, tooth sensitivity (TS), and gingival irritation (GI) were also assessed.
RESULTS


At all evaluation periods, it was not observed differences between WT and CT considering tooth shade (P > 0.7) or CIELab parameters (P > 0.3). At 2- and 4-week, ΔE* ab  and ΔE 00  were higher for CP10 than WT or CT (P = 0.001). WT and CT reported major dissatisfaction with tooth color appearance than CP10 (P = 0.001). At 1- and 2-week, WT experienced GI and TS similar to CT, both lower than CP10 (P < 0.01).
CONCLUSION


There were no significant differences in the whitening efficacy between whitening and conventional toothpastes. Neither of the dentifrices was as effective as at-home bleaching.
CLINICAL SIGNIFICANCE


The silica-based toothpaste containing blue covarine evaluated in this study did not give significant tooth whitening benefits over 2 weeks of use.",2021,"At all evaluation periods, it was not observed differences between WT and CT considering tooth shade (P > 0.7) or CIELab parameters (P > 0.3).",['Seventy-five subjects with shade mean C1 or darker were randomized into three groups (n = 25'],"['CT-conventional toothpaste, WT-whitening toothpaste, and CP10-10% carbamide peroxide', 'WT and CT', 'whitening toothpaste containing blue covarine', 'blue-covarine whitening toothpaste', 'CP10 used bleaching gel']","['whitening efficacy', ""Subjects' perception about tooth color appearance, tooth sensitivity (TS), and gingival irritation (GI"", 'Tooth shade and CIELab parameters', 'efficacy and safety', 'Efficacy']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C2606445', 'cui_str': 'blue covarine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0475833', 'cui_str': 'Tooth color'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",75.0,0.0268266,"At all evaluation periods, it was not observed differences between WT and CT considering tooth shade (P > 0.7) or CIELab parameters (P > 0.3).","[{'ForeName': 'Sônia Saeger', 'Initials': 'SS', 'LastName': 'Meireles', 'Affiliation': 'Department of Operative Dentistry, Federal University of Paraiba, João Pessoa, Paraiba, Brazil.'}, {'ForeName': 'Jossaria Pereira', 'Initials': 'JP', 'LastName': 'de Sousa', 'Affiliation': 'Department of Dentistry, State University of Paraíba, Campina Grande, Paraiba, Brazil.'}, {'ForeName': 'Rodrigo Barros Esteves', 'Initials': 'RBE', 'LastName': 'Lins', 'Affiliation': 'PhD student in Restorative Dentistry, University of Campinas - Piracicaba Dental School, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Fábio Correia', 'Initials': 'FC', 'LastName': 'Sampaio', 'Affiliation': 'Department of Clinical and Social Dentistry, Federal University of Paraiba, João Pessoa, Paraiba, Brazil.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12605']
84,32863142,Peak Serum Chloride and Hyperchloremia in Patients Undergoing Cardiac Surgery Is Not Explained by Chloride-Rich Intravenous Fluid Alone: A Post-Hoc Analysis of the LICRA Trial.,"OBJECTIVES


With the exception of 0.9% saline, little is known about factors that may contribute to increased serum chloride concentration (S Cl - ) in patients undergoing cardiac surgery. For the present study, the authors sought to characterize the association between administered chloride load from intravenous fluid and other perioperative variables, with peak perioperative S Cl - .
DESIGN


Secondary analysis of data from a previously published controlled clinical trial in which patients were assigned to a chloride-rich or chloride-limited perioperative fluid strategy (NCT02020538).
SETTING


Academic medical center.
PARTICIPANTS


The study comprised 1,056 adult patients with normal preoperative S Cl -  undergoing cardiac surgery.
INTERVENTIONS


None MEASUREMENTS AND MAIN RESULTS: Peak perioperative S Cl -  and hyperchloremia, defined as peak S Cl -  >110 mmol/L, were selected as co-primary endpoints. Regression modeling identified factors independently associated with these endpoints. Mean (standard deviation) peak perioperative S Cl -  was 114 (5) mmol/L, and hyperchloremia occurred in 824 (78.0%) of the cohort. In addition to administered volume of 0.9% saline, multivariate linear and logistic regression modeling consistently associated preoperative S Cl -  (regression coefficient 0.5; 95% confidence interval [CI] 0.4-0.6 mmol/L; odds ratio 1.60; 95% CI 1.41-1.82 per 1 mmol/L increase) and cardiopulmonary bypass duration (regression coefficient 0.1; 95% CI 0.1-0.2 mmol/L; odds ratio 1.12; 95% CI 1.06-1.19 per 10 minutes) with both co-primary outcomes. Multivariate modeling only explained approximately 50% of variability in peak S Cl - .
CONCLUSIONS


The present study's data identified an association for both 0.9% saline administration and other nonfluid variables with peak perioperative S Cl -  and hyperchloremia. Stand-alone strategies to limit administration of chloride-rich intravenous fluid may have limited ability to prevent hyperchloremia in this setting.",2021,Multivariate modeling only explained approximately 50% of variability in peak S,"['1,056 adult patients with normal preoperative S Cl -  undergoing cardiac surgery', 'Academic medical center', 'patients undergoing cardiac surgery', 'Patients Undergoing Cardiac Surgery']","['chloride-rich or chloride', 'Chloride-Rich Intravenous Fluid Alone']","['Peak perioperative S', 'hyperchloremia', 'Mean (standard deviation) peak perioperative S', 'cardiopulmonary bypass duration', 'Peak Serum Chloride and Hyperchloremia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0085679', 'cui_str': 'Hyperchloremia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036787', 'cui_str': 'Serum chloride'}]",1056.0,0.290755,Multivariate modeling only explained approximately 50% of variability in peak S,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'McIlroy', 'Affiliation': 'Alfred Hospital, Monash University, Melbourne, Victoria, Australia; Vanderbilt University Medical Center, Nashville, TN. Electronic address: david.r.mcilroy@vumc.org.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Murphy', 'Affiliation': 'Alfred Hospital, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Shotwell', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Dhiraj', 'Initials': 'D', 'LastName': 'Bhatia', 'Affiliation': 'Alfred Hospital, Monash University, Melbourne, Victoria, Australia.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.07.085']
85,32770831,"Cannabidivarin for HIV-Associated Neuropathic Pain: A Randomized, Blinded, Controlled Clinical Trial.","HIV remains a major burden to the health care system and neuropathic pain is the most common neurological complication of HIV infection. Because current treatment strategies often lack satisfying pain relief, cannabinoids (CBs) are discussed as a new option. We investigated cannabidivarin (CBDV) as treatment for HIV-associated neuropathic pain. We conducted a randomized, double-blind, placebo-controlled crossover study. Patients underwent two successive treatment phases (4 weeks each) and were treated with CBDV (400 mg/day) or placebo in a randomized order. A 3-week washout phase was designed to eliminate potential carry-over effects. Patients were followed up for 3 weeks after the end of the second treatment phase. The primary end point was pain intensity on an 11-point numeric rating scale, recorded in a diary. Secondary end points were additional pain medication, pain characteristics, and quality of life. We included 32 patients. The mean pain intensity under CBDV was 0.62 points higher compared with placebo (P = 0.16, 95% confidence interval -0.27 to 1.51). CBDV did not influence the amount of additional pain medication, pain characteristics, or quality of life. The incidence of adverse events was similar during both treatments. No suspected unexpected adverse reactions occurred during either treatment. CBDV was safe but failed to reduce neuropathic pain in patients with HIV. This may be explained by a lack of CB receptor activation, as indicated by preclinical experiments. Although a larger patient number might be desirable, we would not expect a change in the conclusions because the present differences are far from statistical significance. Therefore, we would currently not consider CBDV as a clinically meaningful treatment option for neuropathic pain.",2021,The mean pain intensity under cannabidivarin was 0.62 points higher compared to placebo (p=0.16; 95% CI -0.27 to 1.51).,"['HIV-associated neuropathic pain', '32 patients']","['cannabidivarin (400mg/d) or placebo', 'Cannabidivarin', 'placebo']","['mean pain intensity under cannabidivarin', 'pain intensity on an 11-point numeric rating scale', 'adverse events', 'adverse reactions', 'additional pain medication, pain characteristics or quality of life', 'neuropathic pain', 'additional pain medication, pain characteristics and quality of life']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3657549', 'cui_str': 'cannabidivarin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3657549', 'cui_str': 'cannabidivarin'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1286315', 'cui_str': 'Characteristic of pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}]",32.0,0.414352,The mean pain intensity under cannabidivarin was 0.62 points higher compared to placebo (p=0.16; 95% CI -0.27 to 1.51).,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Eibach', 'Affiliation': 'Department of Anesthesiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Scheffel', 'Affiliation': 'Department of Anesthesiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Cardebring', 'Affiliation': 'Department of Anesthesiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lettau', 'Affiliation': 'Department of Anesthesiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Özgür Celik', 'Affiliation': 'Department of Anesthesiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Morguet', 'Affiliation': 'Department of Cardiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Roehle', 'Affiliation': 'Institute of Biometry and Clinical Epidemiology, Coordinating Center for Clinical Studies, Berlin Institute of Health, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stein', 'Affiliation': 'Department of Anesthesiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2016']
86,32826409,A Maternal-Administered Multimodal Neonatal Bundle in Hospitalized Very Preterm Infants: A Pilot Study.,"BACKGROUND


Premature infants are at an increased risk for developing cerebral palsy (CP). Evidence-based strategies designed to promote healthy brain development and facilitate adaptation after brain injury in infants still admitted to the neonatal intensive care unit (NICU) represent a novel approach that may lead to improved long-term outcomes.
PURPOSE


To investigate the feasibility of a maternal-administered early intervention bundle in very preterm infants prior to NICU discharge.
METHODS


A pilot trial evaluating a maternal-administered NICU-based bundle of interventions in preterm infants (≤32 weeks' gestational age and/or ≤1500 g birth weight). The impact of the bundle on short-term developmental outcomes of infants, as well as maternal stress, anxiety, and depression, is evaluated.
RESULTS


The intervention bundle was implemented in 11 mother-infant dyads (including 1 set of twins) for a median of 8 weeks and was overall well received. Vocal soothing, scent exchange, and comforting touch were feasible, performed at or above the predetermined goal of 71% of the time (5/7 days), while kangaroo care and infant massage were not. Maternal stress, anxiety, and depression were decreased during the study time.
IMPLICATIONS TO PRACTICE


A neonatal multimodal intervention bundle provided by mothers is feasible.
IMPLICATIONS TO RESEARCH


Additional randomized controlled studies are needed to determine whether this type of bundled interventions can (1) improve the neurodevelopmental outcomes of participating infants and (2) improve long-term parental outcomes, including decreased burden of anxiety and depression, as well as improved attachment and optimal patterns of social interaction.",2021,"Maternal stress, anxiety, and depression were decreased during the study time.
","['infants still admitted to the neonatal intensive care unit (NICU', 'very preterm infants prior to NICU discharge', 'Hospitalized Very Preterm Infants', ""preterm infants (≤32 weeks' gestational age and/or ≤1500 g birth weight""]","['maternal-administered NICU-based bundle of interventions', 'maternal-administered early intervention bundle']","['maternal stress, anxiety, and depression', 'neurodevelopmental outcomes', 'Maternal stress, anxiety, and depression']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.048284,"Maternal stress, anxiety, and depression were decreased during the study time.
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Letzkus', 'Affiliation': ""Divisions of Developmental Pediatrics (Dr Letzkus) and Neonatology (Drs Alonzo and Zanelli), Department of Pediatrics, and Children's Hospital Physical and Occupational Therapy (Drs Connaughton and Kelly), University of Virginia, Charlottesville.""}, {'ForeName': 'Corrie', 'Initials': 'C', 'LastName': 'Alonzo', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Connaughton', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Santina', 'Initials': 'S', 'LastName': 'Zanelli', 'Affiliation': ''}]",Advances in neonatal care : official journal of the National Association of Neonatal Nurses,['10.1097/ANC.0000000000000786']
87,32898698,The benefit of adding lidocaine to ketamine during rapid sequence endotracheal intubation in patients with septic shock: A randomised controlled trial.,"BACKGROUND


Patients with septic shock commonly require endotracheal intubation under general anaesthesia in the operating theatre, the emergency department, and the intensive care unit. Hypotension is a serious complication after induction of general anaesthesia, especially in patients with circulatory failure. No randomised controlled trials had previously investigated protocols for induction of anaesthesia in septic shock patients. The aim of the current work is to compare two protocols, lidocaine-ketamine combination versus ketamine full-dose for rapid-sequence endotracheal intubation in patients with septic shock.
METHODS


Forty-four adult patients, with septic shock, scheduled for emergency surgical intervention were enrolled in this randomised, double-blinded, controlled study. Patients were randomised to receive either 1 mg/kg ketamine (ketamine group, n = 22) or 0.5 mg/kg ketamine plus 1 mg/kg lidocaine (ketamine-lidocaine group, n = 22) for induction of anaesthesia in addition to 0.05 mg/kg midazolam (in both groups). Our primary outcome was the mean arterial pressure (MAP). Other outcomes included frequency of post-induction hypotension, heart rate, and cardiac output.
RESULTS


Forty-three patients were available for final analysis. The average MAP reading in the first 5 min post-induction was higher in ketamine-lidocaine group than in the ketamine group {82.8 ± 5.6 mmHg and 73 ± 10.2 mmHg, P < 0.001}. Furthermore, the incidence of post-intubation hypotension was lower in the ketamine-lidocaine group than in the ketamine group {1 patient (5%) versus 17 patients (77%), P < 0.001}. The ketamine-lidocaine group showed higher MAP in almost all the readings after induction compared to ketamine group. Other haemodynamic variables including cardiac output and heart rate were comparable between both study groups.
CONCLUSION


Lidocaine-ketamine combination showed less incidence of hypotension compared to ketamine full-dose when used for rapid-sequence endotracheal intubation in patients with septic shock. REGISTRATION URL: https://clinicaltrials.gov/ct2/show/NCT03844984?cond=NCT03844984&rank=1.",2021,"The average MAP reading in the first 5 minutes post-induction was higher in ketamine-lidocaine group than in the ketamine group {82.8 ± 5.6 mmHg and 73 ± 10.2 mmHg, P < 0.001}.","['patients with septic shock', 'Patients with septic shock commonly require', 'patients with circulatory failure', 'septic shock patients', 'Forty-four adult patients, with septic shock, scheduled for emergency surgical intervention', 'Patients with Septic Shock']","['ketamine (ketamine group, n\u2009=\u200922) or 0.5\u2009mg/kg ketamine plus 1\u2009mg/kg lidocaine (ketamine-lidocaine group, n\u2009=\u200922) for induction of anaesthesia in addition to 0.05\u2009mg/kg midazolam', 'Ketamine', 'endotracheal intubation', 'ketamine', 'Lidocaine-ketamine', 'lidocaine-ketamine combination versus ketamine', 'ketamine-lidocaine', 'Lidocaine']","['incidence of hypotension', 'mean arterial pressure (MAP', 'cardiac output and heart rate', 'incidence of post-intubation hypotension', 'average MAP reading', 'frequency of post-induction hypotension, heart rate, and cardiac output', 'MAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",44.0,0.561023,"The average MAP reading in the first 5 minutes post-induction was higher in ketamine-lidocaine group than in the ketamine group {82.8 ± 5.6 mmHg and 73 ± 10.2 mmHg, P < 0.001}.","[{'ForeName': 'Shymaa', 'Initials': 'S', 'LastName': 'Fathy', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasanin', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt. Electronic address: ahmed.hasanin@kasralainy.edu.eg.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ezzat', 'Initials': 'E', 'LastName': 'Ramzy', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Sarhan', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Almenesey', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Beni Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Ahmed G', 'Initials': 'AG', 'LastName': 'Safina', 'Affiliation': 'Department of General Surgery, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hosny', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ghada Adel', 'Initials': 'GA', 'LastName': 'Hamden', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Gado', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mokhtar', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.06.017']
88,32886901,Cost-Effectiveness of Initial Versus Delayed Lanreotide for Treatment of Metastatic Enteropancreatic Neuroendocrine Tumors.,"BACKGROUND


The Controlled Study of Lanreotide Antiproliferative Response in Neuroendocrine Tumors (CLARINET) trial showed prolonged progression-free survival in patients initially treated with lanreotide versus placebo. We evaluated the cost-effectiveness of upfront lanreotide versus active surveillance with lanreotide administered after progression in patients with metastatic enteropancreatic neuroendocrine tumors (NETs), both of which are treatment options recommended in NCCN Clinical Practice Guidelines in Oncology for Neuroendocrine and Adrenal Tumors.
METHODS


We developed a Markov model calibrated to the CLARINET trial and its extension. We based the active surveillance strategy on the CLARINET placebo arm. We calculated incremental cost-effectiveness ratios (ICERs) in dollars per quality-adjusted life-year (QALY). We modeled lanreotide's cost at $7,638 per 120 mg (average sales price plus 6%), used published utilities (stable disease, 0.77; progressed disease, 0.61), adopted a healthcare sector perspective and lifetime time horizon, and discounted costs and benefits at 3% annually. We examined sensitivity to survival extrapolation and modeled octreotide long-acting release (LAR) ($6,183 per 30 mg). We conducted one-way, multiway, and probabilistic sensitivity analyses.
RESULTS


Upfront lanreotide led to 5.21 QALYs and a cost of $804,600. Active surveillance followed by lanreotide after progression led to 4.84 QALYs and a cost of $590,200, giving an ICER of $578,500/QALY gained. Reducing lanreotide's price by 95% (to $370) or 85% (to $1,128) per 120 mg would allow upfront lanreotide to reach ICERs of $100,000/QALY or $150,000/QALY. Across a range of survival curve extrapolation scenarios, pricing lanreotide at $370 to $4,000 or $1,130 to $5,600 per 120 mg would reach ICERs of $100,000/QALY or $150,000/QALY, respectively. Our findings were robust to extensive sensitivity analyses. The ICER modeling octreotide LAR is $482,700/QALY gained.
CONCLUSIONS


At its current price, lanreotide is not cost-effective as initial therapy for patients with metastatic enteropancreatic NETs and should be reserved for postprogression treatment. To be cost-effective as initial therapy, the price of lanreotide would need to be lowered by 48% to 95% or 27% to 86% to reach ICERs of $100,000/QALY or $150,00/QALY, respectively.",2020,"Active surveillance followed by lanreotide after progression led to 4.84 QALYs and a cost of $590,200, giving an ICER of $578,500/QALY gained.","['patients initially treated with', 'patients with metastatic enteropancreatic NETs', 'patients with metastatic enteropancreatic neuroendocrine tumors (NETs', 'Metastatic Enteropancreatic Neuroendocrine Tumors']","['octreotide long-acting release (LAR', 'CLARINET placebo', 'upfront lanreotide', 'lanreotide versus placebo', 'lanreotide', 'Upfront lanreotide', 'Initial Versus Delayed Lanreotide']","['progression-free survival', 'cost-effectiveness', 'Cost-Effectiveness', 'incremental cost-effectiveness ratios (ICERs) in dollars per quality-adjusted life-year (QALY']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}]","[{'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0562019', 'cui_str': 'dollar'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0475206,"Active surveillance followed by lanreotide after progression led to 4.84 QALYs and a cost of $590,200, giving an ICER of $578,500/QALY gained.","[{'ForeName': 'James I', 'Initials': 'JI', 'LastName': 'Barnes', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Lin', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, California; and.'}, {'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Owens', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Goldhaber-Fiebert', 'Affiliation': 'Center for Primary Care and Outcomes Research/Center for Health Policy, Department of Medicine, Stanford University School of Medicine, Stanford, California; and.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Kunz', 'Affiliation': 'Department of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2020.7563']
89,32888115,Opportunities for caries prevention using an ion-releasing coating material: a randomised clinical study.,"Ion-releasing materials (containing fluoride and boron, for example) have shown caries-preventive effects in vitro. The purpose of the present study was to investigate the impact of multi-ion-releasing coating material on pH stabilisation, plaque accumulation and the bacterial composition of dental plaque during a time period of 90 days. The null hypothesis tested here was that the evaluated material would not show any differences in pH stabilisation, plaque accumulation or bacterial composition compared with control material.The study was carried out as a double-blind, split-mouth, randomised, controlled clinical trial in 28 volunteers. Over the evaluation period (days 4, 30, 60 and 90), pH measurements, plaque index and plaque sampling for bacterial analyses were conducted in a calibrated, standardized manner. The study received ethical permission and was carried out in accordance with the Helsinki Declaration.A significant difference was observed, with less plaque accumulation over time in the subjects in whom the ion-releasing material was applied in comparison to the non-active group. No significant difference was evident in terms of either pH stabilisation or plaque levels of mutans streptococci.The null hypothesis relating to plaque accumulation was rejected, with a lower plaque index shown for the test group up to 60-90 days. No adverse effects during the observation period were observed. Since the studied cohort was healthy from a caries perspective, more clinical studies are needed to further evaluate the caries-prevention potential of the ion-releasing material in other patient groups.",2021,"The null hypothesis relating to plaque accumulation was rejected, with a lower plaque index shown for the test group up to 60-90 days.",['28 volunteers'],[],"['pH measurements, plaque index and plaque sampling', 'pH stabilisation or plaque levels of mutans streptococci', 'adverse effects', 'pH stabilisation, plaque accumulation or bacterial composition', 'plaque accumulation']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]",[],"[{'cui': 'C0202165', 'cui_str': 'Hydrogen ion concentration measurement'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",28.0,0.0357859,"The null hypothesis relating to plaque accumulation was rejected, with a lower plaque index shown for the test group up to 60-90 days.","[{'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Örtengren', 'Affiliation': 'Department of Cariology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Box 450, 405 30, Göteborg, Sweden. ulf.ortengren@odontologi.gu.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lehrkinder', 'Affiliation': 'Department of Cariology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Box 450, 405 30, Göteborg, Sweden.'}, {'ForeName': 'Aram', 'Initials': 'A', 'LastName': 'Safarloo', 'Affiliation': 'Department of Cariology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Box 450, 405 30, Göteborg, Sweden.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Axelsson', 'Affiliation': 'Department of Cariology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Box 450, 405 30, Göteborg, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lingström', 'Affiliation': 'Department of Cariology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Box 450, 405 30, Göteborg, Sweden.'}]",Odontology,['10.1007/s10266-020-00551-7']
90,33060490,The Effect of Mechanical Ventilation With Low Tidal Volume on Blood Loss During Laparoscopic Liver Resection: A Randomized Controlled Trial.,"BACKGROUND


Control of bleeding during laparoscopic liver resection (LLR) is important for patient safety. It remains unknown what the effects of mechanical ventilation with varying tidal volumes on bleeding during LLR. Thus, this study aims to investigate whether mechanical ventilation with low tidal volume (LTV) reduces surgical bleeding during LLR.
METHODS


In this prospective, randomized, and controlled clinical study, 82 patients who underwent scheduled LLR were enrolled and randomly received either mechanical ventilation with LTV group (6-8 mL/kg) along with recruitment maneuver (once/30 min) without positive end-expiratory pressure (PEEP) or conventional tidal volume (CTV; 10-12 mL/kg) during parenchymal resection. The estimated volume of blood loss during parenchymal resection and the incidence of postoperative respiratory complications were compared between 2 groups.
RESULT


The estimated volume of blood loss (median [interquartile range {IQR}]) was decreased in the LTV group compared to the CTV group (301 [148, 402] vs 394 [244, 672] mL, P = .009); blood loss per cm2 of transected surface of liver (5.5 [4.1, 7.7] vs 12.2 [9.8, 14.4] mL/cm2, P < .001) and the risk of clinically significant estimated blood loss (>800 mL) were reduced in the LTV group compared to the CTV group (0/40 vs 8/40, P = .003). Blood transfusion was decreased in the LTV group compared to the CTV group (5% vs 20% of patients, P = .043). No patient in the LTV group but 2 patients in the CTV group were switched from LLR to open hepatectomy. Airway plateau pressure was lower in the LTV group compared to the CTV group (mean ± standard deviation [SD]) (12.7 ± 2.4 vs 17.5 ± 3.5 cm H2O, P = .002).
CONCLUSIONS


Mechanical ventilation with LTV may reduce bleeding during laparoscopic liver surgery.",2021,"Blood transfusion was decreased in the LTV group compared to the CTV group (5% vs 20% of patients , P = .043).",['82 patients who underwent scheduled LLR'],"['mechanical ventilation with low tidal volume (LTV', 'mechanical ventilation with LTV group (6-8 mL/kg) along with recruitment maneuver (once/30 min) without positive end-expiratory pressure (PEEP) or conventional tidal volume (CTV; 10-12 mL/kg) during parenchymal resection', 'Laparoscopic Liver Resection', 'Mechanical Ventilation With Low Tidal Volume', 'CTV', 'LTV', 'laparoscopic liver resection (LLR']","['blood loss per cm of transected surface of liver', 'Airway plateau pressure', 'Blood transfusion', 'estimated volume of blood loss (median [interquartile range {IQR', 'postoperative respiratory complications', 'Blood Loss', 'blood loss', 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0458922', 'cui_str': 'Surface of liver'}, {'cui': 'C3697386', 'cui_str': 'Airway plateau pressure'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}]",82.0,0.168023,"Blood transfusion was decreased in the LTV group compared to the CTV group (5% vs 20% of patients , P = .043).","[{'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hepatology, Southwest Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Shuguo', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Hepatology, Southwest Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Kaizhi', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital, London, United Kingdom.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Chongqing University Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Jiaolin', 'Initials': 'J', 'LastName': 'Ning', 'Affiliation': 'From the Department of Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005242']
91,32939054,Prognostic and predictive significance of nuclear HIF1α expression in locally advanced HNSCC patients treated with chemoradiation with or without nimotuzumab.,"BACKGROUND


Anti-EGFR-based therapies have limited success in HNSCC patients. Predictive biomarkers are greatly needed to identify the patients likely to be benefited from these targeted therapies. Here, we present the prognostic and predictive association of biomarkers in HPV-negative locally advanced (LA) HNSCC patients.
METHODS


Treatment-naive tumour tissue samples of 404 patients, a subset of randomised Phase 3 trial comparing cisplatin radiation (CRT) versus nimotuzumab plus cisplatin radiation (NCRT) were analysed to evaluate the expression of HIF1α, EGFR and pEGFR by immunohistochemistry and EGFR gene copy change by FISH. Progression-free survival (PFS), locoregional control (LRC) and overall survival (OS) were estimated by Kaplan-Meier method. Hazard ratios were estimated by Cox proportional hazard models.
RESULTS


Baseline characteristics of the patients were balanced between two treatment groups (CRT vs NCRT) and were representative of the trial cohort. The median follow-up was of 39.13 months. Low HIF1α was associated with better PFS [HR (95% CI) = 0.62 (0.42-0.93)], LRC [HR (95% CI) = 0.56 (0.37-0.86)] and OS [HR (95% CI) = 0.63 (0.43-0.93)] in the CRT group. Multivariable analysis revealed HIF1α as an independent negative prognostic biomarker. For patients with high HIF1α, NCRT significantly improved the outcomes [PFS:HR (95% CI) = 0.55 (0.37-0.82), LRC:HR (95% CI) = 0.55 (0.36-0.85) and OS:HR (95% CI) = 0.54 (0.36-0.81)] compared to CRT. While in patients with low HIF1α, no difference in the clinical outcomes was observed between treatments. Interaction test suggested a predictive value of HIF1α for OS (P = 0.008).
CONCLUSIONS


High HIF1α expression is a predictor of poor clinical response to CRT in HPV-negative LA-HNSCC patients. These patients with high HIF1α significantly benefited with the addition of nimotuzumab to CRT.
CLINICAL TRIAL REGISTRATION


Registered with the Clinical Trial Registry of India (Trial registration identifier-CTRI/2014/09/004980).",2020,"For patients with high HIF1α, NCRT significantly improved the outcomes [PFS:HR (95% CI) = 0.55 (0.37-0.82), LRC:HR (95% CI) = 0.55 (0.36-0.85) and OS:HR (95% CI) = 0.54 (0.36-0.81)] compared to CRT.","['locally advanced HNSCC patients treated with chemoradiation with or without nimotuzumab', 'HNSCC patients', 'HPV-negative locally advanced (LA) HNSCC patients', 'Treatment-naive tumour tissue samples of 404 patients']",['cisplatin radiation (CRT) versus nimotuzumab plus cisplatin radiation (NCRT'],"['expression of HIF1α, EGFR and pEGFR by immunohistochemistry and EGFR gene copy change by FISH', 'outcomes [PFS:HR', 'Progression-free survival (PFS), locoregional control (LRC) and overall survival (OS', 'Hazard ratios', 'clinical outcomes']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1570308', 'cui_str': 'Nimotuzumab'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C1570308', 'cui_str': 'Nimotuzumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0242982', 'cui_str': 'c-erbB-1 Proto-Oncogenes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",404.0,0.254513,"For patients with high HIF1α, NCRT significantly improved the outcomes [PFS:HR (95% CI) = 0.55 (0.37-0.82), LRC:HR (95% CI) = 0.55 (0.36-0.85) and OS:HR (95% CI) = 0.54 (0.36-0.81)] compared to CRT.","[{'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Patel', 'Affiliation': 'Mahimkar Lab, Cancer Research Institute, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Pandey', 'Affiliation': 'Mahimkar Lab, Cancer Research Institute, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Sadhana', 'Initials': 'S', 'LastName': 'Kannan', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Tanuja A', 'Initials': 'TA', 'LastName': 'Samant', 'Affiliation': 'Mahimkar Lab, Cancer Research Institute, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Gera', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Mittal', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Swapnil', 'Initials': 'S', 'LastName': 'Rane', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Asawari', 'Initials': 'A', 'LastName': 'Patil', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Vijay M', 'Initials': 'VM', 'LastName': 'Patil', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Manoj B', 'Initials': 'MB', 'LastName': 'Mahimkar', 'Affiliation': 'Mahimkar Lab, Cancer Research Institute, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India. mmahimkar@actrec.gov.in.'}]",British journal of cancer,['10.1038/s41416-020-01064-4']
92,33044039,"Evaluation of EDTA, QMix, and Irritrol solutions activated with Er,Cr:YSGG and diode lasers on the push-out bond strength of filling material.","This study was conducted to evaluate the effects of ethylenediaminetetraacetic acid (EDTA), Irritrol, and QMix solutions used with manual irrigation and diode and erbium, chromium-doped yttrium, scandium, gallium, and garnet (Er,Cr:YSGG) laser activation on the bonding ability of sealer to the intraradicular dentin. The root canals of 90 mandibular incisors were instrumented, and the teeth were allocated randomly to nine groups (n = 10/group) receiving final irrigation with different irrigation solutions (EDTA, Irritrol, and QMix) and irrigant activation techniques (manual, diode laser, and Er,Cr:YSGG laser). Following endodontic filling, three sections of 1-mm thickness were obtained from the middle third of each root. The root filling was subjected to a push-out test to examine the bond strength of the sealer to dentin. The test data were examined using analysis of variance with a significance level of ɑ < .05. Failure modes were determined by stereomicroscopy, and the surface characteristics of dentin were observed by scanning electron microscopy. Irritrol showed less push-out bond strength than did the other solutions in the Er,Cr:YSGG laser groups (p < .05). In the diode laser groups, QMix provided greater adhesion than did Irritrol (p < .05). The activation of QMix with the Er,Cr:YSGG laser increased the bond strength more than did manual irrigation (p < .05). No other significant difference was observed between other comparison pairs (p > .05). QMix provided adhesion superior to that of Irritrol when activated with diode and Er,Cr:YSGG lasers. Er,Cr:YSGG laser activation increased the adhesion of filling material with QMix irrigation.",2021,"The activation of QMix with the Er,Cr:YSGG laser increased the bond strength more than did manual irrigation (p < .05).",['90 mandibular incisors'],"['EDTA, QMix, and Irritrol solutions activated with Er,Cr:YSGG and diode lasers', 'final irrigation with different irrigation solutions (EDTA, Irritrol, and QMix) and irrigant activation techniques (manual, diode laser, and Er,Cr:YSGG laser', 'YSGG laser activation', 'Er,Cr', 'ethylenediaminetetraacetic acid (EDTA), Irritrol, and QMix solutions used with manual irrigation and diode and erbium, chromium-doped yttrium, scandium, gallium, and garnet (Er,Cr:YSGG) laser activation']","['push-out bond strength', 'bond strength']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0036274', 'cui_str': 'Scandium'}, {'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0449263', 'cui_str': 'Activation technique'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0449897', 'cui_str': 'Solution used'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",90.0,0.0181346,"The activation of QMix with the Er,Cr:YSGG laser increased the bond strength more than did manual irrigation (p < .05).","[{'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saricam', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Ankara Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Küçük', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Near East University, Mersin, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Akyol', 'Affiliation': 'Tepebasi Oral and Dental Health Education Hospital, Faculty of Dentistry, Ankara Yıldırım Beyazıt University, Ankara, Turkey.'}]",Microscopy research and technique,['10.1002/jemt.23616']
93,33047687,Enhanced recovery after surgery in laparoscopic distal gastrectomy: Protocol for a prospective single-arm clinical trial.,"Background


The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections. However, a recent prospective, randomised, open, parallel-controlled trial (Chinese Laparoscopic Gastrointestinal Surgery Study-01 trial), initiated by our team, indicated that under conventional peri-operative management, the reduction of the post-operative hospital stay of laparoscopic distal gastrectomy (LDG) is quite limited compared with open gastrectomy. Thus, if we could provide valuable clinical evidence for demonstrating the efficacy of the ERAS programme for gastric cancer patients undergoing LDG, it would significantly enhance the peri-operative management of gastrectomy and benefit the patients.
Methods


In this prospective single-arm trial, patients who are 18-75 years of age with gastric adenocarcinoma diagnosed with cT1-4aN0-3M0 and expected to undergo curative resection through LDG, are considered eligible for this study. All participants underwent LDG with peri-operative management under the ERAS programme. The primary outcome measures included the post-operative hospital stays and rehabilitative rate of the post-operative day 4. The secondary outcome measures are morbidity and mortality (time frame: 30 days), post-operative recovery index (time frame: 30 days), post-operative pain intensity (time frame: 3 days) and the medical costs from surgery to discharge.
Conclusion


With reasonable and scientific designing, the trial may be a great help to further discuss the benefit of ERAS programme and thus improving the peri-operative management of patients with gastrectomy.",2020,"The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections.","['All participants underwent LDG with peri-operative management under the ERAS programme', 'gastric cancer patients undergoing LDG', 'patients with gastrectomy', 'patients who are 18-75 years of age with gastric adenocarcinoma diagnosed with cT1-4aN0-3M0 and expected to undergo curative resection through LDG, are considered eligible for this study']","['laparoscopic distal gastrectomy (LDG', 'ERAS programme', 'laparoscopic distal gastrectomy', 'surgery (ERAS) programme']","['morbidity and mortality (time frame: 30 days), post-operative recovery index (time frame: 30 days), post-operative pain intensity (time frame: 3 days) and the medical costs from surgery to discharge', 'post-operative hospital stays and rehabilitative rate of the post-operative day 4', 'length of hospital stay, overall complication rates and medical costs']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0278701', 'cui_str': 'Adenocarcinoma of stomach'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0800456,"The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections.","[{'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuehong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_35_19']
94,32979230,Two randomized controlled trials of the efficacy of acceptance and commitment therapy-based educational course for body shape dissatisfaction.,"The main aim of this project was to explore the efficacy of Acceptance and Commitment Therapy (ACT)-based educational course in different formats (i.e., pure and guided self-help with different durations, and guided self-help with and without access to a discussion forum) for body shape dissatisfaction. Two randomized controlled studies (RCT) were carried out. In the first RCT, the participants were randomized to a 12- or 16-week guided self-help, a 16-week pure self-help, or a waitlist control condition. In the second RCT, the efficacy of 12-week guided self-help with or without access to a discussion forum was investigated. ACT-based self-help resulted in promising improvements in body shape dissatisfaction, and modest effects on general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life). The findings also showed no additional effects of support, access to the online discussion forum, and longer duration of self-help, suggesting the 12-week self-help with or without support is a viable option for reducing body shape dissatisfaction.",2021,"ACT-based self-help resulted in promising improvements in body shape dissatisfaction, and modest effects on general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life).",[],['acceptance and commitment therapy-based educational course'],"['general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life']",[],"[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0447353,"ACT-based self-help resulted in promising improvements in body shape dissatisfaction, and modest effects on general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life).","[{'ForeName': 'Kerim', 'Initials': 'K', 'LastName': 'Selvi', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Parling', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Welch', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",Scandinavian journal of psychology,['10.1111/sjop.12684']
95,33002927,Neuromuscular Blockade Monitoring in Acute Respiratory Distress Syndrome: Randomized Controlled Trial of Clinical Assessment Alone or With Peripheral Nerve Stimulation.,"BACKGROUND


Whether train-of-four (TOF) monitoring is more effective than clinical monitoring to guide neuromuscular blockade (NMB) in patients with acute respiratory distress syndrome (ARDS) is unclear. We compared clinical monitoring alone or with TOF monitoring to guide atracurium dosage adjustment with respect to drug dose and respiratory parameters.
METHODS


From 2015 to 2016, we conducted a randomized controlled trial comparing clinical assessments every 2 hours with or without corrugator supercilii TOF monitoring every 4 hours in patients who developed ARDS (Pao2/Fio2 <150 mm Hg) in a cardiothoracic intensive care unit. The primary outcome was the cumulative atracurium dose (mg/kg/h). Secondary outcomes included respiratory parameters during the neuromuscular blockade.
RESULTS


A total of 38 patients in the clinical + TOF (C + TOF) group and 39 patients in the clinical (C) group were included in an intention-to-treat (ITT) analysis. The cumulative atracurium dose was higher in the C + TOF group (1.06 [0.75-1.30] vs 0.65 [0.60-0.89] mg/kg/h in the C group; P < .001) compared to C group, as well as the atracurium daily dose (C + TOF - C group mean difference = 0.256 mg/kg/h [95% confidence interval {CI}, 0.099-0.416], P = .026). Driving pressures during neuromuscular blocking agent (NMBA) administration did not differ between groups (P = .653). Intensive care unit (ICU) mortality was 22% in the C group and 27% in the C + TOF group (P = .786). Days on ventilation were 17 (8-26) in the C group and 16 (10-35) in the C + TOF group.
CONCLUSIONS


In patients with ARDS, adding TOF to clinical monitoring of neuromuscular blockade did not change ICU mortality or days on mechanical ventilation (MV) but did increase atracurium consumption when compared to clinical assessment alone. TOF monitoring may not be needed in all patients who receive neuromuscular blockade for ARDS.",2021,Driving pressures during neuromuscular blocking agent (NMBA) administration did not differ between groups (P = .653).,"['Acute Respiratory Distress Syndrome', 'patients who developed ARDS (Pao2/FIO2<150 mm Hg) in a cardiothoracic intensive care unit', 'From 2015 to 2016', '38 patients in the clinical + TOF (C + TOF) group and 39 patients in the clinical (C) group were included in an intention-to-treat (ITT) analysis', 'patients with acute respiratory distress syndrome (ARDS']","['train-of-four (TOF) monitoring', 'Neuromuscular Blockade Monitoring', 'neuromuscular blocking agent (NMBA', 'Alone or With Peripheral Nerve Stimulation', 'C + TOF']","['Driving pressures', 'respiratory parameters during the neuromuscular blockade', 'cumulative atracurium dose (mg/kg/h', 'atracurium consumption', 'Intensive care unit (ICU) mortality', 'cumulative atracurium dose']","[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0561865', 'cui_str': 'Neuromuscular blockade monitoring'}, {'cui': 'C0027866', 'cui_str': 'Neuromuscular blocking agent'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0004234', 'cui_str': 'Atracurium'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1320755', 'cui_str': 'mg/kg/hr'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.238656,Driving pressures during neuromuscular blocking agent (NMBA) administration did not differ between groups (P = .653).,"[{'ForeName': 'Saïda', 'Initials': 'S', 'LastName': 'Rezaiguia-Delclaux', 'Affiliation': 'From the Cardiothoracic Intensive Care Unit.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Laverdure', 'Affiliation': 'From the Cardiothoracic Intensive Care Unit.'}, {'ForeName': 'Thibaut', 'Initials': 'T', 'LastName': 'Genty', 'Affiliation': 'From the Cardiothoracic Intensive Care Unit.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Imbert', 'Affiliation': 'From the Cardiothoracic Intensive Care Unit.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Pilorge', 'Affiliation': 'From the Cardiothoracic Intensive Care Unit.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Amaru', 'Affiliation': 'From the Cardiothoracic Intensive Care Unit.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Sarfati', 'Affiliation': 'Physiotherapy Unit, Hôpital Marie Lannelongue, Le Plessis Robinson, Université Paris Sud, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Stéphan', 'Affiliation': 'From the Cardiothoracic Intensive Care Unit.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005174']
96,33063203,Association Between Statins and Cancer Incidence in Diabetes: a Cohort Study of Japanese Patients with Type 2 Diabetes.,"BACKGROUND


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


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


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


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


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


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


Statin use was associated with a reduced incidence and mortality of cancer in Japanese patients with type 2 diabetes.",2021,"Statin use was associated with significantly reduced cancer incidence and mortality after adjustment for confounding factors (cancer incidence: adjusted hazard ratio [HR], 0.67; 95% CI, 0.49-0.90, P = 0.007; cancer mortality: adjusted HR, 0.60; 95% CI, 0.36-0.98, P = 0.04).
","['participants taking any statin at enrollment as the statin group (n\u2009=\u2009650) and the remainder as the no-statin group (n\u2009=\u20091886', 'Diabetes', 'patients with type 2 diabetes', 'Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD', 'Japanese patients with type 2 diabetes', '2536 patients with type 2 diabetes, age 30-85\xa0years, and no history of atherosclerotic cardiovascular disease, from December 2002 until May 2005', 'All participants recruited in the JPAD trial were followed until the day of any fatal event or July 2015', '318 participants developed a new cancer and 123 died as a result', 'Japanese Patients with Type 2 Diabetes']",['aspirin'],"['death from any cancer (cancer mortality', 'cancer incidence and mortality', 'Cancer incidence and mortality', 'incidence and mortality of cancer', 'first occurrence of any cancer (cancer incidence']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",2536.0,0.052467,"Statin use was associated with significantly reduced cancer incidence and mortality after adjustment for confounding factors (cancer incidence: adjusted hazard ratio [HR], 0.67; 95% CI, 0.49-0.90, P = 0.007; cancer mortality: adjusted HR, 0.60; 95% CI, 0.36-0.98, P = 0.04).
","[{'ForeName': 'Sadanori', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': 'Center for Postgraduate Training, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Soejima', 'Affiliation': 'Department of Cardiology, Graduate School of Medical Science, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Center for Health Surveillance & Preventive Medicine, Tokyo Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Nakayama Cardiovascular Clinic, Kumamoto, Japan.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Doi', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Prefectural Seiwa Medical Center, Nara, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Department of Internal Medicine, Jinnouchi Hospital Diabetes Care Center, Kumamoto, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Waki', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Metabolism, Shizuoka City Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Izuru', 'Initials': 'I', 'LastName': 'Masuda', 'Affiliation': 'Medical Examination Center, Takeda Hospital, Kyoto, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Medical University, 840 Shijo, Kashihara, Nara, 634-8522, Japan. saitonaramed@gmail.com.'}]",Journal of general internal medicine,['10.1007/s11606-020-06167-5']
97,32947455,Adjuvant Guided Exercise Therapy Versus Self-Organized Activity in Patients With Major Depression.,"Exercise seems to be effective in reducing depression itself, as well as the risk of relapse. This study evaluated whether standardized guided exercise therapy (GET) in comparison with self-organized activity (SOA) is an effective augmentation therapy in depressive adults. A total of 111 inpatients (66.7% women; mean age, 45.05 ± 12.19 years) with major depression were randomly assigned to either GET or SOA. Interventions were performed three times a week, with each session lasting 50 minutes. Both GET and SOA exerted effects even after a short-term application of 6 weeks. GET was superior to SOA in reducing depression symptom severity, as measured by the Hamilton Depression Scale (p = 0.017), specifically improving suicidality (p = 0.028) as well as time (p = 0.003) and severity of diurnal variation (p = 0.027). The findings support the beneficial role of adjuvant GET in patients with major depression as a feasible treatment in a psychiatric short-term inpatient setting.",2020,"GET was superior to SOA in reducing depression symptom severity, as measured by the Hamilton Depression Scale (p = 0.017), specifically improving suicidality (p = 0.028) as well as time (p = 0.003) and severity of diurnal variation (p = 0.027).","['patients with major depression', 'depressive adults', 'Patients With Major Depression', '111 inpatients (66.7% women; mean age, 45.05 ± 12.19 years) with major depression']","['Adjuvant Guided Exercise Therapy Versus Self-Organized Activity', 'GET or SOA', 'self-organized activity (SOA', 'standardized guided exercise therapy (GET']","['depression symptom severity', 'improving suicidality', 'Hamilton Depression Scale', 'severity of diurnal variation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}]",111.0,0.0157758,"GET was superior to SOA in reducing depression symptom severity, as measured by the Hamilton Depression Scale (p = 0.017), specifically improving suicidality (p = 0.028) as well as time (p = 0.003) and severity of diurnal variation (p = 0.027).","[{'ForeName': 'Ida S', 'Initials': 'IS', 'LastName': 'Haussleiter', 'Affiliation': ''}, {'ForeName': 'Brigitta', 'Initials': 'B', 'LastName': 'Bolsinger', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Hans-Jörg', 'Initials': 'HJ', 'LastName': 'Assion', 'Affiliation': 'LWL Hospital Dortmund, Dortmund, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Juckel', 'Affiliation': ''}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001240']
98,33043600,"Efficacy and Safety of Guselkumab, an Interleukin-23p19-Specific Monoclonal Antibody, Through One Year in Biologic-Naive Patients With Psoriatic Arthritis.","OBJECTIVE


Guselkumab, a human monoclonal antibody specific to interleukin-23p19, demonstrated efficacy and safety versus placebo through week 24 of the phase III DISCOVER-2 trial in biologic-naive patients with psoriatic arthritis (PsA). Here we report 1-year DISCOVER-2 findings.
METHODS


Adults with active PsA (≥5 swollen and ≥5 tender joints; C-reactive protein level ≥0.6 mg/dl) despite standard nonbiologic treatment were randomized to receive subcutaneous injections of guselkumab 100 mg every 4 weeks, guselkumab 100 mg at week 0, week 4 and every 8 weeks thereafter, or placebo with crossover to guselkumab 100 mg every 4 weeks at week 24. We primarily evaluated clinical efficacy through week 52 by imputing missing data (nonresponse for categorical end points; no change/using multiple imputation for continuous end points). Observed radiographic scores and adverse events (AEs) were summarized.
RESULTS


Of 739 randomized, treated patients, 93% completed week 52. The proportions of patients in whom a ≥20% improvement from baseline in American College of Rheumatology criteria (ACR20) was achieved were maintained after week 24, reaching 71% (173 of 245) and 75% (185 of 248) for patients randomized to receive treatment every 4 weeks or every 8 weeks, respectively, by week 52. The proportions of patients in whom ACR50/ACR70 and skin responses, minimal or very low disease activity, and dactylitis or enthesitis resolution were achieved at week 24 were also maintained through week 52. Further, low levels of radiographic progression, along with improvements in physical function and health-related quality of life, were sustained through week 52 with continued guselkumab treatment. Few patients experienced serious infections through week 52, with no evidence of a dosing regimen response or increase from weeks 0-24 (4 of 493 [0.8%]) to weeks 24-52 (3 of 493 [0.6%]) among guselkumab-randomized patients. No patient developed an opportunistic infection or died.
CONCLUSION


In biologic-naive PsA patients, guselkumab provided sustained improvements across diverse manifestations and maintained a favorable risk-benefit profile through week 52.",2021,"OBJECTIVE


Guselkumab, a human monoclonal antibody specific to interleukin-23p19, demonstrated efficacy and safety versus placebo through Week24 of the Phase-3 DISCOVER-2 trial in biologic-naïve psoriatic arthritis (PsA) patients.","['Adults with active PsA (≥5 swollen+≥5 tender joints; C-reactive protein ≥0.6mg/dL) despite standard nonbiologic treatment', 'Biologic-naïve Psoriatic Arthritis Patients', 'biologic-naïve psoriatic arthritis (PsA) patients']","['placebo', 'Guselkumab', 'subcutaneous injections of guselkumab 100mg every-4-weeks (Q4W); guselkumab 100mg at Week0, Week4, Q8W; or placebo with crossover to guselkumab 100mg Q4W at Week24']","['radiographic scores and adverse events (AEs', 'ACR50/ACR70 and skin responses, minimal or very low disease activity, and dactylitis or enthesitis resolution', 'ACR criteria (ACR20', 'physical function and health-related quality-of-life', 'opportunistic infection or died']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0240094', 'cui_str': 'Tenderness of joint'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C1282952', 'cui_str': 'Enthesitis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.236911,"OBJECTIVE


Guselkumab, a human monoclonal antibody specific to interleukin-23p19, demonstrated efficacy and safety versus placebo through Week24 of the Phase-3 DISCOVER-2 trial in biologic-naïve psoriatic arthritis (PsA) patients.","[{'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Proton', 'Initials': 'P', 'LastName': 'Rahman', 'Affiliation': 'Memorial University of Newfoundland, St. Johns, Newfoundland, Canada.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania, and University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Alexa P', 'Initials': 'AP', 'LastName': 'Kollmeier', 'Affiliation': 'Janssen Research and Development, LLC, San Diego, California.'}, {'ForeName': 'Soumya D', 'Initials': 'SD', 'LastName': 'Chakravarty', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, and Drexel University College of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Xie L', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Janssen Research and Development, LLC, San Diego, California.'}, {'ForeName': 'Ramanand A', 'Initials': 'RA', 'LastName': 'Subramanian', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Prasheen', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Shihong', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Yusang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Cytel, Inc., King of Prussia Pennsylvania.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41553']
99,32935315,Specific Disease Knowledge as Predictor of Susceptibility to Availability Bias in Diagnostic Reasoning: a Randomized Controlled Experiment.,"BACKGROUND


Bias in reasoning rather than knowledge gaps has been identified as the origin of most diagnostic errors. However, the role of knowledge in counteracting bias is unclear.
OBJECTIVE


To examine whether knowledge of discriminating features (findings that discriminate between look-alike diseases) predicts susceptibility to bias.
DESIGN


Three-phase randomized experiment. Phase 1 (bias-inducing): Participants were exposed to a set of clinical cases (either hepatitis-IBD or AMI-encephalopathy). Phase 2 (diagnosis): All participants diagnosed the same cases; 4 resembled hepatitis-IBD, 4 AMI-encephalopathy (but all with different diagnoses). Availability bias was expected in the 4 cases similar to those encountered in phase 1. Phase 3 (knowledge evaluation): For each disease, participants decided (max. 2 s) which of 24 findings was associated with the disease. Accuracy of decisions on discriminating features, taken as a measure of knowledge, was expected to predict susceptibility to bias.
PARTICIPANTS


Internal medicine residents at Erasmus MC, Netherlands.
MAIN MEASURES


The frequency with which higher-knowledge and lower-knowledge physicians gave biased diagnoses based on phase 1 exposure (range 0-4). Time to diagnose was also measured.
KEY RESULTS


Sixty-two physicians participated. Higher-knowledge physicians yielded to availability bias less often than lower-knowledge physicians (0.35 vs 0.97; p = 0.001; difference, 0.62 [95% CI, 0.28-0.95]). Whereas lower-knowledge physicians tended to make more of these errors on subjected-to-bias than on not-subjected-to-bias cases (p = 0.06; difference, 0.35 [CI, - 0.02-0.73]), higher-knowledge physicians resisted the bias (p = 0.28). Both groups spent more time to diagnose subjected-to-bias than not-subjected-to-bias cases (p = 0.04), without differences between groups.
CONCLUSIONS


Knowledge of features that discriminate between look-alike diseases reduced susceptibility to bias in a simulated setting. Reflecting further may be required to overcome bias, but succeeding depends on having the appropriate knowledge. Future research should examine whether the findings apply to real practice and to more experienced physicians.",2021,"Higher-knowledge physicians yielded to availability bias less often than lower-knowledge physicians (0.35 vs 0.97; p = 0.001; difference, 0.62 [95% CI, 0.28-0.95]).","['Sixty-two physicians participated', 'Phase 2 (diagnosis', 'Internal medicine residents at Erasmus MC, Netherlands']",[],"['hepatitis-IBD, 4 AMI-encephalopathy', 'Availability bias']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],"[{'cui': 'C0019158', 'cui_str': 'Inflammatory disease of liver'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",,0.0212873,"Higher-knowledge physicians yielded to availability bias less often than lower-knowledge physicians (0.35 vs 0.97; p = 0.001; difference, 0.62 [95% CI, 0.28-0.95]).","[{'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Mamede', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands. s.mamede@erasmusmc.nl.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Goeijenbier', 'Affiliation': 'Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Stephanie C E', 'Initials': 'SCE', 'LastName': 'Schuit', 'Affiliation': 'Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'de Carvalho Filho', 'Affiliation': 'Centre for Educational Research and Development in Health Professions, University Medical Centre, Groningen, The Netherlands.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Staal', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zwaan', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Henk G', 'Initials': 'HG', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}]",Journal of general internal medicine,['10.1007/s11606-020-06182-6']
100,32966755,Aprepitant for Cough in Lung Cancer. A Randomized Placebo-controlled Trial and Mechanistic Insights.,"Rationale:  Effective cough treatments are a significant unmet need in patients with lung cancer. Aprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of NK-1 (neurokinin 1) receptors, a mechanism also implicated in cough. Objectives:  To assess aprepitant in patients with lung cancer with cough and evaluate mechanisms in vagal nerve tissue. Methods : Randomized double-blind crossover trial of patients with lung cancer and bothersome cough. They received 3 days of aprepitant or matched placebo; after a 3-day washout, patients crossed to the alternative treatment. The primary endpoint was awake cough frequency measured at screening and Day 3 of each treatment; secondary endpoints included patient-reported outcomes.  In vitro , the depolarization of isolated guinea pig and human vagus nerve sections in grease-gap recording chambers, indicative of sensory nerve activation, was measured to evaluate the mechanism. Measurements and Main Results:  Twenty patients with lung cancer enrolled, with a mean age 66 years (±7.7); 60% were female and 80% had non-small cell cancer, 50% had advanced stage, and 55% had World Health Organization performance status 1. Cough frequency improved with aprepitant, reducing by 22.2% (95% confidence interval [CI], 2.8-37.7%) over placebo while awake ( P  = 0.03), 30.3% (95% CI, 12.7-44.3) over 24 hours ( P  = 0.002), and 59.8% (95% CI, 15.1-86.0) during sleep ( P  = 0.081). Patient-reported outcomes all significantly improved. Substance P depolarized both guinea pig and human vagus nerve. Aprepitant significantly inhibited substance P-induced depolarization by 78% in guinea pig ( P  = 0.0145) and 94% in human vagus ( P  = 0.0145). Conclusions:  Substance P activation of NK-1 receptors appears to be an important mechanism driving cough in lung cancer, and NK-1 antagonists show promise as antitussive therapies.",2021,"Aprepitant significantly inhibited substance P induced depolarisation by 78% in guinea pig (p=0.0145) and 94% in human vagus (p=0.0145).
","['Lung Cancer', 'lung cancer patients with cough', 'lung cancer patients with bothersome cough', 'lung cancer patients', 'Twenty lung cancer patients enrolled, mean age 66years (±7.7), 60% female, 80% non-small cell cancer, 50% advanced stage and 55% WHO performance status 1']","['aprepitant or matched placebo', 'placebo', 'Placebo']","['substance P induced depolarisation', 'nausea and vomiting', 'awake cough frequency', 'Cough frequency']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0445128', 'cui_str': 'Non-small cell'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",20.0,0.460251,"Aprepitant significantly inhibited substance P induced depolarisation by 78% in guinea pig (p=0.0145) and 94% in human vagus (p=0.0145).
","[{'ForeName': 'Jaclyn A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Harle', 'Affiliation': 'Division of Molecular and Clinical Cancer Sciences, Manchester Academic Health Sciences Centre, and.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dockry', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Russell', 'Affiliation': 'The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Molassiotis', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Yorke', 'Affiliation': 'Division of Nursing, Midwifery and Social Work, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Robinson', 'Affiliation': 'Division of Airway Disease, Respiratory Pharmacology Group, National Heart and Lung Institute, Imperial College London, London, United Kingdom; and.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Birrell', 'Affiliation': 'Division of Airway Disease, Respiratory Pharmacology Group, National Heart and Lung Institute, Imperial College London, London, United Kingdom; and.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Belvisi', 'Affiliation': 'Division of Airway Disease, Respiratory Pharmacology Group, National Heart and Lung Institute, Imperial College London, London, United Kingdom; and.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Blackhall', 'Affiliation': 'Division of Molecular and Clinical Cancer Sciences, Manchester Academic Health Sciences Centre, and.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202006-2359OC']
101,32981933,Efficacy of probiotics on digestive disorders and acute respiratory infections: a controlled clinical trial in young Vietnamese children.,"OBJECTIVES


To evaluate the efficacy of fermented milk containing Lactobacillus casei strain Shirota (LcS) on the incidence of constipation, diarrhea, acute respiratory infections (ARI), and nutritional status of young Vietnamese children.
METHODS


A controlled field trial was conducted with 1003 children (3-5 years old) in Thanh Hoa province in Vietnam. The probiotic group (n = 510) consumed fermented milk 65 mL/day containing 10 8  CFU/mL of LcS for the 12-week intervention period, whereas the control group (n = 493) was not given any. The incidence of constipation, diarrhea, ARI, and anthropometry in children was determined at baseline, after 4, 8, and 12-week intervention, and after the 4-week follow-up period.
RESULTS


Probiotic drink decreased the incidence of constipation after the 12-week intervention period (12.0% vs. 32.0%, OR = 0.28 (95% CI: 0.21-0.40), p < 0.001), tended to decrease the incidence of diarrhea (4.9% vs. 7.9%, OR = 0.60 (95% CI: 0.35-1.01), p = 0.068), and prevented the occurrence of ARI (15.9% vs. 24.5%, OR = 0.58 (95% CI: 0.42-0.79), p < 0.001), when compared with the control group. In contrast, no probiotic effects were observed for the duration of diarrhea or ARI. Weight gain was higher in the probiotic group than in the control group after 4, 8, and 12-week intervention and after the 4-week follow-up period (p < 0.05).
CONCLUSIONS


Daily intake of fermented milk containing LcS strongly prevented the incidence of constipation and ARI in Vietnamese children. This study also revealed the potential effects of the use of a probiotic drink on diarrhea prevention as well as nutritional status improvement.",2021,"Weight gain was higher in the probiotic group than in the control group after 4, 8, and 12-week intervention and after the 4-week follow-up period (p < 0.05).
","['1003 children (3-5 years old) in Thanh Hoa province in Vietnam', 'Vietnamese children', 'young Vietnamese children']","['fermented milk 65\u2009mL/day containing 10 8  CFU/mL of LcS', 'probiotic drink', 'fermented milk containing Lactobacillus casei strain Shirota (LcS', 'probiotics']","['incidence of diarrhea', 'incidence of constipation and ARI', 'occurrence of ARI', 'digestive disorders and acute respiratory infections', 'duration of diarrhea or ARI', 'Weight gain', 'diarrhea prevention', 'constipation, diarrhea, acute respiratory infections (ARI), and nutritional status', 'incidence of constipation, diarrhea, ARI, and anthropometry in children', 'incidence of constipation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0439446', 'cui_str': 'mL/24h'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439361', 'cui_str': 'cfu/mL'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0012242', 'cui_str': 'Disorder of digestive system'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",1003.0,0.0168686,"Weight gain was higher in the probiotic group than in the control group after 4, 8, and 12-week intervention and after the 4-week follow-up period (p < 0.05).
","[{'ForeName': 'Truong Tuyet', 'Initials': 'TT', 'LastName': 'Mai', 'Affiliation': 'National Institute of Nutrition, 48B Tang Bat Ho Street, Hanoi, Vietnam. truongtuyetmai@dinhduong.org.vn.'}, {'ForeName': 'Pham', 'Initials': 'P', 'LastName': 'Thi Thu', 'Affiliation': 'Haiphong University of Medicine and Pharmacy, 72\u2009A, Nguyen Binh Khiem, Ngo Quyen, Haiphong, Vietnam.'}, {'ForeName': 'Hoang', 'Initials': 'H', 'LastName': 'Thi Hang', 'Affiliation': 'National Institute of Nutrition, 48B Tang Bat Ho Street, Hanoi, Vietnam.'}, {'ForeName': 'Tran Thi Thu', 'Initials': 'TTT', 'LastName': 'Trang', 'Affiliation': 'National Institute of Nutrition, 48B Tang Bat Ho Street, Hanoi, Vietnam.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yui', 'Affiliation': 'Yakult Central Institute, 5-11 Izumi, Kunitachi, Tokyo, 186-8650, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shigehisa', 'Affiliation': 'Yakult Honsha European Research Center for Microbiology ESV, Technologiepark 4, 9052, Zwijnaarde, Belgium.'}, {'ForeName': 'Vu Thuy', 'Initials': 'VT', 'LastName': 'Tien', 'Affiliation': 'Yakult Vietnam Co., Ltd., 195, Truong Van Bang Street, Thanh My Loi Ward District 2, Ho Chi Minh, Vietnam.'}, {'ForeName': 'Truong Viet', 'Initials': 'TV', 'LastName': 'Dung', 'Affiliation': 'Hanoi Medical University, 1, Ton That Tung, Dong Da, Hanoi, Vietnam.'}, {'ForeName': 'Phan Bich', 'Initials': 'PB', 'LastName': 'Nga', 'Affiliation': 'National Institute of Nutrition, 48B Tang Bat Ho Street, Hanoi, Vietnam.'}, {'ForeName': 'Nguyen Trong', 'Initials': 'NT', 'LastName': 'Hung', 'Affiliation': 'National Institute of Nutrition, 48B Tang Bat Ho Street, Hanoi, Vietnam.'}, {'ForeName': 'Le Danh', 'Initials': 'LD', 'LastName': 'Tuyen', 'Affiliation': 'National Institute of Nutrition, 48B Tang Bat Ho Street, Hanoi, Vietnam.'}]",European journal of clinical nutrition,['10.1038/s41430-020-00754-9']
102,32962936,Sugammadex for Fast-Track Surgery in Children Undergoing Cardiac Surgery: A Randomized Controlled Study.,"OBJECTIVE


The purpose of this study was to evaluate the safety and efficacy of sugammadex for fast-track surgery in children undergoing cardiac surgery.
DESIGN


This was a prospective, randomized, controlled clinical study.
SETTING


University hospital.
PARTICIPANTS


The study comprised 60 children undergoing cardiac surgery.
INTERVENTIONS


The children in group S received sugammadex, 4 mg/kg, for reversal of neuromuscular block, and the children in group N received neostigmine, 30 µg/kg, and atropine, 15 µg/kg.
MEASUREMENTS AND MAIN RESULTS


The recovery time to a train-of-four of 0.9 and extubation time were significantly shorter in the group S than in group N (3.4 ± 1.2 min v 76.2 ± 20.5 min and 31.0 ± 6.4 min v 125.2 ± 21.6 min, respectively; p < 0.01). The heart rate after drug administration was higher in group S than in group N (102.7 ± 9.4 beats/min v 96.9 ± 8.5 beats/min; p = 0.03), whereas the mean arterial pressure after drug administration was similar in both groups. The length of hospital stay was shorter in group S (5.8 ± 1.0 v 6.5 ± 0.9 days; p = 0.03), and the hospitalization expenses were decreased in group S compared with that of group N ($1,036 ± $114 v $1,286 ± $187; p < 0.01). The incidence of postoperative atelectasis was less in group S than in group N (0 v 20%; p = 0.024).
CONCLUSION


Sugammadex can shorten the extubation time and reduce the incidence of postoperative atelectasis, with fewer adverse events, in children undergoing cardiac surgery. It may be beneficial to use sugammadex for fast-track surgery in children undergoing cardiac surgery.",2021,"Sugammadex can shorten the extubation time and reduce the incidence of postoperative atelectasis, with fewer adverse events, in children undergoing cardiac surgery.","['60 children undergoing cardiac surgery', 'Children Undergoing Cardiac Surgery', 'University hospital', 'children undergoing cardiac surgery']","['sugammadex', 'neostigmine, 30 µg/kg, and atropine, 15 µg/kg', 'Sugammadex']","['hospitalization expenses', 'safety and efficacy', 'extubation time', 'recovery time to a train-of-four of 0.9 and extubation time', 'heart rate', 'incidence of postoperative atelectasis', 'length of hospital stay', 'mean arterial pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0340074', 'cui_str': 'Postoperative atelectasis'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",60.0,0.179327,"Sugammadex can shorten the extubation time and reduce the incidence of postoperative atelectasis, with fewer adverse events, in children undergoing cardiac surgery.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Wenzhou Central Hospital, Wenzhou, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Department of Anesthesiology, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Women and Children's Hospital of Jiaxing University, Jiaxing, China. Electronic address: zhang650679@163.com.""}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.08.069']
103,33032927,Preliminary Evidence That Cortical Amyloid Burden Predicts Poor Response to Antidepressant Medication Treatment in Cognitively Intact Individuals With Late-Life Depression.,"OBJECTIVE


Amyloid accumulation, the pathological hallmark of Alzheimer's disease, may predispose some older adults to depression and cognitive decline. Deposition of amyloid also occurs prior to the development of cognitive decline. It is unclear whether amyloid influences antidepressant outcomes in cognitively intact depressed elders.
DESIGN


A pharmacoimaging trial utilizing florbetapir (18F) PET scanning followed by 2 sequential 8-week antidepressant medication trials.
PARTICIPANTS


Twenty-seven depressed elders who were cognitively intact on screening.
MEASUREMENTS AND INTERVENTIONS


After screening, diagnostic testing, assessment of depression severity and neuropsychological assessment, participants completed florbetapir (18F) PET scanning. They were then randomized to receive escitalopram or placebo for 8 weeks in a double-blinded two-to-one allocation rate. Individuals who did not respond to initial treatment transitioned to a second open-label trial of bupropion for another 8 weeks.
RESULTS


Compared with 22 amyloid-negative participants, 5 amyloid-positive participants exhibited significantly less change in depression severity and a lower likelihood of remission. In the initial blinded trial, 4 of 5 amyloid-positive participants were nonremitters (80%), while only 18% (4 of 22) of amyloid-negative participants did not remit (p = 0.017; Fisher's Exact test). In separate models adjusting for key covariates, both positive amyloid status (t = 3.07, 21 df, p = 0.003) and higher cortical amyloid binding by standard uptake value ratio (t = 2.62, 21 df, p = 0.010) were associated with less improvement in depression severity. Similar findings were observed when examining change in depression status across both antidepressant trials.
CONCLUSIONS


In this preliminary study, amyloid status predicted poor antidepressant response to sequential antidepressant treatment. Alternative treatment approaches may be needed for amyloid-positive depressed elders.",2020,"Individuals who did not respond to initial treatment transitioned to a second open-label trial of bupropion for another 8 weeks.
","['Individuals who did not respond to initial treatment transitioned to a second open-label trial of', 'Intact Individuals With Late-Life Depression', 'amyloid-positive depressed elders', 'Twenty-seven depressed elders who were cognitively intact on screening', 'cognitively intact depressed elders', 'Cognitively']","['florbetapir (18F) PET scanning', 'bupropion', 'escitalopram or placebo']","['depression status', 'depression severity and a lower likelihood of remission', 'cortical amyloid binding by standard uptake value ratio', 'depression severity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C2742211', 'cui_str': 'florbetapir'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",27.0,0.194977,"Individuals who did not respond to initial treatment transitioned to a second open-label trial of bupropion for another 8 weeks.
","[{'ForeName': 'Warren D', 'Initials': 'WD', 'LastName': 'Taylor', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN; Geriatric Research, Education, and Clinical Center (WDT, PAN), Veterans Affairs Tennessee Valley Health System, Nashville, TN. Electronic address: warren.d.taylor@vanderbilt.edu.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Boyd', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Elson', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Andrews', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Albert', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Vega', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Newhouse', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN; Geriatric Research, Education, and Clinical Center (WDT, PAN), Veterans Affairs Tennessee Valley Health System, Nashville, TN.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Woodward', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Hakmook', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics (HK), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Shokouhi', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.09.019']
104,32985121,NeuroSAFE frozen section during robot-assisted radical prostatectomy: peri-operative and histopathological outcomes from the NeuroSAFE PROOF feasibility randomized controlled trial.,"OBJECTIVES


To report on the methods, peri-operative outcomes and histopathological concordance between frozen and final section from the NeuroSAFE PROOF feasibility study (NCT03317990).
PATIENTS AND METHODS


Between May 2018 and March 2019, 49 patients at two UK centres underwent robot-assisted radical prostatectomy (RARP). Twenty-five patient were randomized to NeuroSAFE RARP (intervention arm) and 24 to standard RARP (control arm). Frozen section was compared to final paraffin section margin assessment in the 25 patients in the NeuroSAFE arm. Operation timings and complications were collected prospectively in both arms.
RESULTS


Fifty neurovascular bundles (NVBs) from 25 patients in the NeuroSAFE arm were analysed. When analysed by each pathological section (n = 250, average five per side), we noted a sensitivity of 100%, a specificity of 99.2%, and an area under the curve (AUC) of 0.994 (95% confidence interval [CI] 0.985 to 1; P ≤0.001). On an NVB basis (n = 50), sensitivity was 100%, specificity was 92.7%, and the AUC was 0.963 (95% CI 0.914 to 1; P ≤0.001). NeuroSAFE RARP lasted a mean of 3 h 16 min (knife to skin to off table, 95% CI 3 h 2 min-3 h 30 min) compared to 2 h 4 min (95% CI 2 h 2 min-2 h 25 min; P ≤0.001) for standard RARP. There was no morbidity associated with the additional length of operating time on in the NeuroSAFE arm.
CONCLUSION


This feasibility study demonstrates the safety, reproducibility and excellent histopathological concordance of the NeuroSAFE technique in the NeuroSAFE PROOF trial. Although the technique increases the duration of RARP, this does not cause short-term harm. Confirmation of feasibility has led to the opening of the fully powered NeuroSAFE PROOF randomized controlled trial, which is currently under way at four sites in the UK.",2020,"There was no morbidity associated with the additional length of operation in the NeuroSAFE arm.
","['Between May 2018 and March 2019 49 men at 2 UK centres underwent', '25 men', '25 men in the NeuroSAFE arm', '50 NVB from 25 patients in the NeuroSAFE arm were analysed']","['robot-assisted robotic prostatectomy (RARP', 'NeuroSAFE RARP', 'standard RARP', 'NeuroSAFE frozen section during robot-assisted radical prostatectomy (RARP']",['duration of RARP'],"[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016741', 'cui_str': 'Frozen Sections'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]",25.0,0.0661093,"There was no morbidity associated with the additional length of operation in the NeuroSAFE arm.
","[{'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'Dinneen', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Aiman', 'Initials': 'A', 'LastName': 'Haider', 'Affiliation': 'Department of Histopathology, University College Hospital London, London, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grierson', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Freeman', 'Affiliation': 'Department of Histopathology, University College Hospital London, London, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Histopathology, North Bristol Hospitals Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Briggs', 'Affiliation': 'Department of Urology, Westmoreland Street Hospital, University College Hospital London, London, UK.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Nathan', 'Affiliation': 'Department of Urology, Westmoreland Street Hospital, University College Hospital London, London, UK.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brew-Graves', 'Affiliation': 'Division of Medicine, University College London, London, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Persad', 'Affiliation': 'Department of Urology, North Bristol Hospitals Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Aning', 'Affiliation': 'Department of Urology, North Bristol Hospitals Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Jameson', 'Affiliation': 'Department of Histopathology, University College Hospital London, London, UK.'}, {'ForeName': 'Marzena', 'Initials': 'M', 'LastName': 'Ratynska', 'Affiliation': 'Department of Histopathology, University College Hospital London, London, UK.'}, {'ForeName': 'Imen', 'Initials': 'I', 'LastName': 'Ben-Salha', 'Affiliation': 'Department of Histopathology, University College Hospital London, London, UK.'}, {'ForeName': 'Rhys', 'Initials': 'R', 'LastName': 'Ball', 'Affiliation': 'Department of Histopathology, University College Hospital London, London, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Clow', 'Affiliation': 'Department of Urology, Westmoreland Street Hospital, University College Hospital London, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Allen', 'Affiliation': 'Department of Urology, Westmoreland Street Hospital, University College Hospital London, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Heffernan-Ho', 'Affiliation': 'Department of Urology, Westmoreland Street Hospital, University College Hospital London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Shaw', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}]",BJU international,['10.1111/bju.15256']
105,33004234,The Development and Preliminary Impact of CAMP Air: A Web-based Asthma Intervention to Improve Asthma Among Adolescents.,"OBJECTIVE


Describe the development and preliminary impact of CAMP Air, a web-based intervention for adolescents with uncontrolled asthma.
MATERIALS AND METHODS


CAMP Air was developed using an iterative process with input from stakeholders and incorporating usability testing results (n = 14 adolescents). To test CAMP Air's initial impact, 61 adolescents from two New York City public high schools (n = 37) and from clinics, community-based organizations, and third-party recruitment services (i.e., community sample; n = 24) were enrolled in a randomized pilot trial. Participants were randomized to CAMP Air (n = 30) or information-and-referral control intervention (n = 31). A point-person worked with school participants to complete CAMP Air.
RESULTS


CAMP Air participants were satisfied with the intervention and its value for supporting self-management, completing on average 6 of 7 modules. Relative to controls, CAMP Air participants demonstrated significantly improved asthma knowledge, asthma control, night wakening and school absences, and less risk for urgent care visits. Adolescents enrolled in schools completed more modules and had significantly fewer nights woken and school absences than community enrollees.
CONCLUSION


CAMP Air improves asthma outcomes among adolescents with uncontrolled asthma.
PRACTICE IMPLICATIONS


A web-based intervention CAMP Air is a promising intervention. When a point-person works with adolescents, CAMP Air's access and impact are improved.",2021,"Relative to controls, CAMP Air participants demonstrated significantly improved asthma knowledge, asthma control, night wakening and school absences, and less risk for urgent care visits.","['CAMP Air was developed using an iterative process with input from stakeholders and incorporating usability testing results (n = 14 adolescents', 'Adolescents', 'A point-person worked with school participants to complete CAMP Air', '61 adolescents from two New York City public high schools (n = 37) and from clinics, community-based organizations, and third-party recruitment services (i.e., community sample; n = 24', 'adolescents with uncontrolled asthma']","['CAMP Air', 'CAMP Air (n = 30) or information-and-referral control intervention']","['asthma outcomes', 'nights woken and school absences', 'asthma knowledge, asthma control, night wakening and school absences, and less risk for urgent care visits']","[{'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2924612', 'cui_str': 'Cephalometric point A'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0393761', 'cui_str': 'Middle insomnia'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}]",24.0,0.0356156,"Relative to controls, CAMP Air participants demonstrated significantly improved asthma knowledge, asthma control, night wakening and school absences, and less risk for urgent care visits.","[{'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Bruzzese', 'Affiliation': 'Columbia University School of Nursing, United States. Electronic address: jb3958@cumc.columbia.edu.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'George', 'Affiliation': 'Columbia University School of Nursing, United States.'}, {'ForeName': 'Jianfang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Columbia University School of Nursing, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Evans', 'Affiliation': 'Columbia University Mailman School of Public Health, United States.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Naar', 'Affiliation': 'Florida State University, Center for Translational Behavioral Science, United States.'}, {'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'DeRosier', 'Affiliation': '3C Institute, United States.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Thomas', 'Affiliation': '3C Institute, United States.'}]",Patient education and counseling,['10.1016/j.pec.2020.09.011']
106,33038062,"Efficacy and Safety of E6011, an Anti-Fractalkine Monoclonal Antibody, in Patients With Active Rheumatoid Arthritis With Inadequate Response to Methotrexate: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Study.","OBJECTIVE


To evaluate the efficacy and safety of E6011, a humanized IgG2 monoclonal antibody against human fractalkine (FKN), in a phase II, double-blind, placebo-controlled study in rheumatoid arthritis (RA) patients.
METHODS


Patients with moderate-to-severe RA who had an inadequate response to methotrexate were randomly assigned to a placebo group or to E6011 100-mg, 200-mg, or 400/200-mg groups at a 2:1:2:2 ratio. During the 24-week period, patients received the study drug subcutaneously at weeks 0, 1, and 2 and then once every 2 weeks. The primary end point was the American College of Rheumatology 20% improvement criteria (ACR20) response rate at week 12.
RESULTS


Study drugs were administered to 190 patients (placebo, n = 54; E6011 100 mg, n = 28; E6011 200 mg, n = 54; E6011 400/200 mg, n = 54), and 169 patients completed treatment. A significant difference from placebo was not found in ACR20 response rates at week 12 (37.0% [placebo], 39.3% [100 mg], 48.1% [200 mg], and 46.3% [400/200 mg], using nonresponder imputation). As a secondary end point, ACR20 response rate in the 200-mg and 400/200-mg groups attained statistical significance at week 24 (35.2% [placebo], 39.3% [100 mg], 53.7% [200 mg], and 57.4% [400/200 mg]). Subsequent exploratory subgroup analysis revealed greater efficacy of E6011, particularly in patients with a higher baseline proportion of CD16+ monocytes; ACR20 response rates in this patient subgroup at week 24 were 30.0% (placebo), 46.7% (100 mg), 57.7% (200 mg), and 69.6% (400/200 mg). E6011 administered for 24 weeks was well tolerated.
CONCLUSION


This is the first evidence that E6011, a novel cell trafficking inhibitor targeting the FKN-CX 3  CR1 interaction, is modestly effective with 24 weeks of treatment in RA patients, although the primary end point was not met.",2021,"As a secondary endpoint, ACR20 response in the 200-mg and 400/200-mg groups attained statistical significance at week 24 (35.2%, 39.3%, 53.7%, and 57.4%, respectively).","['rheumatoid arthritis (RA) patients', '169 patients completed treatment', 'Patients with moderate to severe RA with inadequate response to', 'Active Rheumatoid Arthritis Patients with Inadequate Response to', '190 patients (54']","['methotrexate (MTX', 'humanized IgG2 monoclonal antibody against human fractalkine (FKN', 'Methotrexate', 'placebo', 'Placebo']","['American College of Rheumatology (ACR)20 response', 'ACR20 response', 'tolerated']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4517622', 'cui_str': '190'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0020856', 'cui_str': 'Immunoglobulin IgG2'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0535298', 'cui_str': 'Fractalkine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}]",190.0,0.476423,"As a secondary endpoint, ACR20 response in the 200-mg and 400/200-mg groups attained statistical significance at week 24 (35.2%, 39.3%, 53.7%, and 57.4%, respectively).","[{'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Yamanaka', 'Affiliation': 'Sanno Medical Center, Tokyo, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Nanki', 'Affiliation': 'Toho University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisanori', 'Initials': 'H', 'LastName': 'Umehara', 'Affiliation': 'Nagahama City Hospital, Shiga, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yasuda', 'Affiliation': 'KAN Research Institute, Inc, Kobe, Japan.'}, {'ForeName': 'Fumitoshi', 'Initials': 'F', 'LastName': 'Tago', 'Affiliation': 'Eisai Company, Ltd, Tokyo, Japan.'}, {'ForeName': 'Yasumi', 'Initials': 'Y', 'LastName': 'Kitahara', 'Affiliation': 'Eisai Company, Ltd, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kawakubo', 'Affiliation': 'Eisai Company, Ltd, Tokyo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Torii', 'Affiliation': 'Eisai Company, Ltd, Tokyo, Japan.'}, {'ForeName': 'Seiichiro', 'Initials': 'S', 'LastName': 'Hojo', 'Affiliation': 'Eisai Company, Ltd, Tokyo, Japan.'}, {'ForeName': 'Tetsu', 'Initials': 'T', 'LastName': 'Kawano', 'Affiliation': 'KAN Research Institute, Inc, Kobe, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'KAN Research Institute, Inc, Kobe, Japan.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41555']
107,33270205,The Effect of Probiotics Supplementation on Gut Microbiota After Helicobacter pylori Eradication: A Multicenter Randomized Controlled Trial.,"INTRODUCTION


Helicobacter pylori eradication therapy may lead to the perturbation of gut microbiota. We aim to investigate the impact of probiotics on eradication rate and gut microbiota during eradication therapy.
METHODS


A total of 162 patients receiving bismuth quadruple therapy were enrolled and randomly assigned to groups given probiotics (n = 83) or placebo (n = 79) for 4 weeks. Fecal samples were collected before treatment and 2, 4, 6, and 8 weeks after eradication therapy. Gut microbiota was analyzed by 16S rRNA high-throughput sequencing.
RESULTS


The eradication rates in the placebo and probiotics group were 82.43% and 87.01%, respectively (P > 0.05). Compared with baseline, alpha and beta diversity was significantly altered 2 weeks after eradication in both groups, which was restored at week 8. There were no significant differences in diversity between the two groups. H. pylori eradication therapy resulted in enrichment of some detrimental bacteria taxa such as Shigella, Klebsiella, and Streptococcus, while probiotics supplementation could rapidly restore these taxa levels after eradication and increase the taxa of Bacillus and Lactobacillales. Functional analysis revealed that lipopolysaccharide biosynthesis and polymyxin resistance pathways were significantly enriched after eradication, while probiotics supplementation mainly enriched the cofactors and vitamins metabolism pathways. Increased relative abundances of Roseburia and Dialister were associated with the positive eradication outcome.
CONCLUSIONS


Probiotics supplementation might help to construct a beneficial profile of gut microbiota after eradication therapy. Specific bacteria taxa are associated with H. pylori eradication outcome. These findings may be of value in rational use of probiotics during H. pylori eradication.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900022116.",2021,"Functional analysis revealed that lipopolysaccharide biosynthesis and polymyxin resistance pathways were significantly enriched after eradication, while probiotics supplementation mainly enriched the cofactors and vitamins metabolism pathways.",['162 patients receiving bismuth quadruple therapy'],"['Probiotics supplementation', 'Probiotics Supplementation', 'placebo', 'probiotics']","['diversity', 'Gut Microbiota', 'eradication rate and gut microbiota', 'Fecal samples', 'alpha and beta diversity', 'relative abundances of Roseburia and Dialister', 'Gut microbiota', 'eradication rates']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C1008539', 'cui_str': 'Dialister'}]",162.0,0.0988209,"Functional analysis revealed that lipopolysaccharide biosynthesis and polymyxin resistance pathways were significantly enriched after eradication, while probiotics supplementation mainly enriched the cofactors and vitamins metabolism pathways.","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Gastroenterology, Chongqing Iron and Steel General Hospital, Chongqing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Tian', 'Affiliation': ""Department of Gastroenterology, Nanchuan People's Hospital, Nanchuan, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, 958 Hospital of PLA, Chongqing, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Department of Gastroenterology, Chongqing Fifth People's Hospital, Chongqing, China.""}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of North Sichuan Medical College, Nanchong, China.'}, {'ForeName': 'Luo', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Chengdu Medical College, Chengdu, China.'}, {'ForeName': 'Guoce', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'En', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Sumin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China. garinfly@163.com.'}, {'ForeName': 'Shiming', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China. Yangshiming@tmmu.edu.cn.'}]",Infectious diseases and therapy,['10.1007/s40121-020-00372-9']
108,33060493,"Epidural Administration of Ropivacaine Reduces the Amplitude of Transcranial Electrical Motor-Evoked Potentials: A Double-Blinded, Randomized, Controlled Trial.","BACKGROUND


An epidurally administered local anesthetic acts primarily on the epidural nerve roots and can act directly on the spinal cord through the dural sleeve. We hypothesized that epidurally administered ropivacaine would reduce the amplitude of transcranial electrical motor-evoked potentials by blocking nerve conduction in the spinal cord. Therefore, we conducted a double-blind, randomized, controlled trial.
METHODS


Thirty adult patients who underwent lung surgery were randomly allocated to 1 of 3 groups, based on the ropivacaine concentration: the 0.2% group, the 0.375% group, and the 0.75% group. The attending anesthesiologists, neurophysiologists, and patients were blinded to the allocation. The epidural catheter was inserted at the T5-6 or T6-7 interspace by a paramedian approach, using the loss of resistance technique with normal saline. General anesthesia was induced and maintained using propofol and remifentanil. Transcranial electrical motor-evoked potentials were elicited by a train of 5 pulses with an interstimulus interval of 2 milliseconds by using a constant-voltage stimulator and were recorded from the tibialis anterior muscle. Somatosensory-evoked potentials (SSEPs) were evoked by electrical tibial nerve stimulation at the popliteal fossa. After measuring the baseline values of these evoked potentials, 10 mL of epidural ropivacaine was administered at the 0.2%, 0.375%, or 0.75% concentration. The baseline amplitudes and latencies recorded before administering ropivacaine were defined as 100%. Our primary end point was the relative amplitude of the motor-evoked potentials at 60 minutes after the epidural administration of ropivacaine. We analyzed the amplitudes and latencies of these evoked potentials by using the Kruskal-Wallis test and used the Dunn multiple comparison test as the post hoc test for statistical analysis.
RESULTS


The data are expressed as the median (interquartile range). Sixty minutes after epidurally administering ropivacaine, the motor-evoked potential amplitude was lower in the 0.75% group (7% [3%-18%], between-group difference P < .001) and in the 0.375% group (52% [43%-59%]) compared to that in the 0.2% group (96% [89%-105%]). The latency of SSEP was longer in the 0.75% group compared to that in the 0.2% group, but the amplitude was unaffected.
CONCLUSIONS


Epidurally administered high-dose ropivacaine lowered the amplitude of motor-evoked potentials and prolonged the onset latencies of motor-evoked potentials and SSEPs compared to those in the low-dose group. High-dose ropivacaine can act on the motor pathway through the dura mater.",2021,We hypothesized that epidurally administered ropivacaine would reduce the amplitude of transcranial electrical motor-evoked potentials by blocking nerve conduction in the spinal cord.,['Thirty adult patients who underwent lung surgery'],"['ropivacaine', 'propofol and remifentanil', 'epidural ropivacaine', 'Ropivacaine', 'Somatosensory-evoked potentials (SSEPs']","['Amplitude of Transcranial Electrical Motor-Evoked Potentials', 'relative amplitude of the motor-evoked potentials', 'onset latencies of motor-evoked potentials and SSEPs', 'latency of SSEP', 'motor-evoked potential amplitude', 'amplitude of motor-evoked potentials']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038903', 'cui_str': 'Operation on lung'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}]",30.0,0.163123,We hypothesized that epidurally administered ropivacaine would reduce the amplitude of transcranial electrical motor-evoked potentials by blocking nerve conduction in the spinal cord.,"[{'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Furutani', 'Affiliation': 'From the Department of Anesthesiology, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Tobita', 'Affiliation': 'Department of Anesthesiology, Saiseikai Niigata Hospital, Niigata, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Ishii', 'Affiliation': 'Department of Anesthesiology, Nagaoka Chuo General Hospital, Nagaoka City, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Deguchi', 'Affiliation': 'From the Department of Anesthesiology, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Mitsuma', 'Affiliation': 'From the Department of Anesthesiology, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kamiya', 'Affiliation': 'From the Department of Anesthesiology, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'From the Department of Anesthesiology, Niigata University Medical and Dental Hospital, Niigata, Japan.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005236']
109,33273210,Brief Report: Impact of ART on Maternal Health After Cessation of Breastfeeding.,"ABSTRACT


IMPAACT PROMISE 1077BF/FF was a sequentially randomized study of pregnant and postpartum women living with HIV to investigate the efficacy and safety of antiretroviral therapy (ART). This Maternal Health Component investigated efficacy for the risk of developing AIDS or death; and safety among women randomized to continue ART (CTART: N = 289) or discontinue ART (N = 268) after cessation of breastfeeding or after confirmation of infant infection. No AIDS-defining illnesses were reported during follow-up in either arm. Adverse events of grade 3 or higher were more frequent in the CTART arm [hazard ratio = 1.78, 95% confidence interval: (1.05 to 3.02), P-value = 0.03]. The difference in adverse events in the 2 groups was mostly driven by moderate weight loss for women on the CTART arm.",2021,"Adverse events of grade 3 or higher were more frequent in the CTART arm (Hazard Ratio = 1.78, 95% CI (1.05, 3.02), p-value=0.03).","['Maternal Health after Cessation of Breastfeeding', 'pregnant and postpartum women living with HIV']","['antiretroviral therapy (ART', 'discontinue ART (DCART', 'IMPAACT', 'Antiretroviral Therapy']","['Adverse events', 'moderate weight loss', 'adverse events']","[{'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.120527,"Adverse events of grade 3 or higher were more frequent in the CTART arm (Hazard Ratio = 1.78, 95% CI (1.05, 3.02), p-value=0.03).","[{'ForeName': 'Sean S', 'Initials': 'SS', 'LastName': 'Brummel', 'Affiliation': 'The Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Taha E', 'Initials': 'TE', 'LastName': 'Taha', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Konstantia Nadia', 'Initials': 'KN', 'LastName': 'Angelidou', 'Affiliation': 'The Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Friday', 'Initials': 'F', 'LastName': 'Saidi', 'Affiliation': 'University of North Carolina (UNC) Project-Malawi, Kamuzu Central Hospital, Malawi.'}, {'ForeName': 'Patience', 'Initials': 'P', 'LastName': 'Atuhaire', 'Affiliation': 'Makerere University -John Hopkins University Research Collaboration (MUJHU CARE LTD) CRS, Kampala, Uganda.'}, {'ForeName': 'Dingase', 'Initials': 'D', 'LastName': 'Dula', 'Affiliation': 'Johns Hopkins-College of Medicine Research Project, Blantyre, Malawi.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Centre for AIDS Research in South Africa and Department of Obstetrics and Gynecology, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Matubu', 'Affiliation': 'Department of Obstetrics and Gynecology, UZ-UCSF Collaborative Project, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Gift', 'Initials': 'G', 'LastName': 'Chareka', 'Affiliation': 'Department of Obstetrics and Gynecology, UZ-UCSF Collaborative Project, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Neetal', 'Initials': 'N', 'LastName': 'Nevrekar', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College and Clinical Research Site, Pune, India.'}, {'ForeName': 'Tichaona', 'Initials': 'T', 'LastName': 'Vhembo', 'Affiliation': 'University of Zimbabwe College of Health Sciences-Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Pendo', 'Initials': 'P', 'LastName': 'Mlay', 'Affiliation': 'Kilimanjaro Christian Medical Center, Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'George', 'Affiliation': 'Family Health International, Durham, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Basar', 'Affiliation': 'Frontier Science and Technology Research Foundation, Amherst, NY.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'National Institute for Child Health and Human Development, Washington, D.C.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Browning', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Johns Hopkins U. School of Medicine, Baltimore, MD; and.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002586']
110,33293212,Safety and efficacy of the cystic fibrosis transmembrane conductance regulator potentiator icenticaftor (QBW251).,"BACKGROUND


This is the first-in-human study of icenticaftor, an oral potentiator of the cystic fibrosis (CF) transmembrane conductance regulator (CFTR) channel. Restoration of CFTR activity has shown significant clinical benefits, but more studies are needed to address all CFTR mutations.
METHODS


Safety, pharmacodynamics/pharmacokinetics of icenticaftor were evaluated in a randomized, double-blind, placebo-controlled study in healthy volunteers. Efficacy was assessed in adult CF patients with ≥1 pre-specified CFTR Class III or IV mutation (150 and 450 mg bid), or homozygous for F508del mutation (450 mg bid). Primary efficacy endpoint was change from baseline in lung clearance index (LCI 2.5 ). Secondary endpoints included %predicted FEV 1  and sweat chloride level.
RESULTS


Class IV mutations were present in 22 patients, Class III in 2 (both S549N), and 25 were homozygous for F508del. Icenticaftor was well-tolerated in healthy and CF subjects with no unexpected events or discontinuations in the CF groups. The most frequent study-drug related adverse events in CF patients were nausea (12.2%), headache (10.2%), and fatigue (6.1%). Icenticaftor 450 mg bid for 14 days showed significant improvements in all endpoints versus placebo in patients with Class III and IV mutations; mean %predicted FEV 1  increased by 6.46%, LCI 2.5  decreased by 1.13 points and sweat chloride decreased by 8.36 mmol/L. No significant efficacy was observed in patients homozygous for a single F508del.
CONCLUSIONS


Icenticaftor was safe and well-tolerated in healthy volunteers and CF patients, and demonstrated clinically meaningful changes in lung function and sweat chloride level in CF patients with Class III and IV CFTR mutations. ClinicalTrials.gov: NCT02190604.",2021,Icenticaftor was well-tolerated in healthy and CF subjects with no unexpected events or discontinuations in the CF groups.,"['healthy and CF subjects', 'healthy volunteers', 'healthy volunteers and CF patients', 'adult CF patients with ≥1 pre-specified CFTR Class III or IV mutation (150 and 450\xa0mg bid), or homozygous for F508del mutation (450\xa0mg bid']","['cystic fibrosis transmembrane conductance regulator potentiator icenticaftor (QBW251', 'placebo']","['lung clearance index (LCI 2.5 ', 'Efficacy', 'sweat chloride', 'safe and well-tolerated', 'FEV 1  and sweat chloride level', 'nausea', 'lung function and sweat chloride level', 'adverse events', 'Safety and efficacy', 'FEV 1', 'headache']","[{'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}]","[{'cui': 'C4521703', 'cui_str': 'Cystic fibrosis transmembrane conductance regulator potentiator'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231990', 'cui_str': 'Lung clearance index'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",,0.0256865,Icenticaftor was well-tolerated in healthy and CF subjects with no unexpected events or discontinuations in the CF groups.,"[{'ForeName': 'Shamsah', 'Initials': 'S', 'LastName': 'Kazani', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, United States; Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Rowlands', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, United States; Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bottoli', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland. Electronic address: ivan.bottoli@novartis.com.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Milojevic', 'Affiliation': 'Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Alcantara', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, United States; Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Ieuan', 'Initials': 'I', 'LastName': 'Jones', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, United States; Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kulmatycki', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, United States; Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Machineni', 'Affiliation': 'Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Mostovy', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, United States; Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Nicholls', 'Affiliation': 'Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Nick', 'Affiliation': 'National Jewish Health, Denver, CO, United States.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rowe', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Simmonds', 'Affiliation': 'Adult Cystic Fibrosis Centre, Royal Brompton Hospital and Imperial College, London, United Kingdom.'}, {'ForeName': 'Raju', 'Initials': 'R', 'LastName': 'Vegesna', 'Affiliation': 'Novartis Pharmaceuticals corporation, East Hanover, NJ, United States.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Verheijen', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, United States; Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Danahay', 'Affiliation': 'Enterprise Therapeutics, Brighton, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gosling', 'Affiliation': 'Novartis Pharmaceuticals corporation, East Hanover, NJ, United States; Enterprise Therapeutics, Brighton, United Kingdom; Sussex Drug Discovery Centre, University of Sussex, Brighton, United Kingdom.'}, {'ForeName': 'Phaninatha Sarma', 'Initials': 'PS', 'LastName': 'Ayalavajjala', 'Affiliation': 'Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Salman', 'Affiliation': 'Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Strieter', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, MA, United States; Novartis Institutes for BioMedical Research, Basel, Switzerland.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.11.002']
111,33285521,Impact of Exercise on Chemotherapy Tolerance and Survival in Early-Stage Breast Cancer: A Nonrandomized Controlled Trial.,"BACKGROUND


Available preliminary evidence is conflicting on whether exercise can positively influence antineoplastic treatment tolerance and in turn improve survival.
PATIENTS AND METHODS


This study compared chemotherapy treatment tolerance and survival among women receiving adjuvant chemotherapy for early-stage breast cancer who participated in a single-arm trial of supervised aerobic and resistance exercise programming versus a historical cohort that did not receive structured exercise programming.
RESULTS


The exercise group (EX; n=73) and control group (CTR; n=85) participants were matched on age and treatment and balanced on medical history, cancer diagnosis, and body mass index. Attendance in the EX group was 64% ± 27% of 3 offered sessions per week. For all chemotherapy agents combined, the relative risk (RR) of a chemotherapy dose reduction (RR, 0.78; 95% CI, 0.54-1.11) or delay (RR, 1.05; 95% CI, 0.62-1.80) did not differ between groups. However, the EX group had reduced relative and absolute risks of a dose reduction in doxorubicin by 60% and 18%, respectively. For all agents combined, there were no differences between groups in risk of anemia, neutropenia, or weight gain. In the EX group, dose reductions due to neutropenia (P=.027), other infections (P=.049), and fatigue (P=.037) were less common, whereas mucositis was more common (P=.023), compared with the CTR group. The EX group had reduced relative and absolute risks of weight gain on the docetaxel + cyclophosphamide regimen by 38% and 30%, respectively. After a median follow-up of 70 months (range, 54-84 months), there was no difference between the EX and CTR groups in disease-free survival events (n=8 [11%] vs n=9 [11%], respectively; log-rank test, P=.78) or overall survival events (n=5 [7%] vs n=6 [7%], respectively; log-rank test, P=.974).
CONCLUSIONS


Overall, exercise programming during adjuvant chemotherapy does not appear to impact treatment tolerance or survival in women receiving common modern regimens of adjuvant chemotherapy for early-stage breast cancer. However, exercise may provide selective benefits, depending on the treatment regimen received.",2020,"In the EX group, dose reductions due to neutropenia (P=.027), other infections (P=.049), and fatigue (P=.037) were less common, whereas mucositis was more common (P=.023), compared with the CTR group.","['women receiving common modern regimens of adjuvant chemotherapy for early-stage breast cancer', 'women receiving adjuvant chemotherapy for early-stage breast cancer who participated in a single-arm trial of', 'Early-Stage Breast Cancer']","['doxorubicin', 'Exercise', 'supervised aerobic and resistance exercise programming versus a historical cohort that did not receive structured exercise programming', 'chemotherapy', 'docetaxel + cyclophosphamide']","['overall survival events', 'fatigue', 'relative and absolute risks of weight gain', 'mucositis', 'disease-free survival events', 'risk of anemia, neutropenia, or weight gain', 'Chemotherapy Tolerance and Survival', 'neutropenia']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",85.0,0.147673,"In the EX group, dose reductions due to neutropenia (P=.027), other infections (P=.049), and fatigue (P=.037) were less common, whereas mucositis was more common (P=.023), compared with the CTR group.","[{'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Kirkham', 'Affiliation': '1University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': '3British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Cheri L', 'Initials': 'CL', 'LastName': 'Van Patten', 'Affiliation': '3British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kelcey A', 'Initials': 'KA', 'LastName': 'Bland', 'Affiliation': '4Australian Catholic University, Mary Mackillop Institute for Health Research, Melbourne, Victoria, Australia; and.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wollmann', 'Affiliation': '5University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'McKenzie', 'Affiliation': '5University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Taryne', 'Initials': 'T', 'LastName': 'Landry', 'Affiliation': '5University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': '5University of British Columbia, Vancouver, British Columbia, Canada.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2020.7603']
112,33285282,"Two per cent alcoholic chlorhexidine versus alcoholic five per cent povidone-iodine for the prevention of perineural catheter colonisation: The CHLOVEPI randomised, controlled trial.","BACKGROUND


Multimodal analgesia, including a regional technique using perineural catheters (PNCs), is recommended for the treatment of moderate-to-severe acute postoperative pain. Perineural catheters are at risk of bacterial colonisation. In this study, we compared the cutaneous antiseptic efficacy of 2% alcoholic chlorhexidine and povidone-iodine-alcohol for preventing the bacterial colonisation of PNCs in orthopaedic surgery.
METHODS


We performed a randomised, controlled trial, comparing two cutaneous antisepsis strategies, one based on 2% alcoholic chlorhexidine and the other on povidone-iodine-5% alcohol, for placed PNCs before orthopaedic surgery. The primary endpoint was the incidence of catheter bacterial colonisation (threshold > 1000 colony-forming units/ml). The secondary endpoints were the incidence of catheter-related infections and the adverse effects of the antiseptic solutions.
RESULTS


From November 2016 to May 2018, we included 113 patients in this study. The use of alcoholic chlorhexidine was associated with a lower incidence of catheter colonisation (15.5% (n = 9) versus 32.7% (n = 18); OR: 0.28 [0.09-0.77], p =  0.01). No catheter-related infections or adverse effects of antiseptic solutions were observed in either group. The risk factors associated with colonisation were a duration of catheter use ≥ 3 days (p =  0.04) and obesity (p = 0.005). The most frequently identified bacterium was Staphylococcus epidermidis.
CONCLUSION


Skin disinfection with 2% alcoholic chlorhexidine decreases bacterial colonisation rates for placed perineural catheters.",2021,The risk factors associated with colonisation were a duration of catheter use ≥ 3 days (p =  0.04) and obesity (p =  0.005).,"['perineural catheter colonisation', 'placed perineural catheters', 'From November 2016 to May 2018, we included 113 patients in this study']","['povidone-iodine-5% alcohol', 'regional technique using perineural catheters (PNCs', 'alcoholic chlorhexidine and povidone-iodine-alcohol', 'alcoholic chlorhexidine', 'alcoholic chlorhexidine versus alcoholic five per cent povidone-iodine']","['bacterial colonisation rates', 'incidence of catheter-related infections and the adverse effects of the antiseptic solutions', 'catheter colonisation', 'incidence of catheter bacterial colonisation', 'cutaneous antiseptic efficacy']","[{'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0562018', 'cui_str': 'cent'}]","[{'cui': 'C2747813', 'cui_str': 'Bacterial colonisation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0860239', 'cui_str': 'Infection associated with catheter'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",113.0,0.082485,The risk factors associated with colonisation were a duration of catheter use ≥ 3 days (p =  0.04) and obesity (p =  0.005).,"[{'ForeName': 'Hakim', 'Initials': 'H', 'LastName': 'Harkouk', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Ambroise Paré, Boulogne-Billancourt, France; Unité INSERM U987, Université Versailles Saint-Quentin, Versailles, France. Electronic address: hakim.harkouk@aphp.fr.""}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Thibault-Sogorb', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Ambroise Paré, Boulogne-Billancourt, France.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Beauchet', 'Affiliation': 'Unité de recherche clinique, Hôpital Ambroise Paré, Boulogne-Billancourt, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Espinasse', 'Affiliation': 'Service de microbiologie, Hôpital Ambroise Paré, Boulogne-Billancourt, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lawrence', 'Affiliation': 'Service de microbiologie, Hôpital Raymond Poincaré, Garches, France.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Martinez', 'Affiliation': ""Unité INSERM U987, Université Versailles Saint-Quentin, Versailles, France; Service d'anesthésie, Hôpital Raymond Poincaré, Garches, France.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Fletcher', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Ambroise Paré, Boulogne-Billancourt, France; Unité INSERM U987, Université Versailles Saint-Quentin, Versailles, France.""}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.100790']
113,33277338,Baseline Assessment of Circulating MicroRNAs Near Diagnosis of Type 1 Diabetes Predicts Future Stimulated Insulin Secretion.,"Type 1 diabetes is an autoimmune disease resulting in severely impaired insulin secretion. We investigated whether circulating microRNAs (miRNAs) are associated with residual insulin secretion at diagnosis and predict the severity of its future decline. We studied 53 newly diagnosed subjects enrolled in placebo groups of TrialNet clinical trials. We measured serum levels of 2,083 miRNAs, using RNA sequencing technology, in fasting samples from the baseline visit (<100 days from diagnosis), during which residual insulin secretion was measured with a mixed meal tolerance test (MMTT). Area under the curve (AUC) C-peptide and peak C-peptide were stratified by quartiles of expression of 31 miRNAs. After adjustment for baseline C-peptide, age, BMI, and sex, baseline levels of miR-3187-3p, miR-4302, and the miRNA combination of miR-3187-3p/miR-103a-3p predicted differences in MMTT C-peptide AUC/peak levels at the 12-month visit; the combination miR-3187-3p/miR-4723-5p predicted proportions of subjects above/below the 200 pmol/L clinical trial eligibility threshold at the 12-month visit. Thus, miRNA assessment at baseline identifies associations with C-peptide and stratifies subjects for future severity of C-peptide loss after 1 year. We suggest that miRNAs may be useful in predicting future C-peptide decline for improved subject stratification in clinical trials.",2021,"After adjustment for baseline C-peptide, age, BMI and sex, baseline levels of miR-3187-3p, miR-4302, and the miRNA combination of miR-3187-3p/miR-103a-3p predicted differences in MMTT C-peptide AUC/peak levels at the 12-month visit; the combination miR-3187-3p/miR-4723-5p predicted proportions of subjects above/below the 200 pmol/L clinical trial eligibility threshold at the 12-month visit.",['53 newly diagnosed subjects enrolled in placebo groups of TrialNet clinical trials'],[],"['Area under the curve (AUC) C-peptide and peak C-peptide', 'Baseline Assessment of Circulating microRNAs']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4055233', 'cui_str': 'Cell-Free MicroRNA'}]",53.0,0.190259,"After adjustment for baseline C-peptide, age, BMI and sex, baseline levels of miR-3187-3p, miR-4302, and the miRNA combination of miR-3187-3p/miR-103a-3p predicted differences in MMTT C-peptide AUC/peak levels at the 12-month visit; the combination miR-3187-3p/miR-4723-5p predicted proportions of subjects above/below the 200 pmol/L clinical trial eligibility threshold at the 12-month visit.","[{'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Snowhite', 'Affiliation': 'Diabetes Research Institute, Leonard M. Miller School of Medicine, University of Miami, Miami, FL.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Pastori', 'Affiliation': 'Diabetes Research Institute, Leonard M. Miller School of Medicine, University of Miami, Miami, FL.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Sosenko', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, Miami, FL.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Messinger Cayetano', 'Affiliation': 'Department of Public Health Sciences, Leonard M. Miller School of Medicine, University of Miami, Miami, FL.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pugliese', 'Affiliation': 'Diabetes Research Institute, Leonard M. Miller School of Medicine, University of Miami, Miami, FL apuglies@med.miami.edu.'}]",Diabetes,['10.2337/db20-0817']
114,33285517,Evaluating if an Advance Care Planning Intervention Promotes Do-Not-Resuscitate Orders by Facilitating Accurate Prognostic Awareness.,"BACKGROUND


Issuing do-not-resuscitate (DNR) orders has seldom been an outcome in randomized clinical trials of advance care planning (ACP) interventions. The aim of this study was to examine whether an ACP intervention facilitating accurate prognostic awareness (PA) for patients with advanced cancer was associated with earlier use of DNR orders.
PATIENTS AND METHODS


Participants (n=460) were randomly assigned 1:1 to the experimental and control arms, with 392 deceased participants constituting the final sample of this secondary analysis study. Participants in the intervention and control arms had each received an intervention tailored to their readiness for ACP/prognostic information and symptom-management education, respectively. Effectiveness in promoting a DNR order by facilitating accurate PA was determined by intention-to-treat analysis using multivariate logistic regression with hierarchical linear modeling.
RESULTS


At enrollment in the ACP intervention and before death, 9 (4.6%) and 8 (4.1%) participants and 168 (85.7%) and 164 (83.7%) participants in the experimental and control arms, respectively, had issued a DNR order, without significant between-arm differences. However, participants in the experimental arm with accurate PA were significantly more likely than participants in the control arm without accurate PA to have issued a DNR order before death (adjusted odds ratio, 2.264; 95% CI, 1.036-4.951; P=.041). Specifically, participants in the experimental arm who first reported accurate PA 31 to 90 days before death were significantly more likely than their counterparts in the control arm who reported accurate PA to have issued a DNR order in the next wave of assessment (adjusted odds ratio, 13.365; 95% CI, 1.989-89.786; P=.008). Both arms issued DNR orders close to death (median, 5-6 days before death).
CONCLUSIONS


Our ACP intervention did not promote the overall presence of a DNR order. However, our intervention facilitated the issuance of NDR orders before death among patients with accurate PA, especially those who reported accurate PA 31 to 90 days before death, but it did not facilitate the issuance of DNR orders earlier than their counterparts in the control arm.ClinicalTrial.gov Identification: NCT01912846.",2020,"However, participants in the experimental arm with accurate PA were significantly more likely than participants in the control arm without accurate PA to have issued a DNR order before death (adjusted odds ratio, 2.264; 95% CI, 1.036-4.951; P=.041).","['392 deceased participants constituting the final sample of this secondary analysis study', 'Participants (n=460', 'patients with advanced cancer']",['ACP intervention'],['accurate PA 31 to 90 days before death'],"[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",460.0,0.0682497,"However, participants in the experimental arm with accurate PA were significantly more likely than participants in the control arm without accurate PA to have issued a DNR order before death (adjusted odds ratio, 2.264; 95% CI, 1.036-4.951; P=.041).","[{'ForeName': 'Fur-Hsing', 'Initials': 'FH', 'LastName': 'Wen', 'Affiliation': '1Department of International Business, Soochow University, and.'}, {'ForeName': 'Chen Hsiu', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': '2School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan, ROC.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Chou', 'Affiliation': '3Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, ROC.'}, {'ForeName': 'Jen-Shi', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': '3Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, ROC.'}, {'ForeName': 'Wen-Cheng', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': '3Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, ROC.'}, {'ForeName': 'Chia-Hsun', 'Initials': 'CH', 'LastName': 'Hsieh', 'Affiliation': '3Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, ROC.'}, {'ForeName': 'Siew Tzuh', 'Initials': 'ST', 'LastName': 'Tang', 'Affiliation': '3Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Tao-Yuan, Taiwan, ROC.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2020.7601']
115,33387550,"Anesthetic Success Using Nitrous Oxide and a Combination of Lidocaine/Clonidine for the Inferior Alveolar Nerve Block and the Effects on Blood Pressure and Pulse in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Study.","INTRODUCTION


The pulpal anesthetic success rates for an inferior alveolar nerve block (IANB) alone in patients presenting with symptomatic irreversible pulpitis are less than adequate. Nitrous oxide and clonidine have shown increases in IANB success when administered individually, but their success has not been evaluated when used together. The purpose of this prospective, randomized, double-blind study was to determine the effect of nitrous oxide/oxygen plus an IANB using lidocaine/clonidine on the success of the IANB in patients with symptomatic irreversible pulpitis and to evaluate the effect of clonidine on blood pressure and pulse.
METHODS


Sixty-two emergency patients experiencing moderate to severe pain and a diagnosis of symptomatic irreversible pulpitis were enrolled. Subjects were randomly divided into 2 groups and received nitrous oxide/oxygen and an IANB using 2% lidocaine with either 27 μg clonidine or 18 μg epinephrine as vasoconstrictors. Blood pressure and pulse were recorded before and during the emergency endodontic treatment. Anesthetic success was defined as no or mild pain upon access and instrumentation of the canals.
RESULTS


The pulpal anesthetic success rate in both treatments was 58%, with no significant difference between the groups. There was no statistically significant difference in pulse or systolic blood pressure with the use of clonidine compared with epinephrine. Diastolic blood pressure was significant.
CONCLUSIONS


The use of nitrous/oxide plus the addition of lidocaine/clonidine for the IANB in teeth with symptomatic irreversible pulpitis resulted in no statistically significant difference in anesthetic success of the IANB. There were no statistically significant differences in pulse or systolic blood pressure with the use of clonidine compared with epinephrine; diastolic blood pressure was significant.",2021,"There were no statistically significant differences in pulse or systolic blood pressure with the use of clonidine when compared to epinephrine, diastolic blood pressure was significant.","['Patients with Symptomatic Irreversible Pulpitis', 'Sixty-two emergency patients experiencing moderate to severe pain and a diagnosis of symptomatic irreversible pulpitis were enrolled', 'patients with symptomatic irreversible pulpitis', 'patients presenting with symptomatic irreversible pulpitis']","['Nitrous Oxide', 'nitrous oxide/oxygen plus', 'Lidocaine/clonidine', 'lidocaine/clonidine', 'nitrous oxide/oxygen and an IANB using 2% lidocaine', 'epinephrine as vasoconstrictors', 'epinephrine', 'nitrous/oxide', 'inferior alveolar nerve block (IANB) alone', 'clonidine', 'Nitrous oxide and clonidine']","['Blood pressure and pulse', 'diastolic blood pressure', 'pulpal anesthetic success rates', 'Blood Pressure and Pulse', 'blood pressure and pulse', 'Diastolic blood pressure', 'anesthetic success', 'pulse or systolic blood pressure', 'Anesthetic success', 'pulpal anesthetic success rate', 'IANB success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}]",62.0,0.161582,"There were no statistically significant differences in pulse or systolic blood pressure with the use of clonidine when compared to epinephrine, diastolic blood pressure was significant.","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'MacDonald', 'Affiliation': 'Division of Endodontics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Drum', 'Affiliation': 'Division of Endodontics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nusstein', 'Affiliation': 'Division of Endodontics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fowler', 'Affiliation': 'Division of Endodontics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Beck', 'Affiliation': 'Division of Biosciences, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Reader', 'Affiliation': 'Division of Endodontics, The Ohio State University, Columbus, Ohio. Electronic address: reader.2@osu.edu.'}]",Journal of endodontics,['10.1016/j.joen.2020.12.014']
116,33341406,Role of Tris-CaEDTA as an adjuvant with nebulised tobramycin in cystic fibrosis patients with Pseudomonas aeruginosa lung infections: A randomised controlled trial.,"BACKGROUND


We tested if disrupting iron utilisation by P. aeruginosa by adding the Tris-buffered chelating agent CaEDTA to nebulised tobramycin would enhance bacterial clearance and improve lung function in CF patients.
METHODS


In this double-blind, randomised controlled trial, 26 episodes (25 patients) with P. aeruginosa infection admitted to two CF centres for treatment of an acute pulmonary exacerbation were randomly assigned to receive either 75 mg CaEDTA in Tris-buffered saline or placebo (Tris-buffered saline) nebulised in combination with 250 mg tobramycin twice daily for six weeks followed with four week safety follow-up. Primary endpoints were safety, tolerability, and bacterial density of P. aeruginosa. A secondary endpoint was lung function.
RESULTS


The study drug was well tolerated with adverse events comparable in both groups. The mean (SD) reduction in sputum P. aeruginosa count (log 10  CFU/g) in the CaEDTA vs placebo group was 2·05 (2·57) vs 0·82 (2·71) at two weeks relative to admission (p = 0·39). The mean improvement in ppFEV 1  was 16 vs 5 (p = 0·16); 11 vs 2 (p = 0·28); and 6 vs 2 percentage points (p = 0·47) at two, six, and ten weeks in CaEDTA and placebo groups, respectively.
CONCLUSIONS


In this pilot study in CF patients, an increase in the reduction of sputum density of P. aeruginosa and an increase in ppFEV 1  was observed in the group of patients who received Tris-CaEDTA added to inhaled tobramycin compared to the group who received inhaled tobramycin alone, although these differences were not statistically significant. The treatment was also shown to be safe.",2021,"The mean improvement in ppFEV 1  was 16 vs 5 (p = 0·16); 11 vs 2 (p = 0·28); and 6 vs 2 percentage points (p = 0·47) at two, six, and ten weeks in CaEDTA and placebo groups, respectively.
","['CF patients', 'cystic fibrosis patients with Pseudomonas aeruginosa lung infections', '26 episodes (25 patients) with P. aeruginosa infection admitted to two CF centres for treatment of an acute pulmonary exacerbation']","['75\xa0mg CaEDTA in Tris-buffered saline or placebo (Tris-buffered saline) nebulised in combination with 250\xa0mg tobramycin', 'nebulised tobramycin', 'tobramycin', 'placebo']","['mean improvement in ppFEV 1', 'mean (SD) reduction in sputum P. aeruginosa count', 'sputum density of P. aeruginosa', 'ppFEV 1', 'tolerated with adverse events', 'lung function', 'safety, tolerability, and bacterial density of P. aeruginosa']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0041175', 'cui_str': 'Tromethamine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.242001,"The mean improvement in ppFEV 1  was 16 vs 5 (p = 0·16); 11 vs 2 (p = 0·28); and 6 vs 2 percentage points (p = 0·47) at two, six, and ten weeks in CaEDTA and placebo groups, respectively.
","[{'ForeName': 'Ramaa', 'Initials': 'R', 'LastName': 'Puvvadi', 'Affiliation': ""Perth Children's Hospital, Respiratory Medicine, 15 Hospital Avnue, Nedlands, Perth, WA 6009, Australia. Electronic address: ramaa.puvvadi@health.qld.gov.au.""}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Mikkelsen', 'Affiliation': ""Perth Children's Hospital, Respiratory Medicine, 15 Hospital Avnue, Nedlands, Perth, WA 6009, Australia.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'McCahon', 'Affiliation': ""Perth Children's Hospital, Respiratory Medicine, 15 Hospital Avnue, Nedlands, Perth, WA 6009, Australia.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Grogan', 'Affiliation': ""Perth Children's Hospital, Respiratory Medicine, 15 Hospital Avnue, Nedlands, Perth, WA 6009, Australia.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ditcham', 'Affiliation': ""Perth Children's Hospital, Respiratory Medicine, 15 Hospital Avnue, Nedlands, Perth, WA 6009, Australia.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Reid', 'Affiliation': ""Perth Children's Hospital, Respiratory Medicine, 15 Hospital Avnue, Nedlands, Perth, WA 6009, Australia.""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Lamont', 'Affiliation': ""Perth Children's Hospital, Respiratory Medicine, 15 Hospital Avnue, Nedlands, Perth, WA 6009, Australia.""}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Stick', 'Affiliation': ""Perth Children's Hospital, Respiratory Medicine, 15 Hospital Avnue, Nedlands, Perth, WA 6009, Australia.""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Clements', 'Affiliation': ""Perth Children's Hospital, Respiratory Medicine, 15 Hospital Avnue, Nedlands, Perth, WA 6009, Australia.""}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.12.004']
117,33350660,Workplace Mental Health Awareness Training: A Cluster Randomized Controlled Trial.,"OBJECTIVE


To investigate the efficacy of a workplace mental health awareness training program on help-seeking and mental health outcomes.
METHODS


A cluster randomized controlled trial was conducted comparing those who received standard training (N = 210) or standard training with a mental health awareness module (N = 208). Both groups were followed up for 3 years with the primary outcome being likelihood to seek help.
RESULTS


Rates of likely help-seeking were slightly higher in the intervention group 6 months after the training, but this was not maintained over time. There was no significant difference between study conditions for mental health outcomes or actual help-seeking among those with probable mental disorder at any time point.
CONCLUSIONS


Workplace mental health awareness training has a limited short-term impact on likelihood of help-seeking and does not appear to improve mental health outcomes.",2021,"There was no significant difference between study conditions for mental health outcomes or actual help-seeking among those with probable mental disorder at any time point.
",['Workplace Mental Health Awareness Training'],"['standard training (N\u200a=\u200a210) or standard training with a mental health awareness module', 'workplace mental health awareness training program']","['mental health outcomes or actual help-seeking', 'Rates of likely help-seeking']","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",,0.100723,"There was no significant difference between study conditions for mental health outcomes or actual help-seeking among those with probable mental disorder at any time point.
","[{'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia (Ms Tan, Dr Harvey, Dr Deady); School of Psychiatry, University of New South Wales, Sydney, Australia (Ms Tan); Fire and Rescue New South Wales (Mr Dobson, Mr Donohoe); School of Psychology, University of Sydney (Ms Suk, Dr Paterson); School of Psychology (Dr Bryant), University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Samuel B', 'Initials': 'SB', 'LastName': 'Harvey', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Deady', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Dobson', 'Affiliation': ''}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Donohoe', 'Affiliation': ''}, {'ForeName': 'Curie', 'Initials': 'C', 'LastName': 'Suk', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Paterson', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000002121']
118,33316278,Cervical cancer risk and screening among women seeking assistance with basic needs.,"BACKGROUND


In the United States, more than half of cervical cancers occur in women who are inadequately screened. Interventions to improve access to cervical cancer preventive care is critical to reduce health inequities.
OBJECTIVE


This study aimed to evaluate the need for cervical cancer screening among women seeking assistance with basic needs and to assess best approaches to facilitate Papanicolaou test referral.
STUDY DESIGN


This study is a secondary analysis of a randomized controlled trial of low-income female callers to 2-1-1 Missouri, a helpline for local health and social services. The need for cervical cancer screening was assessed. Callers were randomized to 1 of 3 arms, each providing a Papanicolaou test referral: verbal referral only, verbal referral and tailored print reminder, or verbal referral and navigator. The primary outcome was contacting a Papanicolaou test referral 1 month following intervention. Student t tests or Mann-Whitney U tests were used to analyze significant differences in continuous variables, whereas Fisher exact or χ 2  tests were used for categorical variables. We stratified by number of unmet basic needs (0-1 vs ≥2) and compared success of contacting a Papanicolaou test referral among study groups (verbal referral vs tailored reminder vs navigator) using the Fisher exact test and χ 2  test, respectively. Multivariate logistic regression was used to assess risk factors for nonadherence for Papanicolaou test at baseline and at 1 month follow-up, adjusting for race and ethnicity, age, insurance status, self-rated health, smoking, and study group.
RESULTS


Among 932 female callers, 250 (26.8%) needed cervical cancer screening. The frequency of unmet basic needs was high, the most common being lack of money for unexpected expenses (91.2%) and necessities, such as food, shelter, and clothing (73.2%). Among those needing a Papanicolaou test, 211 women received screening referrals. Women in the navigator group (21 of 71, 29.6%) reported higher rates of contacting a Papanicolaou test referral than those exposed to verbal referral only (11/73, 15.1%) or verbal referral and tailored print reminder (9/67, 13.4%) (P=.03). Among 176 women with ≥2 unmet needs who received a Papanicolaou test referral, the provision of a navigator remained associated with contacting the referral (navigator [33.9%] vs verbal referral [17.2%] vs tailored reminder [10.2%]; P=.005). Assignment to the navigator group (adjusted odds ratio, 3.4; 95% confidence interval, 1.4-8.5) and nonwhite race (adjusted odds ratio, 2.0; 95% confidence interval, 1.5-2.8) were independent predictors of contacting a Papanicolaou test referral.
CONCLUSION


Low-income women seeking assistance with basic needs often lack cervical cancer screening. Health navigators triple the likelihood that women will make contact with Papanicolaou test services, but most 2-1-1 callers still fail to schedule Papanicolaou testing despite assistance from navigators. Interventions beyond health navigators are needed to reduce cervical cancer disparities.",2021,"Women in the navigator group (11/73, 15.1%) reported higher rates of contacting a Pap referral than those exposed to verbal referral only (9/67, 13.4%) or verbal referral+tailored print reminder (21/71, 29.6%), p = 0.03.","['176 women with ≥ 2 unmet needs who received a Pap referral, provision of a navigator remained associated with contacting the referral (33.9% vs. verbal referral 17.2% vs. tailored reminder 10.2%, p=0.005', 'low-income female callers to Missouri 2-1-1, a helpline for local health/social services', 'women seeking assistance with basic needs', '932 female callers, 26.8% needed cervical screening']","['Pap referral: verbal referral only, verbal referral+ tailored print reminder, or verbal referral+navigator']","['Cervical cancer risk and screening', 'higher rates of contacting a Pap referral', 'odds ratio (aOR', 'Pap referral one month post-intervention']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026222', 'cui_str': 'Missouri'}, {'cui': 'C1449035', 'cui_str': 'SPRR2A protein, human'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033161', 'cui_str': 'Printing'}]","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",176.0,0.0911297,"Women in the navigator group (11/73, 15.1%) reported higher rates of contacting a Pap referral than those exposed to verbal referral only (9/67, 13.4%) or verbal referral+tailored print reminder (21/71, 29.6%), p = 0.03.","[{'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Kuroki', 'Affiliation': 'Division of Gynecologic Oncology, Washington University School of Medicine, St. Louis, MO. Electronic address: kurokil@wustl.edu.'}, {'ForeName': 'L Stewart', 'Initials': 'LS', 'LastName': 'Massad', 'Affiliation': 'Division of Gynecologic Oncology, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Woolfolk', 'Affiliation': 'Division of Clinical Research, Department of Obstetrics and Gynecology, Washington University, St. Louis, MO.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Thompson', 'Affiliation': 'Health Communication Research Laboratory, Brown School of Social Work, Washington University, St. Louis, MO.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'McQueen', 'Affiliation': 'Health Communication Research Laboratory, Brown School of Social Work, Washington University, St. Louis, MO.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Kreuter', 'Affiliation': 'Health Communication Research Laboratory, Brown School of Social Work, Washington University, St. Louis, MO.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.12.018']
119,33384215,What's in a Name? Enhancing Communication in the Operating Room with the Use of Names and Roles on Surgical Caps.,"OBJECTIVE


A pilot study was conducted in a tertiary referral center to assess whether wearing caps labeled with providers' names and roles has an impact on communication in the operating room (OR).
METHODS


Two obstetricians observed surgeries for name uses and missed communications. Following each case, all providers were given a short survey that queried their attitude about the use of labeled surgical caps, their ability to know the names and roles of other providers during a case, and the impact of scrub attire on identifying others. They were also asked to rate the ease of communication and their ability to recall name and roles of the personnel specific to the case. Patients were asked how they perceived the use of labeled caps by providers.
RESULTS


Twenty scheduled cesarean deliveries were randomized to either labeled (10) or nonlabeled (10) surgical caps. A total of 129 providers participated in the study, with 117 providing responses to the survey. Providers reported knowing the names and roles of colleagues more often with labeled caps vs. nonlabeled caps (names: 77.8% vs. 55.0%, 95% confidence interval [CI] = 64.4%-88.0% vs. 41.6%-67.9%, p = 0.011; roles: 92.5% vs. 78.3%, 95% CI = 81.8%-98.0% vs. 65.8%-88.0%, p = 0.036). Name uses increased (43 vs. 34, p = 0.208), and missed communications decreased (16 vs. 20, p = 0.614) when labeled caps were worn. Providers and patients had an overwhelmingly positive response to labeled caps.
CONCLUSION


This pilot study demonstrated that wearing labeled caps in the OR led to more frequent name uses and less frequent missed communications. Providers and patients embraced the concept of labeled caps and perceived wearing labeled caps as improving communication in the OR.",2021,"Name uses increased (43 vs. 34, p = 0.208), and missed communications decreased (16 vs. 20, p = 0.614) when labeled caps were worn.","['129 providers participated in the study, with 117 providing responses to the survey', 'Twenty scheduled cesarean deliveries']",['labeled (10) or nonlabeled (10) surgical caps'],['missed communications'],"[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0183707', 'cui_str': 'Surgical hood'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}]",129.0,0.0533102,"Name uses increased (43 vs. 34, p = 0.208), and missed communications decreased (16 vs. 20, p = 0.614) when labeled caps were worn.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brodzinsky', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Crowe', 'Affiliation': ''}, {'ForeName': 'Henry Chong', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Sara N', 'Initials': 'SN', 'LastName': 'Goldhaber-Fiebert', 'Affiliation': ''}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Sie', 'Affiliation': ''}, {'ForeName': 'Kimber Lee', 'Initials': 'KL', 'LastName': 'Padua', 'Affiliation': ''}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Daniels', 'Affiliation': ''}]",Joint Commission journal on quality and patient safety,['10.1016/j.jcjq.2020.11.012']
120,33373683,Arthroscopic Bankart repair with and without arthroscopic infraspinatus remplissage in anterior shoulder instability with a Hill-Sachs defect: a randomized controlled trial.,"BACKGROUND


The purpose of this study was to compare patient-reported and clinic outcomes between arthroscopic Bankart repair with (REMP) and without (NO REMP) arthroscopic infraspinatus remplissage in patients with recurrent anterior shoulder instability with a Hill-Sachs lesion and minimal glenoid bone loss.
METHODS


Patients 14 years or older with a recurrent anterior shoulder instability with the presence of an engaging Hill-Sachs defect (of any size) confirmed on computed tomography or magnetic resonance imaging were eligible to participate. Consented patients were randomized intraoperatively to NO REMP or REMP. Study visits were conducted preoperatively and 3, 6, 12, and 24 months postoperatively. The primary outcome was the Western Ontario Shoulder Instability score. Secondary outcomes included incidence of postoperative recurrent shoulder instability, Simple Shoulder Test, American Shoulder and Elbow Surgeons score, range of motion, complications, and revision surgery. To compare groups, a mixed-effects linear model was used for continuous variables and a χ 2  or Fisher's exact test for categorical data. A Kaplan-Meier survival analysis assessed survival distribution between groups.
RESULTS


One hundred and eight patients were randomized to Bankart repair with (n = 54) or without (n = 54) remplissage. The mean follow-up was 26.5 months (21-53 months) and 24.3 months (23-64 months) for the REMP and NO REMP groups, respectively. Rates of postoperative recurrent instability were higher (P = .027) in the NO REMP group with 9 of 50 (18%) vs. 2 of 52 (4%) postoperative dislocations in the REMP group. There were no significant differences in patient-reported outcomes between groups at any time point. Survival curve distributions were also significantly different favoring REMP (χ 2  = 5.255, P = .022). There was a significant difference in rate of revision surgery between groups with 6 in the NO REMP and none in the REMP groups (P = .029). Post hoc, patients were noted to have a higher risk for re-dislocation if their Hill-Sachs lesion was ≥20 mm in width or ≥15% of humeral head diameter. One intraoperative complication was reported in the REMP group.
CONCLUSIONS


There is significantly greater risk of postoperative recurrent instability in patients who did not have a remplissage performed in conjunction with an arthroscopic Bankart repair for the treatment of traumatic recurrent anterior shoulder instability with Hill-Sachs lesions of any size and minimal glenoid bone loss (<15%) at 2 years postoperatively. Otherwise, there are no differences in patient-reported outcomes, complications, or shoulder function at 2 years postoperatively. In addition, the remplissage procedure has significantly lower rates of re-dislocation in high-risk patients with Hill-Sachs lesions ≥20 mm and/or ≥15% in size.",2020,Rates of postoperative recurrent instability were higher (p=0.027) in the NO REMP group with 9/50 (18%) versus 2/52 (4%) postoperative dislocations in the REMP group.,"['Anterior Shoulder Instability with a Hill-Sachs Defect', 'patients with recurrent anterior shoulder instability with a Hill-Sachs lesion and minimal glenoid bone loss', 'Patients 14 years or older with a recurrent anterior shoulder instability with the presence of an engaging Hill-Sachs defect (of any size) confirmed on CT or MRI were eligible to participate', 'One hundred and eight patients were randomized to Bankart repair with (n=54) or without (n=54) remplissage']","['arthroscopic Bankart repair', 'arthroscopic Bankart repair with (REMP) and without (NO REMP) arthroscopic infraspinatus remplissage', 'NO REMP or REMP', 'Arthroscopic Bankart Repair with and without Arthroscopic Infraspinatus Remplissage']","['rate of revision surgery', 'rates of re-dislocation', 'postoperative dislocations', 'Kaplan-Meier survival analysis assessed survival distribution', 'Western Ontario Shoulder Instability score (WOSI', 'Rates of postoperative recurrent instability', 'incidence of postoperative recurrent shoulder instability, Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons (ASES) score, range of motion, complications, and revision surgery', 'Survival curve distributions', 'complications, or shoulder function']","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0442532', 'cui_str': 'Hill'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0410330', 'cui_str': 'Hill-Sachs lesion'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0408087', 'cui_str': 'Arthroscopic reattachment glenoid labrum'}, {'cui': 'C0584882', 'cui_str': 'Infraspinatus muscle structure'}]","[{'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",108.0,0.135042,Rates of postoperative recurrent instability were higher (p=0.027) in the NO REMP group with 9/50 (18%) versus 2/52 (4%) postoperative dislocations in the REMP group.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'MacDonald', 'Affiliation': 'Pan Am Clinic, Winnipeg, MB, Canada; Department of Surgery, Section of Orthopaedic Surgery, University of Manitoba, Winnipeg, MB, Canada. Electronic address: pmacdonald@panamclinic.com.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'McRae', 'Affiliation': 'Department of Surgery, Section of Orthopaedic Surgery, University of Manitoba, Winnipeg, MB, Canada; Department of Research, Pan Am Clinic Foundation, Winnipeg, MB, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Old', 'Affiliation': 'Pan Am Clinic, Winnipeg, MB, Canada; Department of Surgery, Section of Orthopaedic Surgery, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Marsh', 'Affiliation': 'Pan Am Clinic, Winnipeg, MB, Canada; Department of Surgery, Section of Orthopaedic Surgery, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Dubberley', 'Affiliation': 'Pan Am Clinic, Winnipeg, MB, Canada; Department of Surgery, Section of Orthopaedic Surgery, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Stranges', 'Affiliation': 'Pan Am Clinic, Winnipeg, MB, Canada; Department of Surgery, Section of Orthopaedic Surgery, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Koenig', 'Affiliation': 'Pan Am Clinic, Winnipeg, MB, Canada; Department of Surgery, Section of Orthopaedic Surgery, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Leiter', 'Affiliation': 'Department of Surgery, Section of Orthopaedic Surgery, University of Manitoba, Winnipeg, MB, Canada; Department of Research, Pan Am Clinic Foundation, Winnipeg, MB, Canada.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Mascarenhas', 'Affiliation': 'Department of Orthopedic Surgery, University of Texas Health Sciences Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Sharad', 'Initials': 'S', 'LastName': 'Prabhakar', 'Affiliation': 'Pan Am Clinic, Winnipeg, MB, Canada.'}, {'ForeName': 'Treny', 'Initials': 'T', 'LastName': 'Sasyniuk', 'Affiliation': 'Department of Research, Pan Am Clinic Foundation, Winnipeg, MB, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lapner', 'Affiliation': 'Division of Orthopedic Surgery, The Ottawa Hospital, Ottawa, ON, Canada.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.11.013']
121,33390421,Effects of intensive exercise combined with dapagliflozin on body composition in patients with type 2 diabetes: a randomized controlled trial.,"This study was aimed to evaluate the effects of intensive exercise in addition to the administration of sodium-glucose cotransporter 2 inhibitor dapagliflozin (DAPA) on body composition, including fat-free mass, in type 2 diabetes. We randomly assigned 146 patients to 24 weeks of treatment with intensive exercise, including resistance training, plus 5 mg (up to 10 mg) of DAPA daily (IT group) or DAPA alone (CT group). The primary endpoint was the difference in the change in fat-free mass from baseline to 24 weeks between the groups. The skeletal muscle mass index (SMI); metabolic profile, including HbA1c; and regional fat mass were also determined. ANCOVA was used for the group comparison, with least squares mean (LSM) differences and 95% confidence interval (CI). There was no significant difference in the change in fat-free mass (LSM difference -0.1 kg (95% CI: -0.5 to 0.4) and SMI (LSM difference -0.1 kg (95% CI: -0.2 to 0.1) between the groups. In contrast, the reduction of trunk fat mass was significantly higher in the IT group than in the CT group ((LSM difference -0.5 kg [95% CI -0.9 to -0.1]). Higher adherence to the resistance training tended to be associated with changes in HbA1c and high-sensitivity CRP levels. Our study suggests that intensive exercise do not prevent the reduction of fat-free mass after administration of SGLT2 inhibitors but can increase the reduction in abdominal fat, presumably leading to further improvements of hyperglycemia and chronic inflammation than DAPA alone in type 2 diabetes patients.",2021,There was no significant difference in the change in fat-free mass (LSM difference -0.1 kg (95% CI:,"['type 2 diabetes', 'type 2 diabetes patients', 'patients with type 2 diabetes']","['CT', 'sodium-glucose cotransporter 2 inhibitor dapagliflozin (DAPA', 'intensive exercise combined with dapagliflozin', 'intensive exercise', 'intensive exercise, including resistance training, plus 5 mg (up to 10 mg) of DAPA daily (IT group) or DAPA alone (CT group']","['body composition', 'reduction of trunk fat mass', 'body composition, including fat-free mass', 'changes in HbA1c and high-sensitivity CRP levels', 'change in fat-free mass', 'hyperglycemia and chronic inflammation', 'skeletal muscle mass index (SMI); metabolic profile, including HbA1c; and regional fat mass']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammation'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0205147', 'cui_str': 'Regional'}]",146.0,0.134262,There was no significant difference in the change in fat-free mass (LSM difference -0.1 kg (95% CI:,"[{'ForeName': 'Ryotaro', 'Initials': 'R', 'LastName': 'Bouchi', 'Affiliation': 'Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Sonoda', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Itoh', 'Affiliation': 'Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Ono', 'Affiliation': 'Department of Internal Medicine, Takagi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Takato', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kishimoto', 'Affiliation': 'ARO Advanced Medical Center, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}]",Endocrine journal,['10.1507/endocrj.EJ20-0599']
122,33332538,Individualized Aerobic Exercise in Neuromuscular Diseases: A Pilot Study on the Feasibility and Preliminary Effectiveness to Improve Physical Fitness.,"OBJECTIVE


Clear guidelines to prescribe aerobic exercise in neuromuscular diseases (NMD) are lacking, which hampers effective application in neuromuscular rehabilitation. This pilot study evaluated the feasibility and preliminary effectiveness of an individualized aerobic exercise program according to a recently developed training guide (B-FIT) to improve physical fitness in individuals with NMD.
METHODS


Thirty-one individuals who were ambulatory and had 15 different slowly progressive NMD participated in a 4-month, polarized, home-based, aerobic exercise program. The program included 2 low-intensity sessions and 1 high-intensity session per week. Feasibility outcomes were the following: completion rate, proportion of followed sessions, adverse events, and participant and therapist satisfaction based on a self-designed questionnaire. Submaximal incremental exercise tests were used to assess the effects on physical fitness.
RESULTS


Twenty-six participants (84%) completed the B-FIT program, and the proportion of followed sessions was >75%. Three adverse events were reported and resolved. Regarding satisfaction, participants (based on n = 9) reported feeling fitter, but training was considered insufficiently challenging. Physical therapists (n = 5) reported that B-FIT provides a clear, well-grounded guidance. They perceived the time investment for initiating the program and the carry-over to primary care as the main barriers. The mean (SD) submaximal heart rate (based on n = 20) reduced significantly by -6.5 beats per minute (95% CI = -11.8 to -1.2), from 121.7 (16.5) at baseline to 115.2 (14.3) after intervention. Submaximal ratings of perceived exertion, anaerobic threshold, and peak workload also improved significantly (P < .05).
CONCLUSION


The outcomes of this pilot study suggest that individualized aerobic exercise according to B-FIT is feasible and has potential to improve physical fitness in a wide variety of slowly progressive NMD. However, some barriers must be addressed before investigating the efficacy in a randomized controlled trial.
IMPACT


The outcomes of this study demonstrate the feasibility of individualized aerobic exercise according to the B-FIT training guide and the potential to improve physical fitness in NMD. Physical therapists indicated that the use of B-FIT provides a clear, well-grounded guidance. The training guide can support health care professionals in the application of aerobic exercise in adult neuromuscular rehabilitation.
LAY SUMMARY


Individualized exercise according to the B-FIT training guide is feasible in a wide variety of slowly progressive NMD and might help improve physical fitness.",2021,"Submaximal ratings of perceived exertion, anaerobic threshold, and peak workload also improved significantly (P < .05).
","['adult neuromuscular rehabilitation', 'NMD', 'individuals with NMD', 'Neuromuscular Diseases', 'Thirty-two individuals who were ambulatory and had 15 different slowly progressive NMD participated in a 4-month']","['polarized home-based aerobic exercise program', 'prescribe aerobic exercise', 'aerobic exercise', 'Individualized Aerobic Exercise', 'individualized aerobic exercise', 'individualized aerobic exercise program', 'Physical therapists']","['mean (SD) submaximal heart rate', 'completion rate, proportion of followed sessions, adverse events, and participant and therapist satisfaction based on a self-designed questionnaire', 'Submaximal ratings of perceived exertion, anaerobic threshold, and peak workload', 'adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}]",32.0,0.034277,"Submaximal ratings of perceived exertion, anaerobic threshold, and peak workload also improved significantly (P < .05).
","[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Voorn', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, the Netherlands.'}, {'ForeName': 'Fieke S', 'Initials': 'FS', 'LastName': 'Koopman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, the Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Nollet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, the Netherlands.'}, {'ForeName': 'Merel-Anne', 'Initials': 'MA', 'LastName': 'Brehm', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, the Netherlands.'}]",Physical therapy,['10.1093/ptj/pzaa213']
123,33339768,"A phase 3, randomized, double-blind, parallel-group study to evaluate tezacaftor/ivacaftor in people with cystic fibrosis heterozygous for F508del-CFTR and a gating mutation.","BACKGROUND


Tezacaftor (TEZ)/ivacaftor (IVA) is an approved CFTR modulator shown to be efficacious and generally safe and well tolerated in people ≥12 years of age with cystic fibrosis (CF) homozygous for the F508del-CFTR mutation or heterozygous for the F508del-CFTR mutation and a residual function mutation. Although previous studies with IVA alone showed clinical benefits in people with CFTR gating mutations, TEZ/IVA has not yet been evaluated in a Phase 3 study of participants heterozygous for F508del-CFTR and a gating mutation (F/gating genotypes). Here, we present results from a randomized, double-blind, IVA-controlled, parallel-group, Phase 3 study assessing the efficacy, safety, and pharmacokinetics (PK) of TEZ/IVA in participants ≥12 years of age with F/gating genotypes.
METHODS


Enrolled participants entered a 4-week IVA run-in period to create a stable IVA baseline. Participants were then randomized to receive IVA or TEZ/IVA for 8 weeks in an active comparator treatment period (ACTP). The primary endpoint was absolute change in percent predicted forced expiratory volume in 1 second (ppFEV 1 ). Key secondary endpoints were relative change in ppFEV 1  and absolute change in CF Questionnaire-Revised respiratory domain score. Secondary endpoints included absolute change in sweat chloride (SwCl) concentration, PK parameters, and safety. All endpoints except PK parameters and safety were assessed from baseline through Week 8.
RESULTS


Sixty-nine participants (92.0%) in the IVA group and 75 participants (98.7%) in the TEZ/IVA group completed treatment. No improvements were seen in efficacy endpoints from baseline at the end of the IVA run-in period through the end of the ACTP in the IVA group. No significant differences in ppFEV 1  or any key secondary endpoint were observed between the IVA and TEZ/IVA groups. SwCl concentrations decreased more in the TEZ/IVA versus IVA group during the ACTP. The safety profile and PK parameters of TEZ/IVA were consistent with those of previous studies in participants ≥12 years of age with CF.
CONCLUSIONS


This Phase 3 study showed that the dual-combination regimen of TEZ/IVA demonstrated clinical efficacy but did not have significantly greater clinical efficacy than IVA alone in participants ≥12 years of age with F/gating genotypes. However, as reported in other studies, TEZ/IVA was generally safe and well tolerated (NCT02412111).",2021,No significant differences in ppFEV 1  or any key secondary endpoint were observed between the IVA and TEZ/IVA groups.,"['participants ≥12 years of age with CF', 'participants ≥12 years of age with F/gating genotypes', 'Enrolled participants entered a 4-week IVA run-in period to create a stable IVA baseline', 'people ≥12 years of age with cystic fibrosis (CF) homozygous for the F508del-CFTR mutation or heterozygous for the F508del-CFTR mutation and a residual function mutation', 'people with cystic fibrosis heterozygous for F508del-CFTR and a gating mutation']","['TEZ/IVA', 'IVA', 'Tezacaftor (TEZ)/ivacaftor (IVA', 'IVA or TEZ/IVA', 'tezacaftor/ivacaftor']","['SwCl concentrations', 'safe and well tolerated', 'efficacy endpoints', 'absolute change in percent predicted forced expiratory volume in 1 second (ppFEV 1 ', 'safety profile and PK parameters of TEZ/IVA', 'relative change in ppFEV 1  and absolute change in CF Questionnaire-Revised respiratory domain score', 'clinical efficacy', 'efficacy, safety, and pharmacokinetics (PK', 'absolute change in sweat chloride (SwCl) concentration, PK parameters, and safety']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}, {'cui': 'C0855766', 'cui_str': 'Residual function'}]","[{'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0730561', 'cui_str': 'Percent predicted FEV1'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test'}]",,0.246754,No significant differences in ppFEV 1  or any key secondary endpoint were observed between the IVA and TEZ/IVA groups.,"[{'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'McKone', 'Affiliation': ""St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland. Electronic address: emckone@svhg.ie.""}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'DiMango', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University, 622 West 168 Street, PH 8 East, Room 101, New York, NY 10032, United States. Electronic address: ead3@columbia.edu.'}, {'ForeName': 'Sivagurunathan', 'Initials': 'S', 'LastName': 'Sutharsan', 'Affiliation': 'Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany. Electronic address: Sivagurunathan.Sutharsan@rlk.uk-essen.de.'}, {'ForeName': 'Tara Lynn', 'Initials': 'TL', 'LastName': 'Barto', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Baylor College of Medicine, 7200 Cambridge Street, Houston, TX 77030. Electronic address: tara.barto@bcm.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, 50 Northern Avenue, Boston, MA 02210, United States. Electronic address: Daniel_Campbell@vrtx.com.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ahluwalia', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, 50 Northern Avenue, Boston, MA 02210, United States. Electronic address: Neil_Ahluwalia@vrtx.com.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Higgins', 'Affiliation': 'Vertex Pharmaceuticals (Europe) Limited, Level 9, Paddington Central, 2 Kingdom Street, London W2 6BD, United Kingdom. Electronic address: Mark_Higgins@vrtx.com.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Owen', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, 50 Northern Avenue, Boston, MA 02210, United States. Electronic address: Caroline_Owen@vrtx.com.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tullis', 'Affiliation': ""Division of Respirology, Department of Medicine, St. Michael's Hospital, University of Toronto, 30 Bond Street, Toronto, Ontario M5B 1W8, Canada. Electronic address: elizabeth.tullis@unityhealth.to.""}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.11.003']
124,33316426,Stage IIIa Melanoma and Impact of Multiple Positive Lymph Nodes on Survival.,"BACKGROUND


For patients with cutaneous melanoma, having >1 positive lymph node (LN) is associated with worse survival. We hypothesized that for stage IIIA patients, N2a disease (2 to 3 positive LN) would be associated with a worse prognosis compared to those with N1a disease (1 positive LN).
STUDY DESIGN


Stage IIIA melanoma patients in the NCDB Participant User File from 2010 to 2016 were analyzed. Overall survival (OS) between N1a and N2a patients was compared. Subgroup analyses were made between patients undergoing sentinel lymph node (SLN) biopsy alone and those undergoing subsequent completion lymph node dissection (CLND). A separate post hoc analysis of T2a patients undergoing SLN biopsy and CLND from a prospective multicenter randomized clinical trial was performed to validate the findings.
RESULTS


Records of 2,305 IIIA patients were evaluated. In an adjusted survival model, N2a disease was an independent risk factor for worse OS (hazard ratio [HR] 1.56, p = 0.0052). In the subgroup analysis, there was no difference in OS between N1a and N2a disease for patients who underwent SLN biopsy without CLND (p = 0.59), but there was a significant difference in OS for patients who underwent SLN biopsy plus CLND (p = 0.0009). The separate clinical trial database confirmed that for patients with SLN-only disease, there was no difference in OS between N1a and N2a disease.
CONCLUSIONS


For stage IIIA melanoma patients, the distribution of micrometastatic lymph node disease (SLN or non-SLN), rather than the absolute number of SLNs, should be considered when individualizing adjuvant therapy recommendations.",2021,"In an adjusted survival model, N2a disease was an independent risk factor for worse OS (HR 1.56, p = 0.0052).","['2,305 records of IIIA patients were evaluated', 'patients with cutaneous melanoma, having >1 positive lymph node (LN', 'T2a patients undergoing', 'Stage IIIA melanoma patients in the NCDB Participant User File from 2010-2016 were analyzed']",['SLN biopsy and CLND'],"['OS between N1a and N2a disease', 'Overall survival (OS', 'Survival']","[{'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0475387', 'cui_str': 'Tumor stage T2a'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0016094', 'cui_str': 'Filing'}]","[{'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456906', 'cui_str': 'Node stage N1a'}, {'cui': 'C0445079', 'cui_str': 'Node stage N2a'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.485485,"In an adjusted survival model, N2a disease was an independent risk factor for worse OS (HR 1.56, p = 0.0052).","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Woeste', 'Affiliation': 'Division of Surgical Oncology, The Hiram C Polk, Jr, MD Department of Surgery, University of Louisville School of Medicine, Louisville, KY.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'McMasters', 'Affiliation': 'Division of Surgical Oncology, The Hiram C Polk, Jr, MD Department of Surgery, University of Louisville School of Medicine, Louisville, KY.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Egger', 'Affiliation': 'Division of Surgical Oncology, The Hiram C Polk, Jr, MD Department of Surgery, University of Louisville School of Medicine, Louisville, KY. Electronic address: michael.egger@louisville.edu.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.11.015']
125,33323833,Controlled Drinking Behaviors Among Korean American and Korean Male Workers.,"BACKGROUND


A permissive drinking culture is one reason for the high level of alcohol consumption among Korean men. Despite shared experiences of the Korean drinking culture that often encourages social drinking, Korean American and Korean male workers may differ in their drinking behavior. This study examines the predictors of controlled drinking behavior and between these two groups.
OBJECTIVES


The purpose of this study was to examine and compare the predictors of controlled drinking behavior between Korean American and Korean male workers.
METHODS


A total of 282 male participants (141 Korean Americans and 141 Koreans) who engaged in social drinking were surveyed. Ajzen's theory of planned behavior was used to examine the predictors of controlled drinking behavior. Structural equation modeling was employed to test the theoretical model for each group, followed by multiple group analyses.
RESULTS


The majority of participants were college-educated and white-collar workers. Korean American workers had fewer heavy episodic drinking days in the past month than Korean workers. Model testing for each group revealed that subjective norms and perceived behavioral control predicted intentions of controlled drinking, but only perceived behavioral control was a significant predictor of controlled drinking behavior. Multiple group analyses indicated no difference between the two groups regarding the predictors of controlled drinking behaviors.
DISCUSSION


Programs to promote controlled drinking for Korean American and Korean male workers should incorporate strategies to increase perceived behavioral control, such as training on how to decline drinking. In addition, early education for healthy drinking culture with a strict drinking environment needs to be considered to improve controlled drinking behaviors.",2020,"Multiple group analyses indicated no difference between the two groups regarding the predictors of controlled drinking behaviors.
","['282 male participants (141 Korean Americans and 141 Koreans) who engaged in social drinking were surveyed', 'Korean American and Korean Male Workers', 'Korean American workers', 'participants were college-educated and white-collar workers', 'Korean men', 'Korean American and Korean male workers']",[],"['controlled drinking behaviors', 'heavy episodic drinking days']","[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0597921', 'cui_str': 'Korean Americans'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013124', 'cui_str': 'Drinking Behavior'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}]",282.0,0.0157635,"Multiple group analyses indicated no difference between the two groups regarding the predictors of controlled drinking behaviors.
","[{'ForeName': 'Younkyoung', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Chonnam National University College of Nursing, Gwangju City, Republic of Korea Florida State University College of Nursing, Tallahassee, FL University of California School of Nursing, San Francisco, CA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lowe', 'Affiliation': ''}, {'ForeName': 'OiSaeng', 'Initials': 'O', 'LastName': 'Hong', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000495']
126,33346081,Impact of Cavity Shave Margins on Margin Status in Patients with Pure Ductal Carcinoma In Situ.,"BACKGROUND


We examined the impact of cavity shave margins (CSMs) on margin status in patients with pure ductal carcinoma in situ (DCIS) undergoing partial mastectomy (PM).
METHODS


One hundred and nine patients from 2 multicenter, randomized controlled trials were identified with pure DCIS (no invasive cancer). Surgeons performed their best PM, with specimen radiography and resection of selective margins per surgeon discretion. Patients were then randomized to have CSM resected or not. A positive margin was defined as <2 mm from ink.
RESULTS


Median patient age was 63 years; median size of DCIS was 1.20 cm; 43.6% of patients had high-grade DCIS; and 58 (53.2%) patients were randomized to take CSM. The ""shave"" and ""no-shave"" groups were well-matched for age, race, ethnicity, palpability, grade, and size of DCIS. Although 33 (56.9%) of the patients in the shave group had a positive margin before randomization, only 12 (20.7%) had a positive margin after randomization to CSM (p < 0.001). In the no-shave group, 17 patients (33.3%) had a positive margin. Controlling for size and grade of DCIS, taking CSM resulted in a nearly 65% reduction in the positive-margin rate (odds ratio 0.366; 95% CI, 0.136 to 0.981; p = 0.046). Size of DCIS remained an independent predictor of positive margins in the model (odds ratio 1.646; 95% CI, 1.227 to 2.209; p = 0.001).
CONCLUSIONS


CSM reduces positive-margin rates in patients with pure DCIS, and can be a practical solution for DCIS patients who tend to have a high rate of margin positivity.",2021,"Size of DCIS remained an independent predictor of positive margins in the model (OR: 1.646; 95% CI: 1.227-2.209, p=0.001).
","['patients with pure DCIS undergoing partial mastectomy (PM', '109 patients from two multicenter, randomized controlled trials were identified with pure DCIS (no invasive cancer', 'Patients with Pure Ductal Carcinoma in Situ', 'patients with pure DCIS']","['cavity shave margins (CSM', 'CSM', 'Cavity Shave Margins']","['positive margin rates', 'Margin Status', 'Size of DCIS', 'positive margin rate', 'median size of DCIS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0024885', 'cui_str': 'Partial mastectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0518505', 'cui_str': 'Does shave'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]","[{'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",109.0,0.20683,"Size of DCIS remained an independent predictor of positive margins in the model (OR: 1.646; 95% CI: 1.227-2.209, p=0.001).
","[{'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Howard-McNatt', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston-Salem, NC. Electronic address: mmcnatt@wakehealth.edu.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Dupont', 'Affiliation': 'Department of Surgery, Watson Clinic, Lakeland, FL.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Tsangaris', 'Affiliation': 'Department of Surgery, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Garcia-Cantu', 'Affiliation': 'Department of Surgery, Doctors Hospital at Renaissance, Edinburg, TX.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Chiba', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Berger', 'Affiliation': 'Department of Surgery, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Levine', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Gass', 'Affiliation': 'Department of Surgery, Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Ollila', 'Affiliation': 'Department of Surgery, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Anees B', 'Initials': 'AB', 'LastName': 'Chagpar', 'Affiliation': 'Department of Surgery Yale University, New Haven, CT.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.11.019']
127,33346013,Systematic review and narrative review lead experts to different cancer trial predictions: a randomized trial.,"OBJECTIVES


The objective of the study was to assess the impact of narrative review (NR) vs. systematic review (SR) on expert assessments of a clinical trial.
STUDY DESIGN AND SETTING


Experts in colon and rectal surgery were randomized to read an NR or SR for an ongoing clinical trial involving surgery for colorectal cancer. Experts from the United States and Canada completed online or paper surveys between December 2018 and June 2019. After reading the NR or SR, experts predicted the trial's outcome and evaluated the trial under a hypothetical ethical review.
RESULTS


Experts who read the NR (n = 55) compared with those who read the SR (n = 56) were more likely to predict a higher absolute risk reduction, 58% vs. 33%, P = 0.018, mean predictions 10.6% vs. 6.6%, mean difference 4.0% [95% confidence interval: 0.3%, 7.8%]. Experts who read the NR were more likely to evaluate the trial more favorably under a hypothetical ethical review, 48% vs. 26%, P = 0.039, 20.0% vs. 8.9% ""strongly in favor"" of trial being pursued.
CONCLUSION


An NR and an SR for the same trial led to different judgments of likely outcomes and ethical appropriateness. These differences point to a potential source of unaddressed bias in ethical review.",2021,"Experts who read the NR were more likely to evaluate the trial more favorably under a hypothetical ethical review, 48% vs 26%, p = 0.039, 20.0% vs 8.9% ""Strongly in favor"" of trial being pursued.
",['Experts in colon and rectal surgery'],"['NR or SR', 'narrative review (NR) versus systematic review (SR']",['absolute risk reduction'],"[{'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1955832', 'cui_str': 'Review, Systematic'}]","[{'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",56.0,0.14485,"Experts who read the NR were more likely to evaluate the trial more favorably under a hypothetical ethical review, 48% vs 26%, p = 0.039, 20.0% vs 8.9% ""Strongly in favor"" of trial being pursued.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Biomedical Ethics Unit, McGill University, 3647 Peel Street, Montréal, Quebec H3A 1X1, Canada.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Montroy', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, Ontario K1Y 4E9, Canada.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, Ontario K1Y 4E9, Canada.'}, {'ForeName': 'Manoj M', 'Initials': 'MM', 'LastName': 'Lalu', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, Ontario K1Y 4E9, Canada; Department of Anesthesiology and Pain Medicine, University of Ottawa, 75 Laurier Avenue E, Ottawa, Ontario K1N 6N5, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kimmelman', 'Affiliation': 'Biomedical Ethics Unit, McGill University, 3647 Peel Street, Montréal, Quebec H3A 1X1, Canada. Electronic address: jonathan.kimmelman@mcgill.ca.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.12.006']
128,33394101,"Effect of ceritinib on the pharmacokinetics of coadministered CYP3A and 2C9 substrates: a phase I, multicenter, drug-drug interaction study in patients with ALK + advanced tumors.","PURPOSE


Ceritinib is an ALK receptor tyrosine kinase inhibitor approved as first- and second-line treatment in adult patients with ALK + metastatic non-small cell lung cancer (NSCLC). The study investigated the drug-drug interaction (DDI) potential of ceritinib when coadministered with midazolam and warfarin as probe substrates for CYP3A and CYP2C9 activity, respectively.
METHODS


This was a phase I, multicenter, open-label, single sequence, crossover DDI study in 33 adult patients with ALK + NSCLC or other advanced tumors. A single dose of a cocktail consisting of midazolam and warfarin was administered with and without concomitant administration of ceritinib. The primary objective was to evaluate the pharmacokinetics of midazolam and warfarin. Secondary objectives included pharmacokinetics, safety, tolerability, overall response rate (ORR), and duration of response (DOR) of ceritinib 750 mg once daily.
RESULTS


Ceritinib inhibited CYP3A-mediated metabolism of midazolam, resulting in a markedly increased AUC (geometric mean ratio [90% confidence interval]) by 5.4-fold (4.6, 6.3). Ceritinib also led to an increase in the AUC of S-warfarin by 54% (36%, 75%). The pharmacokinetics and safety profile of ceritinib in this study are consistent with previous reports and no new safety signals were reported. Among the 19 patients with NSCLC, efficacy (ORR: 42.1% and DCR: 63.2%) was similar to that reported previously in studies of pretreated patients with ALK + NSCLC.
CONCLUSION


Ceritinib is a strong CYP3A inhibitor and a weak CYP2C9 inhibitor. These findings should be reflected as actionable clinical recommendations in the prescribing information for ceritinib with regards to concomitant medications whose pharmacokinetics may be altered by ceritinib.",2021,"Ceritinib also led to an increase in the AUC of S-warfarin by 54% (36%, 75%).","['33 adult patients with ALK\u2009+\u2009NSCLC or other advanced tumors', 'adult patients with ALK\u2009+\u2009metastatic non-small cell lung cancer (NSCLC', '19 patients with NSCLC', 'patients with ALK\u2009+\u2009advanced tumors']","['midazolam', 'coadministered CYP3A and 2C9 substrates', 'midazolam and warfarin']","['pharmacokinetics, safety, tolerability, overall response rate (ORR), and duration of response (DOR) of ceritinib 750\xa0mg once daily', 'AUC', 'AUC of S-warfarin']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3818721', 'cui_str': 'ceritinib'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]",33.0,0.0885179,"Ceritinib also led to an increase in the AUC of S-warfarin by 54% (36%, 75%).","[{'ForeName': 'Felipe K', 'Initials': 'FK', 'LastName': 'Hurtado', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. felipe.kellermann_hurtado@novartis.com.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Fondazione IRCCS-Istituto Nazionale Dei Tumori, Milano, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'De Castro Carpeño', 'Affiliation': 'Medical Oncology Department, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'de Miguel Luken', 'Affiliation': 'CIOCC-Grupo Hospitalario de Madrid, Hosp. de Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Henry Ford Cancer Institute, Detroit, MI, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Scott', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Yvonne Y', 'Initials': 'YY', 'LastName': 'Lau', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'McCulloch', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Mau-Sorensen', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04180-3']
129,33301814,Long-term Service Use Among Youths Previously Treated for Anxiety Disorder.,"OBJECTIVE


(1) To describe rates of long-term service use among subjects previously enrolled in a landmark study of youth anxiety disorder treatment and followed into early adulthood; (2) to examine predictors of long-term service use; and (3) to examine the relationship between anxiety diagnosis and service use over time.
METHOD


The Child/Adolescent Anxiety Multimodal Extended Long-term Study prospectively assessed youths treated through the Child/Adolescent Anxiety Multimodal Study at ages 7-17 years into early adulthood. A total of 319 youths (mean age 17.7, 55.2% female) previously randomized to cognitive-behavioral therapy, sertraline, combination, or placebo for the treatment of anxiety participated; 318 had service use data. Four annual clinic assessments were conducted along with telephone check-ins every 6 months.
RESULTS


Overall, 65.1% of participants endorsed receiving some form of anxiety treatment over the course of the follow-up period, with more subjects reporting medication use than psychotherapy; 35.2% reported consistent use of services over the course of the study. Overall, service use declined over time in subjects with less severe anxiety but remained more steady in those with recurrent/chronic symptoms. Levels of life stress and depressive symptoms were associated with amount of service use over time whereas treatment-related variables (type of initial intervention, acute response, remission) were not. A subset of youths remained chronically anxious despite consistent service use.
CONCLUSION


These findings point to the need to develop models of care that approach anxiety disorders as chronic health conditions in need of active long-term management.",2021,"Overall, service use declined over time in subjects with less severe anxiety but remained more steady in those with recurrent/chronic symptoms.","['Youth', 'subjects previously enrolled in a landmark study of youth anxiety disorder treatment and followed into early adulthood; (2', 'The Child/Adolescent Anxiety Multi-modal Extended Long-term Study (CAMELS) prospectively assessed youth treated through the Child/Adolescent Anxiety Multimodal Study (CAMS) at ages 7 to 17 years into early adulthood', '319 youth (mean age =17.7; 55.2% female']","['cognitive-behavioral therapy (CBT), sertraline (SRT), combination (COMB) or placebo (PBO']","['Levels of life stress and depressive symptoms', 'severe anxiety']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}]",,0.0300577,"Overall, service use declined over time in subjects with less severe anxiety but remained more steady in those with recurrent/chronic symptoms.","[{'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Peris', 'Affiliation': 'University of California, Los Angeles. Electronic address: tperis@mednet.ucla.edu.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sugar', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Rozenman', 'Affiliation': 'University of Denver, Colorado.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Walkup', 'Affiliation': ""Robert and Ann Lurie Children's Hospital, Chicago, Illinois.""}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Albano', 'Affiliation': 'Columbia University, New York.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Compton', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Sakolsky', 'Affiliation': 'Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Golda', 'Initials': 'G', 'LastName': 'Ginsburg', 'Affiliation': 'University of Connecticut, Mansfield.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Keeton', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'McCracken', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'University of California, Los Angeles.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.07.911']
130,33323287,Focusing on explicit debriefing for novice learners in healthcare simulations: A randomized prospective study.,"INTRODUCTION


Debriefing is essential in simulation-based training, but it is not clear what exactly constitutes a successful debriefing session. Research in educational sciences shows that a structured, explicit and trainer-directed approach is systematically more effective than an implicit, reflective approach with minimal guidance, particularly for novice or intermediate learners. The aim of this study is to compare explicit strongly trainer-guided debriefing with implicit and weakly guided debriefing in nursing training.
METHOD


Single-centre randomized prospective study comparing effectiveness of explicit and implicit debriefing techniques. We focused on the description and the analysis phases of the debriefing. Our main aim was to assess the effectiveness of debriefing in terms of knowledge improvement. We also assessed its effectiveness for self-efficacy and self-confidence.
RESULTS


136 nursing students participated in 46 simulation sessions. Knowledge, self-efficacy and self-confidence increased in all conditions. The results also showed that debriefing with explicit analysis improved learning significantly when compared to the control session.
CONCLUSION


Although the results revealed a beneficial effect of simulation training on self-efficacy, the explicit debriefing technique was shown to produce greater knowledge improvement than the implicit debriefing method in novice learners. Consequently, debriefing technique should be adapted to the objectives of the training and learners.",2021,"Knowledge, self-efficacy and self-confidence increased in all conditions.","['novice learners in healthcare simulations', '136 nursing students participated in 46 simulation sessions']","['explicit debriefing', 'explicit and implicit debriefing techniques', 'explicit strongly trainer-guided debriefing with implicit and weakly guided debriefing', 'simulation training']","['Knowledge, self-efficacy and self-confidence']","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",136.0,0.0179806,"Knowledge, self-efficacy and self-confidence increased in all conditions.","[{'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Secheresse', 'Affiliation': 'Univ. Grenoble Alpes, Laboratory of Research on Acquisition in Context (LaRAC), CS 40700, 38058, Grenoble Cedex 9, France; Hopsim® Healthcare Simulation Center, Metropole Savoie Hospital, BP 31125, 73011, Chambéry Cedex, France. Electronic address: thierry.secheresse@ch-metropole-savoie.fr.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Lima', 'Affiliation': 'Univ. Grenoble Alpes, Laboratory of Research on Acquisition in Context (LaRAC), CS 40700, 38058, Grenoble Cedex 9, France. Electronic address: laurent.lima@univ-grenoble-alpes.fr.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Pansu', 'Affiliation': 'Univ. Grenoble Alpes, Laboratory of Research on Acquisition in Context (LaRAC), CS 40700, 38058, Grenoble Cedex 9, France. Electronic address: pascal.pansu@univ-grenoble-alpes.fr.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102914']
131,33359908,Ultrasound guided lateral quadratus lumborum block enhanced recovery in patients undergoing laparoscopic colorectal surgery.,"PURPOSE


This study aimed to evaluate the effects of lateral quadratus lumborum block (QLB) on postoperative pain and recovery in patients undergoing laparoscopic colorectal surgery.
MATERIALS AND METHODS


Patients between 18 and 70 years old, diagnosed with colon or rectal cancer, with American Society of Anesthesiologists (ASA) physical status I or II, and scheduled for laparoscopic colorectal surgery were recruited. Patients were excluded if they were allergic to local anesthetics and unable to complete the procedure of puncture or follow-up evaluation. All included patients were randomly allocated to either QLB or Sham group. The primary outcome was perioperative cumulative sufentanil consumption.
RESULTS


There were no significant differences between the groups in anesthetic time, operation time, dosage of propofol, and remifentanil (P ​> ​0.05). Patients in the QLB group had significantly less sufentanil consumption both intraoperatively and postoperatively, compared with the Sham group (P ​< ​0.05). Postoperative VAS pain scores on coughing in the QLB group at 2 ​h, 6 ​h, 12 ​h, 24 ​h time points and VAS pain score at rest 2 ​h, 6 ​h after surgery were significantly lower than in the Sham group (P ​< ​0.05). Compared with the Sham group, time to first ambulation and anal flatus after surgery in the QLB group were significantly shorter (P ​< ​0.05). Significant differences of postoperative rescue analgesic usage and QoR-15 score at 48 ​h were found between the two groups (P ​< ​0.05).
CONCLUSIONS


Ultrasound-guided lateral QLB significantly reduced perioperative opioid consumption, alleviated postoperative pain, shortened the time to first ambulation and anal flatus, and enhanced postoperative recovery of the patients undergoing laparoscopic colorectal surgery.",2020,"Significant differences of postoperative rescue analgesic usage and QoR-15 score at 48 ​h were found between the two groups (P ​< ​0.05).
","['Patients were excluded if they were allergic to local anesthetics and unable to complete the procedure of puncture or follow-up evaluation', 'patients undergoing laparoscopic colorectal surgery', 'Patients between 18 and 70 years old, diagnosed with colon or rectal cancer, with American Society of Anesthesiologists (ASA) physical status I or II, and scheduled for laparoscopic colorectal surgery were recruited']","['lateral quadratus lumborum block (QLB', 'QLB', 'Ultrasound guided lateral quadratus lumborum block']","['anesthetic time, operation time, dosage of propofol, and remifentanil', 'postoperative rescue analgesic usage and QoR-15 score', 'Postoperative VAS pain scores on coughing', 'perioperative opioid consumption, alleviated postoperative pain', 'postoperative pain and recovery', 'perioperative cumulative sufentanil consumption', 'sufentanil consumption', 'VAS pain score', 'time to first ambulation and anal flatus']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}]",,0.0946569,"Significant differences of postoperative rescue analgesic usage and QoR-15 score at 48 ​h were found between the two groups (P ​< ​0.05).
","[{'ForeName': 'Danfeng', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Fujian Provincial Medical College, Fujian Medical University, Fuzhou, China; Division of Anesthesia, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Fujian Provincial Medical College, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Fujian Provincial Medical College, Fujian Medical University, Fuzhou, China; Division of Anesthesia, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Division of Anesthesia, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, China.'}, {'ForeName': 'Yanjie', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Division of Anesthesia, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Zenggui', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Fujian Provincial Medical College, Fujian Medical University, Fuzhou, China; Division of Anesthesia, Fujian Provincial Hospital, Fuzhou, China. Electronic address: yuzenggui0919@163.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.12.002']
132,33394566,No sustained effects of an intervention to prevent excessive GWG on offspring fat and lean mass at 54 weeks: Yet a greater head circumference persists.,"BACKGROUND


LIFT (Lifestyle Intervention for Two) trial found that intervening in women with overweight and obesity through promoting healthy diet and physical activity to control gestational weight gain (GWG) resulted in neonates with greater weight, lean mass and head circumference and similar fat mass at birth. Whether these neonate outcomes are sustained at 1-year was the focus of this investigation.
METHODS


Measures included body composition by PEA POD air displacement plethysmography (ADP) and Echo Infant quantitative magnetic resonance (QMR) and head circumference at birth (n = 169), 14 (n = 136) and 54 weeks (n = 137). Differences in fat and lean mass between lifestyle intervention (LI) and Usual care (UC) groups were examined using ANCOVA adjusting for maternal age and BMI, GWG, offspring sex and age.
RESULTS


Compared to UC, LI infants had similar weight (112 ± 131 g; P = .40), fat mass (14 ± 80 g; P = .86), lean mass (100 ± 63 g; P = .12) at 14 weeks and similar weight (168 ± 183 g; P = .36), fat mass (148 ± 124 g; P = .24), lean mass (117 ± 92 g; P = .21) at 54 weeks. Head circumference was greater in LI at 54 weeks (0.46 ± 2.1 cm P = .03).
CONCLUSIONS


Greater lean mass observed at birth in LI offspring was not sustained at 14 and 54 weeks, whereas the greater head circumference in LI offspring persisted at 54 weeks.",2021,"Head circumference was greater in LI at 54 weeks (0.46 ± 2.1 cm P = .03).
","['women with overweight and obesity through promoting healthy diet and physical activity to control gestational weight gain (GWG) resulted in neonates with greater weight, lean mass and head circumference and similar fat mass at birth', 'n = 169), 14 (n = 136) and 54\u2009weeks (n = 137']",['LIFT (Lifestyle Intervention'],"['fat mass', 'body composition by PEA POD air displacement plethysmography (ADP) and Echo Infant quantitative magnetic resonance (QMR) and head circumference at birth', 'Head circumference', 'similar weight', 'lean mass']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517569', 'cui_str': '137'}]","[{'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0419406', 'cui_str': 'Birth head circumference'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.084267,"Head circumference was greater in LI at 54 weeks (0.46 ± 2.1 cm P = .03).
","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Whyte', 'Affiliation': 'New York Nutrition Obesity Research Center, Division of Endocrinology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'New York Nutrition Obesity Research Center, Division of Endocrinology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'New York Nutrition Obesity Research Center, Division of Endocrinology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'New York Nutrition Obesity Research Center, Division of Endocrinology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Widen', 'Affiliation': 'New York Nutrition Obesity Research Center, Division of Endocrinology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Toro-Ramos', 'Affiliation': 'New York Nutrition Obesity Research Center, Division of Endocrinology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Gidwani', 'Affiliation': 'Department Pediatrics, Mount Sinai West Hospital, Mount Sinai Health System, Icahn School of Medicine, New York, New York, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Paley', 'Affiliation': 'Department Pediatrics, Mount Sinai West Hospital, Mount Sinai Health System, Icahn School of Medicine, New York, New York, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Crane', 'Affiliation': 'New York Nutrition Obesity Research Center, Division of Endocrinology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'New York Nutrition Obesity Research Center, Division of Endocrinology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Rosenn', 'Affiliation': 'Department of Obstetrics and Gynecology, Mount Sinai West Hospital, Mount Sinai Health System, Icahn School of Medicine, New York, New York, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'Consultant, New York, New York, USA.'}, {'ForeName': 'F Xavier', 'Initials': 'FX', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Nutrition Obesity Research Center, Division of Endocrinology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Dympna', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'New York Nutrition Obesity Research Center, Division of Endocrinology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}]",Pediatric obesity,['10.1111/ijpo.12767']
133,33487626,Effects of participatory workplace improvement program on stress-related biomarkers and self-reported stress among university hospital nurses: a preliminary study.,"Although participatory workplace improvement programs are known to provide favorable effects on high stress occupations like nursing, no studies have confirmed its effect using biomarkers. The aim of this study was to determine whether a participatory workplace improvement program would decrease stress-related symptoms as evaluated by biomarkers and self-reported stress among hospital nurses. Three actions to alleviate job stress, which were determined through focus group interviews and voting, were undertaken for two months. A total of 31 female Japanese nurses underwent measurement of inflammatory markers, autonomic nervous activity (ANA), and perceived job stress (PJS) at three-time points; before the program (T1), within a week after the completion of the program (T2), and three months after the program (T3). A series of inflammatory markers (Interferon-γ, Interleukin (IL)-6, and IL-12/23p40) decreased significantly at T2, and IL-12/23p40 and IL-15 significantly decreased at T3 compared to T1, while ANA and PJS remained unchanged. Our participatory program exerted beneficial effects in reducing inflammatory responses, but not for ANA and PJS. Further investigations with a better study design, i.e., a randomized controlled trial, and a larger sample size are warranted to determine what exerted beneficial effects on inflammatory markers and why other outcomes remained unchanged.",2021,"A series of inflammatory markers (Interferon-γ, Interleukin (IL)-6, and IL-12/23p40) decreased significantly at T2, and IL-12/23p40 and IL-15 significantly decreased at T3 compared to T1, while ANA and PJS remained unchanged.","['31 female Japanese nurses', 'university hospital nurses']",['participatory workplace improvement program'],"['inflammatory markers (Interferon-γ, Interleukin (IL)-6, and IL-12/23p40', 'inflammatory markers, autonomic nervous activity (ANA), and perceived job stress (PJS', 'stress-related biomarkers and self-reported stress', 'IL-12/23p40 and IL-15']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0254610', 'cui_str': 'Interleukin 15'}]",31.0,0.0278876,"A series of inflammatory markers (Interferon-γ, Interleukin (IL)-6, and IL-12/23p40) decreased significantly at T2, and IL-12/23p40 and IL-15 significantly decreased at T3 compared to T1, while ANA and PJS remained unchanged.","[{'ForeName': 'Tsukumi', 'Initials': 'T', 'LastName': 'Tondokoro', 'Affiliation': 'Graduate School of Medicine, International University of Health and Welfare, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Nakata', 'Affiliation': 'Graduate School of Medicine, International University of Health and Welfare, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Otsuka', 'Affiliation': 'Faculty of Human Sciences, University of Tsukuba, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yanagihara', 'Affiliation': 'Faculty of Food Science and Nutrition, Kyushu Nutrition Welfare University, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Anan', 'Affiliation': 'School of Health Sciences, University of Occupational and Environmental Health, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Kodama', 'Affiliation': 'School of Health Sciences, University of Occupational and Environmental Health, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Satoh', 'Affiliation': 'Shared-Use Research Center, University of Occupational and Environmental Health, Japan.'}]",Industrial health,['10.2486/indhealth.2020-0176']
134,33418103,Persistent occiput posterior position outcomes following manual rotation: a randomized controlled trial.,"BACKGROUND


Persistent occiput posterior position in labor is associated with adverse maternal and perinatal outcomes. Prophylactic manual rotation from the occiput posterior position to the occiput anterior position in the second stage of labor is considered a safe and easy to perform procedure that in observational studies has shown promise as a method for preventing operative deliveries.
OBJECTIVE


This study aimed to determine the efficacy of prophylactic manual rotation in the management of occiput posterior position for preventing operative delivery. The hypothesis was that among women who are at least 37 weeks pregnant and whose baby is in the occiput posterior position early in the second stage of labor, manual rotation will reduce the rate of operative delivery compared with the ""sham"" rotation.
STUDY DESIGN


A double-blinded, parallel, superiority, multicenter, randomized controlled clinical trial in 4 tertiary hospitals was conducted in Australia. A total of 254 nulliparous and parous women with a term pregnancy and a baby in the occiput posterior position in the second stage of labor were randomly assigned to receive either a prophylactic manual rotation (n=127) or a sham rotation (n=127). The primary outcome was operative delivery (cesarean, forceps, or vacuum delivery). Secondary outcomes were cesarean delivery, combined maternal mortality and serious morbidity, and combined perinatal mortality and serious morbidity. Analysis was by intention to treat. Proportions were compared using chi-square tests adjusted for stratification variables using the Mantel-Haenszel method or the Fisher exact test. Planned subgroup analyses by operator experience and by manual rotation technique (digital or whole-hand rotation) were performed.
RESULTS


Operative delivery occurred in 79 of 127 women (62%) assigned to prophylactic manual rotation and 90 of 127 women (71%) assigned to sham rotation (common risk difference, 12; 95% confidence interval, -1.7 to 26; P=.09). Among more experienced operators or investigators, operative delivery occurred in 46 of 74 women (62%) assigned to manual rotation and 52 of 71 women (73%) assigned to a sham rotation (common risk difference, 18; 95% confidence interval, -0.5 to 36; P=.07). Cesarean delivery occurred in 22 of 127 women (17%) in both groups. Instrumental delivery (forceps or vacuum) occurred in 57 of 127 women (45%) assigned to prophylactic manual rotation and 68 of 127 women (54%) assigned to sham rotation (common risk difference, 10; 95% confidence interval, -3.1 to 22; P=.14). There was no significant difference in the combined maternal and perinatal outcomes.
CONCLUSION


Prophylactic manual rotation did not result in a reduction in the rate of operative delivery. Given manual rotation was associated with a nonsignificant reduction in operative delivery, more randomized trials are needed, as our trial might have been underpowered. In addition, further research is required to further explore the potential impact of operator or investigator experience.",2021,"women assigned to a sham rotation (common risk difference 18 percentage points, 95% confidence interval -0.5 to 36, p = 0.07).","['four tertiary hospitals was conducted in Australia', 'Two hundred and fifty-four nulliparous and parous women, with a term pregnancy and a baby in the occiput posterior position in the second stage of labor']","['manual rotation', 'technique of manual rotation (digital or whole hand rotation', 'prophylactic manual rotation', 'prophylactic manual rotation (n=127) or a sham procedure']","['cesarean section; combined maternal mortality and serious morbidity; and combined perinatal mortality and serious morbidity', 'Instrumental delivery (forceps or vacuum', 'Cesarean section', 'Operative delivery', 'combined maternal and perinatal outcomes', 'operative (cesarean section, forceps or vacuum) delivery', 'rate of operative delivery', 'operative delivery']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0856256', 'cui_str': 'Occiput posterior'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0162209', 'cui_str': 'Instrumental delivery'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",254.0,0.372299,"women assigned to a sham rotation (common risk difference 18 percentage points, 95% confidence interval -0.5 to 36, p = 0.07).","[{'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Phipps', 'Affiliation': 'Sydney Institute for Women, Children and their Families, Sydney Local Health District, Sydney, New South Wales, Australia; Discipline of Obstetrics, Gynaecology and Neonatology, The University of Sydney, Sydney, New South Wales, Australia. Electronic address: hala.phipps@health.nsw.gov.au.'}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Hyett', 'Affiliation': 'Sydney Institute for Women, Children and their Families, Sydney Local Health District, Sydney, New South Wales, Australia; Royal Prince Alfred Hospital Women and Babies Ambulatory Care, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Kuah', 'Affiliation': ""Women's and Children's Hospital, Adelaide, South Australia, Australia.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pardey', 'Affiliation': 'Nepean Hospital, Penrith, New South Wales, Australia.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Matthews', 'Affiliation': ""Women's and Children's Hospital, Adelaide, South Australia, Australia.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ludlow', 'Affiliation': 'Discipline of Obstetrics, Gynaecology and Neonatology, The University of Sydney, Sydney, New South Wales, Australia; Royal Prince Alfred Hospital Women and Babies Ambulatory Care, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia; Ultrasound Care, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rajit', 'Initials': 'R', 'LastName': 'Narayan', 'Affiliation': 'Royal Prince Alfred Hospital Women and Babies Ambulatory Care, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Santiagu', 'Affiliation': 'Royal Prince Alfred Hospital Women and Babies Ambulatory Care, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Earl', 'Affiliation': ""Women's and Children's Hospital, Adelaide, South Australia, Australia.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wilkinson', 'Affiliation': ""Women's and Children's Hospital, Adelaide, South Australia, Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bisits', 'Affiliation': ""Royal Hospital for Women, Sydney, New South Wales, Australia; Discipline of Obstetrics, Gynaecology and Neonatology, School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Carseldine', 'Affiliation': 'Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Tooher', 'Affiliation': 'Sydney Institute for Women, Children and their Families, Sydney Local Health District, Sydney, New South Wales, Australia; Royal Prince Alfred Hospital Women and Babies Ambulatory Care, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McGeechan', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney School of Public Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'de Vries', 'Affiliation': 'Sydney Institute for Women, Children and their Families, Sydney Local Health District, Sydney, New South Wales, Australia; Faculty of Medicine and Health, The University of Sydney School of Public Health, Sydney, New South Wales, Australia.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2021.100306']
135,33418053,A randomized trial of subcutaneous allergy immunotherapy in inner-city children with asthma less than 4 years of age.,"BACKGROUND


Allergic sensitization to environmental allergens in the first years of life is a strong predictor of asthma morbidity in children. Allergy immunotherapy can improve asthma and allergy outcomes, but its efficacy in inner-city, atopic children of less than 4 years of age with recurrent wheezing has not yet been established.
OBJECTIVE


To determine whether subcutaneous allergy immunotherapy improves asthma in a population of US inner-city children when started at less than 4 years of age.
METHODS


In a randomized controlled, open-label phase I-II single-center trial in the Bronx, New York, 58 children with recurrent wheezing or physician-diagnosed asthma were randomized to receive asthma standard of care treatment with or without a 3-year course of multiple allergen subcutaneous immunotherapy.
RESULTS


A total of 23 children in the control group and 27 children in the immunotherapy group began the study. A total of 20 of 27 children commencing immunotherapy completed at least 2 years of immunotherapy. There was no difference in asthma medication and symptom scores between the treatment or control groups over time. Similarly, naso-ocular symptoms and allergy medication use were similar in both groups over time. Nevertheless, asthma-related quality of life improved in the immunotherapy group compared with the control group (P = .03).
CONCLUSION


With the exception of asthma-related quality of life, allergy immunotherapy was ineffective in improving asthma outcomes in this population of inner-city children of less than 4 years of age. These findings suggest that the effects of allergy immunotherapy depend on population-specific factors and highlight the importance of precise predictors of immunotherapy efficacy.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01028560.",2021,"Nevertheless, asthma related quality of life improved in the immunotherapy group compared to the control group (p=0.03).
","['asthma in a population of U.S. inner-city children when started at < 4 years of age', 'children', 'population of inner-city children < 4 years of age', 'atopic, inner-city children < 4 years of age with recurrent wheeze', 'inner-city asthmatic children <4 years of age', '58 children with recurrent wheeze or physician-diagnosed asthma', '20 of 27 children commencing immunotherapy completed at least 2 years of immunotherapy', '23 children in the control group and 27 children in the immunotherapy group began the study']","['asthma standard of care treatment with or without a 3-year course of multiple allergen subcutaneous immunotherapy', 'Allergy immunotherapy', 'subcutaneous allergy immunotherapy']","['asthma related quality of life', 'naso-ocular symptoms and allergy medication', 'asthma medication and symptom scores', 'asthma outcomes', 'quality of life']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0392707', 'cui_str': 'Atopy'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0413381', 'cui_str': 'Subcutaneous immunotherapy'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0074744', 'cui_str': 'sodium metabisulfite'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013182', 'cui_str': 'Allergy to drug'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",58.0,0.061176,"Nevertheless, asthma related quality of life improved in the immunotherapy group compared to the control group (p=0.03).
","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'de Vos', 'Affiliation': 'Division of Allergy and Immunology, Albert Einstein College of Medicine, Bronx, New York; Department of Pediatrcis, Jacobi Medical Center, Bronx, New York; Division of Allergy and Immunology, Department of Pediatrics, Montefiore Medical Center, Bronx, New York. Electronic address: gabriele.devos@nychhc.org.'}, {'ForeName': 'Shankar', 'Initials': 'S', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Yikania', 'Initials': 'Y', 'LastName': 'Pichardo', 'Affiliation': 'Department of Pediatrcis, Jacobi Medical Center, Bronx, New York.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nazari', 'Affiliation': 'Department of Medicine, Jacobi Medical Center, Bronx, New York.'}, {'ForeName': 'Yurydia', 'Initials': 'Y', 'LastName': 'Jorge', 'Affiliation': 'Department of Pediatrcis, Jacobi Medical Center, Bronx, New York.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Department of Pediatrics, University of Central Florida, Florida Hospital Medical Center, Orlando, Florida.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Serebrisky', 'Affiliation': 'Department of Medicine, Jacobi Medical Center, Bronx, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenstreich', 'Affiliation': 'Division of Pediatric Pulmonology, Jacobi Medical Center, Bronx, New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wiznia', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, Montefiore Medical Center, Bronx, New York.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.12.016']
136,33485023,Continuous local bupivacaine wound infusion reduces oral opioid use for acute postoperative pain control following myelomeningocele repair.,"BACKGROUND


For pregnancies complicated by fetal myelomeningocele who meet the established criteria, prenatal closure is a viable management option. Prenatal closure is an open procedure, with some techniques requiring greater dissection of maternal tissue than cesarean delivery; pain control is an important postoperative goal. Given the rising rates of opioid dependence and concerns regarding the fetal and neonatal effects of opioid use, our practice has turned to nonopioid pain management techniques.
OBJECTIVE


This study aimed to compare postoperative opioid use and pain scores in women undergoing open fetal myelomeningocele repair with and without continuous local bupivacaine wound infusion.
STUDY DESIGN


This was a retrospective, single-center chart review of all consecutive patients who underwent open myelomeningocele repair from March 2013 to December 2019. Women were enrolled at the time of referral and locally followed for 2 weeks postoperatively. The control group received patient-controlled epidural analgesia for 48 hours with acetaminophen and oral and intravenous opioids as needed. The treatment group received patient-controlled epidural analgesia for 24 hours with acetaminophen, oral and intravenous opioids, and continuous local bupivacaine infusion. Pain scores, medication use, and postoperative milestones and complications through discharge were abstracted from the chart and compared.
RESULTS


Of 72 subjects, 51 were in the control group and 21 in the treatment group. Total opioid use, including intravenous doses (165 vs 52.5 mg; P=.001) and daily average oral opioid use (30 vs 10.5 mg; P=.002) were lower in the treatment group. In addition, 24% of women in the treatment group used no opioid postoperatively, compared with 4% in the control group. There was no difference in postoperative day 1 to 4 pain scores, antiemetic use, or bowel function; the treatment group was discharged significantly earlier.
CONCLUSION


Postoperative opioid use was reduced in women who received continuous local wound infusion of bupivacaine for incisional pain control after prenatal myelomeningocele repair. Pain control is paramount following open myelomeningocele repair; local bupivacaine wound infusion is an important adjunct to reduce opioid use postoperatively.",2021,"Total opioid use, including intravenous doses (165 vs 52.5 mg; P=.001) and daily average oral opioid use (30 vs 10.5 mg; P=.002) were lower in the treatment group.","['acute postoperative pain control following myelomeningocele repair', 'consecutive patients who underwent open myelomeningocele repair from March 2013 to December 2019', 'women undergoing open fetal myelomeningocele repair with and without continuous local bupivacaine wound infusion']","['acetaminophen and oral and intravenous opioids', 'bupivacaine', 'acetaminophen, oral and intravenous opioids, and continuous local bupivacaine infusion', 'bupivacaine wound infusion', 'patient-controlled epidural analgesia']","['postoperative day 1 to 4 pain scores, antiemetic use, or bowel function', 'daily average oral opioid use', 'postoperative opioid use and pain scores', 'Pain scores, medication use, and postoperative milestones and complications through discharge']","[{'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025312', 'cui_str': 'Meningomyelocele'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.0566913,"Total opioid use, including intravenous doses (165 vs 52.5 mg; P=.001) and daily average oral opioid use (30 vs 10.5 mg; P=.002) were lower in the treatment group.","[{'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Porter', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO; Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO. Electronic address: anne.porter@aah.org.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Behrendt', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO; Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Zaretsky', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO; Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Liechty', 'Affiliation': ""Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO; Division of Pediatric Surgery; Department of Surgery, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Wood', 'Affiliation': ""Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Franklin', 'Initials': 'F', 'LastName': 'Chow', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO; Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Henry L', 'Initials': 'HL', 'LastName': 'Galan', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO; Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO; Department of Anesthesiology, University of Colorado School of Medicine, Aurora, CO.""}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2020.100296']
137,33484897,Targeting of uncontrolled hypertension in the emergency department (TOUCHED): Design of a randomized controlled trial.,"BACKGROUND


Uncontrolled or undiagnosed hypertension (HTN) is estimated to be as high as 46% in emergency departments (EDs). Uncontrolled HTN contributes significantly to cardiovascular morbidity and disproportionately affects communities of color. EDs serve high risk populations with uncontrolled conditions that are often missed by other clinical settings and effective interventions for uncontrolled HTN in the ED are critically needed. The ED is well situated to decrease the disparities in HTN control by providing a streamlined intervention to high risk populations that may use the ED as their primary care.
METHODS


Targeting of UnControlled Hypertension in the Emergency Department (TOUCHED), is a two-arm single site randomized controlled trial of 770 adults aged 18-75 presenting to the ED with uncontrolled HTN comparing (1) usual care, versus (2) an Educational and Empowerment (E2) intervention that integrates a Post-Acute Care Hypertension Consultation (PACHT-c) with a mobile health BP self-monitoring kit. The primary outcome is differences in mean systolic blood pressure (SBP) at 6-months post enrollment. Secondary outcomes include differences in mean SBP and mean diastolic BP (DBP) at 3-months and mean DBP at 6-months. Additionally, improvement in cardiovascular risk score, medication adherence, primary care engagement, and HTN knowledge will also be assessed as part of this study.
CONCLUSIONS


The TOUCHED trial will be instrumental in determining the effectiveness of a brief ED-based intervention that is portable to other urban EDs with high-risk populations.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT03749499.",2021,"The TOUCHED trial will be instrumental in determining the effectiveness of a brief ED-based intervention that is portable to other urban EDs with high-risk populations.
","['770 adults aged 18-75 presenting to the ED with uncontrolled HTN comparing (1) usual care, versus (2) an', 'urban EDs with high-risk populations']",['Educational and Empowerment (E2) intervention that integrates a Post-Acute Care Hypertension Consultation (PACHT-c) with a mobile health BP self-monitoring kit'],"['cardiovascular morbidity', 'mean SBP and mean diastolic BP (DBP) at 3-months and mean DBP', 'mean systolic blood pressure (SBP', 'cardiovascular risk score, medication adherence, primary care engagement, and HTN knowledge']","[{'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376635', 'cui_str': 'Postacute Care'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",770.0,0.202538,"The TOUCHED trial will be instrumental in determining the effectiveness of a brief ED-based intervention that is portable to other urban EDs with high-risk populations.
","[{'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Prendergast', 'Affiliation': 'Department of Emergency Medicine, University of Illinois, Chicago, IL, USA. Electronic address: hprender@uic.edu.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Petzel-Gimbar', 'Affiliation': 'Department of Emergency Medicine and College of Pharmacy, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Kitsiou', 'Affiliation': 'Biomedical and Health Information Sciences, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Del Rios', 'Affiliation': 'Department of Emergency Medicine, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Lara', 'Affiliation': 'Department of Emergency Medicine, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Jackson', 'Affiliation': 'Department of Emergency Medicine, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Heinert', 'Affiliation': 'Department of Emergency Medicine, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Carter', 'Affiliation': 'College of Pharmacy, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Ramon A', 'Initials': 'RA', 'LastName': 'Durazo-Arvizu', 'Affiliation': 'Department of Public Health Sciences, Loyola University Chicago, Maywood, IL, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Daviglus', 'Affiliation': 'Institute for Minority Health Research, University of Illinois, Chicago, IL, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106283']
138,33484896,"High-intensity interval training vs. hydrochlorothiazide on blood pressure, cardiovascular health and cognition: Protocol of a non-inferiority trial.","BACKGROUND


While the number of people with hypertension (HBP) continues to increase, the therapeutic target for optimal blood pressure (BP) has been revised to a lower level. Studies have suggested that High-Intensity Interval Training (HIIT) could be as efficient as BP-lowering drugs, but no study has compared their efficacy in a randomized trial. The aim of this protocol is to determine if HIIT is as efficient as Hydrochlorothiazide (HCTZ) in lowering 24 h ambulatory BP in prehypertensive older adults. Moreover, the secondary aim is to determine if HIIT is associated with greater cardiovascular and cognitive benefits than HCTZ.
METHODS


This study is an interventional, single-center, non-inferiority trial, with two randomized parallel groups of prehypertensive participants aged 60 years or more. One group will be prescribed daily doses of 12.5 mg of HCTZ for 12 weeks, and the other group will follow thrice-weekly HIIT for 12 weeks. Each group will be composed of 30 participants. The primary outcome is 24 h ambulatory BP. Secondary outcomes are scores on neuropsychological assessments, balance and gait performances, maximal oxygen uptake, peripheral endothelial function, and arterial stiffness. Non-inferiority tests will be performed on the primary outcome, and secondary outcomes will be compared using independent t-tests.
CONCLUSION


This study will determine if HIIT is at least as efficient as HCTZ in lowering BP in prehypertensive older adults. This study will also determine if HIIT provides greater benefits in terms of cardiovascular and cognitive status (NCT04103411).",2021,This study will determine if HIIT is at least as efficient as HCTZ in lowering BP in prehypertensive older adults.,"['people with hypertension (HBP', 'prehypertensive participants aged 60\u202fyears or more', 'prehypertensive older adults']","['High-intensity interval training vs. hydrochlorothiazide', 'Hydrochlorothiazide (HCTZ', 'HCTZ']","['blood pressure, cardiovascular health and cognition', '24\u202fh ambulatory BP', 'scores on neuropsychological assessments, balance and gait performances, maximal oxygen uptake, peripheral endothelial function, and arterial stiffness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}]",,0.232465,This study will determine if HIIT is at least as efficient as HCTZ in lowering BP in prehypertensive older adults.,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Langeard', 'Affiliation': 'Department of Medicine, Université de Montréal, Montréal, Québec, Canada; Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Montreal Heart Institute, Montréal, Québec, Canada; Research Center, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada. Electronic address: antoine.langeard@unicaen.fr.'}, {'ForeName': 'Simon-Olivier', 'Initials': 'SO', 'LastName': 'Cloutier', 'Affiliation': 'Department of Psychology, Université de Montréal, Montréal, Québec, Canada; Preventive Medicine and Physical Activity Center (centre EPIC), Canada.'}, {'ForeName': 'Miloudza', 'Initials': 'M', 'LastName': 'Olmand', 'Affiliation': 'Department of Psychology, Université de Montréal, Montréal, Québec, Canada; Preventive Medicine and Physical Activity Center (centre EPIC), Canada.'}, {'ForeName': 'Kathia', 'Initials': 'K', 'LastName': 'Saillant', 'Affiliation': 'Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada; Department of Psychology, Université du Québec à Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Gagnon', 'Affiliation': 'Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Montreal Heart Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Catherine-Alexandra', 'Initials': 'CA', 'LastName': 'Grégoire', 'Affiliation': 'Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Montreal Heart Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Fortier', 'Affiliation': 'Montreal Health Innovations Coordinating Center (MHICC), Canada.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Lacroix', 'Affiliation': 'Research Center, Montreal Heart Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lalongé', 'Affiliation': 'Preventive Medicine and Physical Activity Center (centre EPIC), Canada.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Gayda', 'Affiliation': 'Preventive Medicine and Physical Activity Center (centre EPIC), Canada.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Besnier', 'Affiliation': 'Department of Medicine, Université de Montréal, Montréal, Québec, Canada; Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Montreal Heart Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gagnon', 'Affiliation': 'Department of Kinesiology and Exercise Science, Université de Montréal, Québec, Canada; Preventive Medicine and Physical Activity Center (centre EPIC), Canada.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bherer', 'Affiliation': 'Department of Medicine, Université de Montréal, Montréal, Québec, Canada; Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Montreal Heart Institute, Montréal, Québec, Canada; Research Center, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada. Electronic address: louis.bherer@umontreal.ca.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Nigam', 'Affiliation': 'Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Montreal Heart Institute, Montréal, Québec, Canada.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106286']
139,33410589,The effect of pursed-lip breathing combined with number counting on blood pressure and heart rate in hypertensive urgency patients: A randomized controlled trial.,"Hypertensive urgency (HT urgency) is an alarming sign of uncontrolled hypertension. It is aggravated by nonadherence to medication, as well as psychosocial stress. Mindfulness is beneficial for reducing stress, while deep and slow breathing is effective for lowering blood pressure (BP). In our study, we aimed to assess BP and heart rate effects in HT urgency patients practicing pursed-lip breathing and number counting (PLB with NC)-a practice that promotes mindfulness with deep/slow breathing patterns. In a randomized controlled trial, 110 patients were equally allocated to intervention and control groups. The intervention group was trained and encouraged to do PLB with NC during their emergency room admission, while the control group received conventional medical care. The mean systolic BP (SBP), diastolic BP (DBP), and HR of the intervention group in the 3rd hour were significantly lower than the baseline values at -28.2 mm Hg (95%CI;-23.5 to -32.4), -17.1 mm Hg (95%CI;-14.2 to -20.0), and -4.9 beats per minute (bpm) (95%CI;-4.0 to -5.8), respectively. In the control group, both the mean SBP and DBP were also significantly lower in the 3rd hour. However, HR reduction was inconclusive. When the two groups were compared, a greater degree of reduction was found in the intervention group for SBP (9.80 mm Hg, 95%CI; 4.10 to 15.50), DBP (7.69 mm Hg, 95%CI; 3.61 to 11.77), and HR (3.85 bpm, 95%CI; 1.99 to 5.72). In conclusion, PLB with NC was effective for lowering BP and HR. It might be used as a complementary treatment for HT urgency patients.",2021,"When the two groups were compared, a greater degree of reduction was found in the intervention group for SBP (9.80 mm Hg, 95%CI; 4.10 to 15.50), DBP (7.69 mm ","['110 patients', 'HT urgency patients practicing pursed-lip breathing and number counting (PLB with NC)-a practice that promotes mindfulness with deep/slow breathing patterns', 'hypertensive urgency patients', 'HT urgency patients']","['conventional medical care', 'pursed-lip breathing combined with number counting']","['lowering BP and HR', 'BP and heart rate effects', 'blood pressure and heart rate', 'blood pressure (BP', 'DBP', 'Hypertensive urgency (HT urgency', 'mean SBP and DBP', 'mean systolic BP (SBP), diastolic BP (DBP), and HR', 'HR reduction']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745138', 'cui_str': 'Hypertensive urgency'}, {'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0745138', 'cui_str': 'Hypertensive urgency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",110.0,0.0671697,"When the two groups were compared, a greater degree of reduction was found in the intervention group for SBP (9.80 mm Hg, 95%CI; 4.10 to 15.50), DBP (7.69 mm ","[{'ForeName': 'Thapanawong', 'Initials': 'T', 'LastName': 'Mitsungnern', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Nipa', 'Initials': 'N', 'LastName': 'Srimookda', 'Affiliation': 'Accident and Emergency Nursing Department, Faculty of Medicine, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Supap', 'Initials': 'S', 'LastName': 'Imoun', 'Affiliation': 'Accident and Emergency Nursing Department, Faculty of Medicine, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Suntaraporn', 'Initials': 'S', 'LastName': 'Wansupong', 'Affiliation': 'Accident and Emergency Nursing Department, Faculty of Medicine, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Praew', 'Initials': 'P', 'LastName': 'Kotruchin', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.14168']
140,33444781,Dissemination of a telehealth cardiovascular risk service: The CVRS live protocol.,"BACKGROUND


Medical clinics are increasingly hiring clinical pharmacists to improve management of cardiovascular disease (CVD). However, the limited number of clinical pharmacists employed in a clinic may not impact the large number of complex patients needing the services. We have developed a remote telehealth service provided by clinical pharmacists to complement CVD services provided by on-site clinical pharmacists and aid sites without a clinical pharmacist. This cardiovascular risk service (CVRS) has been studied in two NIH-funded trials, however, we identified barriers to optimal intervention implementation. The purpose of this study is to examine how to implement the CVRS into medical offices and see if the intervention will be sustained.
METHODS


This is a 5-year, pragmatic, cluster-randomized clinical trial in 13 primary care clinics across the US. We randomized clinics to receive CVRS or usual care and will enroll 325 patient subjects and 288 key stakeholder subjects. We have obtained access to the electronic medical records (EMRs) of all study clinics to recruit subjects and provide the pharmacist intervention. The intervention is staggered so that after 12 months, the usual care sites will receive the intervention for 12 months. Follow-up will be accomplished though medical record abstraction at baseline, 12 months, 24 months, and 36 months.
CONCLUSIONS


This study will enroll subjects through 2021 and results will be available in 2024. This study will provide unique information on how the CVRS provided by remote clinical pharmacists can be effectively implemented in medical offices, many of which already employ on-site clinical pharmacists.
CLINICAL TRIAL REGISTRATION INFORMATION


NCT03660631: http://clinicaltrials.gov/ct2/show/NCT03660631.",2021,We have developed a remote telehealth service provided by clinical pharmacists to complement CVD services provided by on-site clinical pharmacists and aid sites without a clinical pharmacist.,"['13 primary care clinics across the US', 'enroll subjects through 2021 and results available in 2024', '300 patient subjects and 288 key stakeholder subjects']",['CVRS'],[],"[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],13.0,0.0746287,We have developed a remote telehealth service provided by clinical pharmacists to complement CVD services provided by on-site clinical pharmacists and aid sites without a clinical pharmacist.,"[{'ForeName': 'Korey A', 'Initials': 'KA', 'LastName': 'Kennelty', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, United States; Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, United States. Electronic address: korey-kennelty@uiowa.edu.'}, {'ForeName': 'Nels J', 'Initials': 'NJ', 'LastName': 'Engblom', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, United States.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Carter', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, United States; Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, United States.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Hollingworth', 'Affiliation': 'Department of Educational Policy and Leadership Studies, College of Education, University of Iowa, United States.'}, {'ForeName': 'Barcey T', 'Initials': 'BT', 'LastName': 'Levy', 'Affiliation': 'Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, United States; Department of Epidemiology, College of Public Health, University of Iowa, United States.'}, {'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Finkelstein', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, United States.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Parker', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, United States.'}, {'ForeName': 'Yinghui', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, United States.'}, {'ForeName': 'Kayla L', 'Initials': 'KL', 'LastName': 'Jackson', 'Affiliation': 'Department of Educational Policy and Leadership Studies, College of Education, University of Iowa, United States.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Dawson', 'Affiliation': 'Department of Biostatistics, College of Public Health, University of Iowa, United States.'}, {'ForeName': 'Kathryn K', 'Initials': 'KK', 'LastName': 'Dorsey', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106282']
141,33415649,"Rationale and Design of a Telehealth Self-Management, Shared Care Intervention for Post-treatment Survivors of Lung and Colorectal Cancer.","Survivors of lung and colorectal cancer have high post-treatment needs; the majority are older and suffer from greater comorbidities and poor quality of life (QOL). They remain underrepresented in research, leading to significant disparities in post-treatment outcomes. Personalized post-treatment follow-up care and care coordination among healthcare teams is a priority for survivors of lung and colorectal cancer. However, there are few evidence-based interventions that address survivors' post-treatment needs beyond the use of a follow-up care plan. This paper describes the rationale and design of an evidence-informed telehealth intervention that integrates shared care coordination between oncology/primary care and self-management skills building to empower post-treatment survivors of lung and colorectal cancer. The intervention design was informed by (1) contemporary published evidence on cancer survivorship, (2) our previous research in lung and colorectal cancer survivorship, (3) the chronic care self-management model (CCM), and (4) shared post-treatment follow-up care between oncology and primary care. A two-arm, parallel randomized controlled trial will determine the efficacy of the telehealth intervention to improve cancer care delivery and survivor-specific outcomes. ClinicalTrials.gov Identifier: NCT04428905.",2021,"A two-arm, parallel randomized controlled trial will determine the efficacy of the telehealth intervention to improve cancer care delivery and survivor-specific outcomes.","['Post-treatment Survivors of Lung and Colorectal Cancer', 'lung and colorectal cancer']","['Telehealth Self-Management, Shared Care Intervention', 'chronic care self-management model (CCM), and (4) shared post-treatment follow-up care between oncology and primary care', 'telehealth intervention']",[],"[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3899107', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],,0.0294204,"A two-arm, parallel randomized controlled trial will determine the efficacy of the telehealth intervention to improve cancer care delivery and survivor-specific outcomes.","[{'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Sun', 'Affiliation': 'Department of Population Sciences, City of Hope, Duarte, CA, USA. vsun@coh.org.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Reb', 'Affiliation': 'Department of Population Sciences, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Debay', 'Affiliation': 'Department of Family Medicine, University of California, Riverside, CA, USA.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Fakih', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Ferrell', 'Affiliation': 'Department of Population Sciences, City of Hope, Duarte, CA, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-021-01958-8']
142,33482395,Family automated voice reorientation (FAVoR) intervention for mechanically ventilated patients in the intensive care unit: Study protocol for a randomized controlled trial.,"Delirium in the intensive care unit (ICU) affects up to 80% of critically ill, mechanically ventilated (MV) adults. Delirium is associated with substantial negative outcomes, including increased hospital complications and long-term effects on cognition and health status in ICU survivors. The purpose of this randomized controlled trial is to test the effectiveness of a Family Automated Voice Reorientation (FAVoR) intervention on delirium among critically ill MV patients. The FAVoR intervention uses scripted audio messages, which are recorded by the patient's family and played at hourly intervals during daytime hours. This ongoing orientation to the ICU environment through recorded messages in a voice familiar to the patient may enable the patient to more accurately interpret the environment and thus reduce risk of delirium. The study's primary aim is to test the effect of the FAVoR intervention on delirium in critically ill MV adults in the ICU. The secondary aims are to explore: (1) if the effect of FAVoR on delirium is mediated by sleep, (2) if selected biobehavioral factors moderate the effects of FAVoR on delirium, and (3) the effects of FAVoR on short-term and long-term outcomes, including cognition and health status. Subjects (n = 178) are randomly assigned to the intervention or control group within 48 h of initial ICU admission and intubation. The intervention group receives FAVoR over a 5-day period, while the control group receives usual care. Delirium-free days, sleep and activity, cognition, patient-reported health status and sleep quality, and data regarding iatrogenic/environmental and biobehavioral factors are collected.",2021,"Delirium is associated with substantial negative outcomes, including increased hospital complications and long-term effects on cognition and health status in ICU survivors.","['critically ill MV patients', 'Subjects (n\u202f=\u202f178', 'critically ill MV adults in the ICU', 'mechanically ventilated patients in the intensive care unit', 'critically ill, mechanically ventilated (MV) adults']","['intervention or control group within 48\u202fh of initial ICU admission and intubation', 'FAVoR', 'Family automated voice reorientation (FAVoR) intervention', 'Family Automated Voice Reorientation (FAVoR) intervention', 'FAVoR intervention']","['Delirium-free days, sleep and activity, cognition, patient-reported health status and sleep quality, and data regarding iatrogenic/environmental and biobehavioral factors', 'hospital complications']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0878788,"Delirium is associated with substantial negative outcomes, including increased hospital complications and long-term effects on cognition and health status in ICU survivors.","[{'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Munro', 'Affiliation': 'University of Miami School of Nursing and Health Studies, 5030 Brunson Drive, Coral Gables, FL, United States. Electronic address: cmunro@miami.edu.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'University of Miami School of Nursing and Health Studies, 5030 Brunson Drive, Coral Gables, FL, United States.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Ji', 'Affiliation': 'University of South Florida College of Nursing, 12901 Bruce B. Downs Blvd, Tampa, FL, United States.'}, {'ForeName': 'Maya N', 'Initials': 'MN', 'LastName': 'Elías', 'Affiliation': 'University of Miami School of Nursing and Health Studies, 5030 Brunson Drive, Coral Gables, FL, United States.'}, {'ForeName': 'Xusheng', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'University of Miami School of Nursing and Health Studies, 5030 Brunson Drive, Coral Gables, FL, United States.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Calero', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Medicine, University of South Florida College of Medicine, 12901 Bruce B. Downs Blvd, Tampa, FL, United States.'}, {'ForeName': 'E Wesley', 'Initials': 'EW', 'LastName': 'Ely', 'Affiliation': ""Center for Critical Illness, Brain Dysfunction, and Survivorship (CIBS), Vanderbilt University Medical Center, 2525 West End Avenue Suite 450, Nashville, TN, United States; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, 1161 21st Ave S, Nashville, TN, United States; Veteran's Affairs TN Valley, Geriatrics Research, Education and Clinical Center (GRECC), 1310 24th Ave S, Nashville, TN, United States.""}]",Contemporary clinical trials,['10.1016/j.cct.2021.106277']
143,33491111,"Effects of Switching from Liraglutide or Dulaglutide to Subcutaneous Semaglutide on Glucose Metabolism and Treatment Satisfaction in Patients with Type 2 Diabetes: Protocol for a Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Comparison Study (The SWITCH-SEMA 1 Study).","INTRODUCTION


Glucagon-like peptide (GLP)-1 receptor agonists exert potent hypoglycemic effects in patients with type 2 diabetes (T2D) in a blood glucose concentration-dependent manner. Once-weekly subcutaneous administration of the GLP-1 receptor agonist semaglutide has beneficial effects on glycemic and body weight control, but it is currently unclear if semaglutide provides superior glycemic control compared to conventional GLP-1 receptor agonists in the Japanese population. We aim to compare the effects of once-weekly subcutaneous semaglutide with those of liraglutide or dulaglutide administration in Japanese patients with T2D.
METHODS


This study is a multicenter, prospective, randomized, open-label, blinded-endpoint, parallel-group trial. In total, 100 participants with T2D who have been treated with liraglutide (0.9-1.8 mg/day in plan A) or dulaglutide (0.75 mg/week in plan B) for more than 12 weeks and have a glycated hemoglobin (HbA1c) level of 6.0-9.9% and a body mass index (BMI) of ≥ 22 kg/m 2  will be randomized to either continue using their existing GLP-1 receptor agonist or switch to subcutaneous semaglutide once weekly for 24 weeks. Biochemical analysis, physical assessment, and a quality-of-life questionnaire (DTSQ) will be completed at baseline and at the end of the study. The primary endpoint is the effect of semaglutide on the change in HbA1c. The secondary endpoints are the mean changes in total DTSQ score, body mass, abdominal circumference, systolic and diastolic blood pressure, pulse rate, factors associated with improvement in HbA1c and secondary endpoints, side effects, and other laboratory parameters.
PLANNED OUTCOMES


The results of the study will provide useful information regarding the effects of switching to semaglutide from other GLP-1 receptor agonists on glycemic control in patients with T2D.
ETHICS AND DISSEMINATION


The Hokkaido University Certified Review Board (CRB no. 1180001) has approved the protocol (no. 018-005). The results will be disseminated in peer-reviewed journals and at scientific conferences.
TRIAL REGISTRATION


UMIN000042369 in the University Hospital Medical Information Network (UMIN); jRCT1011200008 in the Japan Registry of Clinical Trials (jRCT); pre-results.",2021,"Once-weekly subcutaneous administration of the GLP-1 receptor agonist semaglutide has beneficial effects on glycemic and body weight control, but it is currently unclear if semaglutide provides superior glycemic control compared to conventional GLP-1 receptor agonists in the Japanese population.","['Patients with Type 2 Diabetes', '100 participants with T2D who have been treated with', 'Japanese patients with T2D.\nMETHODS', 'patients with type 2 diabetes (T2D) in a blood glucose concentration-dependent manner']","['Glucagon-like peptide (GLP)-1 receptor agonists', 'liraglutide', 'Liraglutide or Dulaglutide to Subcutaneous Semaglutide', 'liraglutide or dulaglutide', 'dulaglutide']","['Glucose Metabolism and Treatment Satisfaction', 'mean changes in total DTSQ score, body mass, abdominal circumference, systolic and diastolic blood pressure, pulse rate, factors associated with improvement in HbA1c and secondary endpoints, side effects, and other laboratory parameters', 'effect of semaglutide on the change in HbA1c', 'glycated hemoglobin (HbA1c) level', 'hypoglycemic effects', 'Biochemical analysis, physical assessment, and a quality-of-life questionnaire (DTSQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0014361', 'cui_str': 'Glucagon-Like Polypeptides'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C2936720', 'cui_str': 'Hypoglycemic Effects'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",100.0,0.0801195,"Once-weekly subcutaneous administration of the GLP-1 receptor agonist semaglutide has beneficial effects on glycemic and body weight control, but it is currently unclear if semaglutide provides superior glycemic control compared to conventional GLP-1 receptor agonists in the Japanese population.","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nomoto', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Chiho', 'Initials': 'C', 'LastName': 'Oba-Yamamoto', 'Affiliation': 'Sapporo Diabetes and Thyroid Clinic, Sapporo, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeuchi', 'Affiliation': 'Sapporo Diabetes and Thyroid Clinic, Sapporo, Japan.'}, {'ForeName': 'So', 'Initials': 'S', 'LastName': 'Nagai', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Medicine, Sapporo Medical Center, NTT East Corporation, Sapporo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Internal Medicine, Jiyugaoka Medical Clinic, Obihiro, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Taneda', 'Affiliation': 'Diabetes Center, Manda Memorial Hospital, Sapporo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kurihara', 'Affiliation': 'Kurihara Clinic, Sapporo, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Aoki Clinic, Sapporo, Japan.'}, {'ForeName': 'Hiraku', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kyu Yong', 'Initials': 'KY', 'LastName': 'Cho', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan. hmiyoshi@med.hokudai.ac.jp.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00986-9']
144,33413284,Rationale and design of the validation of bladder health instrument for evaluation in women (VIEW) protocol.,"BACKGROUND


Bladder health is an understudied state and difficult to measure due to lack of valid and reliable instruments. While condition specific questionnaires assess presence, severity and degree of bother from lower urinary tract symptoms, the absence of symptoms is insufficient to assume bladder health. This study describes the methodology used to validate a novel bladder health instrument to measure the spectrum of bladder health from very healthy to very unhealthy in population based and clinical research.
METHODS


Three samples of women are being recruited: a sample from a nationally representative general population and two locally recruited clinical center samples-women with a targeted range of symptom severity and type, and a postpartum group. The general population sample includes 694 women, 18 years or older, randomly selected from a US Postal delivery sequence file. Participants are randomly assigned to electronic or paper versions of the bladder health instrument along with a battery of criterion questionnaires and a demographic survey; followed by a retest or a two-day voiding symptom diary. A total of 354 women around 7 clinical centers are being recruited across a spectrum of self-reported symptoms and randomized to mode of completion. They complete the two-day voiding symptom diary as well as a one-day frequency volume diary prior to an in-person evaluation with a standardized cough stress test, non-invasive urine flowmetry, chemical urine analysis and post void residual measurement. Independent judge ratings of bladder health are obtained by interview with a qualified health care provider. A total of 154 postpartum women recruited around 6 of the centers are completing similar assessments within 6-12 weeks postpartum. Dimensional validity will be evaluated using factor analysis and principal components analysis with varimax rotation, and internal consistency with Cronbach's alpha. Criterion validity will be assessed using multitrait-multimethod matrix including correlations across multiple data sources and multiple types of measures.
DISCUSSION


We aim to validate a bladder health instrument to measure the degree of bladder health within the general population and among women (including postpartum) recruited from local clinical centers. Trial registration NCT04016298 Posted July 11, 2019 ( https://www.clinicaltrials.gov/ct2/show/NCT04016298?cond=bladder+health&draw=2&rank=1 ).",2021,"This study describes the methodology used to validate a novel bladder health instrument to measure the spectrum of bladder health from very healthy to very unhealthy in population based and clinical research.
","['general population and among women (including postpartum) recruited from local clinical centers', '694 women, 18\xa0years or older, randomly selected from a US Postal delivery sequence file', '354 women around 7 clinical centers are being recruited across a spectrum of self-reported symptoms and randomized to mode of completion', '154 postpartum women recruited around 6 of the centers are completing similar assessments within 6-12\xa0weeks postpartum', 'women (VIEW) protocol', 'Three samples of women are being recruited: a sample from a nationally representative general population and two locally recruited clinical center samples-women with a targeted range of symptom severity and type, and a postpartum group']",[],[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],[],354.0,0.175023,"This study describes the methodology used to validate a novel bladder health instrument to measure the spectrum of bladder health from very healthy to very unhealthy in population based and clinical research.
","[{'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lukacz', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, University of California San Diego, San Diego, CA, USA. elukacz@ucsd.edu.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Constantine', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kane Low', 'Affiliation': 'Practice and Professional Graduate Programs, School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Jerry L', 'Initials': 'JL', 'LastName': 'Lowder', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Alayne D', 'Initials': 'AD', 'LastName': 'Markland', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama At Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Mueller', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Loyola University Medical Center, Loyola University Chicago, Maywood, IL, USA.'}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Newman', 'Affiliation': 'Division of Urology, Department of Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Rickey', 'Affiliation': 'Departments of Urology and Obstetrics, Gynecology and Reproductive Sciences, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Rockwood', 'Affiliation': 'Division of Health Policy and Management, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Rudser', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC women's health,['10.1186/s12905-020-01136-w']
145,33421650,Digital training for non-specialist health workers to deliver a brief psychological treatment for depression in India: Protocol for a three-arm randomized controlled trial.,"BACKGROUND


Training non-specialist health workers (NSHWs) at scale is a major barrier to increasing the coverage of depression care in India. This trial will test the effectiveness of two forms of digital training compared to conventional face-to-face training in changing the competence of NSHWs to deliver a brief evidence-based psychological treatment for depression.
METHODS


This protocol is for a three-arm, parallel group randomized controlled trial comparing three ways of training NSHWs to deliver the Healthy Activity Program (HAP), a brief manualized psychotherapy for depression, in primary care. The arms are: digital training (DGT); digital training combined with individualized coaching support (DGT+); and conventional face-to-face training (F2F). The target sample comprises N = 336 government contracted NSHWs in Madhya Pradesh, India. The primary outcome is change of competence to deliver HAP; secondary outcomes include cost-effectiveness of the training programs, change in participants' mental health knowledge, attitudes and behavior, and satisfaction with the training. Assessors blind to participant allocation status will collect outcomes pre- (baseline) and post- (endpoint) training to ascertain differences in outcomes between arms. Training program costs will be collected to calculate incremental costs of achieving one additional unit on the competency measure in the digital compared to face-to-face training programs. Health worker motivation, job satisfaction, and burnout will be collected as exploratory outcome variables.
DISCUSSION


This trial will determine whether digital training is an effective, cost-effective, and scalable approach for building workforce capacity to deliver a brief evidence-based psychological treatment for depression in primary care in a low-resource setting.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04157816.",2021,"This trial will determine whether digital training is an effective, cost-effective, and scalable approach for building workforce capacity to deliver a brief evidence-based psychological treatment for depression in primary care in a low-resource setting.
","['The target sample comprises N\u202f=\u202f336 government contracted NSHWs in Madhya Pradesh, India']","['training NSHWs to deliver the Healthy Activity Program (HAP', 'digital training compared to conventional face-to-face training', 'digital training (DGT); digital training combined with individualized coaching support (DGT+); and conventional face-to-face training (F2F', 'Digital training', 'digital training']","['Health worker motivation, job satisfaction', ""change of competence to deliver HAP; secondary outcomes include cost-effectiveness of the training programs, change in participants' mental health knowledge, attitudes and behavior, and satisfaction with the training""]","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0905819,"This trial will determine whether digital training is an effective, cost-effective, and scalable approach for building workforce capacity to deliver a brief evidence-based psychological treatment for depression in primary care in a low-resource setting.
","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Naslund', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA. Electronic address: John_Naslund@hms.harvard.edu.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Tugnawat', 'Affiliation': 'Sangath, Bhopal, Madhya Pradesh, India.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Sangath, Bhopal, Madhya Pradesh, India.'}, {'ForeName': 'Zafra', 'Initials': 'Z', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, West Haven, CT, USA.'}, {'ForeName': 'Sona', 'Initials': 'S', 'LastName': 'Dimidjian', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, CO, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Fairburn', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Hollon', 'Affiliation': 'Department of Psychology, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Udita', 'Initials': 'U', 'LastName': 'Joshi', 'Affiliation': 'Sangath, Bhopal, Madhya Pradesh, India.'}, {'ForeName': 'Azaz', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Sangath, Bhopal, Madhya Pradesh, India.'}, {'ForeName': 'Chunling', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ""Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA; Division of Global Health Equity, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Mitchell', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Shital', 'Initials': 'S', 'LastName': 'Muke', 'Affiliation': 'Sangath, Bhopal, Madhya Pradesh, India.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Nadkarni', 'Affiliation': 'Centre for Global Mental Health, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK; Sangath, Alto Porvorim, Goa, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Ramaswamy', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Juliana L', 'Initials': 'JL', 'LastName': 'Restivo', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Shrivastava', 'Affiliation': 'Sangath, Bhopal, Madhya Pradesh, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Sangath, Bhopal, Madhya Pradesh, India.'}, {'ForeName': 'Daisy R', 'Initials': 'DR', 'LastName': 'Singla', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sinai Health System, Toronto, Canada.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Bhan', 'Affiliation': 'Sangath, Bhopal, Madhya Pradesh, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA; Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106267']
146,33421648,Group mindful self-compassion training to improve mental health outcomes for LGBTQIA+ young adults: Rationale and protocol for a randomised controlled trial.,"BACKGROUND


Young adults who are lesbian, gay, bisexual, trans, queer or questioning, intersex, asexual and other diverse genders and sexualities (LGBTQIA+) are more likely to experience mental health difficulties and are at significantly elevated risk of substance abuse, self-harm and suicide, relative to their heterosexual, endosex and cisgender peers. There is a need for effective mental health interventions for LGBTQIA+ young adults. Mindful Self-Compassion training is a promising approach; among LGBTQIA+ individuals, self-compassion accounts for more variation in mental health outcomes than bullying, victimization, and adverse childhood experiences combined. Furthermore, LGBTQIA+ individuals with high self-compassion report more positive identity and happiness, less self-stigma, and lower suicidality than those with low self-compassion.
METHOD


This paper outlines the rationale and protocol for a single-blind CONSORT-compliant randomised controlled trial, comparing group Mindful Self-Compassion to a delayed-treatment waitlist control group, for improving mental health, decreasing self-criticism and increasing self-compassion in LGBTQIA+ young adults (age 18-25 years). Mindful Self-Compassion training is an 8-week group program that focuses on cultivating self-compassion and mindfulness. While typically delivered as a face-to-face program, the proposed trial will investigate efficacy of the program when provided via videoconferencing.
DISCUSSION


Videoconference Mindful Self-Compassion training has the potential to improve the mental health of Australian LGBTQIA+ young adults and provide a possible cost-effective, scalable intervention for this population. The proposed trial will be the first to determine its efficacy for LGBTQIA+ young adults and will provide the first data on the delivery of the program via videoconferencing.",2021,Mindful Self-Compassion training is an 8-week group program that focuses on cultivating self-compassion and mindfulness.,"['LGBTQIA+ young adults (age 18-25\u202fyears', 'LGBTQIA+ young adults']","['self-compassion training', 'Mindful Self-Compassion training']",['mental health outcomes'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0362433,Mindful Self-Compassion training is an 8-week group program that focuses on cultivating self-compassion and mindfulness.,"[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Finlay-Jones', 'Affiliation': 'Telethon Kids Institute, PO Box 855, Perth 6872, Australia; School of Psychological Science, The University of Western Australia, 35 Stirling Highway, Perth, WA 6009, Australia. Electronic address: amy.finlay-jones@telethonkids.org.au.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Strauss', 'Affiliation': 'Telethon Kids Institute, PO Box 855, Perth 6872, Australia; School of Psychological Science, The University of Western Australia, 35 Stirling Highway, Perth, WA 6009, Australia. Electronic address: Penelope.strauss@telethonkids.org.au.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Perry', 'Affiliation': 'Telethon Kids Institute, PO Box 855, Perth 6872, Australia. Electronic address: yael.perry@telethonkids.org.au.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Waters', 'Affiliation': 'Telethon Kids Institute, PO Box 855, Perth 6872, Australia; School of Psychological Science, The University of Western Australia, 35 Stirling Highway, Perth, WA 6009, Australia. Electronic address: zoe.waters@telethonkids.org.au.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Gilbey', 'Affiliation': 'Telethon Kids Institute, PO Box 855, Perth 6872, Australia; School of Psychological Science, The University of Western Australia, 35 Stirling Highway, Perth, WA 6009, Australia. Electronic address: ylan.gilbey@telethonkids.org.au.'}, {'ForeName': 'Meg-An', 'Initials': 'MA', 'LastName': 'Windred', 'Affiliation': 'Minus18, 81 Rupert St, Collingwood, VIC 3066, Australia. Electronic address: meg.an@minus18.org.au.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Murdoch', 'Affiliation': 'Minus18, 81 Rupert St, Collingwood, VIC 3066, Australia. Electronic address: adrian@minus18.org.au.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pugh', 'Affiliation': 'Telethon Kids Institute, PO Box 855, Perth 6872, Australia. Electronic address: charlotte.pugh@minus18.org.au.'}, {'ForeName': 'Jeneva L', 'Initials': 'JL', 'LastName': 'Ohan', 'Affiliation': 'School of Psychological Science, The University of Western Australia, 35 Stirling Highway, Perth, WA 6009, Australia. Electronic address: jeneva.ohan@uwa.edu.au.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Telethon Kids Institute, PO Box 855, Perth 6872, Australia; School of Psychological Science, The University of Western Australia, 35 Stirling Highway, Perth, WA 6009, Australia. Electronic address: Ashleigh.lin@telethonkids.org.au.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106268']
147,33421647,"Propranolol for Induction of Labor in Nulliparas trial a double-blind, randomized, placebo-controlled trial.","BACKGROUND


Propranolol hydrochloride is a nonselective beta-adrenergic antagonist that has a known activity in the myometrium. Small trials have shown that propranolol decreases the duration of induced labor, although those studies are limited by methodological variability.
OBJECTIVE


Our objective was to determine whether the addition of a single dose of propranolol to induce labor in nulliparous women would decrease total time to vaginal delivery.
STUDY DESIGN


This study was a double-blind, randomized, placebo-controlled trial of nulliparous patients undergoing term induction of labor with a singleton, nonanomalous gestation. Subjects were randomized to 2 mg of intravenous propranolol hydrochloride or an identical-appearing saline placebo, administered 30 minutes after starting the induction of labor. Investigators, labor floor staff, and patients were blinded to the study drug allocation. The primary outcome was time to vaginal delivery. Secondary outcomes included mode of delivery, duration of the phases of labor, time to full dilation, composite maternal morbidity, and composite neonatal morbidity. Data were analyzed by intention-to-treat analysis with a P value of ≤.05 considered significant.
RESULTS


In this study, 240 patients were enrolled from December 2017 to December 2018, with 121 patients randomized to the propranolol group and 119 to the placebo group. The 2 groups had similar baseline characteristics. Of the patients randomized, 154 (64.2%) delivered vaginally. There was no significant difference in time from the start of the induction of labor to vaginal delivery (13.8±5.4 hours for propranolol vs 14.3±5.3 hours for placebo; P=.58). There was also no difference in the rate of cesarean delivery (38% vs 33.6%; P=.48), time to active labor (11.0±5.0 vs 11.2±4.5 hours; P=.77), or time to full dilation (12.4±5.1 vs 12.8±5.2 hours; P=.60) in patients receiving propranolol compared with those receiving placebo. Subjects randomized to the propranolol group had a significantly lower rate of composite maternal morbidity (28.9% vs 41.2%; risk ratio, 0.70; 95% confidence interval, 0.49-1.00; P=.047). Rates of postpartum hemorrhage (12.4% vs 21.8%; P=.05) and transfusion (0% vs 4.2%; P=.03) were also lower in the treated group. There was no significant difference in neonatal outcomes or composite morbidity (risk ratio, 0.74; 95% confidence interval, 0.44-1.22).
CONCLUSION


In this study, there is no evidence that the addition of a 1-time dose of propranolol to induce labor in nulliparous women decreases time to delivery or the rate of cesarean delivery. However, propranolol significantly reduced composite maternal morbidity without adverse neonatal effects.",2021,"There were no significant differences in neonatal outcomes or composite morbidity (RR 0.74, 95% CI 0.44, 1.22).
","['nulliparous patients undergoing term induction with a singleton, non-anomalous gestation', '240 patients enrolled from December 2017 to December 2018, with 121 patients randomized to', 'Labor in Nulliparas (The PIN Trial']","['propranolol', 'placebo', 'intravenous propranolol hydrochloride or an identical-appearing saline placebo', 'Propranolol hydrochloride', 'Propranolol']","['transfusion', 'time to active labor', 'Rates of postpartum hemorrhage', 'time to full dilation', 'rate of composite maternal morbidity', 'composite maternal morbidity', 'total time to vaginal delivery', 'neonatal outcomes or composite morbidity', 'rate of cesarean section', 'time to vaginal delivery', 'mode of delivery, duration of the phases of labor, time to full dilation, composite maternal morbidity, and composite neonatal morbidity']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0282321', 'cui_str': 'Propranolol hydrochloride'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}]",240.0,0.784519,"There were no significant differences in neonatal outcomes or composite morbidity (RR 0.74, 95% CI 0.44, 1.22).
","[{'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Bigelow', 'Affiliation': 'Minnesota Perinatal Physicians, Allina Health, Minneapolis, MN; Icahn School of Medicine at Mount Sinai, Department of Obstetrics, Gynecology, and Reproductive Science, New York, NY. Electronic address: Catherine.Bigelow@allina.com.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Obstetrics, Gynecology, and Reproductive Science, New York, NY.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overbey', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Obstetrics, Gynecology, and Reproductive Science, New York, NY.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Obstetrics, Gynecology, and Reproductive Science, New York, NY.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2020.100301']
148,33482396,The many faces of recruitment in a randomized controlled trial.,"BACKGROUND


Thoughtful approaches to study recruitment are a critical step in designing and implementing randomized controlled trials. Delays and challenges in recruitment can be costly and can result in smaller than proposed sample sizes which have downstream effects, such as underpowered studies.
PURPOSE


The current study evaluated recruitment methods (e.g., targeted mailings, brochures/flyers, social media) and their relationship to eligibility, randomization, participant characteristics and retention at end of a randomized controlled trial of physical activity adoption and maintenance among breast cancer survivors.
METHODS


Screening data from 874 women was analyzed for recruitment method, study eligibility, randomization and retention through end of treatment. Costs per randomized participant were calculated by recruitment method. Baseline participant characteristics were compared across recruitment methods and between randomized and retained participants.
RESULTS


Rates of participant accrual from eligibility screening through randomization differed statistically significantly depending on recruitment method (p < .05). The highest randomization rates were obtained via targeted mailings (88.2%) and lowest via brochure/flyer (0.4%). Among the randomized sample, there were no differences in demographic characteristics between recruitment methods, however, there were differences within the targeted mailings category (registries vs. organizational recruitment). There were statistically significant differences in costs between recruitment methods (p < .001) with lowest (non-negligible) cost being targeted mailings.
CONCLUSIONS


The current RCT of breast cancer survivors successfully recruited and retained participants, highlighting the need to combine recruitment methods to achieve accrual goals. Recruitment methods differed substantially in their cost and their ability to attract individuals who would ultimately be randomized.",2021,"There were statistically significant differences in costs between recruitment methods (p < .001) with lowest (non-negligible) cost being targeted mailings.
","['Screening data from 874 women was analyzed for recruitment method, study eligibility, randomization and retention through end of treatment', 'breast cancer survivors']",['physical activity adoption'],['highest randomization rates'],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",874.0,0.459324,"There were statistically significant differences in costs between recruitment methods (p < .001) with lowest (non-negligible) cost being targeted mailings.
","[{'ForeName': 'Bernardine M', 'Initials': 'BM', 'LastName': 'Pinto', 'Affiliation': 'College of Nursing, University of South Carolina, 1601 Greene Street, Rm 302B, Columbia, SC 29208, USA. Electronic address: pintob@mailbox.sc.edu.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Center for Health Promotion and Health Equity, Department of Behavioral and Social Sciences, Brown University, School of Public Health, Box G-S121-8, Providence, RI 02912, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106285']
149,33422659,Cervical pessary in singleton gestations with arrested preterm labor: a randomized clinical trial.,"BACKGROUND


Cervical pessary has been proven to be effective in reducing the rate of preterm birth in asymptomatic women with singleton gestations and short cervical length in the midtrimester of pregnancy; however, the efficacy of this device in women with arrested preterm labor is still a subject of debate.
OBJECTIVE


This study aimed to test the hypothesis that the use of a cervical pessary in women with singleton pregnancy and arrested preterm labor would reduce the risk of preterm birth at <37 weeks of gestation.
STUDY DESIGN


This study is a parallel group, nonblinded, randomized trial. Participants included in the study were women with a diagnosis of arrested preterm labor between 24 0/7 and 33 6/7 weeks of gestations. The participants were randomized to either the cervical pessary group or no pessary group in a 1:1 ratio. The primary endpoint was preterm birth at <37 weeks of gestation. A sample size of 120 participants was determined, but the trial was concluded before the completion of enrollment.
RESULTS


A total of 61 women with singleton pregnancies and arrested preterm labor at 24 0/7 to 33 6/7 weeks of gestation were enrolled in the trial. Of the 61 women, 32 were randomized to the cervical pessary group and 29 to the control group. Preterm birth at <37 weeks of gestation occurred in 14 women (43.8%) in the pessary group and 6 women (20.7%) in the control group (relative risk, 2.98; 95% confidence interval, 0.96-9.30).
CONCLUSION


In this underpowered trial, among women with singleton pregnancies and arrested preterm labor, compared with no pessary use, the use of a cervical pessary does not result in a lower rate of preterm birth at <37 weeks of gestation.",2021,"Preterm birth at less than 37 weeks of gestation occurred in 14 women (43.8%) in the pessary group, and 6 women (20.7%) in the control group (relative risk 2.98, 95% confidence interval 0.96 to 9.30).
","['singleton gestations with arrested preterm labor', 'Eligible women were those with a diagnosis of arrested preterm labor between 24 0/7 - 33 6/7 weeks of gestations', '32 women', 'women with singleton pregnancies and arrested preterm labor', 'women with singleton pregnancy, and with arrested preterm labor', 'asymptomatic women with singleton gestations', '61 women with singleton pregnancies and arrested preterm labor at 24 0/7 - 33 6/7 weeks were enrolled in the trial', '120 participants was planned, but the trial was stopped before complete enrollment']","['Cervical pessary', 'cervical pessary or no pessary']","['Preterm birth', 'rate of preterm birth', 'preterm birth at less than 37 weeks of gestation']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",32.0,0.490109,"Preterm birth at less than 37 weeks of gestation occurred in 14 women (43.8%) in the pessary group, and 6 women (20.7%) in the control group (relative risk 2.98, 95% confidence interval 0.96 to 9.30).
","[{'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Mastantuoni', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Saccone', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy. Electronic address: gabriele.saccone.1990@gmail.com.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Gragnano', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Di Spiezio Sardo', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Zullo', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Mariavittoria', 'Initials': 'M', 'LastName': 'Locci', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2021.100307']
150,33429088,The effect of reducing posttraumatic stress disorder symptoms on cardiovascular risk: Design and methodology of a randomized clinical trial.,"Posttraumatic stress disorder (PTSD) has been associated with accelerated progression of coronary heart disease (CHD). However, the underlying pathophysiological pathway has remained elusive and it is unclear whether there is a direct link between PTSD and CHD risk. This paper describes the methods of a randomized controlled trial developed to examine how changes in PTSD symptoms affect CHD disease pathways. One hundred twenty participants with current PTSD and who are free of known CHD will be randomized to receive either an evidence-based treatment for PTSD (Cognitive Processing Therapy; CPT) or a waitlist control (WL). Before and after CPT/WL, participants undergo assessment of CHD risk biomarkers reflecting autonomic nervous system dysregulation, systemic inflammation, and vascular endothelial dysfunction. The primary hypothesis is that individuals who show improvement in PTSD symptoms will show improvement in CHD risk biomarkers, whereas individuals who fail to improve or show worsening PTSD symptoms will have no change or worsening in CHD biomarkers. This study is expected to provide knowledge of the role of both the direct impact of PTSD symptoms on CHD risk pathways and the role of these systems as candidate mechanisms underlying the relationship between PTSD and CHD risk. Further, results will provide guidance on the utility of cognitive therapy as a tool to mitigate the accelerated progression of CHD in PTSD. Clinical Trials Registration: https://clinicaltrials.gov/ct2/show/NCT02736929; Unique identifier: NCT02736929.",2021,"Before and after CPT/WL, participants undergo assessment of CHD risk biomarkers reflecting autonomic nervous system dysregulation, systemic inflammation, and vascular endothelial dysfunction.","['Posttraumatic stress disorder (PTSD', 'One hundred twenty participants with current PTSD and who are free of known CHD']",['evidence-based treatment for PTSD (Cognitive Processing Therapy; CPT) or a waitlist control (WL'],['CHD risk biomarkers'],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1277690', 'cui_str': 'Coronary heart disease risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",120.0,0.0349641,"Before and after CPT/WL, participants undergo assessment of CHD risk biomarkers reflecting autonomic nervous system dysregulation, systemic inflammation, and vascular endothelial dysfunction.","[{'ForeName': 'Stefanie T', 'Initials': 'ST', 'LastName': 'LoSavio', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Beckham', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA.'}, {'ForeName': 'Stephanie Y', 'Initials': 'SY', 'LastName': 'Wells', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA; VA Mid-Atlantic Mental Illness Research, Education, and Clinical Center, Durham, NC, United States of America.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Resick', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sherwood', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'VA Mid-Atlantic Mental Illness Research, Education, and Clinical Center, Durham, NC, United States of America; Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Healthcare System, Durham, NC, United States of America.'}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Kirby', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA; VA Mid-Atlantic Mental Illness Research, Education, and Clinical Center, Durham, NC, United States of America.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Beaver', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA.'}, {'ForeName': 'Michelle F', 'Initials': 'MF', 'LastName': 'Dennis', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA.'}, {'ForeName': 'Lana L', 'Initials': 'LL', 'LastName': 'Watkins', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA. Electronic address: lana.watkins@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106269']
151,33434704,"Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline.","Alzheimer's dementia (AD) is the sixth leading cause of death in the U.S., with an estimated $305 billion cost of care in 2020. Currently there are no cures or therapies to ameliorate the disease progression and symptoms. Growing evidence links a diet characterized by high antioxidant components with benefits to cognitive function, which is indicative of the preventative potential of dietary inteventions. The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study is a 3-year, multicenter, randomized controlled trial to test the effects of the MIND diet on cognitive function in 604 individuals at risk for AD. Men and women ages 65 to 84 years were recruited. Eligible participants were randomized to either the MIND diet with mild caloric restriction or their usual diet with mild caloric restriction. Cognitive assessments, medical history, blood pressure, anthropometric measurements, and blood and urine sample collections will be taken at baseline and follow-up visits. MRI scans will be completed on approximately half of the enrolled participants at the start and end of the study. Unique features of the MIND study include: 1) a dietary pattern, rather than single nutrient or food, tested in an at-risk population; 2) foods featured as key components of the MIND diet (i.e. extra-virgin olive oil, blueberries, and nuts) provided for participants; and 3) MRI scans of brain structure and volume that may provide potential mechanistic evidence on the effects of the diet. Results from the study will be crucial to the development of dietary guidelines for the prevention of AD.",2021,Eligible participants were randomized to either the MIND diet with mild caloric restriction or their usual diet with mild caloric restriction.,"[""Alzheimer's dementia (AD"", '604 individuals at risk for AD', 'Men and women ages 65 to 84\u202fyears were recruited', 'Eligible participants']","['Mediterranean-DASH intervention', 'Mediterranean-DASH Intervention', 'MIND diet with mild caloric restriction or their usual diet with mild caloric restriction', 'MIND diet']","['cognitive decline', 'Cognitive assessments, medical history, blood pressure, anthropometric measurements, and blood and urine sample collections', 'cognitive function']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0810864,Eligible participants were randomized to either the MIND diet with mild caloric restriction or their usual diet with mild caloric restriction.,"[{'ForeName': 'Xiaoran', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Martha Clare', 'Initials': 'MC', 'LastName': 'Morris', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Klodian', 'Initials': 'K', 'LastName': 'Dhana', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ventrelle', 'Affiliation': 'Department of Preventive Medicine, Rush Medical College, Chicago, IL, United States of America.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': ""Department of Nutrition, Harvard School of Public Health, Boston, MA, United States of America; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bishop', 'Affiliation': ""Department of Nutrition, Harvard School of Public Health, Boston, MA, United States of America; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Chiquia S', 'Initials': 'CS', 'LastName': 'Hollings', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Adrianna', 'Initials': 'A', 'LastName': 'Boulin', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Laranjo', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Stubbs', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Reilly', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Carey', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Furtado', 'Affiliation': 'Department of Nutrition, Harvard School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Santica M', 'Initials': 'SM', 'LastName': 'Marcovina', 'Affiliation': 'Northwest Lipid Metabolism and Diabetes Research Laboratories, Seattle, WA, United States of America.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Tangney', 'Affiliation': 'Department of Preventive Medicine, Rush Medical College, Chicago, IL, United States of America; Department of Clinical Nutrition, Rush Medical College, Chicago, IL, United States of America.'}, {'ForeName': 'Neelum T', 'Initials': 'NT', 'LastName': 'Aggarwal', 'Affiliation': ""Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, United States of America; Department of Neurology, Rush University Medical Center, Chicago, IL, United States of America.""}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Arfanakis', 'Affiliation': ""Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, United States of America; Department of Diagnostic Radiology and Nuclear Medicine, Rush University Medical Center, Chicago, IL, United States of America; Department of Biomedical Engineering, Illinois Institute of Technology, Chicago, IL, United States of America.""}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Lisa L', 'Initials': 'LL', 'LastName': 'Barnes', 'Affiliation': ""Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, United States of America; Department of Neurology, Rush University Medical Center, Chicago, IL, United States of America. Electronic address: Lisa_L_Barnes@rush.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2021.106270']
152,33426901,Research Attitudes Questionnaire scores predict Alzheimer's disease clinical trial dropout.,"BACKGROUND


Missing data are a notable problem in Alzheimer's disease clinical trials. One cause of missing data is participant dropout. The Research Attitudes Questionnaire is a 7-item instrument that measures an individual's attitudes toward biomedical research, with higher scores indicating more favorable attitudes. The objective of this study was to describe the performance of the Research Attitudes Questionnaire over time and to examine whether Research Attitudes Questionnaire scores predict study dropout and other participant behaviors that affect trial integrity.
METHODS


The Research Attitudes Questionnaire was collected at baseline and weeks 26 and 52 from each member of 119 participant/study partner dyads enrolled in a Phase 2, randomized, double-blind, placebo-controlled mild-to-moderate Alzheimer's disease clinical trial. Within-subject longitudinal analyses examined change in Research Attitudes Questionnaire scores over time in each population. Logistic regression analyses that controlled for trial arm and clustering in trial sites were used to assess whether baseline Research Attitudes Questionnaire scores predicted trial completion, study medication compliance, and enrollment in optional substudies.
RESULTS


Participants and study partners endorsed statistically similar ratings on the Research Attitudes Questionnaire that were stable over time. Participants with baseline Research Attitudes Questionnaire scores above 28.5 were 4.7 (95% confidence interval = 1.01 to 21.95) times as likely to complete the trial compared to those with lower scores. Applying the same cutoff, baseline study partner Research Attitudes Questionnaire scores were similarly able to predict study completion (odds ratio = 4.2, 95% confidence interval = 1.71 to 10.32). Using a score cutoff of 27.5, higher participant Research Attitudes Questionnaire scores predicted study medication compliance (odds ratio = 5.85, 95% confidence interval = 1.34 to 25.54). No relationship was observed between Research Attitudes Questionnaire score and participation in optional substudies.
CONCLUSION


This brief instrument that measures research attitudes may identify participants at risk for behaviors that cause missing data.",2021,"Using a score cutoff of 27.5, higher participant Research Attitudes Questionnaire scores predicted study medication compliance (odds ratio = 5.85, 95% confidence interval = 1.34 to 25.54).","[""controlled mild-to-moderate Alzheimer's disease clinical trial""]",['placebo'],"['Attitudes Questionnaire scores', 'Research Attitudes Questionnaire scores', 'Research Attitudes Questionnaire']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]",,0.0889511,"Using a score cutoff of 27.5, higher participant Research Attitudes Questionnaire scores predicted study medication compliance (odds ratio = 5.85, 95% confidence interval = 1.34 to 25.54).","[{'ForeName': 'Shana D', 'Initials': 'SD', 'LastName': 'Stites', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Turner', 'Affiliation': 'Department of Neurology, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gurian', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Karlawish', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Grill', 'Affiliation': 'Departments of Psychiatry and Human Behavior and Neurobiology and Behavior, Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774520982315']
153,33435760,Adopting an alternative structure for clinical trials in immunotherapy.,"Background:  This evaluation emphasizes the main points of the original article 'Position paper: new insights into the immunobiology and dynamics of tumor-host interactions require adaptations of clinical studies' by Sprenger et al. and provides further justification for the use of an alternative approach in the design of human clinical trials for new investigational drugs in the field of immuno-oncology. Objective:  Standard trial design utilizing the double blind placebo trial approach, while effective for drugs that directly treat tumors, is too costly, slow, and not effective for drugs and protocols that depend on activation of the immune system for killing of tumors. Methods/results:  This paper has proposed through the use of detailed diagnostic profiling, small groups of patients with similar tumor microenvironment characteristics be grouped to determine the clinical benefit of immunological combinations that enter clinical trials. In addition, mega data from larger trials in which patients are subcategorized as above can provide the necessary data as a substitute for current double blind placebo trials which do not take into account the immune status of the host and tumor. Conclusion:  There needs to be evolution of the clinical trial landscape so that it matches the exponential growth of the field of immunotherapy.",2021,This evaluation emphasizes the main points of the original article 'Position paper: new insights into the immunobiology and dynamics of tumor-host interactions require adaptations of clinical studies' by Sprenger et al. and provides further justification for the use of an alternative approach in the design of human clinical trials for new investigational drugs in the field of immuno-oncology.,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.399534,This evaluation emphasizes the main points of the original article 'Position paper: new insights into the immunobiology and dynamics of tumor-host interactions require adaptations of clinical studies' by Sprenger et al. and provides further justification for the use of an alternative approach in the design of human clinical trials for new investigational drugs in the field of immuno-oncology.,"[{'ForeName': 'Evanthia T', 'Initials': 'ET', 'LastName': 'Roussos Torres', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Epstein', 'Affiliation': 'Department of Pathology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]",Expert review of anticancer therapy,['10.1080/14737140.2021.1875822']
154,33433260,The Effect of Cognitive Rehabilitation on Balance Skills of Individuals with Multiple Sclerosis.,"Balance skills can be affected by slow information processing speed in people with multiple sclerosis. This study explored the effect of cognitive-based rehabilitation on balance skills of individuals with multiple sclerosis. Seventy-one participants with multiple sclerosis were randomly assigned to the usual occupational therapy exercises as a control group (n = 36, male = 10) or the cognitive rehabilitation group (n = 35, male = 10). Using several assessments pre-intervention, post-intervention and two months after completion, participants in the cognitive rehabilitation group showed significant improvement in their balance skills in post-test and as well as follow-up measurements compared to the control group. Results also showed a large effect of cognitive rehabilitation for balance (eta-squared= 0.59) and for information processing speed measured. Inclusion of tasks related to information processing speed to the usual occupational therapy exercises seemed to be able to improve the balance skills of people with multiple sclerosis.",2021,Inclusion of tasks related to information processing speed to the usual occupational therapy exercises seemed to be able to improve the balance skills of people with multiple sclerosis.,"['people with multiple sclerosis', 'Individuals with Multiple Sclerosis', 'individuals with multiple sclerosis', 'Seventy-one participants with multiple sclerosis']","['cognitive rehabilitation group', 'cognitive-based rehabilitation', 'usual occupational therapy exercises', 'Cognitive Rehabilitation']",['balance skills'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0450389', 'cui_str': '71'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",71.0,0.0294071,Inclusion of tasks related to information processing speed to the usual occupational therapy exercises seemed to be able to improve the balance skills of people with multiple sclerosis.,"[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Azimian', 'Affiliation': 'Department of Clinical Sciences, School of Rehabilitation sciences, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yaghoubi', 'Affiliation': 'Department of Occupational Therapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Ahmadi Kahjoogh', 'Affiliation': 'Faculty of Rehabilitation, Department of Occupational Therapy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Akbarfahimi', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation Sciences, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Hojjat Allah', 'Initials': 'HA', 'LastName': 'Haghgoo', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation Sciences, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Vahedi', 'Affiliation': 'Department of Biostatistics, School of Rehabilitation Sciences, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}]",Occupational therapy in health care,['10.1080/07380577.2021.1871698']
155,33431304,"Influence of Fluid Delivery Schedule and Composition on Fluid Balance, Physiologic Strain, and Substrate Use in the Heat.","INTRODUCTION


Wildfire suppression is characterized by high total energy expenditure and water turnover rates. Hydration position stands outline hourly fluid intake rates. However, dose interval remains ambiguous. We aimed to determine the effects of microdosing and bolus-dosing water and microdosing and bolus-dosing carbohydrate-electrolyte solutions on fluid balance, heat stress (physiologic strain index [PSI]), and carbohydrate oxidation during extended thermal exercise.
METHODS


In a repeated-measures cross-over design, subjects completed four 120-min treadmill trials (1.3 m·s -1 , 5% grade, 33°C, 30% relative humidity) wearing a US Forest Service wildland firefighter uniform and a 15-kg pack. Fluid delivery approximated losses calculated from a pre-experiment familiarization trial, providing 22 doses·h -1  or 1 dose·h -1  (46±11, 1005±245 mL·dose -1 ). Body weight (pre- and postexercise) and urine volume (pre-, during, and postexercise) were recorded. Heart rate, rectal temperature, skin temperature, and steady-state expired air samples were recorded throughout exercise. Statistical significance (P<0.05) was determined via repeated-measures analysis of variance.
RESULTS


Total body weight loss (n=11, -0.6±0.3 kg, P>0.05) and cumulative urine output (n=11, 677±440 mL, P>0.05) were not different across trials. The micro-dosed carbohydrate-electrolyte trial sweat rate was lower than that of the bolus-dosed carbohydrate-electrolyte, bolus-dosed water, and microdosed water trials (n=11, 0.8±0.2, 0.9±0.2, 0.9±0.2, 0.9±0.2 L·h -1 , respectively; P<0.05). PSI was lower at 60 than 120 min (n=12, 3.6±0.7 and 4.5±0.9, respectively; P<0.05), with no differences across trials. The carbohydrate-electrolyte trial's carbohydrate oxidation was higher than water trial's (n=12, 1.5±0.3 and 0.8±0.2 g·min -1 , respectively; P<0.05), with no dosing style differences.
CONCLUSIONS


Equal-volume diverse fluid delivery schedules did not affect fluid balance, PSI, or carbohydrate oxidation during extended thermal work.",2021,"RESULTS


Total body weight loss (n=11, -0.6±0.3 kg, P>0.05) and cumulative urine output (n=11, 677±440 mL, P>0.05) were not different across trials.",[],['microdosing and bolus-dosing water and microdosing and bolus-dosing carbohydrate-electrolyte solutions'],"['Total body weight loss', 'PSI', 'fluid balance, PSI, or carbohydrate oxidation', 'fluid balance, heat stress (physiologic strain index [PSI]), and carbohydrate oxidation', 'Body weight (pre- and postexercise) and urine volume (pre-, during, and postexercise', 'Fluid Balance, Physiologic Strain, and Substrate Use', 'carbohydrate oxidation', 'Heart rate, rectal temperature, skin temperature, and steady-state expired air samples', 'cumulative urine output']",[],"[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439472', 'cui_str': 'lb/sq. in'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0282507', 'cui_str': 'Stress Disorders, Heat'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0225387', 'cui_str': 'Exhaled air'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",,0.0713373,"RESULTS


Total body weight loss (n=11, -0.6±0.3 kg, P>0.05) and cumulative urine output (n=11, 677±440 mL, P>0.05) were not different across trials.","[{'ForeName': 'Alejandro M', 'Initials': 'AM', 'LastName': 'Rosales', 'Affiliation': 'University of Montana, Montana Center for Work Physiology and Exercise Metabolism, Missoula, MT.'}, {'ForeName': 'Walter S', 'Initials': 'WS', 'LastName': 'Hailes', 'Affiliation': 'University of Montana, Montana Center for Work Physiology and Exercise Metabolism, Missoula, MT.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Dodds', 'Affiliation': 'University of Montana, Montana Center for Work Physiology and Exercise Metabolism, Missoula, MT.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Marks', 'Affiliation': 'University of Montana, Montana Center for Work Physiology and Exercise Metabolism, Missoula, MT.'}, {'ForeName': 'Brent C', 'Initials': 'BC', 'LastName': 'Ruby', 'Affiliation': 'University of Montana, Montana Center for Work Physiology and Exercise Metabolism, Missoula, MT. Electronic address: brent.ruby@mso.umt.edu.'}]",Wilderness & environmental medicine,['10.1016/j.wem.2020.10.002']
156,33452967,"Miconia albicans and Curcuma longa herbal medicines positively modulate joint pain, function and inflammation in patients with osteoarthritis: a clinical study.","This study aims to evaluate the analgesic and modulating effect of Curcuma longa and Miconia albicans herbal medicines in knee's osteoarthritis (OA) treatment. This longitudinal study evaluated 24 patients with OA. The patients were divided into three groups: ibuprofen (1200 mg/day), C. longa (1000 mg/day) and M. albicans (1000 mg/day). The medications were applied orally for 30 days. The synovial fluid of the knee joint was collect at the first (day 0) and the last medical (day 30) consultation. The groups treated with herbal medicines presented the same results when compared to Ibuprofen. The comparison of the means of Total WOMAC for M. albicans before and after treatment presented a statistically significant difference (mean day 0 = 57.19; mean day 30 = 31.02) as well as variation of Total WOMAC for C. longa (mean day 0 = 54.79; mean day 30 = 37.08). The WOMAC Total and the VASP were compared, it was found that there was a significant decrease in the means in the C. longa and M. albicans groups, as well as in the Ibuprofen group after treatment. The study demonstrated that the treatment of knee OA with C. longa or M. albicans positively interferes with patients pain and functionality, decreased WOMAC and VASP scores, leading to functional improvement of these patients. This is the first clinical study demonstrating the analgesic and anti-inflammatory effect on knee osteoarthritis from M. albicans comparable to Ibuprofen drug.",2021,"The WOMAC Total and the VASP were compared, it was found that there was a significant decrease in the means in the C. longa and M. albicans groups, as well as in the Ibuprofen group after treatment.","[""knee's osteoarthritis (OA) treatment"", 'patients with osteoarthritis', '24 patients with OA']","['herbal medicines', 'ibuprofen', 'Ibuprofen', 'Curcuma longa and Miconia albicans herbal medicines']","['variation of Total WOMAC for C. longa', 'patients pain and functionality, decreased WOMAC and VASP scores', 'joint pain, function and inflammation', 'Total WOMAC for M. albicans', 'WOMAC Total and the VASP']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0077524', 'cui_str': 'Turmeric extract'}, {'cui': 'C1136062', 'cui_str': 'Miconia'}]","[{'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0255567', 'cui_str': 'vasodilator-stimulated phosphoprotein'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",24.0,0.016478,"The WOMAC Total and the VASP were compared, it was found that there was a significant decrease in the means in the C. longa and M. albicans groups, as well as in the Ibuprofen group after treatment.","[{'ForeName': 'Thiago P O', 'Initials': 'TPO', 'LastName': 'Gomes', 'Affiliation': 'Faculdade de Medicina Do Mucuri, Universidade Federal Dos Vales Do Jequitinhonha E Mucuri, Teófilo Otoni, MG, Brasil.'}, {'ForeName': 'Jonathan I N', 'Initials': 'JIN', 'LastName': 'Souza', 'Affiliation': 'Faculdade de Medicina Do Mucuri, Universidade Federal Dos Vales Do Jequitinhonha E Mucuri, Teófilo Otoni, MG, Brasil.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Somerlate', 'Affiliation': 'Faculdade de Medicina Do Mucuri, Universidade Federal Dos Vales Do Jequitinhonha E Mucuri, Teófilo Otoni, MG, Brasil.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Mendonça', 'Affiliation': 'Departamento de Fisioterapia, Universidade Federal Dos Vales Do Jequitinhonha E Mucuri, Diamantina, MG, Brasil.'}, {'ForeName': 'Nerilson M', 'Initials': 'NM', 'LastName': 'Lima', 'Affiliation': 'Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brasil.'}, {'ForeName': 'Gabriela P', 'Initials': 'GP', 'LastName': 'Carli', 'Affiliation': 'Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brasil.'}, {'ForeName': 'Sandra B R', 'Initials': 'SBR', 'LastName': 'Castro', 'Affiliation': 'Departamento de Farmácia, Universidade Federal de Juiz de Fora, Governador Valadares, MG, Brasil.'}, {'ForeName': 'Teresinha', 'Initials': 'T', 'LastName': 'de Jesus A S Andrade', 'Affiliation': 'Núcleo de Pesquisa Aplicada Às Ciências, Instituto Federal Do Maranhão, Maranhão, Brasil.'}, {'ForeName': 'João V L', 'Initials': 'JVL', 'LastName': 'Dias', 'Affiliation': 'Faculdade de Medicina Do Mucuri, Universidade Federal Dos Vales Do Jequitinhonha E Mucuri, Teófilo Otoni, MG, Brasil.'}, {'ForeName': 'Marcone A L', 'Initials': 'MAL', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brasil.'}, {'ForeName': 'Caio C S', 'Initials': 'CCS', 'LastName': 'Alves', 'Affiliation': 'Faculdade de Medicina Do Mucuri, Universidade Federal Dos Vales Do Jequitinhonha E Mucuri, Teófilo Otoni, MG, Brasil.'}, {'ForeName': 'Alessandra P', 'Initials': 'AP', 'LastName': 'Carli', 'Affiliation': 'Instituto de Ciências, Engenharia E Tecnologia, Universidade Federal Dos Vales Do Jequitinhonha E Mucuri, Teófilo Otoni, MG, Brasil. alessandrapcarli@hotmail.com.'}]",Inflammopharmacology,['10.1007/s10787-020-00781-9']
157,33443695,Project ACTIVE: a Randomized Controlled Trial of Personalized and Patient-Centered Preventive Care in an Urban Safety-Net Setting.,"BACKGROUND


Evidence-based preventive care in the USA is underutilized, diminishing population health and worsening health disparities. We developed Project ACTIVE, a program to improve adherence with preventive care goals through personalized and patient-centered care.
OBJECTIVE


To determine whether Project ACTIVE improved utilization of preventive care and/or estimated life expectancy compared to usual care.
DESIGN


Single-site randomized controlled trial.
PARTICIPANTS


Cluster-randomized 140 English or Spanish speaking adult patients in primary care with at least one of twelve unfulfilled preventive care goals based on USPSTF grade A and B recommendations.
INTERVENTION


Project ACTIVE employs a validated mathematical model to predict and rank individualized estimates of health benefit that would arise from improved adherence to different preventive care guidelines. Clinical staff engaged the participant in a shared medical decision-making (SMD) process to identify highest priority unfulfilled clinical goals, and health coaching staff engaged the participant to develop and monitor action steps to reach those goals.
MAIN MEASURES


Change in number of unfulfilled preventive care goals from USPSTF grade A and B recommendations and change in overall gain in estimated life expectancy.
KEY RESULTS


In an intent-to-treat analysis, Project ACTIVE increased the average number of fulfilled preventive care goals out of 12 by 0.68 in the intervention arm compared with 0.15 in the control arm (mean difference [95% CI] 0.53 [0.19-0.86]), yielding a gain in estimated life expectancy of 8.8 months (3.8, 14.2). In a per-protocol analysis, Project ACTIVE increased fulfilled preventive care goals by 0.80 in the intervention arm compared with 0.16 in the control arm (mean difference [95% CI], 0.65 [0.25-1.04]), yielding a gain in estimated life expectancy of 13.7 months (6.2, 21.2). Among the 12 preventive care goals, more improvement occurred for alcohol use, hypertension, hyperlipidemia, depression, and smoking.
CONCLUSIONS


Project ACTIVE improved unfulfilled preventive care goals and improved estimated life expectancy.
CLINICAL TRIAL REGISTRATION NUMBER


NCT04211883.",2021,"Among the 12 preventive care goals, more improvement occurred for alcohol use, hypertension, hyperlipidemia, depression, and smoking.
",['Cluster-randomized 140 English or Spanish speaking adult patients in primary care with at least one of twelve unfulfilled preventive care goals based on USPSTF grade A and B recommendations'],['Personalized and Patient-Centered Preventive Care'],"['fulfilled preventive care goals', 'number of unfulfilled preventive care goals from USPSTF grade A and B recommendations and change in overall gain in estimated life expectancy', 'alcohol use, hypertension, hyperlipidemia, depression, and smoking']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}]","[{'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]",140.0,0.0983633,"Among the 12 preventive care goals, more improvement occurred for alcohol use, hypertension, hyperlipidemia, depression, and smoking.
","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Applegate', 'Affiliation': 'New York University Langone Health, 462 1st Avenue, Desk 2D, New York, NY, 10016, USA. Melanie.A.Applegate@gmail.com.'}, {'ForeName': 'Ebony', 'Initials': 'E', 'LastName': 'Scott', 'Affiliation': 'MDRC, New York, NY, USA.'}, {'ForeName': 'Glen B', 'Initials': 'GB', 'LastName': 'Taksler', 'Affiliation': 'Medicine Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Mirtala', 'Initials': 'M', 'LastName': 'Sanchez', 'Affiliation': 'New York University Langone Health, 462 1st Avenue, Desk 2D, New York, NY, 10016, USA.'}, {'ForeName': 'Nguyet', 'Initials': 'N', 'LastName': 'Duong', 'Affiliation': 'New York University Langone Health, 462 1st Avenue, Desk 2D, New York, NY, 10016, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Mark', 'Affiliation': 'Mount Sinai Health System, New York, NY, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Caniglia', 'Affiliation': 'New York University Langone Health, 462 1st Avenue, Desk 2D, New York, NY, 10016, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wallach', 'Affiliation': 'New York University Langone Health, 462 1st Avenue, Desk 2D, New York, NY, 10016, USA.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Braithwaite', 'Affiliation': 'New York University Langone Health, 462 1st Avenue, Desk 2D, New York, NY, 10016, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06359-z']
158,33446422,Intracranial hemorrhage in patients with atrial fibrillation receiving anticoagulation with warfarin or edoxaban: An in-depth analysis from the ENGAGE AF-TIMI 48 randomized trial.,"Intracranial hemorrhage (ICH) is a known risk of oral anticoagulation; delineating ICH attributes may provide nuanced guidance regarding atrial fibrillation management. We evaluated ICH characteristics and outcomes from Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48), a randomized trial that compared two edoxaban regimens (higher-dose edoxaban regimen 60/30 mg (HDER), lower-dose edoxaban regimen 30/15 mg (LDER)) with warfarin in patients with atrial fibrillation. Patients who suffered ICH vs those who did not were compared and independent predictors of ICH were calculated. We also assessed ICH subtype and etiology. Of 21,105 randomized patients, 322 (1.53%) had ≥ 1 ICH for a total of 368 events. Intraparenchymal hemorrhage (HDER: HR 0.52 [95% CI 0.35-0.77], LDER: HR 0.22 [0.13-0.38]) and subdural hematoma (HDER: HR 0.29 [0.15-0.55], LDER: HR 0.26 [0.13-0.50]) were lower with both HDER and LDER vs warfarin. Subarachnoid hemorrhage frequency was similar in the HDER vs warfarin groups but lower in LDER. Compared to warfarin, edoxaban was associated with lower risk of spontaneous ICH (HDER: HR 0.47 [0.31-0.69], LDER: HR 0.34 [0.22-0.53]) and traumatic ICH (HDER: HR 0.32 [0.17-0.61], LDER: HR 0.31 [0.16-0.59]). In multivariable analysis, randomization to warfarin, increased age, and risk of falling remained independent predictors of ICH. In ENGAGE AF-TIMI 48, ICH was decreased in edoxaban-treated patients compared to warfarin-treated patients, including ICH of both spontaneous and traumatic causes. Both edoxaban regimens lowered intraparenchymal and subdural hemorrhages compared to warfarin. Patient characteristics and medical history may help guide anticoagulation management.",2021,"Compared to warfarin, edoxaban was associated with lower risk of spontaneous ICH (HDER: HR 0.47 [0.31-0.69], LDER: HR 0.34 [0.22-0.53]) and traumatic ICH (HDER: HR 0.32 [0.17-0.61], LDER: HR 0.31 [0.16-0.59]).","['patients with atrial fibrillation', 'patients with atrial fibrillation receiving anticoagulation with', 'Intracranial hemorrhage (ICH', 'Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48', 'Of 21,105 randomized patients, 322 (1.53%) had\u202f≥\u202f1 ICH for a total of 368 events']","['warfarin', 'warfarin, edoxaban', 'edoxaban', 'HDER vs warfarin', 'Factor Xa Next Generation', 'warfarin or edoxaban']","['Intraparenchymal hemorrhage', 'Subarachnoid hemorrhage frequency', 'subdural hematoma', 'lower risk of spontaneous ICH', 'traumatic ICH', 'Intracranial hemorrhage', 'intraparenchymal and subdural hemorrhages']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C4517506', 'cui_str': '1.53'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0015520', 'cui_str': 'Coagulation factor Xa'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018946', 'cui_str': 'Subdural hematoma'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C4545430', 'cui_str': 'Spontaneous intracranial hemorrhage'}, {'cui': 'C0273058', 'cui_str': 'Intracranial hemorrhage following injury'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}]",21105.0,0.111436,"Compared to warfarin, edoxaban was associated with lower risk of spontaneous ICH (HDER: HR 0.47 [0.31-0.69], LDER: HR 0.34 [0.22-0.53]) and traumatic ICH (HDER: HR 0.32 [0.17-0.61], LDER: HR 0.31 [0.16-0.59]).","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Nelson', 'Affiliation': 'Department of Neurology and Anesthesiology & Critical Care Medicine, Johns Hopkins Hospital, Baltimore, MD, USA. Electronic address: snelso43@jhmi.edu.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: rgiugliano@bwh.harvard.edu.""}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: eantman@rics.bwh.harvard.edu.""}, {'ForeName': 'Jeong-Gun', 'Initials': 'JG', 'LastName': 'Park', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: jpark58@bwh.harvard.edu.""}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Norden', 'Affiliation': ""Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Natalia S', 'Initials': 'NS', 'LastName': 'Rost', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA. Electronic address: nrost@partners.org.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Silverman', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA. Electronic address: sbsilverman@partners.org.'}, {'ForeName': 'Aneesh B', 'Initials': 'AB', 'LastName': 'Singhal', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA. Electronic address: asinghal@partners.org.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Lanz', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Munich, Germany. Electronic address: Hans-Joachim.Lanz@daiichi-sankyo.eu.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: ebraunwald@partners.org.""}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: cruff@bwh.harvard.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.10.036']
159,33440330,Pilot randomized trial of pre-hospital advanced therapies for the control of hemorrhage (PATCH) using pelvic binders.,"BACKGROUND


Pelvic fractures represent a small percent of all skeletal injuries but are associated with significant morbidity and mortality secondary to hemodynamic instability from bleeding bone surfaces and disrupted pelvic vasculature. Stabilization of the pelvis prior to arrival at a treatment facility may mitigate the hemodynamic consequences of pelvic ring injuries and improve morbidity and mortality. Whether pelvic compression devices such as pelvic binders or sheets can be safely applied in the prehospital setting has not been well-studied. This study aims to evaluate the safety of applying a pelvic binder to at-risk patients in the field after scalable training and the feasibility of conducting a randomized trial evaluating this practice in the prehospital setting.
METHODS


A pilot study (prospective randomized trial design) was conducted in the pre-hospital environment in an urban area surrounding a level-one trauma center. Pre-hospital emergency medical (EMS) personnel were trained to identify patients at high-risk for pelvic fracture and properly apply a commercial pelvic binder. Adult patients with a high-energy mechanism, suspected pelvic fracture, and ""Priority 1"" criteria were prospectively identified by paramedics and randomized to pelvic binder placement or usual care. Medical records were reviewed for safety outcomes. Secondary outcomes were parameters of efficacy including interventions needed to control hemorrhage (such as angioembolization and surgical control of bleeding) and mortality.
RESULTS


Forty-three patients were randomized to treatment (binder: N=20; nonbinder: N=23). No complications of binder placement were identified. Eight patients (40%) had binders placed correctly at the level of the greater trochanter. Two binders (10%) were placed too proximally and 10 (50%) binders were not visualized on x-ray. Two binder group patients and three nonbinder group patients required angioembolization. None required surgical control of pelvic bleeding. Two nonbinder group patients and one binder group patient were readmitted within 30 days and one nonbinder group patient died within 30 days.
CONCLUSION


Identification of pelvic fractures in the field remains a challenge. However, a scalable training model for appropriate binder placement was successful without secondary injury to patients. The model for conducting prospective, randomized trials in the prehospital setting was successful.",2021,Stabilization of the pelvis prior to arrival at a treatment facility may mitigate the hemodynamic consequences of pelvic ring injuries and improve morbidity and mortality.,"['pre-hospital environment in an urban area surrounding a level-one trauma center', 'Forty-three patients were randomized to treatment (binder', 'Adult patients with a high-energy mechanism, suspected pelvic fracture, and ""Priority 1"" criteria']","['pelvic binder placement or usual care', 'Pre-hospital emergency medical (EMS) personnel', 'pre-hospital advanced therapies']","['complications of binder placement', 'morbidity and mortality', 'angioembolization', 'surgical control of pelvic bleeding', 'efficacy including interventions needed to control hemorrhage (such as angioembolization and surgical control of bleeding) and mortality']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0149531', 'cui_str': 'Fracture of pelvis'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C4708190', 'cui_str': 'Pelvic binder'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1504419', 'cui_str': 'Pelvic haemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}]",43.0,0.0430277,Stabilization of the pelvis prior to arrival at a treatment facility may mitigate the hemodynamic consequences of pelvic ring injuries and improve morbidity and mortality.,"[{'ForeName': 'Sarah N', 'Initials': 'SN', 'LastName': 'Pierrie', 'Affiliation': 'Department of Orthopaedics, San Antonio Military Medical Center, 3551Roger Brooke Dr, Fort Sam, Houston, TX 78234, United States.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Seymour', 'Affiliation': 'Department of Orthopaedic Surgery, Atrium Health Musculoskeletal Institute, 1000 Blythe Boulevard, Charlotte, NC 28203, United States. Electronic address: Rachel.Seymour@atriumhealth.org.'}, {'ForeName': 'Meghan K', 'Initials': 'MK', 'LastName': 'Wally', 'Affiliation': 'Department of Orthopaedic Surgery, Atrium Health Musculoskeletal Institute, 1000 Blythe Boulevard, Charlotte, NC 28203, United States.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Studnek', 'Affiliation': 'The Mecklenburg EMS Agency, 4425 Wilkinson Blvd, Charlotte, NC 28208, United States.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Infinger', 'Affiliation': 'The Mecklenburg EMS Agency, 4425 Wilkinson Blvd, Charlotte, NC 28208, United States.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Hsu', 'Affiliation': 'Department of Orthopaedic Surgery, Atrium Health Musculoskeletal Institute, 1000 Blythe Boulevard, Charlotte, NC 28203, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.12.082']
160,33440262,Pump It Up! A randomized clinical trial to optimize insulin pump self-management behaviors in adolescents with type 1 diabetes.,"Individuals with type 1 diabetes (T1D) must engage in a variety of complex and burdensome self-management behaviors daily to maintain near normal blood glucose levels and prevent complications. There is a need for interventions to improve use of sophisticated diabetes technologies, such as insulin pumps, during adolescence - a very high-risk developmental period for individuals with T1D. All diabetes devices, including insulin pumps, store large amounts of behavioral data that can be downloaded and analyzed to evaluate adherence to recommended T1D self-management behaviors. The overall objective of the present study, Pump it Up!, was to use objectively downloaded insulin pump data to inform and test two interventions to optimize insulin pump use in adolescents with T1D and their caregivers. Multiphase Optimization Strategy (MOST) was used to achieve the overall goal of this study - to separately test the main effect of the Pump It Up! Personalized T1D Self-Management Behaviors Feedback Report and the main effect of Pump It Up! Problem-Solving Skills intervention to improve T1D self-management behaviors using a 2 × 2 factorial design. The purpose of this paper is to describe the Pump It Up! study design and rationale, and participant baseline characteristics. Longitudinal data analyses will be conducted, and moderating effects of psychosocial factors will be examined in relation to primary (insulin pump self-management behaviors) and secondary (A1C) outcomes.",2021,"There is a need for interventions to improve use of sophisticated diabetes technologies, such as insulin pumps, during adolescence - a very high-risk developmental period for individuals with T1D. All diabetes devices, including insulin pumps, store large amounts of behavioral data that can be downloaded and analyzed to evaluate adherence to recommended T1D self-management behaviors.","['Individuals with type 1 diabetes (T1D', 'adolescents with type 1 diabetes', 'adolescents with T1D and their caregivers']","['Problem-Solving intervention', 'Pump', 'insulin pump self-management behaviors', 'Multiphase Optimization Strategy (MOST', 'Pump It Up']",['T1D self-management behaviors'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0577019,"There is a need for interventions to improve use of sophisticated diabetes technologies, such as insulin pumps, during adolescence - a very high-risk developmental period for individuals with T1D. All diabetes devices, including insulin pumps, store large amounts of behavioral data that can be downloaded and analyzed to evaluate adherence to recommended T1D self-management behaviors.","[{'ForeName': 'Holly K', 'Initials': 'HK', 'LastName': ""O'Donnell"", 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, United States. Electronic address: holly.odonnell@cuanschutz.edu.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Vigers', 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, United States. Electronic address: timothy.vigers@cuanschutz.edu.'}, {'ForeName': 'Suzanne Bennett', 'Initials': 'SB', 'LastName': 'Johnson', 'Affiliation': 'Florida State University, College of Medicine, Department of Clinical Sciences, 1115 W. Call Street, Tallahassee, FL 32306, United States. Electronic address: suzanne.johnson@med.fsu.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pyle', 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, United States. Electronic address: laura.pyle@cuanschutz.edu.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Wright', 'Affiliation': 'Florida State University, College of Medicine, Department of Clinical Sciences, 1115 W. Call Street, Tallahassee, FL 32306, United States. Electronic address: nwright@fsu.edu.'}, {'ForeName': 'Larry C', 'Initials': 'LC', 'LastName': 'Deeb', 'Affiliation': 'Florida State University College of Medicine, Department of Medical Humanities and Social Sciences, 1115 W. Call Street, Tallahassee, FL 32306, United States. Electronic address: lcdeeb@yhoo.com.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Driscoll', 'Affiliation': 'University of Florida, Department of Clinical and Health Psychology, 1225 Center Dr., Gainesville, FL 32610, United States; University of Florida Diabetes Institute, College of Medicine, 1275 Center Dr., Gainesville, FL 32610, United States. Electronic address: k.driscoll@phhp.ufl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106279']
161,33451962,Ketamine infusion reduces narcotic requirements following gastric bypass surgery: a randomized controlled trial.,"BACKGROUND


As the obesity epidemic worsens, anesthesiologists should expect to see more obese patients presenting for surgical procedures. Opioids cause respiratory depression, which has caused complications in patients with obstructive sleep apnea. Opioids can also cause nausea, prolonging the time that patients spend in the postanesthesia care unit. Ketamine is a potential analgesic alternative that may have advantages to narcotics in the bariatric population.
OBJECTIVES


To determine whether an intraoperative ketamine infusion would reduce postoperative narcotic use in patients during the first 48 hours after laparoscopic gastric bypass.
SETTING


Major academic medical center.
METHODS


There were 54 participating patients. The intervention group (n = 27) was randomized to receive 100 μg of fentanyl with anesthesia induction, then a 20-mg bolus of ketamine, followed by a 5 μg/kg/min intraoperative ketamine infusion starting after anesthesia induction and ending after wound closure commenced. The control group (narcotic only, n = 27) also received 100 μg of fentanyl at anesthesia induction and intraoperative boluses of fentanyl at the discretion of the anesthesia team, with .3 mg of hydromorphone administered approximately 45 minutes before the completion of surgery.
RESULTS


At 24 hours, the mean morphine-equivalent units (MEUs) were 12.7 (standard deviation [SD], 9.9; 95% confidence interval [CI], 8.8-16.6) for the ketamine group (n = 28) and 16.5 (SD, 9.8; 95% CI, 12.6-20.4) for the control group (n = 28). At 48 hours, the MEUs were 16.7 (SD, 12.0; 95% CI, 11.9-21.4) for the ketamine group and 22.7 (SD, 14.9; 95% CI, 16.8-28.6) for the control group. Cumulative MEUs for 24 hours (P = .039) and 48 hours (P = .058) postoperatively were lower in the ketamine group compared with the narcotic-only (control) group, although the difference at 48 hours did not reach statistical significance. Compared with the narcotic-only group, the ketamine group used 26% fewer MEUs after 24 hours and 31% fewer MEUs after 48 hours. This difference can mostly be attributed to group differences during the first 6 hours after surgery.
CONCLUSIONS


Ketamine successfully reduced the amount of opioids required to control bariatric patients' pain at 24 hours postoperatively, but not over the 48-hour postoperative period.",2021,"Cumulative MEUs for 24 hours (P = .039) and 48 hours (P = .058) postoperatively were lower in the ketamine group compared with the narcotic-only (control) group, although the difference at 48 hours did not reach statistical significance.","['54 participating patients', 'patients with obstructive sleep apnea', 'Major academic medical center', 'obese patients presenting for surgical procedures', 'patients during the first 48 hours after laparoscopic gastric bypass', 'gastric bypass surgery']","['ketamine', 'fentanyl with anesthesia induction, then a 20-mg bolus of ketamine', 'intraoperative ketamine infusion', 'Ketamine', 'Opioids', 'hydromorphone', 'control group (narcotic only, n = 27) also received 100 μg of fentanyl at anesthesia induction and intraoperative boluses of fentanyl']","['narcotic requirements', 'postoperative narcotic use', 'mean morphine-equivalent units (MEUs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]",54.0,0.089712,"Cumulative MEUs for 24 hours (P = .039) and 48 hours (P = .058) postoperatively were lower in the ketamine group compared with the narcotic-only (control) group, although the difference at 48 hours did not reach statistical significance.","[{'ForeName': 'Sonia D', 'Initials': 'SD', 'LastName': 'Mehta', 'Affiliation': 'Department of Anesthesiology, University of Florida College of Medicine, Gainesville, Florida.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Smyth', 'Affiliation': 'Department of Anesthesiology, University of Florida College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Terrie', 'Initials': 'T', 'LastName': 'Vasilopoulos', 'Affiliation': 'Department of Anesthesiology, University of Florida College of Medicine, Gainesville, Florida; Department of Orthopedics and Rehabilitation, University of Florida College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Friedman', 'Affiliation': 'Department of Surgery, University of Florida College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Joshua W', 'Initials': 'JW', 'LastName': 'Sappenfield', 'Affiliation': 'Department of Anesthesiology, University of Florida College of Medicine, Gainesville, Florida. Electronic address: jsappenfield@anest.ufl.edu.'}, {'ForeName': 'Gijo', 'Initials': 'G', 'LastName': 'Alex', 'Affiliation': 'Department of Anesthesiology and Pain Management, University of Texas Southwestern, Dallas, Texas.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.11.027']
162,33453456,"The effect of vitamin C on pulmonary oedema in patients with severe preeclampsia: A single-centre, randomised, placebo-controlled, double-blind trial.","OBJECTIVE


To determine whether vitamin C in the first three days postpartum reduces pulmonary oedema (PE) assessed by lung ultrasound in patients with severe preeclampsia.
DESIGN


Randomised, placebo-controlled, double-blind trial.
SETTING


Tertiary perinatal centre.
POPULATION


Consecutively admitted patients with singleton pregnancies complicated by severe preeclampsia.
METHODS


Thirty-four patients received vitamin C (1.5 g/6 h) (n = 17) or placebo (n = 17) at days 1, 2, and 3 postdelivery. Mann-Whitney-U test was used to compare vitamin C vs placebo groups. A p ≤ 0.05 was considered statistically significant.
MAIN OUTCOME MEASURES


Lung ultrasound was performed once daily in the first three days following delivery. Echo Comet Score (ECS) on day 1 postdelivery was the primary outcome studied and was obtained using the 28-rib interspaces technique. ECS on days 2 and 3 postdelivery were secondary outcomes.
RESULTS


There was no significant difference in ECS on day 1 (median 23 (inter-quartile range (IQR) 21-61) vs 18 (IQR 8-35); p = 0.31). All ultrasound examinations on day 1 were performed within six hours from delivery. On days 2 and 3, ECS was significantly lower in vitamin C group compared to placebo (8 (IQR 3-14) vs 35 (IQR 15-78); p = 0.03 and 5 (IQR 3-10) vs 18 (IQR 18-44); p = 0.04, respectively).
CONCLUSION


A single dose of intravenous vitamin C did not reduce PE in postpartum patients with severe preeclampsia on day 1 after delivery. Repeated doses, however, seem to have a delayed effect with a reduction in PE detected on ultrasound on days 2 and 3 following delivery.
TRIAL REGISTRATION


This trial is registered at ClinicalTrials.gov: ID NCT03451266 (https://clinicaltrials.gov/ct2/show/NCT03451266?term=NCT03451266&draw=2&rank=1).",2021,"On days 2 and 3, ECS was significantly lower in vitamin C group compared to placebo (8 (IQR 3-14) vs 35 (IQR 15-78);","['postpartum patients with severe preeclampsia on day 1 after delivery', '1.5\u2009g/6\u2009hours', 'Thirty-four patients received', 'patients with severe preeclampsia', 'Tertiary perinatal centre', 'Consecutively admitted patients with singleton pregnancies complicated by severe preeclampsia']","['vitamin C vs placebo', 'placebo', 'ECS', 'intravenous vitamin C', 'vitamin C']","['ECS', 'pulmonary oedema (PE', 'Echo Comet Score (ECS', 'pulmonary oedema']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341950', 'cui_str': 'Severe pre-eclampsia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0282670', 'cui_str': 'Comets (Astronomy)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0282670', 'cui_str': 'Comets (Astronomy)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}]",,0.808571,"On days 2 and 3, ECS was significantly lower in vitamin C group compared to placebo (8 (IQR 3-14) vs 35 (IQR 15-78);","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Korenc', 'Affiliation': 'Department of Perinatology, Division of Obstetrics and Gynaecology, University Medical Centre Ljubljana, Slovenia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Zieleskiewicz', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, North Hospital, Aix Marseille University, Marseille, France.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Stopar Pintaric', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Slovenia.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Blajic', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljana, Slovenia.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Ambrozic', 'Affiliation': 'Department of Cardiology, University Medical Centre Ljubljana, Slovenia.'}, {'ForeName': 'Miha', 'Initials': 'M', 'LastName': 'Lucovnik', 'Affiliation': 'Department of Perinatology, Division of Obstetrics and Gynaecology, University Medical Centre Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Slovenia. Electronic address: miha.lucovnik@kclj.si.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2021.100800']
163,33444780,"Changing Behaviour towards Aerobic and Strength Exercise (BASE): Design of a randomised, phase I study determining the safety, feasibility and consumer-evaluation of a remotely-delivered exercise programme in persons with multiple sclerosis.","BACKGROUND


Multiple sclerosis is a chronic progressive neurological disease. Evidence attests to the benefits of exercise, guidelines for exercise in multiple sclerosis are available. Remote-delivery of exercise adherence programmes based on the exercise guidelines require urgent testing.
AIMS


The design, and outcomes of Behaviour towards Aerobic and Strength Exercise in MS (BASE-MS), a remotely-delivered exercise training study based principles of behaviour change, will further evaluate the remote-delivery of the current exercise guidelines.
METHODS


BASE is a 4-month clinically relevant randomised controlled trial to explore the delivery of a remotely supervised, guidelines-based exercise programme for persons with multiple sclerosis, underpinned by principles of health behaviour change. Initially, 72 persons with mild to moderate multiple sclerosis will be randomised in a 1:1:1 allocation to receive the BASE programme, or act as controls continuing usual care. On programme completion, exercise participants will be further randomised to an optimised adherence treatment or usual adherence. Our online survey assesses the primary outcome of exercise participation, and secondary outcomes of symptoms, and correlates of behaviour change at baseline, month four, month five and month eleven. Online surveys will capture coach and participant feedback to identify the contexts, mechanisms and outcomes of BASE implementation.
CONCLUSIONS


The research and clinical landscape for MS management must remain in-step with public health and health communication. BASE tests the remote-delivery of the current exercise guidelines for exercise in persons with MS. Safety, feasibility and evaluative outcomes will provide rich data for future remote-delivery of exercise in neurological conditions.",2021,"The design, and outcomes of Behaviour towards Aerobic and Strength Exercise in MS (BASE-MS), a remotely-delivered exercise training study based principles of behaviour change, will further evaluate the remote-delivery of the current exercise guidelines.
","['persons with multiple sclerosis, underpinned by principles of health behaviour change', 'persons with multiple sclerosis', 'persons with MS', '72 persons with mild to moderate multiple sclerosis']","['Changing Behaviour towards Aerobic and Strength Exercise (BASE', 'Behaviour towards Aerobic and Strength Exercise in MS (BASE-MS', 'remotely-delivered exercise programme', 'BASE programme, or act as controls continuing usual care', 'remotely supervised, guidelines-based exercise programme']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]",[],72.0,0.0842007,"The design, and outcomes of Behaviour towards Aerobic and Strength Exercise in MS (BASE-MS), a remotely-delivered exercise training study based principles of behaviour change, will further evaluate the remote-delivery of the current exercise guidelines.
","[{'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Learmonth', 'Affiliation': 'Discipline of Exercise Science, Murdoch University, Murdoch, WA, Australia; Perron Institute for Neurological and Translational Science, Perth, WA, Australia; Centre for Molecular Medicine and Innovative Therapeutics, Murdoch University, Murdoch, WA, Australia. Electronic address: y.learmonth@murdoch.edu.au.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kaur', 'Affiliation': 'Discipline of Exercise Science, Murdoch University, Murdoch, WA, Australia.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Baynton', 'Affiliation': 'Discipline of Exercise Science, Murdoch University, Murdoch, WA, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fairchild', 'Affiliation': 'Discipline of Exercise Science, Murdoch University, Murdoch, WA, Australia; Centre for Molecular Medicine and Innovative Therapeutics, Murdoch University, Murdoch, WA, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Paul', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'van Rens', 'Affiliation': 'Discipline of Exercise Science, Murdoch University, Murdoch, WA, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106281']
164,33451896,Using a Modified Surprise Question as a Tool to Improve Primary Palliative Care in a Neurocritical Care Unit.,"BACKGROUND


Specialty palliative care is a limited resource. The surprise question (""Would you be surprised if this patient died within the next 12 months?"") is a screening tool for clinicians to identify people nearing the end of life. The researchers used a modified surprise question (MSQ) to improve primary palliative care in a neurocritical care unit.
METHODS


A palliative care physician attended interdisciplinary rounds up to three days a week and asked the primary neurocritical care team, for each patient admitted in the previous 24 hours, the MSQ: ""Would you be surprised if this patient died during this hospital stay?"" If the response was ""No,"" the unit social worker identified the patient's surrogate decision maker (SDM), and the primary team was encouraged to conduct a goals of care (GOC) conversation. The frequency of SDM documentation, occurrence and timing of GOC conversations, and palliative care and hospice consultations were measured for the baseline six months before the intervention, and six months after.
RESULTS


Among 350 patients admitted to the neurocritical care unit during the study, the age, gender, prehospitalization presence of advance directives, and mortality were comparable between the baseline (n = 173) and intervention (n = 177) periods. Compared to the baseline period, there was a higher frequency during the intervention period of documentation of SDM (31.8% vs. 54.2%, p = 0.00002), all GOC conversations (35.3% vs. 53.1%, p = 0.008), GOC conversations conducted by the primary team (27.2% vs. 47.5%, p = 0.00009), palliative care consultations (11.6% vs. 23.2%, p = 0.004), and hospice consultations (2.3% vs. 9.6%, p = 0.004).
CONCLUSION


The MSQ can be used as a tool to identify the risk of mortality, facilitate palliative care delivered by the primary team, and improve end-of-life care.",2021,"The MSQ can be used as a tool to identify the risk of mortality, facilitate palliative care delivered by the primary team, and improve end-of-life care.","['350 patients admitted to the neurocritical care unit during the study, the age, gender, prehospitalization presence of advance directives, and mortality were comparable between the baseline (n\u202f=\u202f173) and intervention (n\u202f=\u202f177) periods']",['modified surprise question (MSQ'],"['GOC conversations', 'hospice consultations', 'frequency of SDM documentation, occurrence and timing of GOC conversations, and palliative care and hospice consultations', 'palliative care consultations']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0554244', 'cui_str': 'Maker'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]",350.0,0.0372397,"The MSQ can be used as a tool to identify the risk of mortality, facilitate palliative care delivered by the primary team, and improve end-of-life care.","[{'ForeName': 'Shilpee', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': ''}, {'ForeName': 'Kavitha', 'Initials': 'K', 'LastName': 'Subramoney', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fraser', 'Affiliation': ''}, {'ForeName': 'Joycelyn', 'Initials': 'J', 'LastName': 'Howard', 'Affiliation': ''}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Sadowski', 'Affiliation': ''}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Azar', 'Affiliation': ''}, {'ForeName': 'Areeba', 'Initials': 'A', 'LastName': 'Kara', 'Affiliation': ''}]",Joint Commission journal on quality and patient safety,['10.1016/j.jcjq.2020.11.013']
165,33459181,Differential effects of bile acids on the postprandial secretion of gut hormones: a randomized crossover study.,"Bile acids (BA) regulate postprandial metabolism directly and indirectly by affecting the secretion of gut hormones like glucagon-like peptide-1 (GLP-1). The postprandial effects of BA on the secretion of other metabolically active hormones are not well understood. The objective of this study was to investigate the effects of oral ursodeoxycholic acid (UDCA) and chenodeoxycholic acid (CDCA) on postprandial secretion of GLP-1, oxyntomodulin (OXM), peptide YY (PYY), glucose-dependent insulinotropic peptide (GIP), glucagon, and ghrelin. Twelve healthy volunteers underwent a mixed meal test 60 min after ingestion of UDCA (12-16 mg/kg), CDCA (13-16 mg/kg), or no BA in a randomized crossover study. Glucose, insulin, GLP-1, OXM, PYY, GIP, glucagon, ghrelin, and fibroblast growth factor 19 were measured prior to BA administration at -60 and 0 min (just prior to mixed meal) and 15, 30, 60, 120, 180, and 240 min after the meal. UDCA and CDCA provoked differential gut hormone responses; UDCA did not have any significant effects, but CDCA provoked significant increases in GLP-1 and OXM and a profound reduction in GIP. CDCA increased fasting GLP-1 and OXM secretion in parallel with an increase in insulin. On the other hand, CDCA reduced postprandial secretion of GIP, with an associated reduction in postprandial insulin secretion. Exogenous CDCA can exert multiple salutary effects on the secretion of gut hormones; if these effects are confirmed in obesity and type 2 diabetes, CDCA may be a potential therapy for these conditions. NEW & NOTEWORTHY  Oral CDCA and UDCA have different effects on gut and pancreatic hormone secretion. A single dose of CDCA increased fasting secretion of the hormones GLP-1 and OXM with an accompanying increase in insulin secretion. CDCA also reduced postprandial GIP secretion, which was associated with reduced insulin. In contrast, UDCA did not change gut hormone secretion fasting or postprandially. Oral CDCA could be beneficial to patients with obesity and diabetes.",2021,"UDCA did not have any significant effects, but CDCA provoked significant increases in GLP-1 and OXM and a profound reduction in GIP.",['Twelve healthy volunteers'],"['oral ursodeoxycholic acid (UDCA) and chenodeoxycholic acid (CDCA', 'UDCA', 'Exogenous CDCA', 'CDCA', 'mixed meal test 60 minutes after ingestion of UDCA', 'CDCA (13-16 mg/kg) or no BA']","['GLP-1 and OXM', 'post-prandial secretion of GLP-1, oxyntomodulin (OXM), peptide YY (PYY), glucose-dependent insulinotropic peptide (GIP), glucagon and ghrelin', 'fasting GLP-1 and OXM secretion', 'UDCA and CDCA provoked differential gut hormone responses', 'Glucose, insulin, GLP-1, OXM, PYY, GIP, glucagon, ghrelin and fibroblast growth factor 19']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0008024', 'cui_str': 'chenodeoxycholic acid'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0086379', 'cui_str': 'Glicentin (33-69)'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0008024', 'cui_str': 'chenodeoxycholic acid'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1431711', 'cui_str': 'FGF19 protein, human'}]",12.0,0.0294342,"UDCA did not have any significant effects, but CDCA provoked significant increases in GLP-1 and OXM and a profound reduction in GIP.","[{'ForeName': 'Emma Rose', 'Initials': 'ER', 'LastName': 'McGlone', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Khalefah', 'Initials': 'K', 'LastName': 'Malallah', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Joyceline', 'Initials': 'J', 'LastName': 'Cuenco', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences and the NNF Center for Basic Metabolic Research, The Panum Institute, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Royce P', 'Initials': 'RP', 'LastName': 'Vincent', 'Affiliation': ""Department of Clinical Biochemistry, King's College Hospital NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Ling', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Omar A', 'Initials': 'OA', 'LastName': 'Khan', 'Affiliation': ""Department of Surgery, St. George's University Hospitals NHS Trust, London, United Kingdom.""}, {'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Leadiant Biosciences, Amberley House, Windsor, Berkshire, United Kingdom.'}, {'ForeName': 'Ahmed R', 'Initials': 'AR', 'LastName': 'Ahmed', 'Affiliation': 'Department of Surgery and Cancer, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Julian R F', 'Initials': 'JRF', 'LastName': 'Walters', 'Affiliation': 'Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Khoo', 'Affiliation': 'Endocrinology, UCL Division of Medicine, Royal Free Hospital, London, United Kingdom.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Bloom', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Tricia M M', 'Initials': 'TMM', 'LastName': 'Tan', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00580.2020']
166,33515786,Improving care coordination for patients with cardiac disease: Study protocol of the randomised controlled new healthcare programme (Cardiolotse).,"INTRODUCTION


A lack of effective coordination and communication between ambulatory care physicians and hospitals, including the lack of follow-up care, poses a challenge to the recovery process of patients suffering from cardiac disease, often resulting in rehospitalisation and adverse outcomes. This innovative care programme aims to bridge the gap between ambulatory and hospital care. A key element of this programme is specifically trained care managers (Cardiolotse) who provide post-discharge support, access to additional resources and help the patient to navigate successfully through the healthcare system.
MATERIAL AND METHODS


The study is set up as a prospective, randomised, controlled trial. Allocation to intervention group (support of care managers) and control group (usual care) follows an allocation ratio of 1:1 using block randomisation. Sample size calculations resulted in 1454patients per group after adjusting for potential non-compliance. All participants are surveyed at discharge, after 3 and 12 months. The primary outcome of the study is the 12-month rehospitalisation rate. Secondary outcomes include differences in length of hospital stay, mortality, quality-adjusted life years, costs and patient satisfaction. Statistical analysis and economic evaluation will be complemented by a process evaluation.
DISCUSSION


The new healthcare programme is designed to support patients when leaving hospital with cardiac conditions by easing the transition between sectors through access to Cardiolotses and individualised care plans. We hypothesise that the programme reduces rehospitalisation and improves clinically relevant patient outcomes.
TRIAL REGISTRATION


German Clinical Trial Register, DRKS00020424. Registered 2020-06-18, http://www.drks.de/DRKS00020424.",2021,Allocation to intervention group (support of care managers) and control group (usual care) follows an allocation ratio of 1:1 using block randomisation.,"['patients with cardiac disease', 'patients suffering from cardiac disease']",[],"['12-month rehospitalisation rate', 'length of hospital stay, mortality, quality-adjusted life years, costs and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}]",[],"[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",,0.137016,Allocation to intervention group (support of care managers) and control group (usual care) follows an allocation ratio of 1:1 using block randomisation.,"[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Geiger', 'Affiliation': 'LMU Munich, Department of Health Services Management, Schackstraße 4, 80539 Munich, Germany. Electronic address: geiger@bwl.lmu.de.'}, {'ForeName': 'Katrin C', 'Initials': 'KC', 'LastName': 'Reber', 'Affiliation': 'AOK - Die Gesundheitskasse, Health Services Management, Wilhelmstr. 1, 10963 Berlin, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Darius', 'Affiliation': 'Vivantes - Netzwerk für Gesundheit GmbH, Aroser Allee 72-76, 13407 Berlin, Germany.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Holzgreve', 'Affiliation': 'Vivantes - Netzwerk für Gesundheit GmbH, Aroser Allee 72-76, 13407 Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Karmann', 'Affiliation': 'Vivantes - Netzwerk für Gesundheit GmbH, Aroser Allee 72-76, 13407 Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Liersch', 'Affiliation': 'AOK - Die Gesundheitskasse, Health Services Management, Wilhelmstr. 1, 10963 Berlin, Germany.'}, {'ForeName': 'Anica', 'Initials': 'A', 'LastName': 'Stürtz', 'Affiliation': 'AOK - Die Gesundheitskasse, Health Services Management, Wilhelmstr. 1, 10963 Berlin, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Riesner', 'Affiliation': 'AOK - Die Gesundheitskasse, Health Services Management, Wilhelmstr. 1, 10963 Berlin, Germany.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Sundmacher', 'Affiliation': 'Chair of Health Economics, Technical University of Munich, Georg-Brauchle-Ring 60/62, 80992, Germany.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106297']
167,33464760,"Comparison of the Analgesic Duration of 0.5% Bupivacaine With 1:200,000 Epinephrine Versus 0.5% Ropivacaine Versus 1% Ropivacaine for Low-Volume Ultrasound-Guided Interscalene Brachial Plexus Block: A Randomized Controlled Trial.","BACKGROUND


Bupivacaine and ropivacaine are the preferred long-acting local anesthetics for peripheral nerve blocks as they provide prolonged analgesia in the postoperative period. No studies have directly compared the analgesic duration of these commonly used local anesthetics in the setting of low-volume ultrasound-guided interscalene block (US-ISB). This study was designed to determine which local anesthetic and concentration provides superior analgesia (duration and quality) for low-volume US-ISB.
METHODS


Sixty eligible patients scheduled for arthroscopic shoulder surgery were randomized (1:1:1) to receive US-ISB (5 mL) with 0.5% bupivacaine with 1:200,000 epinephrine, 0.5% ropivacaine, or 1% ropivacaine. All individuals were blinded including study participants, anesthesiologists, surgeons, research personnel, and statistician. All participants received a standardized general anesthetic and multimodal analgesia. The primary outcome was duration of analgesia defined as the time from the end of injection to the time that the patients reported a significant increase in pain (>3 numeric rating scale [NRS]) at the surgical site.
RESULTS


The mean duration of analgesia for 0.5% bupivacaine with 1:200,000 epinephrine, 0.5% ropivacaine, or 1% ropivacaine was 14.1 ± 7.4, 13.8 ± 4.5, and 15.8 ± 6.3 hours, respectively (analysis of variance [ANOVA], P = .51). There were no observed differences in analgesic duration or other secondary outcomes between the 3 groups with the exception of a difference in cumulative opioid consumption up to 20h00 on the day of surgery in favor of ropivacaine 0.5% over bupivacaine of minimal clinical significance.
CONCLUSIONS


In the context of single-injection low-volume US-ISB, we have demonstrated a similar efficacy between equal concentrations of ropivacaine and bupivacaine. In addition, increasing the concentration of ropivacaine from 0.5% to 1% did not prolong the duration of US-ISB.",2021,"The mean duration of analgesia for 0.5% bupivacaine with 1:200,000 epinephrine, 0.5% ropivacaine, or 1% ropivacaine was 14.1 ± 7.4, 13.8 ± 4.5, and 15.8 ± 6.3 hours, respectively (analysis of variance [ANOVA], P = .51).","['Low-Volume Ultrasound-Guided Interscalene Brachial Plexus Block', 'Sixty eligible patients scheduled for arthroscopic shoulder surgery']","['bupivacaine with 1:200,000 epinephrine, 0.5% ropivacaine, or 1% ropivacaine', 'Bupivacaine With 1:200,000 Epinephrine Versus 0.5% Ropivacaine', 'bupivacaine', 'US-ISB', 'epinephrine', 'ropivacaine', 'standardized general anesthetic and multimodal analgesia', 'Ropivacaine', 'Bupivacaine']","['analgesic duration', 'duration of analgesia defined as the time from the end of injection to the time', 'duration of US-ISB', 'mean duration of analgesia', 'pain (>3 numeric rating scale [NRS', 'cumulative opioid consumption']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",60.0,0.158057,"The mean duration of analgesia for 0.5% bupivacaine with 1:200,000 epinephrine, 0.5% ropivacaine, or 1% ropivacaine was 14.1 ± 7.4, 13.8 ± 4.5, and 15.8 ± 6.3 hours, respectively (analysis of variance [ANOVA], P = .51).","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Safa', 'Affiliation': 'From the Department of Anesthesia, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Flynn', 'Affiliation': 'From the Department of Anesthesia, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'McHardy', 'Affiliation': 'From the Department of Anesthesia, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Department of Research Design and Biostatistics, Institute for Clinical and Evaluative Sciences, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Haslam', 'Affiliation': 'From the Department of Anesthesia, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Henry', 'Affiliation': 'Division of Orthopedic Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Kaustov', 'Affiliation': 'From the Department of Anesthesia, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'From the Department of Anesthesia, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005373']
168,33496955,Stapler-less burst pressure in an ex vivo human gastric tissue: a randomized controlled trial.,"Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable cost-effective alternative procedure. However, no pre-clinical data are currently available on human tissue. We aimed to evaluate whether traditionally suturing without the use of surgical stapling may produce a comparable bursting pressure on human gastric tissue. A prospective cohort of consecutive patients undergoing LSG was divided in two groups to compare a barbed extra-mucosal running suture (stapler-less) versus a standard stapler line. A burst pressure test was applied to the gastric specimen employing high-resolution manometric catheter. Type, location and features of the leak were described. We enrolled a total of 40 obese patients, 20 patients for each group. Median burst pressures of the stapler-less group resulted statistically significant increased (p < 0.0001) than the one in standard stapler group. In all cases, leak occurred along the surgical closure site independently from the used technique (group 1 vs 2; p = N.S.), more often at the proximal stomach (p < 0.05). In human ex vivo model, traditional surgical suture (i.e. running hand-sewn) produced an effective temporary closure, with superior resistance to increasing volume and pressure. How this may impact on clinical LSG outcomes needs further evaluations and was not the object of this study.",2021,Median burst pressures of the stapler-less group resulted statistically significant increased (p < 0.0001) than the one in standard stapler group.,"['40 obese patients, 20 patients for each group', 'consecutive patients undergoing']","['surgical stapling', 'Stapler-less laparoscopic sleeve gastrectomy (LSG', 'barbed extra-mucosal running suture (stapler-less) versus a standard stapler line', 'Stapler-less burst pressure', 'LSG']","['Median burst pressures', 'leak']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0206263', 'cui_str': 'Surgical stapling'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}]",40.0,0.0278734,Median burst pressures of the stapler-less group resulted statistically significant increased (p < 0.0001) than the one in standard stapler group.,"[{'ForeName': 'Gianmattia', 'Initials': 'G', 'LastName': 'Del Genio', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gambardella', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy. claudiog86@hotmail.it.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Tolone', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Brusciano', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Parmeggiani', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}, {'ForeName': 'Mariachiara', 'Initials': 'M', 'LastName': 'Lanza Volpe', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}, {'ForeName': 'Francesco Saverio', 'Initials': 'FS', 'LastName': 'Lucido', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Docimo', 'Affiliation': 'Division of General, Mininvasive and Bariatric Surgery, University of Campania ""Luigi Vanvitelli"", Via Pansini 5, 80100, Naples, Italy.'}]",Updates in surgery,['10.1007/s13304-021-00975-y']
169,33497912,Longitudinal impact and effects of booster sessions in a cognitive training program for healthy older adults.,"This paper reports the results from a 3-year follow-up study to measure the long-term efficacy of a cognitive training for healthy older adults and investigates the effects of booster sessions using an entropy-based metric.
DESIGN


semi-randomized quasi-experimental controlled design.
PARTICIPANTS


50 older adults, (M = 73.3, SD = 7.77) assigned into experimental (N = 25; Mean age = 73.9; SD = 8.62) and control groups (N = 25; mean age = 72.9; SD = 6.97).
INSTRUMENTS


six subtests of WAIS and two episodic memory tasks.
PROCEDURES


the participants were assessed on four occasions: after the end of the original intervention, pre-booster sessions (three years after the original intervention), immediately after the booster sessions and three months after the booster sessions.
RESULTS


the repeated measures ANOVA showed that two of the cognitive gains reported in the original intervention were also identified in the follow-up: Coding (F(1, 44) = 11.79, MSE = 0.77, p = .001, eta squared = 0.084) and Picture Completion (F(1, 47) = 10.01, MSE = 0.73, p = .003, eta squared = 0.060). After the booster sessions, all variables presented a significant interaction between group and time favorable to the experimental group (moderate to high effect sizes). To compare the level of cohesion of the cognitive variables between the groups, an entropy-based metric was used. The experimental group presented a lower level of cohesion on three of the four measurement occasions, suggesting a differential impact of the intervention with immediate and short-term effects, but without long-term effects.",2021,"Coding (F(1, 44) = 11.79, MSE = 0.77, p = .001, eta squared = 0.084) and Picture Completion (F(1, 47) = 10.01, MSE = ","['50 older adults, (M\xa0=\xa073.3, SD\xa0=\xa07.77) assigned into experimental (N\xa0', 'healthy older adults', '25; Mean age\xa0=\xa073.9; SD\xa0=\xa08.62) and control groups (N\xa0=\xa025; mean age\xa0']","['cognitive training', 'cognitive training program', 'booster sessions']",['cognitive gains'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]",[],50.0,0.0388754,"Coding (F(1, 44) = 11.79, MSE = 0.77, p = .001, eta squared = 0.084) and Picture Completion (F(1, 47) = 10.01, MSE = ","[{'ForeName': 'Lucas Matias', 'Initials': 'LM', 'LastName': 'Felix', 'Affiliation': 'Universidade Federal de Minas Gerais, Department of Psychology: 6627 Antonio Carlos avenue, Belo Horizonte, Minas Gerais, 31270-901, Brazil.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Mansur-Alves', 'Affiliation': 'Universidade Federal de Minas Gerais, Department of Psychology: 6627 Antonio Carlos avenue, Belo Horizonte, Minas Gerais, 31270-901, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Teles', 'Affiliation': 'University of Virginia, Deparment of Psychology: 485, McCormick Road, Gilmer Hall, Charlottesville, VA 22903, U.S.. Electronic address: mt2yq@virginia.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jamison', 'Affiliation': 'University of Virginia, Deparment of Psychology: 485, McCormick Road, Gilmer Hall, Charlottesville, VA 22903, U.S.'}, {'ForeName': 'Hudson', 'Initials': 'H', 'LastName': 'Golino', 'Affiliation': 'University of Virginia, Deparment of Psychology: 485, McCormick Road, Gilmer Hall, Charlottesville, VA 22903, U.S.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2021.104337']
170,33515781,Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients.,"BACKGROUND


Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence. We describe a multifaceted, evidence-based, medication adherence monitoring strategy ('TAKE IT') that leverages available transplant center resources to identify potential medication non-adherence and other concerns earlier to prevent complications that could result from inadequate IS adherence.
METHODS


The TAKE IT strategy includes: 1) medication adherence mobile application; 2) routine, online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators; 4) quarterly adherence reports to monitor IS values and summarize adherence trends; 5) deployment of adherence support tools tailored to specific adherence concerns. To test the TAKE IT intervention, we will conduct a two-arm, patient-randomized controlled trial at two large, diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n = 225 per site) within 2 years of transplantation and 2 years of follow-up. Study assessments will take place at baseline, 6 weeks, 6, 12, 18 and 24 months. The primary effectiveness outcome is medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes. Process outcomes and cost-effectiveness will also be examined.
CONCLUSION


The TAKE IT trial presents an innovative approach to monitoring and optimizing medication adherence among a population taking complex medication regimens. This trial seeks to evaluate the effectiveness and feasibility of this strategy compared to usual care.",2021,"BACKGROUND


Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence.","['kidney transplant recipients (KTRs', 'transplant recipients', 'kidney recipients', 'diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n\u202f=\u202f225 per site) within 2\u202fyears of transplantation and 2\u202fyears of follow-up']",['online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators'],"['cost-effectiveness', 'medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0376387', 'cui_str': 'Recipient, Transplant'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.106032,"BACKGROUND


Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Serper', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States of America; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States of America. Electronic address: marinas2@pennmedicine.upenn.edu.'}, {'ForeName': 'Daniela P', 'Initials': 'DP', 'LastName': 'Ladner', 'Affiliation': 'Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America; Division of Organ Transplantation, Department of Surgery, Northwestern Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Curtis', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Sumi S', 'Initials': 'SS', 'LastName': 'Nair', 'Affiliation': 'Mayo Clinic Arizona Transplant Center, Mayo Clinic, Phoenix, AZ, United States of America.'}, {'ForeName': 'Scott I', 'Initials': 'SI', 'LastName': 'Hur', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States of America.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Ho', 'Affiliation': 'Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America; Division of Organ Transplantation, Division of Nephrology/Hypertension Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Friedewald', 'Affiliation': 'Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America; Division of Organ Transplantation, Division of Nephrology/Hypertension Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Reese', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States of America; Department of Biostatistics, Epidemiology & Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America; Renal-Electrolyte and Hypertension Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States of America.'}, {'ForeName': 'Michael M I', 'Initials': 'MMI', 'LastName': 'Abecassis', 'Affiliation': 'Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Wolf', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106294']
171,33515415,The Kinetics of an Antibiotic Stewardship Intervention: A Quasi-Experimental Study.,"INTRODUCTION


Little is known about the kinetics and different phases of a successful antibiotic stewardship program (ASP) intervention.
METHODS


We analyzed the trends of quarterly antibiotic use measured in defined daily dose (DDD)/100 days hospitalization using the Joinpoint Regression Program and interrupted time series analysis to objectively identify shifts in the trends of antibiotic use. We correlated these changes in trends with the introduction of a hospital-wide ASP intervention.
RESULTS


The ASP intervention reduced the overall antibiotic use by 33%, from a prior steady state of 76.5 DDD/100 days hospitalization to a post-intervention steady state of 51.2 DDD/100 days hospitalization (p < 0.001). We identified four distinct phases in the trends: prior steady state (A), early intervention (B), accelerated phase (C), and post steady state (D). From A to B a change of slope (-1.46) [SE 0.37, 95% CI -2.23, -0.69 (p = 0.002)]; B to C, a further decrease of slope (-4.70) [SE 0.64, 95% CI -6.03, -3.37 (p = 0.001)]; between periods C and D, straightening out of the slope (+ 6.84) [SE 0.55, 95% CI 5.70, 7.98 (p < 0.001)] to a new post-intervention steady state. It took 1.5 years after completion of the intervention to reach the new steady state.
CONCLUSIONS


We demonstrate that ASP interventions require time to achieve the maximal effect. Successful interventions require physicians to adapt new prescribing behaviors and gain confidence in the change; this adaptation can be a prolonged process and might even take years after the introduction of the ASP. These factors should be considered when planning and implementing ASP interventions.",2021,"From A to B a change of slope (-1.46) [SE 0.37, 95% CI -2.23, -0.69 (p = 0.002)]; B to C, a further decrease of slope (-4.70) [SE 0.64, 95% CI -6.03, -3.37 (p = 0.001)]; between periods C and D, straightening out of the slope (+ 6.84) [SE 0.55, 95% CI 5.70, 7.98 (p < 0.001)] to a new post-intervention steady state.",[],"['ASP intervention', 'Antibiotic Stewardship Intervention']",['overall antibiotic use'],[],"[{'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0165919,"From A to B a change of slope (-1.46) [SE 0.37, 95% CI -2.23, -0.69 (p = 0.002)]; B to C, a further decrease of slope (-4.70) [SE 0.64, 95% CI -6.03, -3.37 (p = 0.001)]; between periods C and D, straightening out of the slope (+ 6.84) [SE 0.55, 95% CI 5.70, 7.98 (p < 0.001)] to a new post-intervention steady state.","[{'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Shafat', 'Affiliation': 'Infectious Disease Institute, Soroka University Medical Center, Beer Sheba, Israel.'}, {'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Shimoni', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheba, Israel.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nikonov', 'Affiliation': 'Pharmacy Services, Soroka University Medical Center, Beer Sheba, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Nesher', 'Affiliation': 'Infectious Disease Institute, Soroka University Medical Center, Beer Sheba, Israel. nesherke@bgu.ac.il.'}]",Infectious diseases and therapy,['10.1007/s40121-021-00403-z']
172,33476774,"The primary care assessment and research of a telephone intervention for neuropsychiatric conditions with education and resources study: Design, rationale, and sample of the PARTNERs randomized controlled trial.","While most patients with depression, anxiety, or at-risk drinking receive care exclusively in primary care settings, primary care providers experience challenges in diagnosing and treating these common problems. Over the past two decades, the collaborative care model has addressed these challenges. However, this model has been adopted very slowly due to the high costs of care managers; inability to sustain their role in small practices; and the perceived lack of relevance of interventions focused on a specific psychiatric diagnosis. Thus, we designed an innovative randomized clinical trial (RCT), the Primary Care Assessment and Research of a Telephone Intervention for Neuropsychiatric Conditions with Education and Resources study (PARTNERs). This RCT compared the outcomes of enhanced usual care and a novel model of collaborative care in primary care patients with depressive disorders, generalized anxiety, social phobia, panic disorder, at-risk drinking, or alcohol use disorders. These conditions were selected because they are present in almost a third of patients seen in primary care settings. Innovations included assigning the care manager role to trained lay providers supported by computer-based tools; providing all care management centrally by phone - i.e., the intervention was delivered without any face-to-face contact between the patient and the care team; and basing patient eligibility and treatment selection on a transdiagnostic approach using the same eligibility criteria and the same treatment algorithms regardless of the participants' specific psychiatric diagnosis. This paper describes the design of this RCT and discusses the rationale for its main design features.",2021,"This RCT compared the outcomes of enhanced usual care and a novel model of collaborative care in primary care patients with depressive disorders, generalized anxiety, social phobia, panic disorder, at-risk drinking, or alcohol use disorders.","['primary care patients with depressive disorders, generalized anxiety, social phobia, panic disorder, at-risk drinking, or alcohol use disorders', 'neuropsychiatric conditions with education and resources']","['telephone intervention', 'Telephone Intervention']",[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0251913,"This RCT compared the outcomes of enhanced usual care and a novel model of collaborative care in primary care patients with depressive disorders, generalized anxiety, social phobia, panic disorder, at-risk drinking, or alcohol use disorders.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Rodie', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Fitzgibbon', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Perivolaris', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Crawford', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Geist', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Levinson', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mitchell', 'Affiliation': 'Group Health Centre, Sault Ste. Marie, ON, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Oslin', 'Affiliation': 'University of Pennsylvania and the Department of Veteran Affairs, Philadelphia, PA, United States of America.'}, {'ForeName': 'Nadiya', 'Initials': 'N', 'LastName': 'Sunderji', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Waypoint Centre for Mental Health Care, Penetanguishene, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Electronic address: benoit.mulsant@utoronto.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2021.106284']
173,33479452,Reduced metabolic efficiency in sedentary eucaloric conditions predicts greater weight regain in adults with obesity following sustained weight loss.,"BACKGROUND


Successful long-term weight loss maintenance after caloric restriction (CR) is rarely achieved. Besides known metabolic, behavioural, and cognitive factors, 24-hour energy expenditure (24hEE) relative to body size (i.e., metabolic efficiency) might influence subsequent weight loss maintenance.
METHODS


Eleven participants with obesity (BMI = 39.0 ± 8.7 kg/m 2 , body fat = 36.1 ± 6.4%) had 24hEE measured in a whole-room indirect calorimeter during eucaloric conditions and weight stability prior to starting a 6-week inpatient CR study (50% of daily energy needs). Twenty-four-hour energy expenditure was adjusted via regression analysis for fat free mass (FFM) and fat mass (FM) by DXA. Body composition was reassessed at the end of CR and after 1-year follow-up. Free-living weight was assessed by monthly weight measurements during 12 months.
RESULTS


After 6-week CR, participants lost 8.5 ± 2.7% weight (FFM: -6.3 ± 3.6 kg, FM: -3.4 ± 1.2 kg) but regained 5.1 ± 8.0% 1 year following CR, which was mostly due to FFM regain (+5.7 ± 5.5 kg) and unchanged FM. A relatively higher 24hEE by 100 kcal/day prior to CR was associated with an average greater rate of weight regain by +0.3 kg/month during follow-up and a greater final weight regain by +5.1 kg after 1 year of follow-up.
CONCLUSION


These results suggest that reduced metabolic efficiency in 24hEE during eucaloric, sedentary conditions may predict greater weight regain after CR-induced weight loss.",2021,"A relatively higher 24hEE by 100 kcal/day prior to CR was associated with an average greater rate of weight regain by +0.3 kg/month during follow-up and a greater final weight regain by +5.1 kg after 1 year of follow-up.
","['Eleven participants with obesity (BMI\u2009=\u200939.0\u2009±\u20098.7\u2009kg/m 2 , body fat\u2009=\u200936.1\u2009±\u20096.4%) had 24hEE measured in a whole-room indirect calorimeter during eucaloric conditions and weight stability prior to starting a 6-week inpatient CR study (50% of daily energy needs', 'adults with obesity following sustained weight loss']",[],"['weight regain', 'Free-living weight', 'final weight regain', 'Body composition', 'metabolic efficiency', 'FFM regain']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}]",11.0,0.0798656,"A relatively higher 24hEE by 100 kcal/day prior to CR was associated with an average greater rate of weight regain by +0.3 kg/month during follow-up and a greater final weight regain by +5.1 kg after 1 year of follow-up.
","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hollstein', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Heinitz', 'Affiliation': 'Department of Internal Medicine, Clinic for Endocrinology and Nephrology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Basolo', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Krakoff', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Susanne B', 'Initials': 'SB', 'LastName': 'Votruba', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Piaggi', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA. paolo.piaggi@nih.gov.'}]",International journal of obesity (2005),['10.1038/s41366-021-00748-y']
174,33497537,Comparative effects of valsartan plus cilnidipine or hydrochlorothiazide on nocturnal home blood pressure.,"We tested our hypothesis that, in hypertensive patients with higher nocturnal home systolic blood pressure (HSBP) at baseline, a valsartan/cilnidipine (80/10 mg) combination would reduce nocturnal HSBP more markedly than a valsartan/hydrochlorothiazide (80/12.5 mg) combination. Patients measured their nocturnal HSBP over three nights prior to study randomization and at the end of treatment. Sixty-three and 66 patients comprised the valsartan/cilnidipine and valsartan/hydrochlorothiazide groups; their respective baseline nocturnal HSBP values were 124.3 ± 15.6 and 125.8 ± 15.2 mm Hg (P = .597). Nocturnal HSBPs were significantly reduced from baseline in both groups. Although the valsartan/hydrochlorothiazide group exhibited a significantly greater reduction in nocturnal HSBP compared to the valsartan/cilnidipine group (-5.0 vs. -10.0 mm Hg, P = .035), interaction between the treatment groups and the baseline nocturnal HSBP levels for the changes in nocturnal HSBP after the treatment periods was significant (P = .047). The BP-lowering effect of valsartan/cilnidipine was more dependent on baseline nocturnal HSBP than that of valsartan/hydrochlorothiazide.",2021,Nocturnal HSBPs were significantly reduced from baseline in both groups.,"['groups; their respective baseline nocturnal HSBP values were 124.3\xa0±\xa015.6 and 125.8\xa0±', 'Sixty-three and 66 patients comprised the', 'hypertensive patients with higher nocturnal home systolic blood pressure (HSBP) at baseline, a']","['valsartan/hydrochlorothiazide', 'valsartan plus cilnidipine or hydrochlorothiazide', 'valsartan/cilnidipine and valsartan/hydrochlorothiazide', 'valsartan/cilnidipine']","['nocturnal home blood pressure', 'baseline nocturnal HSBP levels', 'Nocturnal HSBPs', 'nocturnal HSBP', 'baseline nocturnal HSBP']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0378675', 'cui_str': 'cilnidipine'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0211567,Nocturnal HSBPs were significantly reduced from baseline in both groups.,"[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hoshide', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Tomitani', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kanegae', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.14199']
175,33497834,Delayed vs. Early Appendectomy (DELAY) trial for adult patients with acute appendicitis: Study protocol for a randomized controlled trial.,"INTRODUCTION


Early appendectomy in patients diagnosed with acute appendicitis is the current standard of treatment in North America. Timely intervention is suggested to avoid the complications associated with perforated appendicitis; however, safety of nighttime operating is a competing concern, with mixed results demonstrated thus far.
OBJECTIVES


This multi-center prospective randomized controlled trial aims to assess whether delaying appendectomy until the following morning versus early appendectomy overnight affects the rate of surgical complications in adult patients diagnosed with acute appendicitis in the evening hours.
METHODS


This is a randomized, controlled trial across two academic institutions with blinded outcome assessors. Patients presenting with imaging-confirmed appendicitis with an expected appendectomy between 8 pm and 4 am and within 6 h of decision to operate will be randomized to early appendectomy (with 6 h of randomization, control arm) or delayed to the following morning (after 6 am, intervention arm). Primary outcome will be 30 day postoperative complications, defined as a composite of: mortality, readmission to hospital, emergency department visit, percutaneous drain insertion, reoperation, prolonged hospital stay (>7 days), and postoperative complications. Secondary outcome measures are operative time, length of stay, time to emergency department visit and compliance to treatment.
DISCUSSION


This is a feasible and pragmatic clinical trial, intended to provide evidence for challenging decision making for the most common surgical disease worldwide. Results of this study will aid surgeons and health care administrators on how to appropriately triage appendectomies for patients with acute appendicitis who present overnight.",2021,"This is a feasible and pragmatic clinical trial, intended to provide evidence for challenging decision making for the most common surgical disease worldwide.","['adult patients with acute appendicitis', 'patients with acute appendicitis who present overnight', 'patients diagnosed with acute appendicitis', 'adult patients diagnosed with acute appendicitis in the evening hours', 'Patients presenting with imaging-confirmed appendicitis']",[],"['rate of surgical complications', '30\u202fday postoperative complications, defined as a composite of: mortality, readmission to hospital, emergency department visit, percutaneous drain insertion, reoperation, prolonged hospital stay (>7\u202fdays), and postoperative complications', 'operative time, length of stay, time to emergency department visit and compliance to treatment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]",[],"[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.200542,"This is a feasible and pragmatic clinical trial, intended to provide evidence for challenging decision making for the most common surgical disease worldwide.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Surgery, Queen's University, Victory 3, Kingston General Hospital, 76 Stuart Street, Kingston, Ontario K7L 2V7, Canada. Electronic address: lisa.zhang@queensu.ca.""}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Lemke', 'Affiliation': 'Department of Surgery, Western University, 339 Windermere Road, London, Ontario N6A 5A5, Canada. Electronic address: mlemke@uwo.ca.'}, {'ForeName': 'Zuhaib M', 'Initials': 'ZM', 'LastName': 'Mir', 'Affiliation': ""Department of Surgery, Queen's University, Victory 3, Kingston General Hospital, 76 Stuart Street, Kingston, Ontario K7L 2V7, Canada. Electronic address: zuhaib.mir@queensu.ca.""}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Patel', 'Affiliation': ""Department of Surgery, Queen's University, Victory 3, Kingston General Hospital, 76 Stuart Street, Kingston, Ontario K7L 2V7, Canada. Electronic address: sunil.patel@kingstonhsc.ca.""}]",Contemporary clinical trials,['10.1016/j.cct.2021.106288']
176,33497833,"Behavioral cancer pain intervention using videoconferencing and a mobile application for medically underserved patients: Rationale, design, and methods of a prospective multisite randomized controlled trial.","BACKGROUND


Women with breast cancer in medically underserved areas are particularly vulnerable to persistent pain and disability. Behavioral pain interventions reduce pain and improve outcomes. Cancer patients in medically underserved areas receive limited adjunctive cancer care, as many lack access to pain therapists trained in behavioral interventions, face travel barriers to regional medical centers, and may have low literacy and limited resources. mHealth technologies have the potential to decrease barriers but must be carefully adapted for, and efficacy-tested with, medically underserved patients. We developed an mHealth behavioral pain coping skills training intervention (mPCST-Community). We now utilize a multisite randomized controlled trial to: 1) test the extent mPCST-Community reduces breast cancer patients' pain severity (primary outcome), pain interference, fatigue, physical disability, and psychological distress; 2) examine potential mediators of intervention effects; and 3) evaluate the intervention's cost and cost-effectiveness.
METHODS/DESIGN


Breast cancer patients (N = 180) will be randomized to mPCST-Community or an attention control. mPCST-Community's four-session protocol will be delivered via videoconferencing at an underserved community clinic by a remote pain therapist at a major medical center. Videoconference sessions will be supplemented with a mobile application. Participants will complete self-report measures at baseline, post-intervention, and 3- and 6-month follow-ups.
CONCLUSIONS


mPCST-Community has the potential to reduce pain and disability, and decrease barriers for cancer patients in medically underserved areas. This is one of the first trials to test an mHealth behavioral cancer pain intervention developed specifically for medically underserved communities. If successful, it could lead to widespread implementation and decreased health disparities.",2021,"CONCLUSIONS


mPCST-Community has the potential to reduce pain and disability, and decrease barriers for cancer patients in medically underserved areas.","['medically underserved patients', 'cancer patients in medically underserved areas', 'reduces breast cancer patients', 'Women with breast cancer in medically underserved areas', 'medically underserved communities', 'Cancer patients in medically underserved areas receive limited adjunctive cancer care', 'Breast cancer patients (N\u202f=\u202f180']","['Videoconference sessions', 'mHealth behavioral pain coping skills training intervention (mPCST-Community', 'mPCST-Community or an attention control', 'Behavioral pain interventions', 'Behavioral cancer pain intervention using videoconferencing and a mobile application', 'mHealth behavioral cancer pain intervention', 'mPCST-Community']","[""intervention's cost and cost-effectiveness"", 'pain severity (primary outcome), pain interference, fatigue, physical disability, and psychological distress', 'pain and disability']","[{'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025112', 'cui_str': 'Area, Medically Underserved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",180.0,0.108694,"CONCLUSIONS


mPCST-Community has the potential to reduce pain and disability, and decrease barriers for cancer patients in medically underserved areas.","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Kelleher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Winger', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Shelby D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Population Health Sciences, Duke University Medical Center, Durham, NC, USA; Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Beverly E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'The Department of Psychology, The University of Alabama, Tuscaloosa, AL, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Samsa', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA; Duke Cancer Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Majestic', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Shelby', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Sutton', 'Affiliation': 'Duke Cancer Network, Duke University, Durham, NC, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Somers', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA. Electronic address: tamara.somers@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106287']
177,33504932,"A short, attribution theory-based video intervention does not reduce weight bias in a nationally representative sample of registered dietitians: a randomized trial.","BACKGROUND/OBJECTIVES


Weight bias among registered dietitians (RDs) is a concern and effective interventions to reduce weight bias are sparse. Our objective was to determine if a short, attribution theory-based online video intervention would reduce weight bias in RDs.
SUBJECTS/METHODS


Dietitians from a nationally representative sample were recruited for a randomized, parallel-arm study with online surveys at pre-, post-intervention and 1-month follow-up. One hundred and forty-seven RDs who watched one of three videos embedded in an online survey from June to August 2019 were considered for the analysis. RDs were randomized to watch either the intervention, positive control, or negative control video. The primary outcome was the change in the ""blame"" component of the Anti-Fat Attitude Test (AFAT) from pre-to immediate post-intervention. Differences in changes in AFAT and Implicit Association Test (IAT) scores across treatment groups were assessed via linear models; multiple imputation were performed for missing data.
RESULTS


Baseline demographics, AFAT and IAT scores of the 147 participants who watched a video were not significantly different between the study groups (p > 0.05). The intervention group's AFAT-blame score reduced by an average of 0.05 between pre- and immediate post-intervention but was not statistically significant (p = 0.76, confidence intervals (CI) = -0.40, 0.30). Furthermore, there were no significant changes for AFAT-social, AFAT-physical subscores, and IAT within or between groups between pre- and immediate post-intervention (p > 0.05). Due to high attrition rates, the changes at 1-month follow-up are not reported.
CONCLUSIONS


This study was the first to explore the effectiveness of an online video intervention to reduce weight bias in RDs. This study was unable to detect a significant impact of a short, attribution theory-based video intervention on weight bias in practicing RDs and future larger studies are needed to confirm our findings.",2021,"Furthermore, there were no significant changes for AFAT-social, AFAT-physical subscores, and IAT within or between groups between pre- and immediate post-intervention (p > 0.05).","['Dietitians from a nationally representative sample', 'One hundred and forty-seven RDs who watched one of three videos embedded in an online survey from June to August 2019 were considered for the analysis']","['online video intervention', 'positive control, or negative control video', 'attribution theory-based video intervention']","['Baseline demographics, AFAT and IAT scores', 'weight bias', 'AFAT-social, AFAT-physical subscores, and IAT', 'change in the ""blame"" component of the Anti-Fat Attitude Test (AFAT', 'AFAT and Implicit Association Test (IAT) scores']","[{'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0431066', 'cui_str': 'Attitude testing'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.100387,"Furthermore, there were no significant changes for AFAT-social, AFAT-physical subscores, and IAT within or between groups between pre- and immediate post-intervention (p > 0.05).","[{'ForeName': 'Nadeeja N', 'Initials': 'NN', 'LastName': 'Wijayatunga', 'Affiliation': 'Department of Nutrition and Hospitality Management, University of Mississippi, Oxford, MS, USA.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Bailey', 'Affiliation': 'Well Done Nutrition, LLC, Morristown, NJ, USA.'}, {'ForeName': 'Seth S', 'Initials': 'SS', 'LastName': 'Klobodu', 'Affiliation': 'Department of Nutrition and Food Science, California State University, Chico, CA, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Dawson', 'Affiliation': 'Department of Nutritional Sciences, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Knight', 'Affiliation': 'Department of Nutritional Sciences, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Dhurandhar', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, 43011, USA. emily.dhurandhar@ttu.edu.'}]",International journal of obesity (2005),['10.1038/s41366-021-00740-6']
178,33507360,Re: Results of a randomized trial of treatment modalities in patients with low or early‑intermediate risk prostate cancer (PREFERE trial).,"The authors of this ""Letter to the Editors"" express their major concern about selective and biased reporting in this paper.",2021,"The authors of this ""Letter to the Editors"" express their major concern about selective and biased reporting in this paper.",['patients with low or early‑intermediate risk prostate cancer (PREFERE trial'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],,0.0287849,"The authors of this ""Letter to the Editors"" express their major concern about selective and biased reporting in this paper.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Boehle', 'Affiliation': 'Department of Urology, University of Luebeck, Ratzeburger Allee 160, Luebeck, 23562, Germany. boehle@urologie-bad-schwartau.de.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kahmann', 'Affiliation': 'MVZ Ihre Urologen GbR, Britzer Damm 63, 12347, Berlin, Germany.'}, {'ForeName': 'Thomas Oliver', 'Initials': 'TO', 'LastName': 'Henkel', 'Affiliation': 'MVZ Ihre Urologen GbR, Britzer Damm 63, 12347, Berlin, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Zimmermann', 'Affiliation': 'Praxiszentrum Alstertal, Heegbarg 2, 22391, Hamburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Machtens', 'Affiliation': 'Department of Urology, Marien-Krankenhaus, Dr.-Robert-Koch-Straße 18, 51465, Bergisch Gladbach, Germany.'}]",Journal of cancer research and clinical oncology,['10.1007/s00432-020-03499-x']
179,33515414,Safety of Dalbavancin in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Nephrotoxicity Rates Compared with Vancomycin: A Post Hoc Analysis of Three Clinical Trials.,"INTRODUCTION


Dalbavancin is a lipoglycopeptide antibiotic approved as a single- and two-dose regimen for adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive organisms. We present nephrotoxicity rates for patients with ABSSSI who received dalbavancin in three pivotal clinical trials and compare the rates with vancomycin.
METHODS


In a phase 3b clinical trial (DUR001-303), patients were randomized to dalbavancin single-dose (1500 mg intravenous [IV]) or two-dose regimen (1000 mg IV on day 1, 500 mg IV on day 8). In two phase 3 clinical trials (DISCOVER 1 and DISCOVER 2), patients were randomized to dalbavancin (two-dose regimen) or vancomycin 1 g (or 15 mg/kg) IV every 12 h for at least 3 days with an option to switch to orally administered linezolid 600 mg every 12 h for 10-14 days. Patients on dalbavancin with a creatinine clearance below 30 mL/min not on regular dialysis received a reduced dose of 1000 mg (single-dose arm) or 750 mg IV on day 1, 375 mg IV on day 8 (two-dose arm). Nephrotoxicity was defined as a 50% increase from baseline serum creatinine (SCr) or an absolute increase in SCr of 0.5 mg/dL at any time point. P values were obtained using the Cochran-Mantel-Haenszel test.
RESULTS


In dalbavancin-treated patients, rates of nephrotoxicity were low. The safety population with available creatinine values included 1325/1347 patients on any regimen of dalbavancin, and 54/651 patients who received vancomycin intravenously for at least 10 days and were not switched to orally administered linezolid. Patients on any regimen of dalbavancin had a lower rate of nephrotoxicity compared with patients receiving vancomycin intravenously for at least 10 days (3.7% vs 9.3%, respectively; P = 0.039).
CONCLUSIONS


Nephrotoxicity rates were lower in patients on dalbavancin relative to vancomycin for at least 10 days. On the basis of this experience, dalbavancin may be less nephrotoxic than intravenously administered vancomycin.",2021,"Patients on any regimen of dalbavancin had a lower rate of nephrotoxicity compared with patients receiving vancomycin intravenously for at least 10 days (3.7% vs 9.3%, respectively; P = 0.039).
","['adults with acute bacterial skin and skin structure infections (ABSSSI', 'patients with ABSSSI who received', '1325/1347 patients on any regimen of dalbavancin, and 54/651 patients who received']","['dalbavancin', 'linezolid', 'vancomycin', 'Dalbavancin', 'Vancomycin']","['Nephrotoxicity', 'baseline serum creatinine (SCr', 'rate of nephrotoxicity', 'Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Nephrotoxicity Rates', 'nephrotoxicity rates', 'rates of nephrotoxicity', 'Nephrotoxicity rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C4552483', 'cui_str': 'ABSSSI'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1172636', 'cui_str': 'dalbavancin'}]","[{'cui': 'C1172636', 'cui_str': 'dalbavancin'}, {'cui': 'C0663241', 'cui_str': 'linezolid'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}]",,0.0767393,"Patients on any regimen of dalbavancin had a lower rate of nephrotoxicity compared with patients receiving vancomycin intravenously for at least 10 days (3.7% vs 9.3%, respectively; P = 0.039).
","[{'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Gonzalez', 'Affiliation': 'AbbVie, Madison, NJ, USA. papitin@yahoo.com.'}, {'ForeName': 'Urania', 'Initials': 'U', 'LastName': 'Rappo', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mas Casullo', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Akinapelli', 'Affiliation': 'Independent Consultant, Hamden, CT, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'McGregor', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nowak', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Sailaja', 'Initials': 'S', 'LastName': 'Puttagunta', 'Affiliation': 'Iterum Therapeutics, Old Saybrook, CT, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Dunne', 'Affiliation': 'Iterum Therapeutics, Old Saybrook, CT, USA.'}]",Infectious diseases and therapy,['10.1007/s40121-021-00402-0']
180,33493954,Effects of light-to-moderate intensity aerobic exercise on objectively measured sleep parameters among community-dwelling older people.,"OBJECTIVES


Although exercise improves sleep parameters in older people, most studies have been designed for people with insomnia or sleep complaints. Little is known of the effects of exercise among older people without sleep problems. We investigated the effects of 3-month light-to-moderate intensity aerobic exercise intervention on objectively measured sleep quantity and quality among community-dwelling older people.
METHODS


Fifty-eight community-dwelling older people were assigned into an exercise (EX) or control (CON) groups, and 49 participants (65.7 ± 5.7 years. BMI 24.4 ± 3.9 kg/m 2 ) were enrolled in the analysis. EX group members attended 60 min/week group-based exercise program and performed ≥140 min of home-based exercise, at ≥50% of maximum heart rate to exceed 200 min of total exercise per week. Sleep was assessed by an accelerometer and the Pittsburgh Sleep Quality Index (PSQI) before and after intervention.
RESULTS


In the EX group, total sleep time, hours in waking after sleep onset, sleep efficiency and consecutive wake episodes ≥10 min (WE≥10 min) significantly improved (p<0.05). EX group showed a significantly greater reduction in WE≥10 min than the CON group (p<0.05). The subgroup analyses in the EX group according to baseline PSQI cutoff value showed no differences in changes between subgroups.
CONCLUSIONS


Three-month aerobic exercise improved objectively measured sleep quality in community-dwelling older people. Baseline sleep conditions did not significantly influence the magnitude of changes in sleep quality and quantity. These results suggest that light aerobic exercise can improve sleep among community-dwelling older people, regardless of baseline sleep status, but the effect may be small.",2021,EX group showed a significantly greater reduction in WE≥10 min than the CON group (p<0.05).,"['older people without sleep problems', 'older people', 'people with insomnia or sleep complaints', 'community-dwelling older people', 'Fifty-eight community-dwelling older people', 'groups, and 49 participants (65.7\xa0±\xa05.7 years']","['exercise (EX) or control (CON', 'light aerobic exercise', 'EX group members attended 60\xa0min/week group-based exercise program and performed ≥140\xa0min of home-based exercise, at ≥50% of maximum heart rate to exceed 200\xa0min of total exercise per week', 'light-to-moderate intensity aerobic exercise', 'light-to-moderate intensity aerobic exercise intervention', 'CON', 'aerobic exercise']","['sleep quality and quantity', 'Pittsburgh Sleep Quality Index (PSQI', 'Sleep', 'sleep quality', 'sleep parameters', 'sleep quantity and quality', 'total sleep time, hours in waking after sleep onset, sleep efficiency and consecutive wake episodes ≥10']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",,0.0335926,EX group showed a significantly greater reduction in WE≥10 min than the CON group (p<0.05).,"[{'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Miyazaki', 'Affiliation': 'Faculty of Human Sciences, Shimane University, 1060 Nishikawatsu, Matsue, Shimane 690-8504, Japan. Electronic address: miyazaki@hmn.shimane-u.ac.jp.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ayabe', 'Affiliation': 'Faculty of Computer Science and Systems Engineering, Okayama Prefectural University, 111 Kuboki, Soja, Okayama, 719-1197, Japan. Electronic address: ayabe@ss.oka-pu.ac.jp.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kumahara', 'Affiliation': 'Faculty of Nutritional Sciences, Nakamura Gakuen University, 5-7-1 Befu, Jounan-ku, Fukuoka 814-0198, Japan. Electronic address: kumahara@nakamura-u.ac.jp.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Morimura', 'Affiliation': 'Faculty of Education, Shujitsu University, 1-6-1 Nishigawara, Naka-ku, Okayama-shi, Okayama 703-8516, Japan. Electronic address: k_morimura@shujitsu.ac.jp.'}, {'ForeName': 'Yoshihide', 'Initials': 'Y', 'LastName': 'Inukai', 'Affiliation': 'Faculty of Computer Science and Systems Engineering, Okayama Prefectural University, 111 Kuboki, Soja, Okayama, 719-1197, Japan. Electronic address: Inukaiyoshihide@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104336']
181,33493833,Plasma syndecan-1 is associated with fluid requirements and clinical outcomes in emergency department patients with sepsis.,"BACKGROUND


Degradation of the endothelial glycocalyx is recognized as a major part of the pathophysiology of sepsis. Previous clinical studies, mostly conducted in intensive care settings, showed associations between glycocalyx shedding and clinical outcomes. We aimed to explore the association of plasma syndecan-1, a marker of glycocalyx degradation, with the subsequent fluid requirements and clinical outcomes of emergency department patients with sepsis.
METHODS


This was a post hoc analysis of a randomized trial of fluid resuscitation in the emergency department. The study was conducted in the emergency department of an urban 1500-bed tertiary care center. The data of 95 adults who were diagnosed with sepsis-induced hypoperfusion and had undergone baseline syndecan-1 measurement were included. The syndecan-1 levels at baseline (T0) and hour 6 (T6) were studied to characterize their association with clinical outcomes, including subsequent fluid administration, organ failure outcomes and mortality.
RESULTS


The median syndecan-1 levels at T0 and T6 were 207 (IQR 135-438) and 207 (IQR 128-490) ng/ml, respectively. Syndecan-1 levels at T0 were correlated with baseline sequential organ failure assessment (SOFA) score (ρ = 0.35, p < 0.001). Syndecan-1 levels at both T0 and T6 were correlated with subsequent fluid administration over 24 and 72 h and associated with the diagnosis of septic shock, the maximum dose of vasopressors and the need for renal replacement therapy (p < 0.05). Higher syndecan-1 levels at T6 were associated with higher 90-day mortality (p = 0.03).
CONCLUSIONS


In the emergency department, syndecan-1 levels were associated with fluid requirements, sepsis severity, organ dysfunction, and mortality.",2021,"Syndecan-1 levels at both T0 and T6 were correlated with subsequent fluid administration over 24 and 72 h and associated with the diagnosis of septic shock, the maximum dose of vasopressors and the need for renal replacement therapy (p < 0.05).","['95 adults who were diagnosed with sepsis-induced hypoperfusion and had undergone baseline syndecan-1 measurement were included', 'emergency department patients with sepsis', 'emergency department of an urban 1500-bed tertiary care center']",['fluid resuscitation'],"['baseline sequential organ failure assessment (SOFA) score', 'subsequent fluid administration, organ failure outcomes and mortality', 'Syndecan-1 levels', '90-day mortality', 'median syndecan-1 levels', 'fluid requirements, sepsis severity, organ dysfunction, and mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0442856', 'cui_str': 'Hypoperfusion'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",,0.219709,"Syndecan-1 levels at both T0 and T6 were correlated with subsequent fluid administration over 24 and 72 h and associated with the diagnosis of septic shock, the maximum dose of vasopressors and the need for renal replacement therapy (p < 0.05).","[{'ForeName': 'Jutamas', 'Initials': 'J', 'LastName': 'Saoraya', 'Affiliation': 'Division of Academic Affairs, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Department of Emergency Medicine, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Lipda', 'Initials': 'L', 'LastName': 'Wongsamita', 'Affiliation': 'Department of Emergency Medicine, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Nattachai', 'Initials': 'N', 'LastName': 'Srisawat', 'Affiliation': 'Division of Nephrology, Department of Medicine, and Critical Care Nephrology Research Unit, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Excellent Center for Critical Care Nephrology, King Chulalongkorn Memorial Hospital, Bangkok, Thailand; Academy of Science, Royal Society of Thailand, Bangkok, Thailand.'}, {'ForeName': 'Khrongwong', 'Initials': 'K', 'LastName': 'Musikatavorn', 'Affiliation': 'Department of Emergency Medicine, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Bangkok, Thailand; Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: khrongwong.m@chulahospital.org.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.01.019']
182,33503496,A randomized trial of physical activity for cognitive functioning in breast cancer survivors: Rationale and study design of I Can! Improving Cognition After Cancer.,"INTRODUCTION


Difficulties with cognition are extremely common among breast cancer survivors and can significantly impact quality of life, daily functioning, and ability to return to work. One promising intervention is increasing physical activity, as it has been effective in improving cognition in non-cancer populations. Few physical activity intervention trials with cognition outcomes have included cancer survivors. This project builds upon our previous work indicating that increased physical activity can improve objectively measured processing speed and self-reported cognition among breast cancer survivors.
METHODS


The I Can! study will examine whether a physical activity intervention improves cognition among 250 post-treatment breast cancer survivors (Stages I-III, <5 years post-treatment) who are reporting cognitive difficulties. This 2-arm randomized controlled trial comparing a 6-month physical activity intervention (Exercise Group) to a health & wellness attention-comparison condition (Health & Wellness Group) will examine intervention effects on cognition (at 3 and 6 months) and maintenance of effects at 12 months. The primary aim is to investigate the impact of exercise on objectively measured processing speed and self-reported cognition. Secondary aims are to investigate maintenance of cognitive changes and examine candidate biological mechanisms and psychological mediators.
CONCLUSION


The I Can! study will contribute to the scientific, public health, and survivorship intervention literature by providing new information on the impact of physical activity for cognitive impairment in breast cancer survivors. Findings from this study will inform guidelines for physical activity to improve the lives of millions of breast cancer survivors.",2021,This 2-arm randomized controlled trial comparing a 6-month physical activity intervention (Exercise Group) to a health & wellness attention-comparison condition (Health & Wellness Group) will examine intervention effects on cognition (at 3 and 6 months) and maintenance of effects at 12 months.,"['250 post-treatment breast cancer survivors (Stages I-III, <5\u202fyears post-treatment) who are reporting cognitive difficulties', 'breast cancer survivors']","['physical activity intervention', 'physical activity', 'physical activity intervention (Exercise Group) to a health & wellness attention-comparison condition (Health & Wellness Group']",[],"[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],,0.0294257,This 2-arm randomized controlled trial comparing a 6-month physical activity intervention (Exercise Group) to a health & wellness attention-comparison condition (Health & Wellness Group) will examine intervention effects on cognition (at 3 and 6 months) and maintenance of effects at 12 months.,"[{'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, UC San Diego, La Jolla, CA, USA; UC San Diego Moores Cancer Center, UC San Diego, La Jolla, CA, USA. Electronic address: sjhartman@ucsd.edu.'}, {'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Weiner', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, UC San Diego, La Jolla, CA, USA; UC San Diego Moores Cancer Center, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, UC San Diego, La Jolla, CA, USA; UC San Diego Moores Cancer Center, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Dorothy D', 'Initials': 'DD', 'LastName': 'Sears', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, UC San Diego, La Jolla, CA, USA; UC San Diego Moores Cancer Center, UC San Diego, La Jolla, CA, USA; Department of Medicine, UC San Diego, La Jolla, CA, USA; College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Barton W', 'Initials': 'BW', 'LastName': 'Palmer', 'Affiliation': 'Department of Psychiatry, UC San Diego, La Jolla, CA, USA; Veterans Affairs San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Parker', 'Affiliation': 'UC San Diego Moores Cancer Center, UC San Diego, La Jolla, CA, USA; Department of Medicine, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ahles', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Irwin', 'Affiliation': 'Department of Chronic Disease Epidemiology, Yale School of Public Health, USA.'}, {'ForeName': 'Kaylene', 'Initials': 'K', 'LastName': 'Au', 'Affiliation': 'UC San Diego Moores Cancer Center, UC San Diego, La Jolla, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106289']
183,33473176,Effectiveness of liraglutide 3 mg for the treatment of obesity in a real-world setting without intensive lifestyle intervention.,"OBJECTIVE


We investigated the efficacy and safety of liraglutide 3 mg daily in combination with diet and exercise 2, 4, and 6 months after initiation in real-world settings in Korea.
METHODS


People first using liraglutide starting in 2018 were recruited from ten sites in Korea. Body weight and body mass index (BMI) were measured after 2, 4, and 6 months and compared with baseline values.
RESULTS


The full cohort comprised 769 participants: 672 in the 2-month group, 427 in the 4-month group, and 219 in the 6-month group. The baseline mean ± standard deviation of BMI and body weight were 32.2 ± 5.1 kg/m 2 , and 87.5 ± 18.8 kg, respectively. Body weight and BMI decreased after initiation of liraglutide treatment: -2.94 kg and -1.08 kg/m 2  at 2 months; -4.23 kg and -1.55 kg/m 2  at 4 months, and -5.14 kg and -1.89 kg/m 2  at 6 months (all P < 0.001). In the 6-month cohort, 52.5% and 18.3% of subjects lost ≥5% and ≥10% of body weight, respectively. After 6 months, systolic and diastolic blood pressure decreased significantly by 3.90 and 1.93 mmHg, respectively. In those with diabetes mellitus, HbA1c and fasting glucose levels decreased significantly by 1.14% and 27.8 mg/dl, respectively. Among all participants, 27.6% experienced adverse effects, including nausea (20.8%), vomiting (5.2%), diarrhoea (2.5%), and skin rash (3.6%). Documented reasons for discontinuation of treatment were lack of effect (4.4%), adverse events (4.3%), and high cost (3.1%).
CONCLUSIONS


In real-world settings in Korea, daily treatment with liraglutide 3 mg was associated with clinically meaningful weight loss without serious adverse events.",2021,"After 6 months, systolic and diastolic blood pressure decreased significantly by 3.90 and 1.93 mmHg, respectively.","['real-world settings in Korea', 'obesity in a real-world setting without intensive lifestyle intervention', 'People first using liraglutide starting in 2018 were recruited from ten sites in Korea', '769 participants: 672 in the 2-month group, 427 in the 4-month group, and 219 in the 6-month group']",['liraglutide'],"['vomiting', 'skin rash', 'HbA1c and fasting glucose levels', 'Body weight and BMI', 'efficacy and safety', 'baseline mean\u2009±\u2009standard deviation of BMI and body weight', 'adverse events', 'adverse effects, including nausea', 'systolic and diastolic blood pressure', 'diarrhoea', 'Body weight and body mass index (BMI']","[{'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517648', 'cui_str': '219'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.0502349,"After 6 months, systolic and diastolic blood pressure decreased significantly by 3.90 and 1.93 mmHg, respectively.","[{'ForeName': 'Jung Ha', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Family Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Ju Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Family Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Jong Han', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hye Soon', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Family Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hyun-Young', 'Initials': 'HY', 'LastName': 'Shin', 'Affiliation': 'Department of Family Medicine, College of Medicine, Hanyang University, Myongji Hospital, Goyang, South Korea.'}, {'ForeName': 'Jae Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Daejeon Endo Internal Medicine Clinic, Daejeon, South Korea.'}, {'ForeName': 'Jin-Wook', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Family Medicine, Obesity and Metabolic Disease Center, Seongnam Central Hospital, Seongnam, South Korea.'}, {'ForeName': 'Hae-Jin', 'Initials': 'HJ', 'LastName': 'Ko', 'Affiliation': 'Department of Family Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Suk', 'Initials': 'S', 'LastName': 'Chon', 'Affiliation': 'Department of Endocrinology and Metabolism, Kyung Hee University College of Medicine, Kyung Hee University Hospital, Seoul, South Korea.'}, {'ForeName': 'Bu Kyung', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Chul Sik', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, South Korea.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea. limsoo@snu.ac.kr.'}]",International journal of obesity (2005),['10.1038/s41366-021-00739-z']
184,33474645,"Effects of the Once-Weekly DPP4 Inhibitor Omarigliptin on Glycemic Control in Patients with Type 2 Diabetes Mellitus on Maintenance Hemodialysis: A 24-Week Open-Label, Multicenter Randomized Controlled Study.","INTRODUCTION


Dipeptidyl peptidase 4 (DPP4) inhibitors are widely used in patients with type 2 diabetes mellitus (T2DM) on maintenance hemodialysis (HD), but the efficacy of the once-weekly DPP4 inhibitor omarigliptin is not known.
METHODS


This prospective, randomized, open-label, parallel-group, non-inferiority/superiority, once-daily DPP4 inhibitor linagliptin-controlled, multicenter study examined glycemic control and safety of omarigliptin (UMIN000024284). Sample size was calculated to confirm non-inferiority in terms of changes in glycated hemoglobin (HbA1c). We enrolled 33 patients with T2DM on maintenance HD who had been treated with linagliptin for at least 3 months. The patients were randomized to receive omarigliptin (12.5 mg/week; n = 16) or linagliptin (5 mg/day; n = 17). Primary endpoints were changes in HbA1c and glycoalbumin (GA) over 24 weeks.
RESULTS


Differences in the mean change in primary endpoint values between the omarigliptin and linagliptin groups were - 0.61% [- 1.14, - 0.09] for HbA1c, with a two-tailed upper 95% limit (i.e., one-tailed 97.5% upper limit) of 0.25%, below the non-inferiority limit, and - 1.67% [- 4.23, + 0.88] for GA, with a two-tailed upper 95% limit of 0.75%, above the non-inferiority limit. At 24 weeks, the omarigliptin group showed significantly greater reduction in HbA1c than the linagliptin group (- 0.2% ± 0.6% vs. 0.4% ± 0.8%, two-tailed p = 0.024) and significantly greater reduction in blood glucose after a single HD session (- 18.4 ± 31.4 mg/dL vs. 25.2 ± 59.5 mg/dL, respectively, two-tailed p = 0.019). No subjects in the omarigliptin group developed hypoglycemia.
CONCLUSIONS


Our data showed that omarigliptin was non-inferior to linagliptin in glycemic control. Omarigliptin is feasible for glycemic control in patients with T2DM on maintenance HD.
CLINICAL TRIALS REGISTRATION


UMIN000024284.",2021,"At 24 weeks, the omarigliptin group showed significantly greater reduction in HbA1c than the linagliptin group (- 0.2% ± 0.6% vs. 0.4% ± 0.8%, two-tailed p = 0.024) and significantly greater reduction in blood glucose after a single HD session (- 18.4 ± 31.4 mg/dL vs. 25.2 ± 59.5 mg/dL, respectively, two-tailed p = 0.019).","['33 patients with T2DM on maintenance HD who had been treated with linagliptin for at least 3\xa0months', 'patients with T2DM on maintenance HD', 'patients with type\xa02 diabetes mellitus (T2DM) on maintenance hemodialysis (HD', 'Patients with Type\xa02 Diabetes Mellitus on Maintenance Hemodialysis']","['Dipeptidyl peptidase\xa04 (DPP4) inhibitors', 'linagliptin', 'omarigliptin', 'Omarigliptin', 'DPP4 Inhibitor Omarigliptin']","['reduction in HbA1c', 'blood glucose', 'changes in HbA1c and glycoalbumin (GA', 'hypoglycemia', 'glycated hemoglobin (HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C4279587', 'cui_str': 'Omarigliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0061700', 'cui_str': 'Glycated albumin'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",33.0,0.0355739,"At 24 weeks, the omarigliptin group showed significantly greater reduction in HbA1c than the linagliptin group (- 0.2% ± 0.6% vs. 0.4% ± 0.8%, two-tailed p = 0.024) and significantly greater reduction in blood glucose after a single HD session (- 18.4 ± 31.4 mg/dL vs. 25.2 ± 59.5 mg/dL, respectively, two-tailed p = 0.019).","[{'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Yoshizawa', 'Affiliation': 'Department of Applied Molecular Medicine, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Hosojima', 'Affiliation': 'Department of Clinical Nutrition Science, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan. hoso9582@med.niigata-u.ac.jp.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kabasawa', 'Affiliation': 'Department of Clinical Nutrition Science, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan.'}, {'ForeName': 'Naohito', 'Initials': 'N', 'LastName': 'Tanabe', 'Affiliation': 'Health and Nutrition, University of Niigata Prefecture, 471 Ebigase, Higashi-ku, Niigata, Niigata, 950-8680, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ugamura', 'Affiliation': 'Department of Applied Molecular Medicine, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Koda', 'Affiliation': 'Koda Internal Medicine Clinic, 3748 Yoshida, Tsubame, Niigata, 959-0264, Japan.'}, {'ForeName': 'Hisaki', 'Initials': 'H', 'LastName': 'Shimada', 'Affiliation': 'Shinrakuen Hospital, 3-3-11 Shin-dori-minami, Nishi-ku, Niigata, Niigata, 950-2087, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Takasawa', 'Affiliation': 'Shinrakuen Hospital, 3-3-11 Shin-dori-minami, Nishi-ku, Niigata, Niigata, 950-2087, Japan.'}, {'ForeName': 'Takahito', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Kataguilli Medical Center, 4-3-9 Sumiyoshi-cho, Shibata, Niigata, 957-0061, Japan.'}, {'ForeName': 'Tadahiro', 'Initials': 'T', 'LastName': 'Kitamura', 'Affiliation': 'Metabolic Signal Research Center, Institute for Molecular and Cellular Regulation, Gunma University, 3-39-15 Showa-machi, Maebashi, Gunma, 371-8512, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Metabolic Signal Research Center, Institute for Molecular and Cellular Regulation, Gunma University, 3-39-15 Showa-machi, Maebashi, Gunma, 371-8512, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Health Administration Center, Niigata University, 8050, Ikarashi 2-no-cho, Nishi-ku, Niigata, Niigata, 950-2181, Japan.'}, {'ForeName': 'Ichiei', 'Initials': 'I', 'LastName': 'Narita', 'Affiliation': 'Department of Clinical Nephrology and Rheumatology, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Saito', 'Affiliation': 'Department of Applied Molecular Medicine, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00991-y']
185,33503531,"The effectiveness of intradermal sterile water injection for low back pain in the emergency department: A prospective, randomized controlled study.","AIM


Low back pain (LBP) is a common musculoskeletal complaint among emergency department (ED) admissions. In this study, it was aimed to compare the effectiveness of systemic treatment with intradermal sterile water injection (ISWI) treatment protocol combined with systemic therapy in patients with LBP of unclear chronicity.
METHODS


A prospective randomized, unblinded, controlled clinical study was conducted on patients admitted to the ED for LBP of unclear chronicity. One hundred twelve patients were randomly assigned to two groups; Group ISWI (n = 56) administered ISWI in the LBP region of patients along with systemic intravenous dexketoprofen therapy, while the other group (n = 56) received only systemic intravenous dexketoprofen therapy. The treatment methods' effectiveness was compared by measuring the pain intensity with the Visual Analog Scale (VAS) at admission, 10th minutes, 20th minutes, 30th minutes, and 24 h later. Also, opioid and analgesic consumptions in 24 h after treatment and patient satisfactions were compared.
RESULTS


In the treatment of LBP, ISWI treatment was found to be more effective in relieving pain than systemic therapy alone (p < 0.001). Also, it was observed that opioid consumption in the ED and analgesic consumption within 24 h after treatments were decreased in the ISWI group (p < 0.001). The patient satisfaction in the ED was statistically increased (p < 0.001).
DISCUSSION


In this unblinded study, ISWI with systemic therapy improved pain outcomes more than systemic therapy alone. Further research is needed to determine whether this was due entirely to placebo effect.",2021,"The patient satisfaction in the ED was statistically increased (p < 0.001).
","['patients admitted to the ED for LBP of unclear chronicity', 'patients with LBP of unclear chronicity', 'low back pain in the emergency department', 'One hundred twelve patients']","['dexketoprofen therapy', 'systemic intravenous dexketoprofen therapy', 'intradermal sterile water injection', 'ISWI', 'Low back pain (LBP', 'intradermal sterile water injection (ISWI) treatment protocol combined with systemic therapy']","['opioid consumption', 'relieving pain', 'analgesic consumption', 'pain outcomes', 'pain intensity with the Visual Analog Scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0547045', 'cui_str': 'Chronicity'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C1163679', 'cui_str': 'Water 1 g/mL solution for injection'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",112.0,0.127486,"The patient satisfaction in the ED was statistically increased (p < 0.001).
","[{'ForeName': 'Erdal', 'Initials': 'E', 'LastName': 'Tekin', 'Affiliation': 'Department of Emergency Medicine, Ataturk University Faculty of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey. Electronic address: erdal.tekin@atauni.edu.tr.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Gur', 'Affiliation': 'Department of Emergency Medicine, Ataturk University Faculty of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Bayraktar', 'Affiliation': 'Department of Family Medicine, Ataturk University Faculty of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Ozlu', 'Affiliation': 'Department of Emergency Medicine, Ataturk University Faculty of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Bahar Keskin', 'Initials': 'BK', 'LastName': 'Celik', 'Affiliation': 'Department of Emergency Medicine, Ataturk University Faculty of Medicine, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.01.038']
186,33503497,Design and rationale of an intervention to improve cancer prevention using clinical decision support and shared decision making: A clinic-randomized trial.,"BACKGROUND


Despite decades of research the gap in primary and secondary cancer prevention services in the U. S. remains unacceptably wide. Innovative interventions are needed to address this persistent challenge. Electronic health records linked with Web-based clinical decision support may close this gap, especially if delivered to both patients and their providers.
OBJECTIVES


The Cancer Prevention Wizard (CPW) study is an implementation, clinic-randomized trial designed to achieve these aims: 1) assess impact of the Cancer Prevention Wizard-Clinical Decision Support (CPW-CDS) alone and CPW-CDS plus Shared Decision Making Tools (CPW + SDMTs) compared to usual care (UC) on tobacco cessation counseling and drugs, HPV vaccinations, and screening tests for breast, cervical, colorectal, or lung cancer; 2) assess cost of the CPW-CDS intervention; and 3) describe critical facilitators and barriers for CPW-CDS implementation, use, and clinical impact using a mixed-methods approach supported by the CFIR and RE-AIM frameworks.
METHODS


34 predominantly rural, primary care clinics were randomized to CPW-CDS, CPW + SMDTs, or UC. Between August 2018 and October 2020, primary care providers and their patients who met inclusion criteria in intervention clinics were exposed to the CPW-CDS with or without SDMTs. Study outcomes at 12 months post index visit include patients up to date on screening tests and HPV vaccinations, overall healthcare costs, and diagnostic codes and billing levels for cancer prevention services.
CONCLUSIONS


We will test in rural primary care settings whether CPW-CDS with or without SDMTs can improve delivery of primary and secondary cancer prevention services. The trial and analyses are ongoing with results expected in 2021.",2021,"Study outcomes at 12 months post index visit include patients up to date on screening tests and HPV vaccinations, overall healthcare costs, and diagnostic codes and billing levels for cancer prevention services.
","['Between August 2018 and October 2020, primary care providers and their patients who met inclusion criteria in intervention clinics', '34 predominantly rural, primary care clinics']","['Cancer Prevention Wizard-Clinical Decision Support (CPW-CDS) alone and CPW-CDS plus Shared Decision Making Tools (CPW\u202f+\u202fSDMTs', 'CPW-CDS, CPW\u202f+\u202fSMDTs, or UC', 'CPW-CDS with or without SDMTs']","['screening tests and HPV vaccinations, overall healthcare costs, and diagnostic codes and billing levels for cancer prevention services']","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",34.0,0.0519174,"Study outcomes at 12 months post index visit include patients up to date on screening tests and HPV vaccinations, overall healthcare costs, and diagnostic codes and billing levels for cancer prevention services.
","[{'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Elliott', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: thomas.e.elliott@healthpartners.com.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Patrick.j.oconnor@healthpartners.com.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Asche', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Steve.e.asche@healthpartners.com.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Saman', 'Affiliation': 'Essentia Institute of Rural Health, 502 E. 2nd St., Duluth, MN 55805, USA. Electronic address: Daniel.Saman@essentiahealth.org.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Dehmer', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Steven.p.dehmer@healthpartners.com.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Ekstrom', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Heidi.l.ekstrom@healthpartners.com.'}, {'ForeName': 'Clayton I', 'Initials': 'CI', 'LastName': 'Allen', 'Affiliation': 'Essentia Institute of Rural Health, 502 E. 2nd St., Duluth, MN 55805, USA. Electronic address: Clayton.Allen@essentiahealth.org.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Bianco', 'Affiliation': 'Essentia Health, Duluth, MN, USA. Electronic address: Joseph.Bianco@essentiahealth.org.'}, {'ForeName': 'Ella A', 'Initials': 'EA', 'LastName': 'Chrenka', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Ella.a.chrenka@healthpartners.com.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Freitag', 'Affiliation': 'Essentia Institute of Rural Health, 502 E. 2nd St., Duluth, MN 55805, USA. Electronic address: Laura.Freitag@essentiahealth.org.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Harry', 'Affiliation': 'Essentia Institute of Rural Health, 502 E. 2nd St., Duluth, MN 55805, USA. Electronic address: Melissa.Harry@essentiahealth.org.'}, {'ForeName': 'Anjali R', 'Initials': 'AR', 'LastName': 'Truitt', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Anjali.r.truitt@healthpartners.com.'}, {'ForeName': 'JoAnn M', 'Initials': 'JM', 'LastName': 'Sperl-Hillen', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Joann.m.sperlhillen@healthpartners.com.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106271']
187,33509019,Effect of CYP2C9 genetic polymorphism and breviscapine on losartan pharmacokinetics in healthy subjects.,"1. Breviscapine was an active ingredient of flavonoid glycosides. Our present study was conducted to evaluate the impact of breviscapine on the pharmacokinetics of losartan and its active metabolite E-3174, and that relationship with the gene polymorphism of CYP2C9 in healthy Chinese volunteers, to provide a basis for clinical rational drug use.2. The genotypes of 217 healthy Chinese subjects were determined using PCR-RFLP. Twelve healthy subjects were selected and were known CYP2C9 genotypes (six CYP2C9*1/*3 and six CYP2C9*1/*1) in a two-phase randomised crossover design study. These subjects were given daily doses of 120 mg (40 mg, three times a day) of breviscapine or a placebo for 14 days, followed by 50 mg losartan on day 15.3. Compared with individuals carrying the CYP2C9*1/*1 genotype, the CYP2C9*1/*3 genotype showed an increase in the AUC (0-36)  (833.6 ± 379.8 ng h ml -1  vs. 526.1 ± 140.1 ng h ml -1 ,  p  < 0.05) and a decrease in the MR (the metabolic ratio of losartan, AUC E-3174 /AUC losartan ) (2.67 ± 1.40 vs. 4.56 ± 0.83,  p  < 0.05) of losartan during the placebo treatment phase. Individuals with genotype CYP2C9*1/*3 showed a significant increase in AUC (0-36)  (2335 ± 851.8 ng h ml -1  vs. 1927 ± 949.5 ng h ml -1 ,  p  < 0.05) and AUC (0-∞)  (2363 ± 875.6 ng h ml -1  vs. 1966 ± 966.1 ng h ml -1 ,  p  < 0.05) of E-3174 after breviscapine treatment compared to the placebo group.4. In healthy subjects, breviscapine had no significant effect on the pharmacokinetics of losartan. The activity of CYP2C9 enzyme to losartan metabolism was more significant in subjects with CYP2C9*1/*3 than those with CYP2C9*1/*1 genotype.",2021,"Individuals with genotype CYP2C9*1/*3 showed a significant increase in AUC  (0-36)  (2335 ± 851.8 ng h ml -1  vs. 1927 ± 949.5 ng h ml -1 , p < 0.05) and AUC  (0-∞)  (2363 ± 875.6 ng","['healthy Chinese volunteers', 'Twelve healthy subjects', 'healthy subjects', '217 healthy Chinese subjects']","['Breviscapine', 'placebo', 'breviscapine or a placebo', 'CYP2C9 genetic polymorphism and breviscapine', 'losartan', 'breviscapine']","['activity of CYP2C9 enzyme to losartan metabolism', 'MR', 'pharmacokinetics of losartan', 'AUC']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517646', 'cui_str': '217'}]","[{'cui': 'C0054048', 'cui_str': 'breviscapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0608437', 'cui_str': 'CYP2C9 protein, human'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0608437', 'cui_str': 'CYP2C9 protein, human'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",12.0,0.0826301,"Individuals with genotype CYP2C9*1/*3 showed a significant increase in AUC  (0-36)  (2335 ± 851.8 ng h ml -1  vs. 1927 ± 949.5 ng h ml -1 , p < 0.05) and AUC  (0-∞)  (2363 ± 875.6 ng","[{'ForeName': 'Hang-Xing', 'Initials': 'HX', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacology, College of Pharmacy, Dali University, Dali, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Pharmacology, College of Pharmacy, Dali University, Dali, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacology, College of Pharmacy, Dali University, Dali, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Pharmacology, College of Pharmacy, Dali University, Dali, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ai', 'Affiliation': 'Department of Pharmacology, College of Pharmacy, Dali University, Dali, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Dali University, Dali, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Dali State Comprehensive Technical Inspection Center, Dali University, Dali, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Department of Pharmacology, College of Pharmacy, Dali University, Dali, China.'}]",Xenobiotica; the fate of foreign compounds in biological systems,['10.1080/00498254.2021.1880670']
188,33517104,"The comparative effects of spinal manipulation, myofascial release and exercise in tension-type headache patients with neck pain: A randomized controlled trial.","OBJECTIVES


To evaluate the effects of two manual treatment methods on pain, disability, and pressure pain threshold (PPT) in tension-type headache (TTH) patients with and neck pain.
METHODS


Forty-five patients with TTH were randomly assigned to one of three groups and received eight sessions treatment: manipulation plus exercise (manipulation), suboccipital inhibition plus exercise (myofascial release), and exercise only (control). Headache frequency, pain severity (VAS-headache, VAS-neck pain) and headache and neck disability (HIT-6 and NDI, respectively) were measured at baseline, posttreatment, and at the third month follow-up. PPT was also evaluated on the temporalis muscle.
RESULTS


Manipulation group was statistically better than myofascial release group in terms of headache frequency, headache severity, and PPT scores. Also, manipulation group showed statistically significant improvements in all outcome criteria when compared control group.
CONCLUSIONS


Manipulation and exercise, in addition to pharmacologic treatment in TTH patients with cervical dysfunction appear to be a promising approach.",2021,"RESULTS


Manipulation group was statistically better than myofascial release group in terms of headache frequency, headache severity, and PPT scores.","['Forty-five patients with TTH', 'tension-type headache (TTH) patients with and neck pain', 'TTH patients with cervical dysfunction', 'tension-type headache patients with neck pain']","['spinal manipulation, myofascial release and exercise', 'eight sessions treatment: manipulation plus exercise (manipulation), suboccipital inhibition plus exercise (myofascial release), and exercise only (control']","['Headache frequency, pain severity (VAS-headache, VAS-neck pain) and headache and neck disability (HIT-6 and NDI, respectively', 'pain, disability, and pressure pain threshold (PPT', 'headache frequency, headache severity, and PPT scores']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",45.0,0.0458596,"RESULTS


Manipulation group was statistically better than myofascial release group in terms of headache frequency, headache severity, and PPT scores.","[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Corum', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: mustafacorum@gmail.com.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Aydin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: drtugbaaydin@gmail.com.'}, {'ForeName': 'Cansın', 'Initials': 'C', 'LastName': 'Medin Ceylan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: cansinmedin@hotmail.com.'}, {'ForeName': 'Fatma Nur', 'Initials': 'FN', 'LastName': 'Kesiktas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: nur.kesiktas@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101319']
189,33517103,Green tea extract for mild-to-moderate diabetic peripheral neuropathy A randomized controlled trial.,"BACKGROUND AND AIM


This randomized study aimed to evaluate the effect of green tea extract (GTE) intake on clinical and neurophysiological parameters in patients with mild-to-moderate diabetic peripheral neuropathy (DPN).
PATIENTS AND METHODS


The present study included 194 patients with DPN. Patients were randomized into two treatment arms: GTE (n = 96) and placebo (n = 98) arms who received allocated treatment for 16 weeks. Symptoms of DPN were assessed using Toronto Clinical Scoring System (TCSS). Sensorineural pain was assessed using visual analog scale (VAS). Neural dysfunction was evaluated using the vibration perception thresholds (VPT). Assessments were made at baseline and after 4, 8, and 16 weeks of starting treatment.
RESULTS


At baseline and after 4 weeks of treatment, VAS, TCSS and VPT were comparable in the studied groups. However, after 8 weeks of treatment, patients in GTE group expressed lower VAS scores, significantly lower TCSS scores and significantly lower VPT. As treatment continued, the differences between groups regarding the outcome parameters became more evident at 16 weeks.
CONCLUSIONS


GTE intake may have a beneficial value in treatment of DPN.",2021,"However, after 8 weeks of treatment, patients in GTE group expressed lower VAS scores, significantly lower TCSS scores and significantly lower VPT.","['194 patients with DPN', 'mild-to-moderate diabetic peripheral neuropathy', 'patients with mild-to-moderate diabetic peripheral neuropathy (DPN']","['GTE', 'placebo', 'green tea extract (GTE) intake', 'Green tea extract']","['Sensorineural pain', 'VAS, TCSS and VPT', 'vibration perception thresholds (VPT', 'Symptoms of DPN', 'Neural dysfunction', 'VAS scores', 'visual analog scale (VAS', 'TCSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",194.0,0.185216,"However, after 8 weeks of treatment, patients in GTE group expressed lower VAS scores, significantly lower TCSS scores and significantly lower VPT.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Essmat', 'Affiliation': 'Department of Neurology, Al-Azhar University, Faculty of Medicine, Cairo, Egypt. Electronic address: ahmadesmat81@yahoo.com.'}, {'ForeName': 'Mohammed Salah', 'Initials': 'MS', 'LastName': 'Hussein', 'Affiliation': 'Internal Medicine Department, Al-Azhar University, Faculty of Medicine, Cairo, Egypt.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101317']
190,33517038,Exercise effects on backward walking speed in people with dementia: A randomized controlled trial.,"BACKGROUND


Multidirectional walking, including backward walking, is integral to daily activities, and seems particularly challenging in older age, and in people with pathology affecting postural control such as dementia.
RESEARCH QUESTION


Does exercise influence backward walking speed in people with dementia, when tested using habitual walking aids and without, and do effects differ according to walking aid use?
METHODS


This study included 141 women and 45 men (mean age 85 years) with dementia from the Umeå Dementia and Exercise (UMDEX), a cluster-randomized controlled trial study set in 16 nursing homes in Umeå, Sweden. Participants were randomized to a High-Intensity Functional Exercise (HIFE) program targeting lower limb strength-, balance and mobility exercise or to a seated attention control activity. Blinded assessors measured 2.4-meter usual backward walking speed, at baseline, 4 - (intervention completion) and 7-month follow-up; tested 1) with habitual walking aids allowed, and 2) without walking aids.
RESULTS


Linear mixed models showed no between-group effect in either backward walking speed test at 4 or 7 months; test 1) 0.005 m/s, P = .788 and -0.006 m/s, P = .754 and test 2) 0.030 m/s, P = .231 and 0.015 m/s, P = .569, respectively. In interaction analyses, exercise effects differed significantly between participants who habitually walked unaided compared with those that used a walking aid at 7 months (0.094 m/s, P = .027).
SIGNIFICANCE


In this study of older people with dementia living in nursing homes, the effects of exercise had no overall effects on backwards walking speed. Nevertheless, some benefit was indicated in participants who habitually walked unaided, which is promising and merits further investigation in future studies.",2021,"RESULTS


Linear mixed models showed no between-group effect in either backward walking speed test at 4 or 7 months; test 1) 0.005 m/s, P","['141 women and 45 men (mean age 85 years) with dementia from the Umeå Dementia and Exercise (UMDEX), a cluster-randomized controlled trial study set in 16 nursing homes in Umeå, Sweden', 'older people with dementia living in nursing homes', 'people with dementia']","['High-Intensity Functional Exercise (HIFE) program targeting lower limb strength-, balance and mobility exercise or to a seated attention control activity', 'habitual walking aids allowed, and 2) without walking aids']","['backward walking speed', 'exercise effects', 'backward walking speed test']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0557834', 'cui_str': 'Walking aid'}]","[{'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",141.0,0.208358,"RESULTS


Linear mixed models showed no between-group effect in either backward walking speed test at 4 or 7 months; test 1) 0.005 m/s, P","[{'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Toots', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå University, 901 87, Umeå, Sweden. Electronic address: annika.toots@umu.se.'}, {'ForeName': 'Lillemor', 'Initials': 'L', 'LastName': 'Lundin-Olsson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå University, 901 87, Umeå, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, 901 87, Sweden.'}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Gustafson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, 901 87, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Rosendahl', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå University, 901 87, Umeå, Sweden.'}]",Gait & posture,['10.1016/j.gaitpost.2020.12.028']
191,33529588,"Early Onset and Broad Activity of Reproxalap in a Randomized, Double-Masked, Vehicle-Controlled Phase 2b Trial in Dry Eye Disease.","PURPOSE


To assess the activity of reproxalap, a novel reactive aldehyde species (RASP) inhibitor, relative to vehicle in patients with dry eye disease (DED) DESIGN: Randomized, double-masked, vehicle-controlled Phase 2b trial METHODS: Three hundred patients with DED were randomly assigned 1:1:1 at multiple US sites to receive 0.1% topical ocular reproxalap, 0.25% topical ocular reproxalap, or vehicle. Eyes were treated bilaterally 4 times daily for 12 weeks. Standard signs and symptoms of DED were assessed at baseline and at Weeks 2, 4, 8, and 12.
RESULTS


A dose response was observed for signs and symptoms of DED. Relative to vehicle over 12 weeks of therapy, the largest symptomatic improvement was observed in ocular dryness (0.25%, P = .047), and the largest objective sign improvement was observed in nasal region fluorescein staining (0.25%, P = .030). A greater proportion of patients receiving 0.25% reproxalap vs. vehicle reported dryness scores of 0 (P = .012). Improvements in combined DED symptoms were evident by the first post-baseline visit (Week 2, 0.25%, P < .0001) in patients with baseline scores greater than or equal to median values. No significant changes in safety measures were observed.
CONCLUSION


The novel RASP inhibitor reproxalap demonstrated rapid, broad, and clinically relevant symptomatic control, in conjunction with statistically significant improvement over vehicle in signs of DED as demonstrated by fluorescein staining, in DED patients over 12 weeks of therapy. The results represent the first vehicle-controlled evidence for the therapeutic potential of RASP inhibition to mitigate the signs and symptoms of dry eye disease.",2021,"Relative to vehicle over 12 weeks of therapy, the largest symptomatic improvement was observed in ocular dryness (0.25% P = .047), and the largest objective sign improvement was observed in nasal region fluorescein staining (0.25% P = .030).","['Three hundred patients with DED', 'patients with dry eye disease (DED']","['topical ocular reproxalap, 0.25% topical ocular reproxalap, or vehicle']","['ocular dryness', 'safety measures', 'dryness scores', 'nasal region fluorescein staining', 'Standard signs and symptoms of DED', 'largest objective sign improvement']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0446452', 'cui_str': 'Region of nose'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",300.0,0.248719,"Relative to vehicle over 12 weeks of therapy, the largest symptomatic improvement was observed in ocular dryness (0.25% P = .047), and the largest objective sign improvement was observed in nasal region fluorescein staining (0.25% P = .030).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'From Aldeyra Therapeutics (D.C., T.C.B.), Lexington, Massachusetts.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Tauber', 'Affiliation': 'Tauber Eye Center (J.T.), Kansas City, Missouri.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sheppard', 'Affiliation': 'Virginia Eye Consultants (J.S.), Norfolk, Virginia, USA.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Brady', 'Affiliation': 'From Aldeyra Therapeutics (D.C., T.C.B.), Lexington, Massachusetts. Electronic address: tbrady@aldeyra.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2021.01.011']
192,33524659,Clinical efficacy of adductor canal block in medial open wedge high tibial osteotomy.,"BACKGROUND


To evaluate the effect of adductor canal block (ACB) on short-term postoperative outcomes in patients who underwent medial open-wedge high tibial osteotomy (MOWHTO) compared to that of a placebo.
METHODS


35 patients who underwent unilateral MOWHTO between 2017 and 2019 were prospectively reviewed and randomly divided into two groups: 19 patients who received a single-shot ACB and 16 patients who received a saline injection (a placebo group). Primary outcomes were (1) pain measured using the visual analog scale and range of motion, (2) patient satisfaction, (3) postoperative need for additional opioids, (3) quadriceps strength (the time to straight leg raising [SLR]), (4) clinical outcomes, and (5) complications.
RESULTS


The pain score was lower in the ACB group than in the placebo group in the first 12 h (p = 0.04). ACB did not exhibit significantly less quadriceps strength weakness postoperatively. There was no statistical difference in the time to SLR (23.5 ± 17.7 h in ACB vs. 27.6 ± 11.4 in placebo, p = 0.520). The opioid consumption rate within postoperative 12 h was significantly decreased after ACB (16.7% in ACB, 70% in placebo, p = 0.017). The proportion of patients with more than 5 opioid injections within 72 h postoperatively was lower in the ACB group (8.3% in ACB, 50% in placebo, p = 0.043). Both groups did not show any localized and systemic complications.
CONCLUSION


ACB following MOWHTO exhibited better outcomes than a placebo with respect to opioid consumption with no changes in the quadriceps strength and complications.
LEVEL OF EVIDENCE


II, Prospectively comparative study.",2021,"ACB following MOWHTO exhibited better outcomes than a placebo with respect to opioid consumption with no changes in the quadriceps strength and complications.
","['35 patients who underwent unilateral MOWHTO between 2017 and 2019 were prospectively reviewed and randomly divided into two groups: 19 patients who received a', 'patients who underwent medial open-wedge high tibial osteotomy (MOWHTO', 'medial open wedge high tibial osteotomy']","['ACB', 'placebo', 'saline injection (a placebo', 'adductor canal block (ACB', 'single-shot ACB', 'adductor canal block']","['pain score', 'opioid consumption rate', '1) pain measured using the visual analog scale and range of motion, (2) patient satisfaction, (3) postoperative need for additional opioids, (3) quadriceps strength (the time to straight leg raising [SLR]), (4) clinical outcomes, and (5) complications', 'time to SLR', 'quadriceps strength and complications', 'quadriceps strength weakness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0445153', 'cui_str': 'Opening wedge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3714552', 'cui_str': 'Debility'}]",35.0,0.218775,"ACB following MOWHTO exhibited better outcomes than a placebo with respect to opioid consumption with no changes in the quadriceps strength and complications.
","[{'ForeName': 'Jae Ang', 'Initials': 'JA', 'LastName': 'Sim', 'Affiliation': 'Department of Orthopaedics Surgery, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: sim_ja@gilhospital.com.'}, {'ForeName': 'Mi Geum', 'Initials': 'MG', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: mikeum2@gilhospital.com.'}, {'ForeName': 'Wol Seon', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: cherish@gilhospital.com.'}, {'ForeName': 'Beom Koo', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedics Surgery, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: knee@gilhospital.com.'}, {'ForeName': 'Byung Hoon', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedics Surgery, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: oselite@naver.com.'}]",The Knee,['10.1016/j.knee.2020.12.017']
193,33526855,Six-month changes in ghrelin and glucagon-like peptide-1 with weight loss are unrelated to long-term weight regain in obese older adults.,"BACKGROUND AND OBJECTIVE


Weight loss (WL) and subsequent regain are complex physiologic processes, and our understanding of the hormonal changes associated with these processes continues to evolve. We aimed to examine the effects of behavioral WL on 6-month changes in ghrelin and GLP-1 and evaluate the effects of these changes in gut hormones on weight regain among older adults.
SUBJECTS AND METHODS


One hundred seventy-seven obese (BMI: 33.5 (3.5) kg/m 2 ) older adults (66.9 ± 4.7 years, 71.2% female, 67.6% white) were randomized to WL (WL; n = 68), WL plus aerobic training (n = 79), or WL plus resistance training (n = 75) for 18 months. Ghrelin, GLP-1, power of food scale (PFS), and weight were measured at baseline, 6 months, and 18 months.
RESULTS


There was no differential treatment effect on change in either gut hormone, however, there was a significant time effect across all groups (p < 0.001), with increases in ghrelin (∆ = +106.77 pg/ml; 95% CI = + 84.82, +128.71) and decreases in GLP-1 (∆ = -4.90 pM; 95% CI = -6.27, -3.51) at 6-month. Ratings on the PFS decreased from baseline to 6-month and there was significant loss of weight from baseline to either 6- or 18-month, ∆ = -7.96 kg; 95% CI = -7.95, -8.78 and ∆ = -7.80 kg; 95% CI = -8.93, -6.65, respectively (p < 0.001). Changes in ghrelin and GLP-1 at 6-month did not predict weight regain from 6- to 18-month.
DISCUSSION AND CONCLUSION


Among older adults with obesity and cardiometabolic disease, the intensive phase of dietary WL results in increasing levels of ghrelin and decreasing levels of GLP-1 that are unrelated to weight regain a year later. Registered with ClinicalTrials.gov (NCT01547182).",2021,"Ratings on the PFS decreased from baseline to 6-month and there was significant loss of weight from baseline to either 6- or 18-month, ∆ = -7.96 kg; 95% CI = -7.95, -8.78 and ∆ = -7.80 kg; 95% CI = -8.93, -6.65, respectively (p < 0.001).","['older adults', 'One hundred seventy-seven obese', 'obese older adults', 'BMI: 33.5 (3.5) kg/m 2 ) older adults (66.9\u2009±\u20094.7 years, 71.2% female, 67.6% white', 'older adults with obesity and cardiometabolic disease']","['WL plus aerobic training (n\u2009=\u200979), or WL plus resistance training']","['PFS', 'GLP-1', 'weight regain', 'loss of weight', 'Ghrelin, GLP-1, power of food scale (PFS), and weight']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}]",177.0,0.0764704,"Ratings on the PFS decreased from baseline to 6-month and there was significant loss of weight from baseline to either 6- or 18-month, ∆ = -7.96 kg; 95% CI = -7.95, -8.78 and ∆ = -7.80 kg; 95% CI = -8.93, -6.65, respectively (p < 0.001).","[{'ForeName': 'Jared J', 'Initials': 'JJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Internal Medicine, Section on Gastroenterology, Wake Forest School of Medicine, Winston-Salem, NC, USA. jarejesk@wakehealth.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fanning', 'Affiliation': 'Department of Health & Exercise Science, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'Department of Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health & Exercise Science, Wake Forest University, Winston-Salem, NC, USA.'}]",International journal of obesity (2005),['10.1038/s41366-021-00754-0']
194,33529810,"Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study.","INTRODUCTION


Dapoxetine on demand has been approved for premature ejaculation (PE) management in China; however, studies on the efficacy and safety of this treatment in the Chinese population are scarce.
AIM


The aim of this study was to evaluate the safety and effectiveness of dapoxetine 30 mg and 60 mg on demand in Chinese men with PE.
METHODS


Phase IV real-world study on 1,252 patients with PE. If men reported no response to dapoxetine 30 mg after 4 weeks treatment, dapoxetine has been uptitrated at 60 mg for 4 weeks more.
MAIN OUTCOME MEASURE


Self-reported data were collected for demographics, general and sexual health characteristics, PE severity, and treatment safety and effectiveness, as measured by the PE profile questionnaire.
RESULTS


Adverse events (AEs), such as nausea, thirst, headache, and dizziness, similarly to previous literature, were detected. The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively). No new safety concerns were observed. The overall effectiveness rates were 88.2% in subjects using 30 mg of dapoxetine, whereas a rescue from the previous failure was in 55.7% in the patients who received 60 mg after the initial 30 mg. Overall, 83.2% responded to dapoxetine at dosages equal to or lower than 60 mg.
CONCLUSION


The results in this study demonstrated in a large Chinese population that on-demand dapoxetine is a safe and effective symptomatic treatment in patients with PE. J Peng, L Yang, L Liu, et al. Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study. Sex Med 2020;XX:XXX-XXX.",2021,"The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively).","['patients with PE', 'Chinese men with PE', '1,252 patients with PE', 'Chinese Men With Premature Ejaculation', 'premature ejaculation (PE) management in China']","['dapoxetine', 'Dapoxetine']","['safety and effectiveness', 'Adverse events (AEs), such as nausea, thirst, headache, and dizziness', 'overall effectiveness rates', 'treatment-emergent AEs rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0215087', 'cui_str': 'dapoxetine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",1252.0,0.0218966,"The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Andrology Center, Department of Urology, Peking University First Hospital, Peking University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Urology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, North Theater General Hospital, Shenyang, China.'}, {'ForeName': 'Renyuan', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Shanghai Jingan District Central Hospital, Shanghai, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ningchen', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Urology, General Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yongguang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology, Beijing Anzhen Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuqiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Urology, Second Hospital of Shandong University, Ji'nan, China.""}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Beijing Chaoyang Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Guowei', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': ""Department of Urology, Shanghai Fifth People's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Suyog', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Medical Department, A Menarini Asia Pacific, Singapore.'}, {'ForeName': 'Emmanuele A', 'Initials': 'EA', 'LastName': 'Jannini', 'Affiliation': 'Chair of Endocrinology and Medical Sexology (ENDOSEX), Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Andrology Center, Department of Urology, Peking University First Hospital, Peking University, Beijing, China. Electronic address: zhangzhichao@bjmu.edu.cn.'}]",Sexual medicine,['10.1016/j.esxm.2020.100296']
195,33535141,Culture moderates the relationship between self-control ability and free will beliefs in childhood.,"We investigate individual, developmental, and cultural differences in self-control in relation to children's changing belief in ""free will"" - the possibility of acting against and inhibiting strong desires. In three studies, 4- to 8-year-olds in the U.S., China, Singapore, and Peru (N = 441) answered questions to gauge their belief in free will and completed a series of self-control and inhibitory control tasks. Children across all four cultures showed predictable age-related improvements in self-control, as well as changes in their free will beliefs. Cultural context played a role in the timing of these emerging free will beliefs: Singaporean and Peruvian children's beliefs changed at later ages than Chinese and U.S. children. Critically, culture moderated the link between self-control abilities and free will beliefs: Individual differences in self-control behaviors were linked to individual differences in free will beliefs in U.S. children, but not in children from China, Singapore or Peru. There was also evidence of a causal influence of self-control performance on free will beliefs in our U.S. sample. In Study 2, a randomly assigned group of U.S. 4- and 5-year-olds who failed at two self-control tasks showed reduced belief in free will, but a group of children who completed free will questions first did not show changes to self-control. Together these results suggest that culturally-acquired causal-explanatory frameworks for action, along with observations of one's own abilities, might influence children's emerging understanding of free will.",2021,"Critically, culture moderated the link between self-control abilities and free will beliefs: Individual differences in self-control behaviors were linked to individual differences in free will beliefs in U.S. children, but not in children from China, Singapore or Peru.",['childhood'],['U.S. 4- and 5-year-olds who failed at two self-control tasks'],[],"[{'cui': 'C0231335', 'cui_str': 'Childhood'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",[],,0.0150515,"Critically, culture moderated the link between self-control abilities and free will beliefs: Individual differences in self-control behaviors were linked to individual differences in free will beliefs in U.S. children, but not in children from China, Singapore or Peru.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'East China Normal University, China.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Wente', 'Affiliation': 'University of California, Berkeley, USA.'}, {'ForeName': 'María Fernández', 'Initials': 'MF', 'LastName': 'Flecha', 'Affiliation': 'Pontificia Universidad Católica del Perú, Peru.'}, {'ForeName': 'Denise Segovia', 'Initials': 'DS', 'LastName': 'Galvan', 'Affiliation': 'Pontificia Universidad Católica del Perú, Peru.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Gopnik', 'Affiliation': 'University of California, Berkeley, USA.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Kushnir', 'Affiliation': 'Cornell University, USA. Electronic address: tk397@cornell.edu.'}]",Cognition,['10.1016/j.cognition.2021.104609']
196,33515785,"A randomized, controlled trial of the safety planning intervention: Research design and methods.","BACKGROUND


Brief interventions for suicide risk among patients treated in acute care settings like the emergency department are needed. The Safety Planning Intervention is a promising approach but has yet to undergo a high quality, individual level randomized controlled trial.
PURPOSE


This paper describes the methods associated with an individual level randomized controlled trial of the Safety Planning Intervention compared to a control condition comprised of reviewing risk factors and warning signs.
METHODS


The sample comprised patients 18 years and older presenting to one of three different emergency departments with suicide related emergencies (target n = 484). Eligible patients were approached, consented, and randomized to the intervention (Safety Planning Intervention) or control (risk factors and warning signs). They were assessed at 1, 3 and 6 months after their index visit. The primary outcome is suicidal behavior. The study also assessed mechanisms of action. Data analyses are pending.
CONCLUSIONS


We identified and addressed key challenges to studying suicidal patients in the emergency department, including difficulty enrolling during the emergency department visit, ascertaining outcomes in patients that are historically very difficult to follow, and addressing the ambiguity of suicidal behavior. ClinicalTrials.gov Identifier: NCT03227991.",2021,"This paper describes the methods associated with an individual level randomized controlled trial of the Safety Planning Intervention compared to a control condition comprised of reviewing risk factors and warning signs.
","['Eligible patients', 'patients 18\u202fyears and older presenting to one of three different emergency departments with suicide related emergencies (target n\u202f=\u202f484', 'suicidal patients in the emergency department, including difficulty enrolling during the emergency department visit']","['Safety Planning Intervention', 'intervention (Safety Planning Intervention) or control (risk factors and warning signs']",['suicidal behavior'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0220912', 'cui_str': 'signs'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}]",484.0,0.148182,"This paper describes the methods associated with an individual level randomized controlled trial of the Safety Planning Intervention compared to a control condition comprised of reviewing risk factors and warning signs.
","[{'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Boudreaux', 'Affiliation': 'Departments of Emergency Medicine, Psychiatry, and Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA. Electronic address: Edwin.Boudreaux@umassmed.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA. Electronic address: bhs2@cumc.columbia.edu.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Green', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA. Electronic address: kelgreen@pennmedicine.upenn.edu.'}, {'ForeName': 'Hanga', 'Initials': 'H', 'LastName': 'Galfalvy', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA. Electronic address: hanga.galfalvy@nyspi.columbia.edu.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA. Electronic address: gregbrow@pennmedicine.upenn.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106291']
197,33540298,"The effect on gastrointestinal system functions, pain and anxiety of acupressure applied following laparoscopic cholecystectomy operation: A randomised, placebo-controlled study.","The aim of this randomised, placebo-controlled, 3-way blinded study was to determine the effect on GIS symptoms, pain and anxiety of acupressure applied for a total of 12 min, as 3 min at each of the ST25, CV12, TH6, and HT7 acupuncture points, at 0, 4 and 8 h after laparoscopic cholecystectomy operation. The research data were collected using a patient data collection form, the Numeric Pain Intensity Scale and the State-Trait Anxiety Inventory. The patients were evaluated in respect of the time to first flatus and defecation, pain and the State-Trait Anxiety points at 0, 4, and 8 h postoperatively. The application of acupressure was determined to have signficantly reduced acute postoperative pain and shortened the time to defecation (p < 0.05). The application of acupressure can be recommended in the nursing interventions following laparoscopic cholecystectomy to reduce acute pain and shorten the time to defecation.",2021,The application of acupressure was determined to have signficantly reduced acute postoperative pain and shortened the time to defecation (p < 0.05).,[],"['laparoscopic cholecystectomy operation', 'placebo', 'acupressure']","['acute postoperative pain', 'gastrointestinal system functions, pain and anxiety of acupressure', 'Numeric Pain Intensity Scale and the State-Trait Anxiety Inventory', 'GIS symptoms, pain and anxiety of acupressure', 'time to first flatus and defecation, pain and the State-Trait Anxiety points']",[],"[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0012240', 'cui_str': 'Structure of digestive system'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0815319', 'cui_str': 'Geographical Information Systems'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.05456,The application of acupressure was determined to have signficantly reduced acute postoperative pain and shortened the time to defecation (p < 0.05).,"[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Soylu', 'Affiliation': 'Erciyes University, Institute of Health Sciences, Surgical Nursing, Kayseri, Turkey. Electronic address: dsoylu@ksu.edu.tr.'}, {'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Tekinsoy Kartın', 'Affiliation': 'Erciyes University, Faculty of Health Sciences, Nursing Department, Kayseri, Turkey. Electronic address: ptekinsoy@erciyes.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101304']
198,33539993,The shifting perspectives study protocol: Cognitive remediation therapy as an adjunctive treatment to family based treatment for adolescents with anorexia nervosa.,"BACKGROUND


Adolescents with anorexia nervosa have set-shifting inefficiencies that can be exacerbated by starvation and that may interfere with outcomes of treatment interventions. Cognitive Remediation Therapy (CRT), an adjunctive treatment focused on improving set-shifting, can target inefficiencies and may augment treatment effectiveness. The best way to add CRT to the standard of care (Family Based Treatment, FBT) for adolescents with anorexia remains understudied.
METHODS/DESIGN


This is a randomized controlled trial designed to determine if CRT is effective in increasing flexibility in adolescents with anorexia and/or their parents. Participants are adolescents 12-18 years old with anorexia and their parents. 54 family groups will be randomized into one of three groups: FBT only, FBT plus Parent-focused CRT, or FBT plus Adolescent-focused CRT. Psychosocial, neurocognitive, and behavioral measures will be collected throughout the study.
DISCUSSION


This is the first study of its kind to apply CRT to parents. All forms of CRT in the context of anorexia have targeted the individual with anorexia's thinking style. We propose that it may be impactful to target the parent of the adolescent with anorexia as parents carry the burden of treatment and re-nourishment of their child during FBT and may have similar thinking styles.
CONCLUSION


This study takes an experimental therapeutics approach to further our understanding of the mechanisms of treatment for adolescents with anorexia. It focuses on increasing cognitive flexibility in patients or their parents and determining the appropriate dose of CRT needed to achieve positive change.
TRIAL REGISTRATION


ClinicalTrails.gov Identifier NCT03928028.",2021,"54 family groups will be randomized into one of three groups: FBT only, FBT plus Parent-focused CRT, or FBT plus Adolescent-focused CRT.","['adolescents with anorexia and/or their parents', 'Adolescents with anorexia nervosa', 'Participants are adolescents 12-18\u202fyears old with anorexia and their parents', 'adolescents with anorexia remains understudied', 'adolescents with anorexia', 'adolescents with anorexia nervosa']","['CRT', 'Cognitive remediation therapy', 'Cognitive Remediation Therapy (CRT', 'FBT only, FBT plus Parent-focused CRT, or FBT plus Adolescent-focused CRT']","['Psychosocial, neurocognitive, and behavioral measures', 'cognitive flexibility']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",,0.0465957,"54 family groups will be randomized into one of three groups: FBT only, FBT plus Parent-focused CRT, or FBT plus Adolescent-focused CRT.","[{'ForeName': 'C Alix', 'Initials': 'CA', 'LastName': 'Timko', 'Affiliation': ""Eating Disorder Assessment and Treatment Program, Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America. Electronic address: timkoc@email.chop.edu.""}, {'ForeName': 'Anushua', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': ""Eating Disorder Assessment and Treatment Program, Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Kathleen Kara', 'Initials': 'KK', 'LastName': 'Fitzpatrick', 'Affiliation': 'Private Practice, Palo Alto, CA, United States of America.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Howe', 'Affiliation': 'The Fuqua School of Business, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': 'School of Nursing and Health Sciences and Public Health, La Salle University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Mears', 'Affiliation': ""Eating Disorder Assessment and Treatment Program, Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Heckert', 'Affiliation': ""Deptartment of Clinical Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ubel', 'Affiliation': 'The Fuqua School of Business, Duke University, Durham, NC, United States of America; Sanford School of Policy, Duke University, Durham, NC, United States of America; School of Medicine, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Ehrenreich-May', 'Affiliation': 'Psychology Department, University of Miami, Miami, FL, United States of America.'}, {'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Peebles', 'Affiliation': ""Craig Dalsimer Division of Adolescent Medicine, Department of Pediatrics, Children's Hospital of Philadelphia, United States of America; Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2021.106313']
199,33539991,The active workplace study: Protocol for a randomized controlled trial with sedentary workers.,"OBJECTIVES


Sedentary behavior is pervasive in the workplace and is harmful to health. Research on the effectiveness of comprehensive workplace interventions to reduce sedentary behavior and improve worker health and safety is crucial as sedentary jobs become more common.
METHODS


We developed a Total Worker Health intervention targeting sedentary behavior in call centers, and are evaluating intervention effectiveness in a randomized controlled trial. Four worksites will be randomly assigned to an intervention or control condition. The intervention condition includes the provision of active workstations along with programs and procedures at environmental, organizational, and individual levels. Control worksites will receive active workstations with no additional support, following common organizational practices.
RESULTS


Outcomes include objectively measured physical activity, biological markers of health, and self-report survey data at baseline, after the 6-month intervention or control period, and at a 12-month follow-up.
CONCLUSIONS


The aims of the study are to determine whether a Total Worker Health intervention has stronger impacts on workplace sedentary behavior, uninterrupted bouts of sitting, and worker health and safety compared to a usual practice control condition. The study will inform future workplace sedentary behavior intervention and dissemination research, along with organizational best practices for reducing sedentary behavior in the workplace.",2021,"The intervention condition includes the provision of active workstations along with programs and procedures at environmental, organizational, and individual levels.",['sedentary workers'],"['Total Worker Health intervention', 'comprehensive workplace interventions', 'Total Worker Health intervention targeting sedentary behavior']","['physical activity, biological markers of health, and self-report survey data', 'workplace sedentary behavior, uninterrupted bouts of sitting, and worker health and safety', 'worker health and safety']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",4.0,0.104672,"The intervention condition includes the provision of active workstations along with programs and procedures at environmental, organizational, and individual levels.","[{'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wipfli', 'Affiliation': 'OHSU-PSU School of Public Health, Portland State University, PO Box 751, SCH, Portland, OR 97207-0751, United States of America; Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, 3222 SW Research Drive L606 Portland, Oregon 97239, United States of America. Electronic address: bwipfli@pdx.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wild', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, 3222 SW Research Drive L606 Portland, Oregon 97239, United States of America. Electronic address: wilsa@ohsu.edu.'}, {'ForeName': 'Ginger C', 'Initials': 'GC', 'LastName': 'Hanson', 'Affiliation': 'School of Nursing, Johns Hopkins University, 525 N. Wolfe Street, Baltimore, MD 21205, United States of America. Electronic address: ghanson4@jhu.edu.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Shea', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, 3222 SW Research Drive L606 Portland, Oregon 97239, United States of America. Electronic address: sheast@ohsu.edu.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Winters-Stone', 'Affiliation': ""OHSU School of Nursing, Oregon Health & Science University, 3455 SW US Veteran's Hospital Rd, Portland, OR 97239, United States of America. Electronic address: wintersk@ohsu.edu.""}, {'ForeName': 'Saurabh S', 'Initials': 'SS', 'LastName': 'Thosar', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, 3222 SW Research Drive L606 Portland, Oregon 97239, United States of America. Electronic address: thosar@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106311']
200,33515784,Promoting physical activity in young adult cancer survivors using mHealth and adaptive tailored feedback strategies: Design of the Improving Physical Activity after Cancer Treatment (IMPACT) randomized controlled trial.,"INTRODUCTION


Despite the health benefits of physical activity for cancer survivors, nearly 60% of young adult cancer survivors (YACS) are physically inactive. Few physical activity interventions have been designed specifically for YACS.
PURPOSE


To describe the rationale and design of the IMPACT (IMproving Physical Activity after Cancer Treatment) trial, which tests the efficacy of a theory-based, mobile physical activity intervention for YACS.
METHODS


A total of 280 physically inactive YACS (diagnosed at ages 18-39) will be randomized to a self-help control or intervention condition. All participants will receive an activity tracker and companion mobile app, cellular-enabled scale, individual videochat session, and access to a Facebook group. Intervention participants will also receive a 6-month mobile intervention based on social cognitive theory, which targets improvements in behavioral capability, self-regulation, self-efficacy, and social support, and incorporates self-regulation strategies and behavior change techniques. The program includes: behavioral lessons; adaptive goal-setting in response to individuals' changing activity patterns; tailored feedback based on objective data and self-report measures; tailored text messages; and Facebook prompts encouraging peer support. Assessments occur at baseline, 3, 6, and 12 months. The primary outcome is total physical activity min/week at 6 months (assessed via accelerometry); secondary outcomes include total physical activity at 12 months, sedentary behavior, weight, and psychosocial measures.
CONCLUSIONS


IMPACT uniquely focuses on physical activity in YACS using an automated tailored mHealth program. Study findings could result in a high-reach, physical activity intervention for YACS that has potential to be adopted on a larger scale and reduce cancer-related morbidity. ClinicalTrials.gov Identifier: NCT03569605.",2021,"Intervention participants will also receive a 6-month mobile intervention based on social cognitive theory, which targets improvements in behavioral capability, self-regulation, self-efficacy, and social support, and incorporates self-regulation strategies and behavior change techniques.","['young adult cancer survivors', '280 physically inactive YACS (diagnosed at ages 18-39']","['mobile intervention based on social cognitive theory', 'activity tracker and companion mobile app, cellular-enabled scale, individual videochat session, and access to a Facebook group', 'self-help control or intervention condition', 'theory-based, mobile physical activity intervention']","['behavioral capability, self-regulation, self-efficacy, and social support', 'total physical activity minutes/week at 6\u202fmonths (assessed via accelerometry); secondary outcomes include total physical activity at 12\u202fmonths, sedentary behavior, weight, and psychosocial measures']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",280.0,0.0428451,"Intervention participants will also receive a 6-month mobile intervention based on social cognitive theory, which targets improvements in behavioral capability, self-regulation, self-efficacy, and social support, and incorporates self-regulation strategies and behavior change techniques.","[{'ForeName': 'Carmina G', 'Initials': 'CG', 'LastName': 'Valle', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: carmina.valle@unc.edu.'}, {'ForeName': 'Bernardine M', 'Initials': 'BM', 'LastName': 'Pinto', 'Affiliation': 'School of Nursing, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Diamond', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lindsey N', 'Initials': 'LN', 'LastName': 'Horrell', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Brooke T', 'Initials': 'BT', 'LastName': 'Nezami', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Hatley', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Coffman', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Polzien', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Derek P', 'Initials': 'DP', 'LastName': 'Hales', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Rini', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Rosenstein', 'Affiliation': 'Departments of Psychiatry and Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106293']
201,33545575,"The effects of yoga on dyspnea, sleep and fatigue in chronic respiratory diseases.","PURPOSE


This study was carried out to find out the effects of yoga applied to chronic respiratory disease patients on dyspnea, sleep quality and fatigue.
MATERIAL AND METHOD


The study was conducted between May and August 2020 as a randomized controlled study. 'Personal Information Form', 'Respiratory Functions Monitoring Form', 'COPD and Asthma Fatigue Scale (CAFS), ""Asthma and COPD Sleep Impact Scale (CASIS)"" and Modified Medical Research Council Dyspnea Scale (mMRC) were used in data collection.
RESULTS


When the post-test mean scores of the patients in the experimental and control group were compared, it was found that CAFS, CASIS and mMRC mean scores of the patients in the experimental group decreased positively compared to the patients in the control group and the difference between was found to be statistically significant (p < 0.05).
CONCLUSION


Yoga has been found to reduce the severity of dyspnea and fatigue and improve sleep quality in chronic respiratory diseases.",2021,"When the post-test mean scores of the patients in the experimental and control group were compared, it was found that CAFS, CASIS and mMRC mean scores of the patients in the experimental group decreased positively compared to the patients in the control group and the difference between was found to be statistically significant (p < 0.05).
",['chronic respiratory diseases'],[],"['severity of dyspnea and fatigue and improve sleep quality', 'dyspnea, sleep and fatigue', 'dyspnea, sleep quality and fatigue', 'CAFS, CASIS and mMRC mean scores', 'Personal Information Form\', \'Respiratory Functions Monitoring Form\', \'COPD and Asthma Fatigue Scale (CAFS), ""Asthma and COPD Sleep Impact Scale (CASIS)"" and Modified Medical Research Council Dyspnea Scale (mMRC']","[{'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.0106463,"When the post-test mean scores of the patients in the experimental and control group were compared, it was found that CAFS, CASIS and mMRC mean scores of the patients in the experimental group decreased positively compared to the patients in the control group and the difference between was found to be statistically significant (p < 0.05).
","[{'ForeName': 'Zülfünaz', 'Initials': 'Z', 'LastName': 'Özer', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Istanbul Sabahattin Zaim University, Istanbul, Turkey. Electronic address: zulfinazozer@gmail.com.'}, {'ForeName': 'Gülcan', 'Initials': 'G', 'LastName': 'Bahçecioğlu Turan', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Firat University, Elazıg, Turkey. Electronic address: glcnbah@hotmail.com.'}, {'ForeName': 'Meyreme', 'Initials': 'M', 'LastName': 'Aksoy', 'Affiliation': 'Department of Nursing, Faculty of Health Science Siirt University, Siirt, Turkey. Electronic address: meryeme_072@hotmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101306']
202,33545441,A randomized controlled trial of prophylactic early manual rotation of the occiput posterior fetus at the beginning of the second stage vs expectant management.,"BACKGROUND


Women whose fetuses are in the occiput posterior head position at the time of delivery are known to have longer second stages of labor and more complicated deliveries including more operative deliveries (cesarean, forceps, or vacuum-assisted delivery) and more third- and fourth-degree lacerations than those whose fetuses are in the occiput anterior position.
OBJECTIVE


We hypothesized that rotating the fetus at the start of the second stage might decrease these complications.
STUDY DESIGN


At Utah Valley Regional Medical Center, we randomized term (37 weeks or beyond), nulliparous patients with epidurals and a singleton fetus in the occiput posterior position to either attempted early manual rotation to occiput anterior or to a control group managed expectantly. The control group could later be rotated if indicated by the clinical setting. The primary outcome was the length of the second stage of labor. Dichotomous outcomes were compared utilizing the chi-square test, and continuous outcomes were compared utilizing the Student t test or Wilcoxon rank sum test. The sample size estimate was for 64 patients to be randomized (32 in each group) to show a difference of 36 minutes of pushing time between the 2 groups.
RESULTS


We randomized 65 patients (33 to early manual rotation and 32 to control). When we examined a variety of baseline obstetrical characteristics, we found no statistically different values for the 2 groups. The early manual rotation group had a shorter median second stage of labor (65 minutes vs 82 minutes; P=.04).
CONCLUSION


Early manual rotation of the occiput posterior fetus led to a shorter second stage of labor in this small randomized trial. Future larger randomized trials are needed to validate these findings.",2021,"The EMR group had a shorter median second stage of labor (65 minutes vs. 82 minutes, p=0.04).
","['nulliparous patients with epidurals and a singleton fetus in the OP position, to either', '65 patients (33 to EMR and 32 to control']","['Prophylactic Early Manual Rotation', 'EMR', 'attempted early manual rotation (EMR) to occiput anterior, or to a control group managed expectantly']","['length of the second stage of labor', 'shorter median second stage of labor']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0856256', 'cui_str': 'Occiput posterior'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0230005', 'cui_str': 'Occipital region structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",65.0,0.0955666,"The EMR group had a shorter median second stage of labor (65 minutes vs. 82 minutes, p=0.04).
","[{'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Broberg', 'Affiliation': ""Valley Women's Health, Provo, UT (Dr Broberg); Utah Valley Hospital, Intermountain Healthcare, Provo, UT (Dr Broberg). Electronic address: broberg@valleywomenshealth.com.""}, {'ForeName': 'Aaron B', 'Initials': 'AB', 'LastName': 'Caughey', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR (Dr Caughey).'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2021.100327']
203,33515782,A cluster-randomized control trial targeting parents of pediatric cancer survivors with obesity: Rationale and study protocol of NOURISH-T.,"Approximately 40-50% of pediatric cancer survivors (PCS) are overweight or obese; increasing their risk for metabolic syndrome and other negative long-term physical health complications. Using our successful pilot trial testing the preliminary feasibility and efficacy of NOURISH for Healthy Transitions (NOURISH-T), we refined our intervention, now NOURISH-T+, and will implement these refinements in this larger, multi-site randomized control trial. Parents of PCS with overweight/obesity (BMI ≥ 85th%ile), age 5-12, ≥6 months off treatment are randomly assigned to the NOURISH-T+ intervention or Enhanced Usual Care (EUC) comparison. Parents in NOURISH-T+ will participate in a 6-session, manualized intervention, with an additional dietician session and 2 PCS sessions, as well as post-intervention booster sessions. EUC consists of a one-time informational session, nationally available brochures and follow-up check-ins. Both study conditions will be conducted remotely via a videoconferencing platform. Parents and PCS will be assessed on anthropometric measures, physical activity (PA) and dietary behaviors at baseline, 3-, 6-, and 12-months post-intervention. We will enroll a diverse group of 260 parents/PCS dyads from four pediatric oncology clinics with the aim of evaluating the efficacy of our intervention across diverse pediatric oncology clinics. Our main aim is to compare the impact of NOURISH-T+ with EUC on PCS BMI z-score. Secondary aims are to compare intervention impact on PCS PA and eating behaviors and parent BMI and behaviors as well as to explore potential moderators of the intervention. Our longer-term goal is to establish a framework for future translation and dissemination of NOURISH-T+.",2021,"Using our successful pilot trial testing the preliminary feasibility and efficacy of NOURISH for Healthy Transitions (NOURISH-T), we refined our intervention, now NOURISH-T+, and will implement these refinements in this larger, multi-site randomized control trial.","['pediatric cancer survivors with obesity', 'Parents of PCS with overweight/obesity (BMI\u202f≥\u202f85th%ile), age 5-12, ≥6\u202fmonths off treatment', '260 parents/PCS dyads from four pediatric oncology clinics']",['NOURISH-T+ intervention or Enhanced Usual Care (EUC) comparison'],"['PCS BMI z-score', 'anthropometric measures, physical activity (PA) and dietary behaviors', 'PCS PA and eating behaviors and parent BMI and behaviors']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C3816504', 'cui_str': 'Pediatric oncology clinic'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",,0.0564866,"Using our successful pilot trial testing the preliminary feasibility and efficacy of NOURISH for Healthy Transitions (NOURISH-T), we refined our intervention, now NOURISH-T+, and will implement these refinements in this larger, multi-site randomized control trial.","[{'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Stern', 'Affiliation': 'Department of Child and Family Studies, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, United States of America. Electronic address: mstern1@usf.edu.'}, {'ForeName': 'Heewon L', 'Initials': 'HL', 'LastName': 'Gray', 'Affiliation': 'College of Public Health, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Ruble', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Soca Lozano', 'Affiliation': 'College of Education, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Albizu-Jacob', 'Affiliation': 'Department of Child and Family Studies, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'Department of Child and Family Studies, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Kamar', 'Initials': 'K', 'LastName': 'Godder', 'Affiliation': ""Nicklaus Children's Hospital, Miami, FL, United States of America.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Fuemmeler', 'Affiliation': 'Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Mazzeo', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106296']
204,33545163,Relationship Between Time From Diagnosis and Morbidity or Mortality in Pulmonary Arterial Hypertension: Results From the Phase III GRIPHON Study.,"BACKGROUND


Early initiation of pulmonary arterial hypertension (PAH) therapies is associated with improved long-term outcomes, yet data on the early use of prostacyclin pathway agents are limited. In these post hoc analyses of the GRIPHON study, the largest randomized controlled trial for PAH to date, the prognostic value of time from diagnosis and its impact on treatment response were examined.
RESEARCH QUESTION


How does time from diagnosis impact morbidity and mortality events and response to selexipag treatment in patients with PAH?
STUDY DESIGN AND METHODS


The GRIPHON study randomly assigned 1,156 patients with PAH to selexipag or placebo treatment. Patients were categorized post hoc into a time from diagnosis of ≤ 6 months and > 6 months at randomization. Hazard ratios (selexipag vs placebo) were calculated for the primary end point of morbidity and mortality events by time from diagnosis using Cox proportional hazard models.
RESULTS


Time from diagnosis was ≤ 6 months in 34.9% and > 6 months in 65.1% of patients. Time from diagnosis was prognostic of morbidity and mortality, with newly diagnosed patients having a poorer long-term outcome than patients diagnosed for longer. Compared with placebo, selexipag reduced the risk of morbidity and mortality in patients with a time from diagnosis of ≤ 6 months and > 6 months, with a more pronounced effect in newly diagnosed patients (hazard ratio, 0.45 [95% CI, 0.33-0.63] and 0.74 [95% CI, 0.57-0.96], respectively; P = .0219 for interaction).
INTERPRETATION


In the GRIPHON study, newly diagnosed PAH patients had a worse prognosis than patients with a longer time from diagnosis. The benefit of selexipag treatment on disease progression was more pronounced in patients treated earlier than in patients treated later.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT01106014; URL:www.clinicaltrials.gov.",2021,The benefit of selexipag treatment on disease progression was more pronounced in patients treated earlier than in patients treated later.,"['patients with PAH', 'and Methods', 'pulmonary arterial hypertension', '1156 patients with PAH to selexipag or']",['placebo'],"['risk of morbidity/mortality', 'Hazard ratios', 'disease progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C2000145', 'cui_str': 'selexipag'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",1156.0,0.242122,The benefit of selexipag treatment on disease progression was more pronounced in patients treated earlier than in patients treated later.,"[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Gaine', 'Affiliation': 'National Pulmonary Hypertension Unit, Mater Misericordiae University Hospital, Dublin, Ireland. Electronic address: sgaine@mater.ie.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sitbon', 'Affiliation': 'Hôpital Universitaire de Bicêtre, Université Paris-Sud, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Channick', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Chin', 'Affiliation': 'UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Sauter', 'Affiliation': 'Actelion Pharmaceuticals, Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Nazzareno', 'Initials': 'N', 'LastName': 'Galiè', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine-DIMES, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Marius M', 'Initials': 'MM', 'LastName': 'Hoeper', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School and German Center for Lung Research, Hannover, Germany.'}, {'ForeName': 'Vallerie V', 'Initials': 'VV', 'LastName': 'McLaughlin', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Preiss', 'Affiliation': 'Actelion Pharmaceuticals, Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Rubin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of California, San Diego, CA.'}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Simonneau', 'Affiliation': 'Hôpital Universitaire de Bicêtre, Université Paris-Sud, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tapson', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Hossein-Ardeschir', 'Initials': 'HA', 'LastName': 'Ghofrani', 'Affiliation': 'University of Giessen and Marburg Lung Center, Giessen, Germany, and member of the German Center for Lung Research, and Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Lang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Allgemeines Krankenhaus, Vienna, Austria.'}]",Chest,['10.1016/j.chest.2021.01.066']
205,33545574,The effect of compound Da-Cheng-Qi Decoction on the treatment of malignant bowel obstruction with transnasal ileus tube.,"OBJECTIVE


To study the effect of compound Da-Cheng-Qi Decoction (CDCQD) on the treatment of malignant bowel obstruction (MBO) with transnasal ileus tube (TIT).
METHODS


We observed 30 cases of MBO from July 2018 to August 2019. The patients were divided into the control group (n = 15) and the CDCQD group (n = 15) according to a random number table. All patients were inserted the TIT after admission. Twenty-four hours later, the CDCQD group began to take 100 ml CDCQD twice a day for 7 days. The control group took the plain boiled water instead. Other treatment was the same in the two groups. The waistline reduction, the release time of abdominal pain and distention, recovery of exhaust and defecation time, drainage volume of TIT were observed and compared between the two groups.
RESULTS


Three days after insertion of TIT, the abdominal plain film was re-examined in the two groups. Most of the patients' gas-liquid level disappeared and there was no significant difference between the two groups (P > 0.05). The effective rate of CDCQD group (86.7%) was significantly higher than that of control group (53.3%). The recovery time of exhaust and defecation in the CDCQD group was earlier than that in the control group (P < 0.05). The daily drainage volume of TIT in the CDCQD group was less than that in the control group, especially from the fourth day to the sixth day after insertion of TIT, with a significant difference (P < 0.05).
CONCLUSION


TIT is an effective treatment for patients with MBO. With the basis of TIT treatment, CDCQD therapy can improve the curative effect of MBO. It can promote intestinal exhaust and defecation and improves the curative effect of palliative treatment of MBO. It is an effective method to assist Tit in the treatment for MBO patients.",2021,Most of the patients' gas-liquid level disappeared and there was no significant difference between the two groups (P > 0.05).,"['30 cases of MBO from July 2018 to August 2019', 'malignant bowel obstruction (MBO) with transnasal ileus tube (TIT', 'patients with MBO', 'malignant bowel obstruction with transnasal ileus tube', 'MBO patients']","['compound Da-Cheng-Qi Decoction', 'plain boiled water instead', 'TIT', 'compound Da-Cheng-Qi Decoction (CDCQD', 'CDCQD']","['curative effect of MBO', 'recovery time of exhaust and defecation', 'effective rate', 'release time of abdominal pain and distention, recovery of exhaust and defecation time, drainage volume of TIT', 'daily drainage volume of TIT', 'gas-liquid level']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0021843', 'cui_str': 'Intestinal obstruction'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C2935869', 'cui_str': 'Da-Cheng-Qi'}, {'cui': 'C0439892', 'cui_str': 'Boiled water'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0175730', 'cui_str': 'Tube'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0021843', 'cui_str': 'Intestinal obstruction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0162882,Most of the patients' gas-liquid level disappeared and there was no significant difference between the two groups (P > 0.05).,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Nutrition, Tianjin Nankai Hospital, 300100, Tianjin, China. Electronic address: xiangqixiangqi@163.com.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Shimin', 'Affiliation': 'Department of Gastrointestinal Surgery, Tianjin Nankai Hospital, 300100, Tianjin, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Gastrointestinal Surgery, Tianjin Nankai Hospital, 300100, Tianjin, China.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101316']
206,33548303,"Topical timolol 0.5% gel-forming solution for erythema in rosacea: A quantitative, split-face, randomized, and rater-masked pilot clinical trial.",,2021,,['for Erythema in Rosacea'],['Topical Timolol 0.5% Gel-Forming Solution'],[],"[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]",[],,0.365336,,"[{'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Chien', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Noori', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Rachidi', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Connolly', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sabrina Sisto', 'Initials': 'SS', 'LastName': 'Alessi César', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sewon', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Garza', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: LAG@jhmi.edu.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2021.01.098']
207,33547848,Lenvatinib versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma: An inverse probability of treatment weighting analysis.,"PURPOSE


Data from common clinical practice were used to generate balanced cohorts of patients receiving either sorafenib or lenvatinib, for unresectable hepatocellular carcinoma, with the final aim to investigate their declared equivalence.
METHODS


Clinical features of lenvatinib and sorafenib patients were balanced through inverse probability of treatment weighting (IPTW) methodology, which weights patients' characteristics and measured outcomes of each patient in both treatment arms. Overall survival was the primary endpoint and occurrence of adverse events was the secondary.
RESULTS


The analysis included 385 patients who received lenvatinib, and 555 patients who received sorafenib. In the unadjusted cohort, lenvatinib did not show a survival advantage over sorafenib (HR: 0.85, 95% CI 0.70-1.02). After IPTW adjustment, lenvatinib still not returned a survival advantage over sorafenib (HR: 0.82, 95% CI: 0.62-1.07) even in presence of balanced baseline characteristics. Lenvatinib provided longer survival than sorafenib in patients previously submitted to TACE (HR: 0.69), with PS of 0 (HR: 0.73) or without extrahepatic disease (HR: 0.69).
CONCLUSION


Present results confirmed randomized controlled trial in the real-life setting, but also suggests that in earlier stages some benefit can be expected.",2021,"Lenvatinib provided longer survival than sorafenib in patients previously submitted to TACE (HR: 0.69), with PS of 0 (HR: 0.73) or without extrahepatic disease (HR: 0.69).
","['unresectable hepatocellular carcinoma', '385 patients who received lenvatinib, and 555 patients who received']","['Lenvatinib versus Sorafenib', 'sorafenib or lenvatinib', 'sorafenib']","['survival advantage', 'longer survival', 'Overall survival']","[{'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C4517810', 'cui_str': '555'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",385.0,0.335091,"Lenvatinib provided longer survival than sorafenib in patients previously submitted to TACE (HR: 0.69), with PS of 0 (HR: 0.73) or without extrahepatic disease (HR: 0.69).
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Casadei-Gardini', 'Affiliation': 'Vita-Salute San Rafaele University, Milan, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Scartozzi', 'Affiliation': 'Department of Medical Oncology, University Hospital of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Tada', 'Affiliation': 'Department of Internal Medicine, Japanese Red Cross Society Himeji Hospital, Himeji, Japan.'}, {'ForeName': 'Changhoon', 'Initials': 'C', 'LastName': 'Yoo', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Shimose', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'Department of Translational Research and New Surgical and Medical Technologies, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Medical Oncology Unit 1, Veneto Institute of Oncology IOV - IRCCS, Padova, Italy.'}, {'ForeName': 'Luca Giovanni', 'Initials': 'LG', 'LastName': 'Frassineti', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Silvestris', 'Initials': 'S', 'LastName': 'Nicola', 'Affiliation': 'Medical Oncology Unit, IRCCS IstitutoTumori ""Giovanni Paolo II"" of Bari, Bari, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Piscaglia', 'Affiliation': 'Division of Internal Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kumada', 'Affiliation': 'Faculty of Nursing, Gifu Kyoritsu University, Ogaki, Japan.'}, {'ForeName': 'Hyung-Don', 'Initials': 'HD', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Japanese Red Cross Society Himeji Hospital, Himeji, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Koga', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Vivaldi', 'Affiliation': 'Department of Translational Research and New Surgical and Medical Technologies, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Soldà', 'Affiliation': 'Medical Oncology Unit 1, Veneto Institute of Oncology IOV - IRCCS, Padova, Italy.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hiraoka', 'Affiliation': 'Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan.'}, {'ForeName': 'Yeonghak', 'Initials': 'Y', 'LastName': 'Bang', 'Affiliation': 'Department of Internal Medicine, Japanese Red Cross Society Himeji Hospital, Himeji, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Atsukawa', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Torimura', 'Affiliation': 'Department of Internal Medicine, Japanese Red Cross Society Himeji Hospital, Himeji, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Tsuj', 'Affiliation': 'Center of Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.'}, {'ForeName': 'Ei', 'Initials': 'E', 'LastName': 'Itobayashi', 'Affiliation': 'Department of Gastroenterology, Asahi General Hospital, Asahi, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Toyoda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Fukunishi', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Milan, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Rimini', 'Affiliation': 'Vita-Salute San Rafaele University, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cascinu', 'Affiliation': 'Vita-Salute San Rafaele University, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Cucchetti', 'Affiliation': 'Division of Internal Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14817']
208,33549192,"Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial.","BACKGROUND


Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. This study investigated the efficacy and safety of bimekizumab in patients with moderate to severe plaque psoriasis, the effects of treatment withdrawal, and two maintenance dosing schedules over 56 weeks.
METHODS


BE READY was a phase 3, multicentre, randomised, double-blind, placebo-controlled trial done at 77 sites (hospitals, clinics, private doctor's practices, and dedicated clinical research centres) in nine countries across Asia, Australia, Europe, and North America. Adult patients aged 18 years or older with moderate to severe plaque psoriasis were stratified by region and previous biologic exposure, and randomly assigned (4:1) to receive bimekizumab 320 mg every 4 weeks or placebo every 4 weeks by use of interactive response technology. Coprimary endpoints were the proportion of patients achieving 90% or greater improvement from baseline in the Psoriasis Area Severity Index (PASI90) and the proportion of patients achieving a score of 0 (clear) or 1 (almost clear) on the five-point Investigator's Global Assessment (IGA) scale at week 16 (non-responder imputation). Bimekizumab-treated patients achieving PASI90 at week 16 were re-allocated (1:1:1) to receive bimekizumab 320 mg every 4 weeks, every 8 weeks, or placebo for weeks 16-56. Efficacy analyses were done in the intention-to-treat population; the safety analysis set comprised all patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov (NCT03410992), and is now completed.
FINDINGS


Between Feb 5, 2018, and Jan 7, 2020, 435 patients were randomly assigned to receive either bimekizumab 320 mg every 4 weeks (n=349) or placebo every 4 weeks (n=86). Coprimary endpoints were met: at week 16, 317 (91%) of 349 patients receiving bimekizumab 320 mg every 4 weeks achieved PASI90, compared with one (1%) of 86 patients receiving placebo (risk difference 89·8 [95% CI 86·1-93·4]; p<0·0001); and 323 (93%) of 349 patients receiving bimekizumab 320 mg every 4 weeks achieved an IGA score of 0 or 1 versus one (1%) of 86 patients receiving placebo (risk difference 91·5 [95% CI 88·0-94·9]; p<0·0001). Responses were maintained through to week 56 with bimekizumab 320 mg every 8 weeks and every 4 weeks. Treatment-emergent adverse events in the initial treatment period (up to week 16) were reported in 213 (61%) of 349 patients receiving bimekizumab 320 mg every 4 weeks and 35 (41%) of 86 patients receiving placebo every 4 weeks. From week 16 to week 56, treatment-emergent adverse events were reported in 78 (74%) of 106 patients receiving bimekizumab 320 mg every 4 weeks, 77 (77%) of 100 patients receiving bimekizumab 320 mg every 8 weeks, and 72 (69%) of 105 patients receiving placebo.
INTERPRETATION


Bimekizumab showed high levels of response, which were durable over 56 weeks, with both maintenance dosing schedules (every 4 weeks and every 8 weeks). Moreover, bimekizumab was well tolerated, with no unexpected safety findings. Data presented here further support the therapeutic value of bimekizumab and inhibition of IL-17F in addition to IL-17A for patients with moderate to severe plaque psoriasis.
FUNDING


UCB Pharma.",2021,"From week 16 to week 56, treatment-emergent adverse events were reported in 78 (74%) of 106 patients receiving bimekizumab 320 mg every 4 weeks, 77 (77%) of 100 patients receiving bimekizumab 320 mg every 8 weeks, and 72 (69%) of 105 patients receiving placebo.
","['Adult patients aged 18 years or older with moderate to severe plaque psoriasis', ""77 sites (hospitals, clinics, private doctor's practices, and dedicated clinical research centres) in nine countries across Asia, Australia, Europe, and North America"", 'Between Feb 5, 2018, and Jan 7, 2020, 435 patients', 'patients with moderate to severe plaque psoriasis', 'moderate to severe plaque psoriasis (BE READY']","['bimekizumab', 'Bimekizumab-treated patients achieving PASI90', 'bimekizumab 320 mg every 4 weeks or placebo', 'placebo']","['IGA score', 'Bimekizumab efficacy and safety', 'efficacy and safety', ""Psoriasis Area Severity Index (PASI90) and the proportion of patients achieving a score of 0 (clear) or 1 (almost clear) on the five-point Investigator's Global Assessment (IGA) scale""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0587704', 'cui_str': 'Private doctor'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",435.0,0.526995,"From week 16 to week 56, treatment-emergent adverse events were reported in 78 (74%) of 106 patients receiving bimekizumab 320 mg every 4 weeks, 77 (77%) of 100 patients receiving bimekizumab 320 mg every 8 weeks, and 72 (69%) of 105 patients receiving placebo.
","[{'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, USA. Electronic address: kegordon@mcw.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': 'Skin Health Institute, Carlton, and The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'The Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pinter', 'Affiliation': 'Department of Dermatology, University Hospital Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Vender', 'Affiliation': 'Division of Dermatology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Vanvoorden', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Madden', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'White', 'Affiliation': 'UCB Pharma, Berkshire, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cioffi', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(21)00126-4']
209,33548749,Effects of deep tissue massage on pain and comfort after cesarean: A randomized controlled trial.,"PURPOSE


In this study, it was aimed to determine the effect of deep tissue massage (DTM) applied by midwife on pain and comfort after cesarean section.
MATERIAL AND METHODS


This study was designed as a randomized controlled trial conducted with experimental and control groups. The data were collected using a personal information form, visual analogue scale (VAS), the Postpartum Comfort Questionnaire (PPCQ). DTM was applied to participants in the experimental group twice (at the 10th and 22nd h) after cesarean. No applications were performed in the control group.
RESULTS


According to the measurements, the mean VAS score of the mother in the experimental group was lower than that of the control group (17.51 ± 6.15, 56.16 ± 9.53; respectively) and PPCQ total and sub-dimension mean scores were found to be statistically significant in favor of the experimental group (p < 0.001).
CONCLUSIONS


It was indicated that DTM application decreased the levels of pain and increased the comfort levels of the women who had cesarean sections.",2021,"According to the measurements, the mean VAS score of the mother in the experimental group was lower than that of the control group (17.51 ± 6.15, 56.16 ± 9.53; respectively) and PPCQ total and sub-dimension mean scores were found to be statistically significant in favor of the experimental group (p < 0.001).
",['after cesarean'],"['DTM', 'deep tissue massage (DTM', 'deep tissue massage']","['pain and comfort', 'visual analogue scale (VAS), the Postpartum Comfort Questionnaire (PPCQ', 'levels of pain', 'PPCQ total and sub-dimension mean scores', 'mean VAS score']",[],"[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.0341934,"According to the measurements, the mean VAS score of the mother in the experimental group was lower than that of the control group (17.51 ± 6.15, 56.16 ± 9.53; respectively) and PPCQ total and sub-dimension mean scores were found to be statistically significant in favor of the experimental group (p < 0.001).
","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Güney', 'Affiliation': 'Inonu University, Department of Midwifery, 44280 Malatya, Turkey. Electronic address: esra.guney@inonu.edu.tr.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Uçar', 'Affiliation': 'Inonu University, Department of Midwifery, 44280 Malatya, Turkey. Electronic address: tuba.ucar@inonu.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101320']
210,33548748,Clinical and phytochemical studies of Plantago major in pressure ulcer treatment: A randomized controlled trial.,"BACKGROUND


Plantago major L. is used by local people to improve various wounds and lesions such as pressure ulcer. In this study, the therapeutic effects of P. major topical formulation on the stage 1 pressure ulcer in patients have been investigated.
MATERIALS AND METHODS


This randomized triple blind clinical trial study was performed on 130 patients. During the 14 days of study, each of the test and control groups was checked according to check list. Also the topical formulation was standardized by HPLC based on the amount of quercetin.
RESULTS


The findings of this study indicated a significant difference in resolution of the damage between the test and control groups. Topical formulation was standardized by HPLC based on the quercetin (1.88 mg/100g) and no side effects associated with this topical formulation was found.
CONCLUSION


The results confirmed the traditional use of P. major in resolution of the damage. CLINICAL TRIAL ID: (IRCT201609209014N117).",2021,"Topical formulation was standardized by HPLC based on the quercetin (1.88 mg/100g) and no side effects associated with this topical formulation was found.
",['130 patients'],[],[],"[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],130.0,0.0438995,"Topical formulation was standardized by HPLC based on the quercetin (1.88 mg/100g) and no side effects associated with this topical formulation was found.
","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Ghiasian', 'Affiliation': 'Department of Neurology, School of Medicine, Hamadan University of Medical Science, Hamadan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Niroomandi', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Dastan', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Poorolajal', 'Affiliation': 'Department of Epidemiology, School of Public Health, Hamadan University of Medical Science, Hamadan, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Zare', 'Affiliation': 'Department of Neurology, School of Medicine, Hamadan University of Medical Science, Hamadan, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ataei', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: s.ataei@umsha.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101325']
211,33548747,"Effect of therapeutic touch on daytime sleepiness, stress and fatigue among students of nursing and midwifery: A randomized sham-controlled trial.","OBJECTIVES


This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality and fatigue among students of nursing and midwifery.
METHODS


96 students were randomized into three groups: the therapeutic touch (TT) group, the sham therapeutic touch (STT) group, and the control group. In this randomized sham-controlled study, the TT group was subjected to therapeutic touch twice a week for four weeks with each session lasting 20 min.
RESULTS


When the TT group was compared to the STT and control groups following the intervention, the decrease in the levels of stress (p < 0.001), fatigue (p < 0.001) and daytime sleepiness (p < 0.001), and the increase in the sleep quality (p < 0.001) were found to be significant.
CONCLUSION


It was found that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.",2021,"It was found that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.","['students of nursing and midwifery', '96 students']","['STT', 'therapeutic touch', 'therapeutic touch (TT) group, the sham therapeutic touch (STT']","['stress, daytime sleepiness, sleep quality and fatigue', 'daytime sleepiness', 'levels of stress, fatigue and daytime sleepiness', 'sleep quality', 'fatigue', 'daytime sleepiness, stress and fatigue', 'levels of stress']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",96.0,0.0270069,"It was found that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.","[{'ForeName': 'Birgül', 'Initials': 'B', 'LastName': 'Vural Doğru', 'Affiliation': 'Mersin University, Faculty of Nursing, Internal Nursing Department, Mersin, Turkey. Electronic address: bvuraldogru@gmail.com.'}, {'ForeName': 'Hediye', 'Initials': 'H', 'LastName': 'Utli', 'Affiliation': 'Mardin Artuklu University, Elderly Care Department, Mardin, Turkey. Electronic address: hediyeutli@gmail.com.'}, {'ForeName': 'Fisun', 'Initials': 'F', 'LastName': 'Şenuzun Aykar', 'Affiliation': 'Izmir Tinaztepe University, Faculty of Health Sciences, Nursing Department, Izmir, Turkey. Electronic address: fisunsenuzun@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101322']
212,33550193,"The effect of rosemary essential oil inhalation on sleepiness and alertness of shift-working nurses: A randomized, controlled field trial.","BACKGROUND


Sleepiness during the night shift is a common complaint of shift workers, including the nurses. This study investigated the effects of inhaled rosemary oil on sleepiness and alertness of shift-working nurses.
METHODS


Eighty shift-working nurses were selected and assigned randomly into control (n = 40) and intervention (n = 40) groups. Both groups completed the Karolinska Sleep Questionnaire and Epworth Sleepiness Survey before the intervention. The intervention group received one drop of rosemary essential oil using a mask. The control group received a drop of distilled water instead, after which the questionnaires were completed for a second time.
RESULTS


The sleepiness mean score in the intervention group reduced from 12.15 to 8.3, while it increased from 11.41 to 13.76 in the control group (P < 0.001). The alertness mean scores changed from 4.45 to 3.25 and from 4.41 to 5.34 in intervention and control groups, respectively (P < 0.001).
CONCLUSION


Rosemary aroma decreased sleepiness and increased alertness in shift-working nurses.",2021,"The alertness mean scores changed from 4.45 to 3.25 and from 4.41 to 5.34 in intervention and control groups, respectively (P < 0.001).
","['sleepiness and alertness of shift-working nurses', 'Eighty shift-working nurses', 'n\xa0=\xa040) and intervention (n\xa0=\xa040']","['Rosemary aroma', 'rosemary essential oil using a mask', 'rosemary essential oil inhalation', 'inhaled rosemary oil']","['sleepiness mean score', 'Karolinska Sleep Questionnaire and Epworth Sleepiness Survey', 'alertness mean scores', 'sleepiness and increased alertness']","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0939869', 'cui_str': 'rosemary extract'}, {'cui': 'C2987717', 'cui_str': 'Scents'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0304114', 'cui_str': 'rosemary oil'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",80.0,0.0394962,"The alertness mean scores changed from 4.45 to 3.25 and from 4.41 to 5.34 in intervention and control groups, respectively (P < 0.001).
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Nasiri', 'Affiliation': 'Medical Toxicology and Drug Abuse Research Center (MTDRC), Birjand University of Medical Sciences, Birjand, Iran. Electronic address: nasiri2006@bums.ac.ir.'}, {'ForeName': ""Masoomeh Mo'tamed"", 'Initials': 'MM', 'LastName': 'Boroomand', 'Affiliation': 'MScN, Department of Nursing, Nursing and Midwifery Faculty, Birjand University of Medical Sciences, Birjand, Iran. Electronic address: motamed@bums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101326']
213,33549600,"Information Pamphlet Given to Relatives During the End-of-Life Decision in the ICU: An Assessor-blinded, Randomized Controlled Trial.","BACKGROUND


Symptoms of posttraumatic stress disorder (PTSD) are common in family members of patients who have died in the ICU.
RESEARCH QUESTION


Could a pamphlet describing the role of relatives in the end-of-life decision decrease their risk of developing PTSD-related symptoms?
STUDY DESIGN AND METHODS


In this assessor-blinded, randomized controlled trial, 90 relatives of adult patients for whom an end-of-life decision was anticipated were enrolled. Relatives were randomly assigned to receive oral information as well as an information pamphlet explaining that the end-of-life decision is made by physicians (Group 1; n = 45) or oral information alone (Group 2; n = 45). PTSD-related symptoms were blindly assessed at 90 days following the patient's death by using the Impact of Event Scale (scores range from 0 [indicating no symptoms] to 75 [indicating severe symptoms]). Anxiety and depression symptoms were assessed by using the Hospital Anxiety and Depression Scale score (range, 0-21 [higher scores indicate worse symptoms]).
RESULTS


On day 90, the number of relatives with PTSD-related symptoms was significantly lower in Group 1 than in Group 2: 18 of 45 vs 33 of 45 (P = .001). The risk ratio of having PTSD-related symptoms in Group 2 compared with Group 1 was 1.8 (95% CI, 1.2-2.7). The mean Impact of Event Scale and Hospital Anxiety and Depression Scale scores were significantly reduced in Group 1 compared with Group 2: 28 ± 10 vs 38 ± 14 (P < .001) and 13 ± 5 vs 17 ± 8 (P = .023), respectively.
INTERPRETATION


An information pamphlet describing the relatives' role during end-of-life decisions significantly reduced their risk of developing PTSD-related symptoms.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov; No.: NCT02329418; URL: www.clinicaltrials.gov).",2021,"On day 90, the number of relatives with PTSD-related symptoms was significantly lower in Group 1 than in Group 2: 18/45 versus 33/45 (P=0.001).","['and Methods', 'family members of patients who have died in the intensive care unit (ICU', '90 relatives of adult patients for whom an end-of-life decision was anticipated were enrolled']","['oral information alone', 'ICU']","['risk ratio of having PTSD-related symptoms', 'mean IES and HADS scores', 'number of relatives with PTSD-related symptoms', 'Hospital Anxiety and Depression Scale (HADS) score', 'Anxiety and depression symptoms']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451226', 'cui_str': 'Impact of event scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",90.0,0.218202,"On day 90, the number of relatives with PTSD-related symptoms was significantly lower in Group 1 than in Group 2: 18/45 versus 33/45 (P=0.001).","[{'ForeName': 'Sylvaine', 'Initials': 'S', 'LastName': 'Robin', 'Affiliation': 'Department of Anesthesia and Critical Care, France Université Grenoble Alpes, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Cyrielle', 'Initials': 'C', 'LastName': 'Labarriere', 'Affiliation': 'Department of Anesthesia and Critical Care, Annecy Genevois Hospital, Annecy, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Sechaud', 'Affiliation': 'Department of Anesthesia and Critical Care, France Université Grenoble Alpes, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Dessertaine', 'Affiliation': 'Department of Anesthesia and Critical Care, France Université Grenoble Alpes, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'Department of Public Health, France Université Grenoble Alpes, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Payen', 'Affiliation': 'Department of Anesthesia and Critical Care, France Université Grenoble Alpes, CHU Grenoble Alpes, Grenoble, France. Electronic address: jfpayen@univ-grenoble-alpes.fr.'}]",Chest,['10.1016/j.chest.2021.01.072']
214,33587897,"QT effects of bedaquiline, delamanid, or both in patients with rifampicin-resistant tuberculosis: a phase 2, open-label, randomised, controlled trial.","BACKGROUND


Bedaquiline and delamanid are the first drugs of new classes registered for tuberculosis treatment in 40 years. Each can prolong the QTc interval, with maximum effects occurring weeks after drug initiation. The cardiac safety and microbiological activity of these drugs when co-administered are not well-established. Our aim was to characterise the effects of bedaquiline, delamanid, or both on the QTc interval, longitudinally over 6 months of multidrug treatment, among patients with multidrug-resistant or rifampicin-resistant tuberculosis taking multidrug background therapy.
METHODS


ACTG A5343 is a phase 2, open-label, randomised, controlled trial in which adults with multidrug-resistant or rifampicin-resistant tuberculosis receiving multidrug background treatment were randomly assigned 1:1:1 by centrally, computer-generated randomisation, by means of permuted blocks to receive bedaquiline, delamanid, or both for 24 weeks. Participants were enrolled at TASK in Cape Town and the South African Tuberculosis Vaccine Initiative in Worcester, both in South Africa, and Hospital Maria Auxiliadora in Peru. Individuals with QTc greater than 450 ms were excluded. HIV-positive participants received dolutegravir-based antiretroviral therapy. Clofazimine was disallowed, and levofloxacin replaced moxifloxacin. ECG in triplicate and sputum cultures were done fortnightly. The primary endpoint was mean QTcF change from baseline (averaged over weeks 8-24); cumulative culture conversation at week 8-24 was an exploratory endpoint. Analyses included all participants who initiated study tuberculosis treatment (modified intention-to-treat population). This trial is registered with ClinicalTrials.gov, NCT02583048 and is ongoing.
FINDINGS


Between Aug 26, 2016 and July 13, 2018, of 174 screened, 84 participants (28 in each treatment group, and 31 in total with HIV) were enrolled. Two participants did not initiate study treatment (one in the delamanid group withdrew consent and one in the bedaquiline plus delamanid group) did not meet the eligibility criterion). Mean change in QTc from baseline was 12·3 ms (95% CI 7·8-16·7; bedaquiline), 8·6 ms (4·0-13·1; delamanid), and 20·7 ms (16·1-25·3) (bedaquiline plus delamanid). There were no grade 3 or 4 adverse QTc prolongation events and no deaths during study treatment. Cumulative culture conversion by week 8 was 21 (88%) of 24 (95% CI 71-97; bedaquiline), 20 (83%) of 24 (65-95; delamanid), and 19 (95%) of 20 (79-100; bedaquiline plus delamanid) and was 92% (77-99) for bedaquiline, 91% (76-99), for delamanid, and 95% (79-100) for bedaquiline plus delamanid at 24 weeks.
INTERPRETATION


Combining bedaquiline and delamanid has a modest, no more than additive, effect on the QTc interval, and initial microbiology data are encouraging. This study provides supportive evidence for use of these agents together in patients with multidrug-resistant or rifampicin-resistant tuberculosis with normal baseline QTc values.
FUNDING


Division of AIDS, National Institutes of Health.",2021,"Cumulative culture conversion by week 8 was 21 (88%) of 24 (95% CI 71-97; bedaquiline), 20 (83%) of 24 (65-95; delamanid), and 19 (95%) of 20 (79-100; bedaquiline plus delamanid) and was 92% (77-99) for bedaquiline, 91% (76-99), for delamanid, and 95% (79-100) for bedaquiline plus delamanid at 24 weeks.
","['patients with multidrug-resistant or rifampicin-resistant tuberculosis with normal baseline QTc values', 'Between Aug 26, 2016 and July 13, 2018, of 174 screened, 84 participants (28 in each treatment group, and 31 in total with HIV) were enrolled', 'participants who initiated study tuberculosis treatment (modified intention-to-treat population', 'adults with multidrug-resistant or rifampicin-resistant tuberculosis receiving multidrug background treatment', 'patients with multidrug-resistant or rifampicin-resistant tuberculosis taking multidrug background therapy', 'patients with rifampicin-resistant tuberculosis', 'Participants were enrolled at TASK in Cape Town and the South African Tuberculosis Vaccine Initiative in Worcester, both in South Africa, and Hospital Maria Auxiliadora in Peru', 'Individuals with QTc greater than 450 ms were excluded']","['dolutegravir-based antiretroviral therapy', 'Clofazimine', 'bedaquiline, delamanid, or both for 24 weeks', 'levofloxacin replaced moxifloxacin']","['mean QTcF change', 'cardiac safety and microbiological activity', 'Mean change in QTc', 'cumulative culture conversation', 'Cumulative culture conversion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1532782', 'cui_str': 'Rifampicin resistant tuberculosis'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0041305', 'cui_str': 'Tuberculosis vaccine'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0008996', 'cui_str': 'Clofazimine'}, {'cui': 'C1664205', 'cui_str': 'bedaquiline'}, {'cui': 'C3489682', 'cui_str': 'delamanid'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",84.0,0.331246,"Cumulative culture conversion by week 8 was 21 (88%) of 24 (95% CI 71-97; bedaquiline), 20 (83%) of 24 (65-95; delamanid), and 19 (95%) of 20 (79-100; bedaquiline plus delamanid) and was 92% (77-99) for bedaquiline, 91% (76-99), for delamanid, and 95% (79-100) for bedaquiline plus delamanid at 24 weeks.
","[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: kdooley1@jhmi.edu.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Rosenkranz', 'Affiliation': 'Frontier Science Foundation, Brookline, MA, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Conradie', 'Affiliation': 'University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moran', 'Affiliation': 'Social & Scientific Systems, Silver Spring, MD, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hafner', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'von Groote-Bidlingmaier', 'Affiliation': 'TASK Applied Science, Cape Town, South Africa.'}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': 'Asociación Civil Impacta Salud y Educacion, Lima, Peru.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Shenje', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, Cape Town, South Africa; Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'De Los Rios', 'Affiliation': 'Asociación Civil Impacta Salud y Educacion, Lima, Peru.'}, {'ForeName': 'Kyla', 'Initials': 'K', 'LastName': 'Comins', 'Affiliation': 'TASK Applied Science, Cape Town, South Africa.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Morganroth', 'Affiliation': 'ERT, Philadelphia, PA, USA.'}, {'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Diacon', 'Affiliation': 'TASK Applied Science, Cape Town, South Africa; Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Yoninah S', 'Initials': 'YS', 'LastName': 'Cramer', 'Affiliation': 'Frontier Science Foundation, Brookline, MA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Donahue', 'Affiliation': 'Frontier Science and Technology Research Foundation, Amherst, NY, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Maartens', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Cape Town, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30770-2']
215,33581476,Effect of augmented reality books in salivary cortisol levels in hospitalized pediatric patients: A randomized cross-over trial.,"OBJECTIVE


This study sought to assess the effect of reading augmented reality (AR) books on salivary cortisol levels in hospitalized pediatric patients compared to reading a standard children's book.
METHODS


This was a randomized, two-period, cross-over trial in hospitalized children aged 7-11 years. AR books currently in the market were used as intervention. Complete block randomization was used to randomize the order of the intervention. Children allocated to the 'AR-first' group received the book, a tablet and were left to interact independently with the technology for an hour. After a 48 -h wash-out period, children received a standard book. 'Standard-book-first' group received only the standard book and after wash-out received the tablet and the AR book. Salivary cortisol and a validated visual analogue scale (VAS) for psychological stress were assessed at the beginning and at the end of each intervention.
RESULTS


A total of 29 children were recruited in the study. One was lost during follow up. Cortisol levels decreased after the AR intervention (P = 0.019). Nevertheless, the decrease was not greater than the one associated to reading the standard book. VAS scores increased after the AR intervention (P < 0.001).
DISCUSSION


There is evidence of order and sequence effects that might explain results. First assessment of AR-based interventions on stress. Results justify further research.
CONCLUSIONS


There was no evidence that reading AR books diminished cortisol levels more than reading a standard book. AR-books improved VAS score for psychological stress compared to a standard book.",2021,"VAS scores increased after the AR intervention (P < 0.001).
","['hospitalized children aged 7-11 years', '29 children were recruited in the study', 'hospitalized pediatric patients']","['reading augmented reality (AR) books', 'augmented reality books']","['Cortisol levels', 'VAS scores', 'cortisol levels', 'salivary cortisol levels', 'VAS score', 'Salivary cortisol and a validated visual analogue scale (VAS) for psychological stress']","[{'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0006002', 'cui_str': 'Book'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}]",29.0,0.0428494,"VAS scores increased after the AR intervention (P < 0.001).
","[{'ForeName': 'Dulce E', 'Initials': 'DE', 'LastName': 'Alarcón-Yaquetto', 'Affiliation': 'Unidad de Informática Biomédica en Salud Global, Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia, Lima, Peru; Departamento de Ciencias Biológicas y Fisiológicas, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Peru. Electronic address: dulce.alarcon@upch.pe.'}, {'ForeName': 'Jean P', 'Initials': 'JP', 'LastName': 'Tincopa', 'Affiliation': 'Unidad de Informática Biomédica en Salud Global, Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia, Lima, Peru; Laboratorio de Ingeniería Biomédica, Escuela de Ingeniería, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Guillén-Pinto', 'Affiliation': 'Facultad de Medicina Alberto Hurtado, Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Nacional Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Nataly', 'Initials': 'N', 'LastName': 'Bailon', 'Affiliation': 'Departamento de Ciencias Biológicas y Fisiológicas, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'César P', 'Initials': 'CP', 'LastName': 'Cárcamo', 'Affiliation': 'Unidad de Informática Biomédica en Salud Global, Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia, Lima, Peru.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2021.104404']
216,33581958,Use of modified 3D digital surgical guides in the treatment of complex mandibular fractures.,"The objective of this study was to evaluate the use of 3D modified digital surgical guide plates combined with preformed titanium plates in the treatment of complex mandibular fractures. Patients with complex mandibular fractures were randomized into three groups. Group A was treated with a combination of 3D modified digital surgical guide plates and preformed titanium plates, Group B was treated with preformed titanium plates only, and Group C was treated conventionally. The key design point of the guide plates is the ""slot"" structure, which is crucial for accurately locating the preformed titanium plate. Clinical outcomes, including facial symmetry, surgical accuracy, and maximum deviation were quantitatively assessed postoperatively. Twenty-two patients were recruited for this study, eight for Group A, six for Group B, and eight for Group C. Group A exhibited better postoperative clinical outcomes. Among three groups, significant improvements were found in Group A for facial symmetry (S1 [0.74 ± 0.17 mm, P < 0.001], S2 [0.86 ± 0.21 mm, P = 0.004], S3 [0.92 ± 0.26 mm, P < 0.001], S4 [0.32 ± 0.09 mm, P < 0.001], S5 [0.47 ± 0.16 mm, P = 0.042], S6 [0.35 ± 0.04 mm, P = 0.001], S10 [0.50 ± 0.31 mm, P = 0.048], S11 [0.97 ± 0.29 mm, P = 0.018]) and surgical accuracy (T1 [R, 0.56 ± 0.18 mm, P = 0.021], T1 [L, 0.60 ± 0.30 mm, P = 0.022], T2 [L, 0.76 ± 0.21 mm, P = 0.006], T4 [R, 0.37 ± 0.15 mm, P < 0.001], T4 [L, 0.40 ± 0.15 mm, P = 0.001], T8 [R, 0.40 ± 0.15 mm, P = 0.007], T8 [L, 0.31 ± 0.29 mm, P = 0.001], T9 [L, 0.51 ± 0.33 mm, P = 0.042], T10 [R, 0.58 ± 0.28 mm, P = 0.049], T10 [L, 0.53 ± 0.34 mm, P = 0.046], T11 [R, 0.54 ± 0.13 mm, P = 0.021], T12 [0.45 ± 0.16 mm, P = 0.003]). The ideal postoperative effect was found in Group A with maximum deviation analysis. 3D printed modified digital surgical guide plates can effectively improve treatment outcomes in complex mandibular fractures.",2021,"Among three groups, significant improvements were found in Group A for facial symmetry (S1 [0.74 ± 0.17 mm, P < 0.001], S2 [0.86 ± 0.21 mm, P = 0.004], S3 [0.92 ± 0.26 mm, P < 0.001], S4 [0.32 ± 0.09 mm, P ","['Patients with complex mandibular fractures', 'complex mandibular fractures']","['3D modified digital surgical guide plates combined with preformed titanium plates', 'modified 3D digital surgical guides', '3D modified digital surgical guide plates and preformed titanium plates, Group B was treated with preformed titanium plates']","['facial symmetry', 'facial symmetry, surgical accuracy, and maximum deviation', 'surgical accuracy', 'postoperative clinical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0424480', 'cui_str': 'Facial symmetry'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",22.0,0.0624845,"Among three groups, significant improvements were found in Group A for facial symmetry (S1 [0.74 ± 0.17 mm, P < 0.001], S2 [0.86 ± 0.21 mm, P = 0.004], S3 [0.92 ± 0.26 mm, P < 0.001], S4 [0.32 ± 0.09 mm, P ","[{'ForeName': 'Luyang', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'The State Key Laboratory of Oral Diseases, Sichuan University, Chengdu, 610041, PR China; Department of Oral and Maxillofacial Surgery, West China College of Stomatology, Sichuan University, Chengdu, 610041, PR China; National Engineering Laboratory for Oral Regenerative Medicine, Chengdu, 610041, PR China.'}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Stomatology Hospital, Zhejiang University School of Medicine, 310000, PR China.'}, {'ForeName': 'Zeyou', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'The State Key Laboratory of Oral Diseases, Sichuan University, Chengdu, 610041, PR China; Department of Oral and Maxillofacial Surgery, West China College of Stomatology, Sichuan University, Chengdu, 610041, PR China; National Engineering Laboratory for Oral Regenerative Medicine, Chengdu, 610041, PR China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'The State Key Laboratory of Oral Diseases, Sichuan University, Chengdu, 610041, PR China; Department of Oral and Maxillofacial Surgery, West China College of Stomatology, Sichuan University, Chengdu, 610041, PR China; Engineering Research Center of Oral Translational Medicine, Ministry of Education, Chengdu, 610041, PR China. Electronic address: dr.jielong@hotmail.com.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2021.01.016']
217,33570716,Injection Technique Education in Patients with Diabetes Injecting Insulin into Areas of Lipohypertrophy: A Randomized Controlled Trial.,"INTRODUCTION


The aim of this randomized controlled trial was to assess the impact of providing intensive injection technique (IT) education to patients routinely injecting insulin into sites of lipohypertrophy (LH).
METHODS


Between November 2016 and May 2018, insulin-injecting patients with LH treated at Tianjin Metabolism Hospital (a public tertiary medical institution), Tianjin, China, were included in a 6-month prospective randomized controlled trial and randomized into either the intervention (the IT-education group) or the control (control group) arm. The control and IT-education groups were seen by different groups of trained nurses on different clinic days. IT education emphasized moving injections to normal tissue sites, within-and between-site injection rotation, an initial reduction of insulin total daily dose (TDD), and stopping needle reuse. Needles were provided to the IT group, while controls acquired needles in their usual way. Differences in changes in glycated hemoglobin (HbA1c) and insulin TDD were the primary and main secondary endpoints, respectively.
RESULTS


The control (n = 104) and IT-education (N = 106) groups had similar demographic parameters (97% with type 2 diabetes) and baseline IT behavior. HbA1c reduction was similar in the IT-education and control group in the intention-to-treat (ITT) analysis (6-month between-group difference 0.16% [1.7 mmol/mol], 95% confidence interval [CI] - 0.11, 0.43 [- 1.2, 4.7]; p = 0.239) but was significant by the per-protocol (PP) analysis (difference 0.31% [3.4 mmol/mol], 95% CI 0.02, 0.60 [0.2, 6.6]; p = 0.038). Changes in TDD insulin in the IT-education group were approximately - 7 and - 8 IU by the ITT and PP analyses, respectively, versus - 1 IU (nonsignificant) in the controls (both between-group differences p ≤ 0.05). Despite the study design, IT education ""contamination"" (unplanned adoption of IT-intervention behaviors) was documented in 63 control patients. By post hoc analyses, HbA1c in ""contaminated"" controls decreased by 0.70% (7.7 mmol/mol) vs. 0.20% (2.2 mmol/mol) in ""non-contaminated' patients (p = 0.019) at 6 months.
CONCLUSIONS


Proper IT, including learning to not inject into sites of LH, proper within- and between site rotation, needle reuse reduction, and the use of 4-mm, 32-G needles in Chinese patients injecting into sites of LH enables a safe reduction of TDD insulin while maintaining overall glycemic control.
TRIAL REGISTRATION


Trial registration: ChiCTR-IOR-16009270 in the Chinese Clinical Trials Registry.",2021,"HbA1c reduction was similar in the IT-education and control group in the intention-to-treat (ITT) analysis (6-month between-group difference 0.16% [1.7 mmol/mol], 95% confidence interval [CI] - 0.11, 0.43 [- 1.2, 4.7]; p = 0.239) but was significant by the per-protocol (PP) analysis (difference 0.31% [3.4 mmol/mol], 95% CI 0.02, 0.60 [0.2, 6.6]; p = 0.038).","['patients routinely injecting insulin into sites of lipohypertrophy (LH', '63 control patients', 'Patients with Diabetes', 'Between November 2016 and May 2018, insulin-injecting patients with LH treated at Tianjin Metabolism Hospital (a public tertiary medical institution), Tianjin, China']","['intensive injection technique (IT) education', 'Injection Technique Education']","['Changes in TDD insulin', 'HbA1c reduction', 'glycated hemoglobin (HbA1c) and insulin TDD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C1262113', 'cui_str': 'Lipohypertrophy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.153188,"HbA1c reduction was similar in the IT-education and control group in the intention-to-treat (ITT) analysis (6-month between-group difference 0.16% [1.7 mmol/mol], 95% confidence interval [CI] - 0.11, 0.43 [- 1.2, 4.7]; p = 0.239) but was significant by the per-protocol (PP) analysis (difference 0.31% [3.4 mmol/mol], 95% CI 0.02, 0.60 [0.2, 6.6]; p = 0.038).","[{'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'NHC Key Laboratory of Hormone and Development, Tianjin Key Laboratory of Metabolic Diseases, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China. xfx22081@vip.163.com.'}, {'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'Xing', 'Affiliation': 'NHC Key Laboratory of Hormone and Development, Tianjin Key Laboratory of Metabolic Diseases, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'NHC Key Laboratory of Hormone and Development, Tianjin Key Laboratory of Metabolic Diseases, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'NHC Key Laboratory of Hormone and Development, Tianjin Key Laboratory of Metabolic Diseases, Chu Hsien-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Medical Affairs, Becton Dickinson and Company, Inc., Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Diabetes Care, Becton Dickinson and Company, Inc., Franklin Lakes, NJ, USA.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Pflug', 'Affiliation': 'Diabetes Care, Becton Dickinson and Company, Inc., Franklin Lakes, NJ, USA.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Strauss', 'Affiliation': 'Former Global Medical Affairs, BD Diabetes Care, Becton Dickinson and Company, Inc., Erembodegem, Belgium.'}, {'ForeName': 'Laurence J', 'Initials': 'LJ', 'LastName': 'Hirsch', 'Affiliation': 'Former Global Medical Affairs, BD Diabetes Care, Becton Dickinson and Company, Inc., Franklin Lakes, NJ, 07417, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-021-01013-1']
218,33582295,Harnessing mobile technology to reduce mental health disorders in college populations: A randomized controlled trial study protocol.,"About a third of college students struggle with anxiety, depression, or an eating disorder, and only 20-40% of college students with mental disorders receive treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for a new approach to detect mental health problems and engage college students in services. We have developed a transdiagnostic, low-cost mobile mental health targeted prevention and intervention platform that uses population-level screening to engage college students in tailored services that address common mental health problems. We will test the impact of this mobile mental health platform for service delivery in a large-scale trial across 20+ colleges. Students who screen positive or at high-risk for clinical anxiety, depression, or an eating disorder and who are not currently engaged in mental health services (N = 7884) will be randomly assigned to: 1) intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center). We will test whether the mobile mental health platform, compared to referral, is associated with improved uptake, reduced clinical cases, disorder-specific symptoms, and improved quality of life and functioning. We will also test mediators, predictors, and moderators of improved mental health outcomes, as well as stakeholder-relevant outcomes, including cost-effectiveness and academic performance. This population-level approach to service engagement has the potential to improve mental health outcomes for the millions of students enrolled in U.S. colleges and universities.",2021,"We will test whether the mobile mental health platform, compared to referral, is associated with improved uptake, reduced clinical cases and disorder-specific symptoms, and improved quality of life and functioning.","['college students struggle with anxiety, depression, or an eating disorder, and only 20-40% of college students with mental disorders receive treatment', 'students enrolled in U.S. colleges and universities', 'Students who screen positive or at high-risk for clinical anxiety, depression, or an eating disorder and who are not currently engaged in mental health services (N\u202f=\u202f7884', 'college populations']","['Harnessing mobile technology', 'intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center']","['cost-effectiveness and academic performance', 'mental health disorders']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3873748', 'cui_str': 'Harness'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",7884.0,0.257177,"We will test whether the mobile mental health platform, compared to referral, is associated with improved uptake, reduced clinical cases and disorder-specific symptoms, and improved quality of life and functioning.","[{'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Fitzsimmons-Craft', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: fitzsimmonse@wustl.edu.'}, {'ForeName': 'C Barr', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA; Center for m(2)Health, Palo Alto University, Palo Alto, CA, USA. Electronic address: btaylor@stanford.edu.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, Penn State University, University Park, PA, USA. Electronic address: mgn1@psu.edu.'}, {'ForeName': 'Nur Hani', 'Initials': 'NH', 'LastName': 'Zainal', 'Affiliation': 'Department of Psychology, Penn State University, University Park, PA, USA. Electronic address: nvz5057@psu.edu.'}, {'ForeName': 'Elsa E', 'Initials': 'EE', 'LastName': 'Rojas-Ashe', 'Affiliation': 'Center for m(2)Health, Palo Alto University, Palo Alto, CA, USA. Electronic address: erojas@paloaltou.edu.'}, {'ForeName': 'Sarah Ketchen', 'Initials': 'SK', 'LastName': 'Lipson', 'Affiliation': 'Department of Health Law Policy and Management, Boston University School of Public Health, Boston, MA, USA. Electronic address: sklipson@bu.edu.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Firebaugh', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: mcallewaert@wustl.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ceglarek', 'Affiliation': 'Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, USA. Electronic address: peterceg@umich.edu.'}, {'ForeName': 'Naira', 'Initials': 'N', 'LastName': 'Topooco', 'Affiliation': 'Center for m(2)Health, Palo Alto University, Palo Alto, CA, USA; Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden. Electronic address: naira.topooco@liu.se.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Jacobson', 'Affiliation': 'Departments of Biomedical Data Science and Psychiatry, Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Hanover, NH, USA. Electronic address: Nicholas.C.Jacobson@dartmouth.edu.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA. Electronic address: andrea.graham@northwestern.edu.'}, {'ForeName': 'Hyungjin Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA. Electronic address: myrakim@umich.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eisenberg', 'Affiliation': 'Department of Health Policy and Management, Fielding School of Public Health, University of California at Los Angeles, Los Angeles, CA, USA. Electronic address: daniel.eisenberg@ucla.edu.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: wilfleyd@wustl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106320']
219,33551848,Contrast Tempo of Movement and Its Effect on Power Output and Bar Velocity During Resistance Exercise.,"In this study, we examined the impact of contrast movement tempo (fast vs. slow) on power output and bar velocity during the bench press exercise. Ten healthy men (age = 26.9 ± 4.1 years; body mass = 90.5 ± 10.3 kg; bench press 1RM = 136.8 ± 27.7 kg) with significant experience in resistance training (9.4 ± 5.6 years) performed the bench press exercise under three conditions: with an explosive tempo of movement in each of three repetitions (E/E/E = explosive, explosive, explosive); with a slow tempo of movement in the first repetition and an explosive tempo in the next two repetitions (S/E/E = slow, explosive, explosive); and with a slow tempo of movement in the first two repetitions and an explosive tempo in the last repetition (S/S/E = slow, slow, explosive). The slow repetitions were performed with a 5/0/5/0 (eccentric/isometric/concentric/isometric) movement tempo, while the explosive repetitions were performed with an X/0/X/0 (X- maximal speed of movement) movement tempo. During each experimental session, the participants performed one set of three repetitions at 60%1RM. The two-way repeated measures ANOVA showed a statistically significant interaction effect for peak power output (PP;  p  = 0.03;  η   2  = 0.26) and for peak bar velocity (PV;  p  = 0.04;  η   2  = 0.24). Futhermore there was a statistically significant main effect of condition for PP ( p  = 0.04;  η   2  = 0.30) and PV ( p  = 0.02;  η   2  = 0.35). The  post hoc  analysis for interaction revealed that PP was significantly higher in the 2nd and 3rd repetition for E/E/E compared with the S/S/E ( p  < 0.01 for both) and significantly higher in the 2nd repetition for the S/E/E compared with S/S/E ( p  < 0.01). The  post hoc  analysis for interaction revealed that PV was significantly higher in the 2nd and 3rd repetition for E/E/E compared with the S/S/E ( p  < 0.01 for both), and significantly higher in the 2nd repetition for the S/E/E compared with the S/S/E ( p  < 0.01). The  post hoc  analysis for main effect of condition revealed that PP and PV was significantly higher for the E/E/E compared to the S/S/E ( p  = 0.04;  p  = 0.02; respectively). The main finding of this study was that different distribution of movement tempo during a set has a significant impact on power output and bar velocity in the bench press exercise at 60%1RM. However, the use of one slow repetition at the beginning of a set does not decrease the level of power output in the third repetition of that set.",2020,Futhermore there was a statistically significant main effect of condition for PP ( p  = 0.04;  η   2  = 0.30) and PV ( p  = 0.02;  η   2  = 0.35).,['Ten healthy men (age = 26.9 ± 4.1 years; body mass = 90.5 ± 10.3 kg; bench press 1RM = 136.8 ± 27.7 kg) with significant experience in resistance training (9.4 ± 5.6 years) performed the'],"['bench press exercise under three conditions: with an explosive tempo of movement in each of three repetitions (E/E/E = explosive, explosive, explosive); with a slow tempo of movement in the first repetition and an explosive tempo in the next two repetitions (S/E/E = slow, explosive, explosive); and with a slow tempo of movement in the first two repetitions and an explosive tempo', 'contrast movement tempo (fast vs. slow', 'slow repetitions were performed with a 5/0/5/0 (eccentric/isometric/concentric/isometric) movement tempo, while the explosive repetitions were performed with an X/0/X/0 (X- maximal speed of movement) movement tempo']","['peak bar velocity', 'power output and bar velocity', 'Power Output and Bar Velocity During Resistance Exercise', 'level of power output', 'peak power output (PP', 'PP', 'PP and PV']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",10.0,0.0550049,Futhermore there was a statistically significant main effect of condition for PP ( p  = 0.04;  η   2  = 0.30) and PV ( p  = 0.02;  η   2  = 0.35).,"[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Jarosz', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Filip-Stachnik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Bialas', 'Affiliation': 'Faculty of Physical Education, Gdańsk University of Physical Education and Sport, Gdańsk, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Rzeszutko-Belzowska', 'Affiliation': 'College of Medical Sciences, Institute of Physical Culture Studies, University of Rzeszów, Rzeszów, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Stastny', 'Affiliation': 'Department of Sport Games, Faculty of Physical Education and Sport, Charles University, Prague, Czechia.'}]",Frontiers in physiology,['10.3389/fphys.2020.629199']
220,33589771,Three-year effects of bariatric surgery on obstructive sleep apnea in patients with obesity grade 1 and 2: a sub-analysis of the GATEWAY trial.,"BACKGROUND


Most of the evidence on bariatric surgery on obstructive sleep apnea (OSA) is based on observational studies and/or short-term follow-up in patients with obesity grade 3.
SUBJECTS/METHODS


This randomized study compared the effects of roux-en-Y gastric bypass (RYGB) or usual care (UC) on OSA severity in patients with obesity grade 1-2. Mild, moderate, and severe OSA was defined by the apnea-hypopnoea index (AHI): 5-14.9; 15-29.9, and ≥30 events/h, respectively. OSA remission was defined by converting any form of OSA into normal AHI (<5 events/h).
RESULTS


After 3-year of follow-up, the body-mass index increased in the UC while decreased in the RYGB group: +1.7 (-1.9; 2.7) versus -10.6 (-12.7; -9.2) kg/m 2 , respectively. The AHI increased by 5 (-4.2; 12.7) in the UC group while reduced in the RYGB group to -13.2 (-22.7; -7) events/h. UC significantly increase the frequency of moderate OSA (from 15.4 to 46.2%). In contrast, RYGB had a huge impact on reaching no OSA status (from 4.2 to 70.8%) in parallel to a decrease of moderate (from 41.7 to 8.3%) and severe OSA (from 20.8 to 0%).
CONCLUSIONS


RYGB is an attractive strategy for mid-term OSA remission or decrease moderate-to-severe forms of OSA in patients with obesity grade 1-2.",2021,"After 3-year of follow-up, the body-mass index increased in the UC while decreased in the RYGB group: +1.7 (-1.9; 2.7) versus -10.6 (-12.7; -9.2) kg/","['obstructive sleep apnea (OSA', 'patients with obesity grade 3', 'patients with obesity grade 1 and 2', 'patients with obesity grade 1-2']","['roux-en-Y gastric bypass (RYGB) or usual care (UC', 'bariatric surgery']","['OSA remission', 'reaching no OSA status', 'severe OSA', 'frequency of moderate OSA', 'Mild, moderate, and severe OSA', 'body-mass index', 'AHI', 'obstructive sleep apnea']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0207901,"After 3-year of follow-up, the body-mass index increased in the UC while decreased in the RYGB group: +1.7 (-1.9; 2.7) versus -10.6 (-12.7; -9.2) kg/","[{'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Furlan', 'Affiliation': 'Program in Cardiology, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciano F', 'Initials': 'LF', 'LastName': 'Drager', 'Affiliation': 'Hypertension Unit, University of São Paulo Medical School, São Paulo, Brazil. luciano.drager@incor.com.br.'}, {'ForeName': 'Renato Nakagawa', 'Initials': 'RN', 'LastName': 'Santos', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Angela Cristine', 'Initials': 'AC', 'LastName': 'Bersch-Ferreira', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Tamiris A', 'Initials': 'TA', 'LastName': 'Miranda', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Rachel Helena V', 'Initials': 'RHV', 'LastName': 'Machado', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Eliana V', 'Initials': 'EV', 'LastName': 'Santucci', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Luiz A', 'Initials': 'LA', 'LastName': 'Bortolotto', 'Affiliation': 'Hypertension Unit, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Lorenzi-Filho', 'Affiliation': 'Sleep Laboratory, Pulmonary Division, Heart Institute (InCor), São Paulo, Brazil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Albert Einstein Hospital, São Paulo, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Schiavon', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil. cschiavon@hcor.com.br.'}]",International journal of obesity (2005),['10.1038/s41366-021-00752-2']
221,33588227,Bifactor model of cognition in schizophrenia: Evidence for general and specific abilities.,"BACKGROUND


Despite extensive study of cognition in schizophrenia, it remains unclear as to whether cognitive deficits and their latent structure are best characterized as reflecting a generalized deficit, specific deficits, or some combination of general and specific constructs.
METHOD


To clarify latent structure of cognitive abilities, confirmatory factor analysis was used to examine the latent structure of cognitive data collected for the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) for Schizophrenia study. Baseline assessment data (n = 813) were randomly divided into calibration (n = 413) and cross-validation samples (n = 400). To examine whether generalized or specific deficit models provided better explanation of the data, we estimated first-order, hierarchical, and bifactor models.
RESULTS


A bifactor model with seven specific factors and one general factor provided the best fit to the data for both the calibration and cross-validation samples.
CONCLUSIONS


These findings lend support for a replicable bifactor model of cognition in schizophrenia, characterized by both a general cognitive factor and specific domains. This suggests that cognitive deficits in schizophrenia might be best understood by separate general and specific contributions.",2021,"A bifactor model with seven specific factors and one general factor provided the best fit to the data for both the calibration and cross-validation samples.
",['schizophrenia'],[],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]",[],[],813.0,0.0242855,"A bifactor model with seven specific factors and one general factor provided the best fit to the data for both the calibration and cross-validation samples.
","[{'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Becker', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Anthony O', 'Initials': 'AO', 'LastName': 'Ahmed', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Benning', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Barchard', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'John', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA; Department of Brain Health, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Allen', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA. Electronic address: daniel.allen@unlv.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.01.051']
222,33582566,Associations between fatigue impact and lifestyle factors in people with multiple sclerosis - The Danish MS hospitals rehabilitation study.,"BACKGROUND


The lack of medical treatment options to reduce fatigue in patients with multiple sclerosis (MS) emphasize the importance of identifying potential non-pharmacological modifiable factors, as this may help advance current treatment strategies. The aim of this study was to identify potential modifiable lifestyle factors as well as patient- and disease-related characteristics, that are associated with fatigue in a large sample of clinically well-characterized patients with MS.
METHODS


This study was a secondary analysis of a pragmatic randomized controlled trial of inpatient multidisciplinary rehabilitation in Denmark. MS patients aged 18 to 65 years and with a disease severity score ≤ 7.5 according to the Expanded Disability Status Scale participated. Data on patient- and disease-related characteristics, fatigue impact (Modified Fatigue Impact Scale (MFIS)), and on lifestyle factors (tobacco smoking, alcohol intake, and physical activity), were collected at baseline. A linear mixed model was used to compare MFIS total, physical, cognitive, and psychosocial scores across subgroups of selected characteristics. Regression analyses were used to examine associations between lifestyle factors and MFIS total, physical, cognitive, and psychosocial scores.
RESULTS


In the sample of 417 MS patients, median age was 51 years, 69% were female, median time since diagnosis was 8 years, with 41% having relapsing remitting MS. Higher MFIS total scores were observed in MS patients with shorter time since diagnosis, being a tobacco smoker, and not undertaking regular physical activity. Somewhat similar findings were observed for MFIS subscores (physical, cognitive, psychosocial), especially MFIS physical scores. In the multivariate analyses, physical activity was significantly associated with fatigue impact on total, physical and psychosocial functioning. Tobacco smoking was significantly associated with fatigue impact on psychosocial functioning. Alcohol intake was not associated with fatigue impact. None of the lifestyle factors were associated with fatigue impact on cognitive functioning. In the adjusted models time since diagnosis was significantly associated with fatigue impact on total, physical and cognitive functioning, as was disease severity with fatigue impact on physical and cognitive functioning.
CONCLUSION


Physical activity showed the most pronounced associations with fatigue impact on physical and psychosocial functioning, while the impact on cognitive functioning showed a trend. Tobacco smoking contributed significantly to impact on psychosocial functioning, while alcohol intake did not contribute to fatigue impact. Introducing or supporting maintenance of physical activity/exercise and cessation of tobacco smoking seems to be a useful approach for rehabilitation services to help patients with MS manage fatigue.",2021,"Somewhat similar findings were observed for MFIS subscores (physical, cognitive, psychosocial), especially MFIS physical scores.","['patients with multiple sclerosis (MS', 'MS patients aged 18 to 65 years and with a disease severity score ≤ 7.5 according to the Expanded Disability Status Scale participated', '417 MS patients, median age was 51 years, 69% were female, median time since diagnosis was 8 years, with 41% having relapsing remitting MS', 'people with multiple sclerosis - The Danish MS hospitals rehabilitation study', 'inpatient multidisciplinary rehabilitation in Denmark']",['physical activity/exercise and cessation of tobacco smoking'],"['Alcohol intake', 'fatigue impact on cognitive functioning', 'Tobacco smoking', 'MFIS total, physical, cognitive, and psychosocial scores', 'lifestyle factors and MFIS total, physical, cognitive, and psychosocial scores', 'physical and psychosocial functioning', 'Higher MFIS total scores', 'fatigue impact on total, physical and cognitive functioning', 'MFIS subscores (physical, cognitive, psychosocial), especially MFIS physical scores', 'patient- and disease-related characteristics, fatigue impact (Modified Fatigue Impact Scale (MFIS)), and on lifestyle factors (tobacco smoking, alcohol intake, and physical activity', 'fatigue impact on total, physical and psychosocial functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",417.0,0.0213903,"Somewhat similar findings were observed for MFIS subscores (physical, cognitive, psychosocial), especially MFIS physical scores.","[{'ForeName': 'Sverker', 'Initials': 'S', 'LastName': 'Johansson', 'Affiliation': 'Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden; Allied Health Professionals Function, Medical Unit Occupational Therapy & Physiotherapy, Karolinska University Hospital, Stockholm, Sweden. Electronic address: sverker.johansson@ki.se.'}, {'ForeName': 'Anders G', 'Initials': 'AG', 'LastName': 'Skjerbæk', 'Affiliation': 'MS Hospitals in Denmark, Ry and Haslev, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nørgaard', 'Affiliation': 'MS Hospitals in Denmark, Ry and Haslev, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Boesen', 'Affiliation': 'MS Hospitals in Denmark, Ry and Haslev, Denmark.'}, {'ForeName': 'Lars G', 'Initials': 'LG', 'LastName': 'Hvid', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102799']
223,33582525,Efficacy of intensive orbitofrontal continuous Theta Burst Stimulation (iOFcTBS) in Obsessive Compulsive Disorder: A Randomized Placebo Controlled Study.,"Transcranial magnetic stimulation (TMS) can non-invasively modulate specific brain regions in Obsessive-compulsive disorder (OCD). Citing orbito-frontal cortex (OFC) hyper-connectivity with striatum as the most consistent finding implicated in patho-physiologically of OCD, we aimed to study the effect of novel continuous Theta Burst Stimulation (cTBS) targeting OFC in OCD subjects on a randomized placebo control design. Thirty-three patients were randomly allocated to active cTBS (n= 18) and sham (n= 15) groups. They received 10 TBS sessions, 2 per day (total of 1200 pulses; intensive protocol) for 5 days in a week. The Yale Brown Obsessive Compulsive Scale (Y-BOCS), Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), and Clinical Global Impression-Severity (CGI-S) scores were assessed at baseline, after last session and at 2 weeks post-rTMS. On repeated measures-ANOVA, a significant group*time effect (from pretreatment to 2 weeks post TBS) for obsessions, compulsions, HAM-A, HAM-D, and CGI scores was found. But when controlled for confounding variables, only HAM-A scores and CGI effect retained statistical significance. We conclude that intensive OFC cTBS (iOFcTBS) in OCD is well tolerated with clinically significant improvements in anxiety symptoms and global severity. This improvement in anxiety symptoms could be due to modulations of state dependent dysregulation in OCD.",2021,Transcranial magnetic stimulation (TMS) can non-invasively modulate specific brain regions in Obsessive-compulsive disorder (OCD).,"['Obsessive-compulsive disorder (OCD', 'Obsessive Compulsive Disorder', 'Thirty-three patients']","['Transcranial magnetic stimulation (TMS', 'active cTBS', 'intensive orbitofrontal continuous Theta Burst Stimulation (iOFcTBS', 'Placebo', 'intensive OFC cTBS']","['obsessions, compulsions, HAM-A, HAM-D, and CGI scores', 'anxiety symptoms and global severity', 'Yale Brown Obsessive Compulsive Scale\xa0(Y-BOCS), Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), and Clinical Global Impression-Severity (CGI-S) scores', 'anxiety symptoms']","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1861537', 'cui_str': 'Orofacial Cleft 1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}]","[{'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",33.0,0.0778492,Transcranial magnetic stimulation (TMS) can non-invasively modulate specific brain regions in Obsessive-compulsive disorder (OCD).,"[{'ForeName': 'Parth', 'Initials': 'P', 'LastName': 'Dutta', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Dhyani', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India.'}, {'ForeName': 'Shobit', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India. Electronic address: shobit.garg@gmail.com.'}, {'ForeName': 'Sai Krishna', 'Initials': 'SK', 'LastName': 'Tikka', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Raipur, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Khattri', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mishra', 'Affiliation': 'Clinical Psychology, Government Medical College and Hospital, Chandigarh, India.'}]",Psychiatry research,['10.1016/j.psychres.2021.113784']
224,33588077,Rationale and protocol for a randomized waitlist controlled trial of videoconference delivered cognitive behaviour therapy for insomnia (CBT-I) to improve perceived cognitive impairment (PCI) among cancer survivors.,"Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia) are commonly reported barriers preventing cancer survivors from resuming normal functioning. Cognitive-behaviour therapy for insomnia (CBT-I) is the treatment of choice for insomnia among cancer survivors. Literature suggests that treatment with CBT-I may lead to an improvement in PCI, but this needs to be tested in a sample of patients with PCI at study entry with cognitive impairments as the primary study outcome. Here we describe the design of a clinical trial to evaluate the efficacy of videoconference-delivered CBT-I for the improvement of PCI among cancer survivors. This project is a randomized waitlist-controlled trial with a recruitment target of 124 adult cancer survivors (solid tumors and hematological malignancies) who have completed primary treatment at least 6 months prior, report PCI and meet criteria for insomnia disorder. Participants will complete assessments at baseline, 4 weeks (mid-treatment), 8 weeks (post treatment), and 3 and 6 months post-treatment. The primary outcome is the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog). Treatment of PCI in cancer patients is a priority for clinicians, researchers, and patients. This research will increase our understanding of the mechanisms of cognitive impairment associated with cancer, and potentially expand currently available treatment options.",2021,Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia) are commonly reported barriers preventing cancer survivors from resuming normal functioning.,"['124 adult cancer survivors (solid tumors and hematological malignancies) who have completed primary treatment at least 6\u202fmonths prior, report PCI and meet criteria for insomnia disorder', 'cancer survivors', 'cancer patients']","['videoconference-delivered CBT-I', 'videoconference delivered cognitive behaviour therapy', 'Cognitive-behaviour therapy', 'PCI']","['Functional Assessment of Cancer Therapy - Cognitive Function', 'Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]",124.0,0.109037,Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia) are commonly reported barriers preventing cancer survivors from resuming normal functioning.,"[{'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University, Newfoundland and Labrador, Canada; Discipline of Oncology, Faculty of Medicine, Memorial University, Newfoundland and Labrador, Canada; Beatrice Hunter Cancer Research Institute, Halifax, Nova Scotia, Canada. Electronic address: sheila.garland@mun.ca.'}, {'ForeName': 'Josée', 'Initials': 'J', 'LastName': 'Savard', 'Affiliation': 'École de psychologie, Université Laval and CHU de Québec-Université Laval Research Center, Quebec, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Dalton', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Nyissa A', 'Initials': 'NA', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University, Newfoundland and Labrador, Canada; Beatrice Hunter Cancer Research Institute, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Seal', 'Affiliation': 'Discipline of Oncology, Faculty of Medicine, Memorial University, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rash', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Sondria', 'Initials': 'S', 'LastName': 'Browne', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Urquhart', 'Affiliation': 'Department of Community Health and Epidemiology, Faculty of Medicine, Dalhousie University, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thoms', 'Affiliation': 'Discipline of Oncology, Faculty of Medicine, Memorial University, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Veeresh', 'Initials': 'V', 'LastName': 'Gadag', 'Affiliation': 'Division of Community Health and Humanities, Faculty of Medicine, Memorial University, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Laing', 'Affiliation': 'Discipline of Oncology, Faculty of Medicine, Memorial University, Newfoundland and Labrador, Canada.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106322']
225,33556325,COVID-19 vaccine hesitancy in a representative working-age population in France: a survey experiment based on vaccine characteristics.,"BACKGROUND


Opinion polls on vaccination intentions suggest that COVID-19 vaccine hesitancy is increasing worldwide; however, the usefulness of opinion polls to prepare mass vaccination campaigns for specific new vaccines and to estimate acceptance in a country's population is limited. We therefore aimed to assess the effects of vaccine characteristics, information on herd immunity, and general practitioner (GP) recommendation on vaccine hesitancy in a representative working-age population in France.
METHODS


In this survey experiment, adults aged 18-64 years residing in France, with no history of SARS-CoV-2 infection, were randomly selected from an online survey research panel in July, 2020, stratified by gender, age, education, household size, and region and area of residence to be representative of the French population. Participants completed an online questionnaire on their background and vaccination behaviour-related variables (including past vaccine compliance, risk factors for severe COVID-19, and COVID-19 perceptions and experience), and were then randomly assigned according to a full factorial design to one of three groups to receive differing information on herd immunity (>50% of adults aged 18-64 years must be immunised [either by vaccination or infection]; >50% of adults must be immunised [either by vaccination or infection]; or no information on herd immunity) and to one of two groups regarding GP recommendation of vaccination (GP recommends vaccination or expresses no opinion). Participants then completed a series of eight discrete choice tasks designed to assess vaccine acceptance or refusal based on hypothetical vaccine characteristics (efficacy [50%, 80%, 90%, or 100%], risk of serious side-effects [1 in 10 000 or 1 in 100 000], location of manufacture [EU, USA, or China], and place of administration [GP practice, local pharmacy, or mass vaccination centre]). Responses were analysed with a two-part model to disentangle outright vaccine refusal (irrespective of vaccine characteristics, defined as opting for no vaccination in all eight tasks) from vaccine hesitancy (acceptance depending on vaccine characteristics).
FINDINGS


Survey responses were collected from 1942 working-age adults, of whom 560 (28·8%) opted for no vaccination in all eight tasks (outright vaccine refusal) and 1382 (71·2%) did not. In our model, outright vaccine refusal and vaccine hesitancy were both significantly associated with female gender, age (with an inverted U-shaped relationship), lower educational level, poor compliance with recommended vaccinations in the past, and no report of specified chronic conditions (ie, no hypertension [for vaccine hesitancy] or no chronic conditions other than hypertension [for outright vaccine refusal]). Outright vaccine refusal was also associated with a lower perceived severity of COVID-19, whereas vaccine hesitancy was lower when herd immunity benefits were communicated and in working versus non-working individuals, and those with experience of COVID-19 (had symptoms or knew someone with COVID-19). For a mass vaccination campaign involving mass vaccination centres and communication of herd immunity benefits, our model predicted outright vaccine refusal in 29·4% (95% CI 28·6-30·2) of the French working-age population. Predicted hesitancy was highest for vaccines manufactured in China with 50% efficacy and a 1 in 10 000 risk of serious side-effects (vaccine acceptance 27·4% [26·8-28·0]), and lowest for a vaccine manufactured in the EU with 90% efficacy and a 1 in 100 000 risk of serious side-effects (vaccine acceptance 61·3% [60·5-62·1]).
INTERPRETATION


COVID-19 vaccine acceptance depends on the characteristics of new vaccines and the national vaccination strategy, among various other factors, in the working-age population in France.
FUNDING


French Public Health Agency (Santé Publique France).",2021,"Outright vaccine refusal was also associated with a lower perceived severity of COVID-19, whereas vaccine hesitancy was lower when herd immunity benefits were communicated and in working versus non-working individuals, and those with experience of COVID-19 (had symptoms or knew someone with COVID-19).","['adults aged 18-64 years residing in France, with no history of SARS-CoV-2 infection, were randomly selected from an online survey research panel in July, 2020, stratified by gender, age, education, household size, and region and area of residence to be representative of the French population', '1942 working-age adults, of whom 560 (28·8%) opted for no vaccination in all eight tasks (outright vaccine refusal) and 1382 (71·2%) did not', 'representative working-age population in France']","['vaccination or infection]; >50% of adults must be immunised [either by vaccination or infection]; or no information on herd immunity', 'COVID-19 vaccine hesitancy', 'GP recommendation of vaccination (GP recommends vaccination or expresses no opinion']",['risk of serious side-effects'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4277540', 'cui_str': 'Vaccine Refusal'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1135927', 'cui_str': 'Herd Immunity'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.123408,"Outright vaccine refusal was also associated with a lower perceived severity of COVID-19, whereas vaccine hesitancy was lower when herd immunity benefits were communicated and in working versus non-working individuals, and those with experience of COVID-19 (had symptoms or knew someone with COVID-19).","[{'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Schwarzinger', 'Affiliation': 'Department of Methodology and Innovation in Prevention, Bordeaux University Hospital, Bordeaux, France; University of Bordeaux, Inserm UMR 1219-Bordeaux Population Health, Bordeaux, France. Electronic address: michael.schwarzinger@chu-bordeaux.fr.'}, {'ForeName': 'Verity', 'Initials': 'V', 'LastName': 'Watson', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Arwidson', 'Affiliation': 'Santé Publique France, Saint Maurice, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Alla', 'Affiliation': 'Department of Methodology and Innovation in Prevention, Bordeaux University Hospital, Bordeaux, France; University of Bordeaux, Inserm UMR 1219-Bordeaux Population Health, Bordeaux, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Luchini', 'Affiliation': 'Aix-Marseille University, Centre National de la recherche Scientifique, Aix-Marseille School of Economics, Marseille, France.'}]",The Lancet. Public health,['10.1016/S2468-2667(21)00012-8']
226,33571687,"Comparing recruitment strategies for a digital smoking cessation intervention: Technology-assisted peer recruitment, social media, ResearchMatch, and smokefree.gov.","BACKGROUND


Choosing the right recruitment strategy has implications for the successful conduct of a trial. Our objective was to compare a novel peer recruitment strategy to four other recruitment strategies for a large randomized trial testing a digital tobacco intervention.
METHODS


We compared enrollment rates, demographic and baseline smoking characteristics, and odds of completing the 6-month study by recruitment strategy. Cost of recruitment strategies per retained participant was calculated using staff personnel time and advertisement costs.
FINDINGS


We enrolled 1487 participants between August 2017 and March 2019 from: Peer recruitment n = 273 (18.4%), Facebook Ads n = 505 (34%), Google Ads = 200 (13.4%), ResearchMatch n = 356 (23.9%) and Smokefree.govn = 153 (10.3%). Mean enrollment rate per active recruitment month: 1) Peer recruitment, n = 13.9, 2) Facebook ads, n = 25.3, 3) Google ads, n = 10.51, 4) Research Match, n = 59.3, and 5) Smokefree.gov, n = 13.9. Peer recruitment recruited the greatest number of males (n = 110, 40.3%), young adults (n = 41, 14.7%), participants with a high school degree or less (n = 24, 12.5%) and smokers within one's social network. Compared to peer recruitment (retention rate = 57%), participants from Facebook were less likely (OR 0.46, p < 0.01, retention rate = 40%), and those from ResearchMatch were more likely to complete the study (OR 1.90, p < 0.01, retention rate = 70%). Peer recruitment was moderate in cost per retained participant ($47.18) and substantially less costly than Facebook ($173.60).
CONCLUSIONS


Though peer recruitment had lower enrollment than other strategies, it may provide greater access to harder to reach populations and possibly others who smoke within one's social network while being moderately cost-effective. ClinicalTrials.gov: NCT03224520.",2021,"Compared to peer recruitment (retention rate = 57%), participants from Facebook were less likely (OR 0.46, p < 0.01, retention rate = 40%), and those from ResearchMatch were more likely to complete the study (OR 1.90, p < 0.01, retention rate = 70%).","[""Peer recruitment recruited the greatest number of males (n\u202f=\u202f110, 40.3%), young adults (n\u202f=\u202f41, 14.7%), participants with a high school degree or less (n\u202f=\u202f24, 12.5%) and smokers within one's social network"", 'We enrolled 1487 participants between August 2017 and March 2019 from: Peer recruitment n\u202f=\u202f273 (18.4']","['digital tobacco intervention', 'Facebook Ads']","['Mean enrollment rate per active recruitment month: 1) Peer recruitment, n\u202f=\u202f13.9, 2']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517562', 'cui_str': '13.9'}]",1487.0,0.147848,"Compared to peer recruitment (retention rate = 57%), participants from Facebook were less likely (OR 0.46, p < 0.01, retention rate = 40%), and those from ResearchMatch were more likely to complete the study (OR 1.90, p < 0.01, retention rate = 70%).","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Faro', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States. Electronic address: Jamie.faro@umassmed.edu.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Nagawa', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Orvek', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Bridget M', 'Initials': 'BM', 'LastName': 'Smith', 'Affiliation': 'Center of Innovation for Complex Chronic Healthcare (CINCCH), Spinal Cord Injury Quality Enhancement Research Initiative (QUERI), Hines VAMC, Chicago, IL, United States; Department of Pediatrics and Center for Community Health, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Blok', 'Affiliation': 'Department of Systems, Populations and Leadership, University of Michigan School of Nursing, Ann Arbor, MI, United States.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Houston', 'Affiliation': 'Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC, United States.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Kamberi', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Jeroan J', 'Initials': 'JJ', 'LastName': 'Allison', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Sharina D', 'Initials': 'SD', 'LastName': 'Person', 'Affiliation': 'Division of Biostatistics and Health Services Research, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Rajani S', 'Initials': 'RS', 'LastName': 'Sadasivam', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106314']
227,33578359,Short and long versions of a 12-week netball specific neuromuscular warm-up improves landing technique in youth netballers.,"OBJECTIVE


To investigate the efficacy of two 'NetballSmart', netball specific warm-ups in improving landing technique measures in New Zealand secondary school netball players.
DESIGN


Multi-site cluster experimental trial.
PARTICIPANTS


77 youth participants, mean ± SD age = 15.8 ± 0.9 were recruited from secondary school netball teams.
SETTING


12 teams from 6 schools performed either the NetballSmart Dynamic Warm-up (NSDW) (n = 37); or Power warm-up (PWU) (n = 40), three times a week for 12 weeks. All players within a school (2 teams) were assigned the same warm-up, avoiding treatment contamination.
MAIN OUTCOME MEASURES


A series of unilateral and bilateral drop vertical jumps on to a portable force plate were completed by all participants. Measures included peak vertical ground reaction force (GRF) for single-leg and bilateral landings; frontal plane projection angle (FPPA) for right and left single-leg landings and Landing error scoring system (LESS) for bilateral landings. Paired t-tests were used to assess mean differences pre and post the warm-up. Generalised linear mixed effects models were developed to evaluate the effects between the NSDW and PWU groups.
RESULTS


Significant improvements were found in all the landing technique outcome measures for both warm-up groups (ES Range- GRF = -0.6 to -1.1; FPPA = 0.8 to 1.2; LESS = -1.6 to-3.2; p < 0.05). Results of mixed effects models revealed that there was only a significantly greater improvement in LESS for the PWU group (β = -0.30, p = 0.001).
CONCLUSION


Results show both warm-ups can improve landing technique measures in youth secondary school netball players. It is recommended that coaches should consider implementing one of the two warm-ups in their netball programmes. Their choice of warm-up will likely be dependent on their environment and time demands.",2021,"RESULTS


Significant improvements were found in all the landing technique outcome measures for both warm-up groups (ES Range- GRF = ","['12 teams from 6 schools performed either the', 'All players within a school (2 teams', 'youth secondary school netball players', '77 youth participants, mean\xa0±', 'New Zealand secondary school netball players', 'SD age\xa0', '15.8\xa0±\xa00.9 were recruited from secondary school netball teams', 'youth netballers']","[""two 'NetballSmart', netball specific warm-ups"", 'NetballSmart Dynamic Warm-up (NSDW) (n\xa0=\xa037); or Power warm-up (PWU']","['LESS', 'landing technique measures', 'peak vertical ground reaction force (GRF) for single-leg and bilateral landings; frontal plane projection angle (FPPA) for right and left single-leg landings and Landing error scoring system (LESS) for bilateral landings', 'landing technique outcome measures']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0840974', 'cui_str': 'Netball'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191316', 'cui_str': '15.8'}, {'cui': 'C4068881', 'cui_str': '0.9'}]","[{'cui': 'C0840974', 'cui_str': 'Netball'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]","[{'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",77.0,0.0207781,"RESULTS


Significant improvements were found in all the landing technique outcome measures for both warm-up groups (ES Range- GRF = ","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Belcher', 'Affiliation': 'Sports Performance Research Institute New Zealand, School of Sport and Recreation, Faculty of Health and Environmental Sciences, Auckland University of Technology, New Zealand; Netball New Zealand, Auckland, New Zealand. Electronic address: Suzanne.belcher@netballnorthern.co.nz.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Whatman', 'Affiliation': 'Sports Performance Research Institute New Zealand, School of Sport and Recreation, Faculty of Health and Environmental Sciences, Auckland University of Technology, New Zealand.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Brughelli', 'Affiliation': 'Sports Performance Research Institute New Zealand, School of Sport and Recreation, Faculty of Health and Environmental Sciences, Auckland University of Technology, New Zealand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Borotkanics', 'Affiliation': 'Sports Performance Research Institute New Zealand, School of Sport and Recreation, Faculty of Health and Environmental Sciences, Auckland University of Technology, New Zealand.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.01.016']
228,33581283,Cortical plasticity is correlated with cognitive improvement in Alzheimer's disease patients after rTMS treatment.,"OBJECTIVE


Repetitive transcranial magnetic stimulation (rTMS) has been widely used in non-invasive treatments for different neurological disorders. Few biomarkers are available for treatment response prediction. This study aims to analyze the correlation between changes in long-term potentiation (LTP)-like cortical plasticity and cognitive function in patients with Alzheimer's disease (AD) that underwent rTMS treatment.
METHODS


A total of 75 AD patients were randomized into either 20 Hz rTMS treatment at the dorsolateral prefrontal cortex (DLPFC) group (n = 37) or a sham treatment group (n = 38) for 30 sessions over six weeks (five days per week) with a three-month follow-up. Neuropsychological assessments were conducted using the Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment-Cognitive Component (ADAS-Cog). The cortical plasticity reflected by the motor-evoked potential (MEP) before and after high-frequency repetitive TMS to the primary motor cortex (M1) was also examined prior to and after the treatment period.
RESULTS


The results showed that the cognitive ability of patients who underwent the MMSE and ADAS-Cog assessments showed small but significant improvement after six weeks of rTMS treatment compared with the sham group. The cortical plasticity improvement correlated to the observed cognition change.
CONCLUSIONS


Cortical LTP-like plasticity could predict the treatment responses of cognitive improvements in AD patients receiving rTMS intervention. This warrants future clinical trials using cortical LTP as a predictive marker.",2021,"The cortical plasticity reflected by the motor-evoked potential (MEP) before and after high-frequency repetitive TMS to the primary motor cortex (M1) was also examined prior to and after the treatment period.
","['AD patients receiving rTMS intervention', ""Alzheimer's disease patients after rTMS treatment"", ""patients with Alzheimer's disease (AD) that underwent rTMS treatment"", '75 AD patients']","['20 Hz rTMS treatment at the dorsolateral prefrontal cortex (DLPFC', 'rTMS', 'Repetitive transcranial magnetic stimulation (rTMS']","['cognitive ability', ""Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment-Cognitive Component (ADAS-Cog""]","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",75.0,0.0409499,"The cortical plasticity reflected by the motor-evoked potential (MEP) before and after high-frequency repetitive TMS to the primary motor cortex (M1) was also examined prior to and after the treatment period.
","[{'ForeName': 'Xingxing', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Gangqiao', 'Initials': 'G', 'LastName': 'Qi', 'Affiliation': ""Taizhou Second People's Hospital, Taizhou, Zhejiang, China.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Guomin', 'Initials': 'G', 'LastName': 'Lian', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Shaochang', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': ""The Second People's Hospital of Lishui, Lishui, Zhejiang, China. Electronic address: seywsc@163.com.""}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China. Electronic address: ytf0707@126.com.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China. Electronic address: wyzhouds@sina.com.'}]",Brain stimulation,['10.1016/j.brs.2021.01.012']
229,33567390,Descriptives and baseline ecological momentary assessed predictors of weight change over the course of psychological treatments for binge eating disorder.,"OBJECTIVE


The objectives were to examine individual variability in weight change across psychological treatments for binge-eating disorder (BED) and to examine baseline predictors (i.e., BED symptoms, affect, and appetite) of weight change using ecological momentary assessment (EMA).
METHOD


Adults with BED (N = 110) enrolled in a randomized clinical trial in which they received one of two psychological treatments for BED. At baseline, participants completed a 7-day EMA protocol measuring BED symptoms, affect, and appetite. Height and weight were measured at baseline, mid-treatment, end-of-treatment, and follow-up, and body mass index (BMI) was calculated.
RESULTS


On average, participants evidenced a 2% increase in BMI at end-of-treatment and a 1% increase between end-of-treatment and 6-month follow-up assessments. Although results showed that BMI increased over time, the quadratic term reflected a deceleration in this effect. There were interactions between positive affect and the linear trajectory across time predicting BMI, indicating that individuals reporting higher positive affect at baseline evidenced a flatter trajectory of weight gain. There was a main effect of overeating as assessed by EMA and interactions between overeating and linear and quadratic trajectories across time predicting BMI. Individuals who reported greater overeating at baseline had higher BMI across time. However, the BMI of individuals with lower overeating increased linearly, and increases in BMI among those with average or high rates of overeating appeared to stabilize over time.
CONCLUSION


Despite the variability in weight change, baseline positive affect and overeating may be ecological targets for improving weight outcomes in psychological treatments for BED.",2021,There was a main effect of overeating as assessed by EMA and interactions between overeating and linear and quadratic trajectories across time predicting BMI.,"['binge-eating disorder (BED', 'binge eating disorder', 'Adults with BED']",[],"['weight gain', 'Height and weight', 'BMI', '7-day EMA protocol measuring BED symptoms, affect, and appetite']","[{'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}]",110.0,0.0695477,There was a main effect of overeating as assessed by EMA and interactions between overeating and linear and quadratic trajectories across time predicting BMI.,"[{'ForeName': 'Tyler B', 'Initials': 'TB', 'LastName': 'Mason', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, United States of America. Electronic address: tylermas@usc.edu.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Gail A', 'Initials': 'GA', 'LastName': 'Williams-Kerver', 'Affiliation': 'Department of Biobehavioral Research, Sanford Health, Fargo, ND, United States of America; Department of Psychiatry and Behavioral Science, University of North Dakota School of Medicine and Health Sciences, Fargo, ND, United States of America.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Department of Biobehavioral Research, Sanford Health, Fargo, ND, United States of America; Department of Psychiatry and Behavioral Science, University of North Dakota School of Medicine and Health Sciences, Fargo, ND, United States of America.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Engel', 'Affiliation': 'Department of Biobehavioral Research, Sanford Health, Fargo, ND, United States of America; Department of Psychiatry and Behavioral Science, University of North Dakota School of Medicine and Health Sciences, Fargo, ND, United States of America.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School, Minneapolis, MN, United States of America.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wonderlich', 'Affiliation': 'Department of Biobehavioral Research, Sanford Health, Fargo, ND, United States of America; Department of Psychiatry and Behavioral Science, University of North Dakota School of Medicine and Health Sciences, Fargo, ND, United States of America.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School, Minneapolis, MN, United States of America.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2021.110373']
230,33588078,The multi-ethnic study of atherosclerosis individual response to vitamin D trial: Building a randomized clinical trial into an observational cohort study.,"The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D 3  supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response.",2021,"The final study visit was attended by 611 participants (92%), and median adherence was 98%.","['2210 MESA participants approached for screening, and 96% of those found to be eligible', '666 racially and ethnically diverse participants from January 2017 to April 2019']","['vitamin D 3  supplementation', 'vitamin D supplementation', 'VITamin D (INVITe', 'placebo']",['median adherence'],"[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",2210.0,0.263891,"The final study visit was attended by 611 participants (92%), and median adherence was 98%.","[{'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, United States of America. Electronic address: deboer@uw.edu.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Prince', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Kayleen', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Norrina B', 'Initials': 'NB', 'LastName': 'Allen', 'Affiliation': 'Department of Internal Medicine, Northwestern University, Chicago, IL, United States of America.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Burke', 'Affiliation': 'Division of Public Health Sciences Wake Forest School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Hoofnagle', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The Institute for Translational Genomics and Population Sciences, Department of Pediatrics, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Kiang J', 'Initials': 'KJ', 'LastName': 'Liu', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, IL, United States of America.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'McClelland', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Michos', 'Affiliation': 'Division of Cardiology, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States of America; Department of Epidemiology and the Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Psaty', 'Affiliation': 'Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology and Health Services, University of Washington, Seattle, WA, United States of America; Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY, United States of America; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, United States of America.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Rice', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Jerome I', 'Initials': 'JI', 'LastName': 'Rotter', 'Affiliation': 'The Institute for Translational Genomics and Population Sciences, Department of Pediatrics, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Siscovick', 'Affiliation': 'New York Academy of Medicine, New York, NY, United States of America.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Tracy', 'Affiliation': 'Departments of Pathology & Laboratory Medicine, and Biochemistry, University of Vermont Larner College of Medicine, Burlington, VT, United States of America.'}, {'ForeName': 'Karol E', 'Initials': 'KE', 'LastName': 'Watson', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States of America.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Kestenbaum', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106318']
231,33592551,Effects of art-based mandala intervention on distress and anxiety in cancer patients.,"OBJECTIVE


This study was planned to determine the effect of art-based mandala intervention on the distress and anxiety experienced by cancer patients.
METHODS


This semi-experimental study with a single group pretest-posttest design was performed with 12 breast cancer survival patients. The data were collected through ""Patient Diagnostic Form"", ""Distress Thermometer"", ""Trait Anxiety Inventory"". Patients participated in the ""Art-Based Mandala Interventıon"" for eight weeks, one day a week, 2 h each. The distress and anxiety levels of the patients were measured before starting the program and at the end of the program.
RESULTS


Cancer patients experienced moderate level of anxiety (50.66 ± 6.91) and clinically significant distress (4.08 ± 2.74). Anxiety scores of cancer patients decreased significantly after the program compared to before the program (p < 0.05). The distress scores of cancer patients increased after the program compared to before the program (p > 0.05).
CONCLUSION


After the art-based mandala intervention program, anxiety scores of breast cancer survival patients decreased, and distress scores increased.",2021,Anxiety scores of cancer patients decreased significantly after the program compared to before the program (p < 0.05).,"['cancer patients', 'distress and anxiety experienced by cancer patients', '12 breast cancer survival patients']",['art-based mandala intervention'],"['anxiety scores of breast cancer survival', 'moderate level of anxiety', 'distress and anxiety', 'Anxiety scores of cancer patients', 'distress scores of cancer patients', 'distress and anxiety levels']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",12.0,0.0286735,Anxiety scores of cancer patients decreased significantly after the program compared to before the program (p < 0.05).,"[{'ForeName': 'Hatice Karabuga', 'Initials': 'HK', 'LastName': 'Yakar', 'Affiliation': 'Faculty of Health Sciences, Department of Nursing, Marmara University, Istanbul, Turkey. Electronic address: hatice.karabuga@marmara.edu.tr.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Yilmaz', 'Affiliation': 'Mandala Meditation Therapy Specialist, Bachelor of Arts in Human Behavior, Newport International University, California, United States.'}, {'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Ozkol', 'Affiliation': 'License Graduated Nurse, Faculty of Health Sciences, Department of Nursing, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Fadime', 'Initials': 'F', 'LastName': 'Gevher', 'Affiliation': 'License Graduated Nurse, Faculty of Health Sciences, Department of Nursing, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Celik', 'Affiliation': 'License Graduated Nurse, Faculty of Health Sciences, Department of Nursing, Marmara University, Istanbul, Turkey.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101331']
232,33588138,Evaluation and comparison of the efficacy of long-acting betamethasone and dexamethasone as injections in the treatment of idiopathic sudden hearing loss.,"INTRODUCTION & OBJECTIVE


The aim of the present study was to determine the efficacy of long-acting betamethasone, and its comparison with Dexamethasone as an intratympanic injection in the treatment of Sudden Sensorineural Hearing Loss (SSNHL).
MATERIALS AND METHODS


Thirty-one patients who do not respond to systemic steroids and poor prognosis patients were enrolled in this study. The patients divided randomly into two groups: 1- Dexamethasone and 2- Long acting betamethasone. Dexamethasone (0.4 ml/mg) or long-acting betamethasone (0.1 ml/mg) was slowly injected (0.4 to 0.6 cc) into the superior-anterior area of the tympanic membrane as 6 injections twice a week for a total of 3 weeks. Right after the treatment and one, two and six months after completion of treatment, an audiometry was performed and compared with the pre-injection values.
RESULTS


Speech Reception Threshold (SRT) showed improvements in both groups immediately after treatment and in the follow-up period, compared to baseline. Speech Discrimination Score (SDS) also improved in both groups directly after treatment and at one-month follow-up. The hearing improvement in the Dexamethasone group was clinically better than in the Beta group, but due to the non-parametric data, it was not possible to analyze the hearing improvement process in the variable group.
CONCLUSION


According to the results obtained in this study, intratympanic corticosteroid injection in the treatment of patients with SSNHL has positive and promising results on improving hearing level.",2021,"RESULTS


Speech Reception Threshold (SRT) showed improvements in both groups immediately after treatment and in the follow-up period, compared to baseline.","['Sudden Sensorineural Hearing Loss (SSNHL', 'idiopathic sudden hearing loss', 'Thirty-one patients who do not respond to systemic steroids and poor prognosis patients']","['betamethasone', 'Dexamethasone (0.4\xa0ml/mg) or long-acting betamethasone', 'Dexamethasone and 2- Long acting betamethasone', 'Dexamethasone', 'long-acting betamethasone and dexamethasone']","['Speech Discrimination Score (SDS', 'hearing level', 'hearing improvement process', 'hearing improvement', 'Speech Reception Threshold (SRT']","[{'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0011057', 'cui_str': 'Sudden hearing loss'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0429202', 'cui_str': 'Speech discrimination score'}, {'cui': 'C0175841', 'cui_str': 'Hearing level'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}]",31.0,0.0155399,"RESULTS


Speech Reception Threshold (SRT) showed improvements in both groups immediately after treatment and in the follow-up period, compared to baseline.","[{'ForeName': 'Hakima', 'Initials': 'H', 'LastName': 'Abdullah', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Erfanian', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: r_erfanian@sina.tums.ac.ir.""}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Yazdani', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: n_yazdani@tums.ac.ir.""}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Hajbegloo', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Ardavan', 'Initials': 'A', 'LastName': 'Tajdini', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: a-tajdini@sina.tums.ac.ir.""}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.102955']
233,33592561,"First-line Chemotherapy in Advanced Biliary Tract Cancer Ten Years After the ABC-02 Trial: ""And Yet It Moves!""","Biliary tract cancers (BTCs) include a heterogeneous group of highly aggressive hepatobiliary malignancies, representing the 3% of all gastrointestinal cancers and the second most frequent type of primary liver cancer after hepatocellular carcinoma. Ten years after the publication of the phase III, randomized, ABC-02 trial, the combination of cisplatin plus gemcitabine remains the standard first-line treatment for patients with advanced BTC. In the last decade, a large number of attempts has been made to improve the efficacy of the reference doublet by using novel drugs or adding a third agent to cisplatin-gemcitabine. Unfortunately, despite the addition of different cytotoxic drugs failed to improve clinical outcomes in several studies, recently published clinical trials have provided interesting results, and other first-line chemotherapy options are currently under investigation in randomized phase III studies. Moreover, recent years have witnessed the parallel emergence of molecularly targeted therapies and immune checkpoint inhibitors, with these novel agents having the potential to revolutionize the therapeutic algorithm of advanced BTC. In this review, we will provide an overview on first-line therapeutic opportunities currently available in the management of advanced BTCs, especially focusing on recently published data and ongoing clinical trials in this setting.",2021,"Ten years after the publication of the phase III, randomized, ABC-02 trial, the combination of cisplatin plus gemcitabine remains the standard first-line treatment for patients with advanced BTC.","['patients with advanced BTC', 'Ten Years', 'Advanced Biliary Tract Cancer']","['cisplatin plus gemcitabine', 'cisplatin-gemcitabine', 'First-line Chemotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0053251', 'cui_str': 'Benzotrichloride'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0327104,"Ten years after the publication of the phase III, randomized, ABC-02 trial, the combination of cisplatin plus gemcitabine remains the standard first-line treatment for patients with advanced BTC.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rizzo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi University Hospital, Bologna, Italy; Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, via Albertoni, 15 Bologna, Italy. Electronic address: rizzo.alessandro179@gmail.com.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Brandi', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi University Hospital, Bologna, Italy; Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, via Albertoni, 15 Bologna, Italy.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2021.100335']
234,33601285,A tailored mindfulness-based program for resident physicians: A qualitative study.,"BACKGROUND


Diminished well-being is prevalent in resident physicians. This qualitative study explored the effects of a tailored mindfulness-based program (MBP) aimed at increasing resident physicians' well-being. A second goal was to compare the MBP with an active control group.
MATERIALS AND METHODS


We conducted interviews with 35 resident physicians: 21 physicians attended an eight-week MBP (intervention group) and 14 physicians received text-based information about mindfulness for self-study (control group). The interviews were analyzed using thematic analysis.
RESULTS


Participants in the intervention group reported that the MBP helped them integrate mindfulness into their everyday life, increased their self-awareness, equanimity and well-being, and had positive effects on their self-care and interactions with patients. In the control group, the perceived effects were minor.
CONCLUSION


A tailored mindfulness-based program can help resident physicians care for their own well-being during medical residency and can have positive effects on their interactions with patients.",2021,"RESULTS


Participants in the intervention group reported that the MBP helped them integrate mindfulness into their everyday life, increased their self-awareness, equanimity and well-being, and had positive effects on their self-care and interactions with patients.",['We conducted interviews with 35 resident physicians: 21 physicians attended an eight-week'],"['MBP (intervention group) and 14 physicians received text-based information about mindfulness for self-study (control group', 'tailored mindfulness-based program (MBP']","['MBP helped them integrate mindfulness into their everyday life, increased their self-awareness, equanimity and well-being']","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C3146223', 'cui_str': 'Awareness of self'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0147913,"RESULTS


Participants in the intervention group reported that the MBP helped them integrate mindfulness into their everyday life, increased their self-awareness, equanimity and well-being, and had positive effects on their self-care and interactions with patients.","[{'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'Aeschbach', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 8, 79104, Freiburg, Germany; Department of Occupational and Consumer Psychology, Institute of Psychology, University of Freiburg, Engelbergerstraße 41, 79106, Freiburg, Germany. Electronic address: vanessa.aeschbach@uniklinik-freiburg.de.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Fendel', 'Affiliation': 'Department of Occupational and Consumer Psychology, Institute of Psychology, University of Freiburg, Engelbergerstraße 41, 79106, Freiburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 8, 79104, Freiburg, Germany.'}, {'ForeName': 'Anja S', 'Initials': 'AS', 'LastName': 'Göritz', 'Affiliation': 'Department of Occupational and Consumer Psychology, Institute of Psychology, University of Freiburg, Engelbergerstraße 41, 79106, Freiburg, Germany.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101333']
235,33592310,Improving racial disparities in unmet palliative care needs among intensive care unit family members with a needs-targeted app intervention: The ICUconnect randomized clinical trial.,"INTRODUCTION


The technologies used to treat the millions who receive care in intensive care unit (ICUs) each year have steadily advanced. However, the quality of ICU-based communication has remained suboptimal, particularly concerning for Black patients and their family members. Therefore we developed a mobile app intervention for ICU clinicians and family members called ICUconnect that assists with delivering need-based care.
OBJECTIVE


To describe the methods and early experiences of a clustered randomized clinical trial (RCT) being conducted to compare ICUconnect vs. usual care.
METHODS AND ANALYSIS


The goal of this two-arm, parallel group clustered RCT is to determine the clinical impact of the ICUconnect intervention in improving outcomes overall and for each racial subgroup on reducing racial disparities in core palliative care outcomes over a 3-month follow up period. ICU attending physicians are randomized to either ICUconnect or usual care, with outcomes obtained from family members of ICU patients. The primary outcome is change in unmet palliative care needs measured by the NEST instrument between baseline and 3 days post-randomization. Secondary outcomes include goal concordance of care and interpersonal processes of care at 3 days post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization. We will use hierarchical linear models to compare outcomes between the ICUconnect and usual care arms within all participants and assess for differential intervention effects in Blacks and Whites by adding a patient-race interaction term. We hypothesize that both compared to usual care as well as among Blacks compared to Whites, ICUconnect will reduce unmet palliative care needs, psychological distress and healthcare resource utilization while improving goal concordance and interpersonal processes of care. In this manuscript, we also describe steps taken to adapt the ICUconnect intervention to the COVID-19 pandemic healthcare setting.
ENROLLMENT STATUS


A total of 36 (90%) of 40 ICU physicians have been randomized and 83 (52%) of 160 patient-family dyads have been enrolled to date. Enrollment will continue until the end of 2021.",2021,The technologies used to treat the millions who receive care in intensive care unit (ICUs) each year have steadily advanced.,"['Blacks and Whites by adding a patient-race interaction term', 'ICU attending physicians', 'A total of 36 (90%) of 40 ICU physicians have been randomized and 83 (52%) of 160 patient-family dyads have been enrolled to date']","['ICUconnect intervention', 'ICUconnect vs. usual care', 'ICUconnect']","['change in unmet palliative care needs measured by the NEST instrument', 'goal concordance of care and interpersonal processes of care at 3\u202fdays post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1320929', 'cui_str': 'Attending physician'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]",,0.132682,The technologies used to treat the millions who receive care in intensive care unit (ICUs) each year have steadily advanced.,"[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: christopher.cox@duke.edu.'}, {'ForeName': 'Isaretta L', 'Initials': 'IL', 'LastName': 'Riley', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: isaretta.riley@duke.edu.'}, {'ForeName': 'Deepshikha C', 'Initials': 'DC', 'LastName': 'Ashana', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: deepshikha.ashana@duke.edu.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Haines', 'Affiliation': 'Department of Surgery, Division of Trauma and Critical Care and Acute Care Surgery, Duke University, Durham, North Carolina, United States of America. Electronic address: krista.haines@duke.edu.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America; Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, United States of America. Electronic address: maren.olsen@duke.edu.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: jessie.gu@duke.edu.'}, {'ForeName': 'Elias H', 'Initials': 'EH', 'LastName': 'Pratt', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: elias.pratt@duke.edu.'}, {'ForeName': 'Mashael', 'Initials': 'M', 'LastName': 'Al-Hegelan', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: mashael.alhegelan@duke.edu.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Harrison', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University, Durham, NC, United States of America. Electronic address: robert.w.harrison@duke.edu.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Naglee', 'Affiliation': 'Department of Anesthesia, Division of Neurology, Duke University, Durham, NC, United States of America. Electronic address: colleen.naglee@duke.edu.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Frear', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: allie.frear@duke.edu.'}, {'ForeName': 'Hongqiu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America; Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, United States of America. Electronic address: honqiu.yang@duke.edu.'}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Division of Geriatrics, Center for the Study of Aging and Human Development, Duke University, Durham, NC, United States of America; Durham Veterans Affairs Geriatrics Research Education and Clinical Center (GRECC), United States of America. Electronic address: kimberly.s.johnson@duke.edu.'}, {'ForeName': 'Sharron L', 'Initials': 'SL', 'LastName': 'Docherty', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, United States of America. Electronic address: sharron.docherty@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106319']
236,33594581,"Efficacy and Safety of Luseogliflozin in Patients with Type 2 Diabetes Complicated by Hepatic Dysfunction: A Single-Site, Single-Arm, Open-Label, Exploratory Trial.","INTRODUCTION


Improvements in glycemic control and hepatic function are clinically important goals in the treatment of patients with type 2 diabetes mellitus (T2DM) complicated by hepatic dysfunction. The favorable effects of the sodium-glucose co-transporter inhibitor luseogliflozin on hepatic dysfunction were anticipated for humans. Nevertheless, few clinical studies have confirmed its real-world efficacy on hepatic dysfunction. This trial assessed the efficacy and safety of luseogliflozin in patients with T2DM complicated by hepatic dysfunction.
METHODS


This prospective, single-site, single-arm, open-label, exploratory trial included 55 subjects with T2DM complicated by hepatic dysfunction. Subjects were administered luseogliflozin and observed for 52 weeks. The primary endpoints were the change in aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (γ-GTP), and hemoglobin A1c (HbA1c) from baseline to week 52. The secondary endpoints included body weight, body mass index (BMI), waist circumference, blood pressure, fasting plasma glucose (FPG), homeostatic model assessment beta (HOMA-β), homeostatic model assessment of insulin resistance (HOMA-IR), ferritin, Mac-2 binding protein (M2-BP), fatty liver index (FLI), fibrosis-4 (FIB-4) index, type IV collagen 7S domain, nonalcoholic fatty liver disease (NAFLD) fibrosis score, high-sensitivity C-reactive protein (hs-CRP), and interleukin-6 (IL-6).
RESULTS


AST, ALT, γ-GTP, and HbA1c significantly decreased from baseline to week 52. Body weight, BMI, waist circumference, and FPG also significantly decreased. HOMA-IR significantly decreased but HOMA-β was unchanged. FLI, ferritin, M2-BP, and NAFLD fibrosis scores significantly decreased whereas the FIB-4 index and type IV collagen 7S domain did not significantly change. The hs-CRP and IL-6 levels did not significantly change.
CONCLUSION


Luseogliflozin administration in patients with T2DM complicated by hepatic dysfunction was well tolerated, did not worsen the hepatic condition, and might even be beneficial to improve hepatic function, reduce liver fat, and attenuate liver injury and fibrosis.
TRIAL REGISTRATION


This study was registered under the University Hospital Medical Information Network Clinical Trial Registry (UMIN-CTR) (No. UMIN000025808) and the Japan Registry of Clinical Trials (jRCT) (No. jRCTs021180017).",2021,"Luseogliflozin administration in patients with T2DM complicated by hepatic dysfunction was well tolerated, did not worsen the hepatic condition, and might even be beneficial to improve hepatic function, reduce liver fat, and attenuate liver injury and fibrosis.
","['Patients with Type', 'patients with type\xa02 diabetes mellitus (T2DM) complicated by hepatic dysfunction', 'patients with T2DM complicated by hepatic dysfunction', '2 Diabetes Complicated by Hepatic Dysfunction', '55 subjects with T2DM complicated by hepatic dysfunction']","['luseogliflozin', 'Luseogliflozin', 'sodium-glucose co-transporter inhibitor luseogliflozin']","['HOMA-IR', 'change in aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (γ-GTP), and hemoglobin A1c (HbA1c', 'hepatic dysfunction', 'body weight, body mass index (BMI), waist circumference, blood pressure, fasting plasma glucose (FPG), homeostatic model assessment beta (HOMA-β), homeostatic model assessment of insulin resistance (HOMA-IR), ferritin, Mac-2 binding protein (M2-BP), fatty liver index (FLI), fibrosis-4 (FIB-4) index, type\xa0IV collagen 7S domain, nonalcoholic fatty liver disease (NAFLD) fibrosis score, high-sensitivity C-reactive protein (hs-CRP), and interleukin-6 (IL-6', 'efficacy and safety', 'FLI, ferritin, M2-BP, and NAFLD fibrosis scores', 'hs-CRP and IL-6 levels', 'Body weight, BMI, waist circumference, and FPG', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}]","[{'cui': 'C2933904', 'cui_str': '1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0018353', 'cui_str': 'Guanosine triphosphate'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0217525', 'cui_str': 'LGALS3BP protein, human'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0009333', 'cui_str': 'Collagen type IV'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",55.0,0.0238725,"Luseogliflozin administration in patients with T2DM complicated by hepatic dysfunction was well tolerated, did not worsen the hepatic condition, and might even be beneficial to improve hepatic function, reduce liver fat, and attenuate liver injury and fibrosis.
","[{'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Seino', 'Affiliation': 'Seino Internal Medical Clinic, Kaisei, Koriyama, Fukushima, Japan. kn7jh5@bma.biglobe.ne.jp.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-021-01014-0']
237,33605157,"A prospective, randomized, controlled, crossover study comparing three multilayered foam dressings for the management of chronic wounds.","Aim:  Compare foam dressings - Mepilex Border Flex (MxBF), Allevyn Life (AL) and Optifoam Gentle EX (OGEX) - in treatment of chronic wounds.  Materials & methods:  Prospective, randomized, controlled trial (crossover design). Subjects received one dressing for 2 weeks, then comparator dressing for following 2 weeks. Wound/periwound characteristics evaluated weekly at dressing change. Primary end point: dressing durability (incidence of exudate strikethrough).  Results:  Higher incidence of intact dressings (no strikethrough) at Day 7 (Week 1) with MxBF (6/17; 35.3%) compared with AL (1/18; 5.6%), and with MxBF (7/16; 43.8%) compared with OGEX (2/16; 12.5%; p < 0.05). No significant differences between groups regarding wound size reduction.  Conclusion:  MxBF had statistically greater durability than AL/OGEX during first critical week of treatment.",2021,No significant differences between groups regarding wound size reduction.  ,['chronic wounds'],"['MxBF', 'AL/OGEX', 'multilayered foam dressings', 'foam dressings\xa0- Mepilex Border Flex (MxBF), Allevyn Life (AL) and Optifoam Gentle EX (OGEX) ']","['wound size reduction', 'dressing durability (incidence of exudate strikethrough']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C3164124', 'cui_str': 'Foam dressing'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0658918', 'cui_str': 'allevyn'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}]",,0.0319908,No significant differences between groups regarding wound size reduction.  ,"[{'ForeName': 'Oscar M', 'Initials': 'OM', 'LastName': 'Alvarez', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, NJ 07103, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Granick', 'Affiliation': 'Vascular & Wound Care Center, University Hospital, Rutgers New Jersey Medical School, Newark, NJ 07101, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reyzelman', 'Affiliation': 'California School of Podiatric Medicine at Samuel Merritt University, CA 94609, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Serena', 'Affiliation': 'Serena Group Research Foundation, Cambridge, MA 02140, USA.'}]",Journal of comparative effectiveness research,['10.2217/cer-2020-0268']
238,33607374,"The pneumatization of the sphenoid sinus, its variations and relations with surrounding neurovascular anatomic structures: A computerized tomography study.","INTRODUCTION AND OBJECTIVES


The wide range of variability of SS pneumatization and relation with surrounding structures can result in serious complications; seeing that, the assessment of regional anatomy is essential for both surgeons and radiologists. We mainly aim to reveal the possible correlation between the SS pneumatization types and protrusion/dehiscence of the adjacent neurovascular structures in a larger population by using computerized tomography (CT) images.
METHODS


The type of SS pneumatization (I-IV), pneumatization of anterior clinoid process (ACP), greater wing of sphenoid (GWS), and pterygoid process (PP) was evaluated. Protrusion and dehiscence of ICA, ON, MN, and VN was noted.
RESULTS


1003 patients were included into the study. ICA, ON, and MN protrusions were not seen in patients with the type I or II SS on both sides. These protrusions were most frequently seen along with the type IV SS on both sides (p < 0.05). ICA, ON, MN, and VN dehiscence was not found in any patients with the type I SS. The rate of ICA protrusion increased with presence of GWS and PP; ICA dehiscence was found to be positively correlated with ACP, GWS, and PP pneumatization.
CONCLUSIONS


Variations, either amount or the extent, of the pneumatization of the SS are related with the presence of protrusion/dehiscence of ICA, ON, MN and VN. Knowing and reporting these relations can decrease the rate of complications during skull base surgery.",2021,"ICA, ON, and MN protrusions were not seen in patients with the type I or II SS on both sides.",['1003 patients were included into the study'],[],"['rate of ICA protrusion', 'SS pneumatization (I-IV), pneumatization of anterior clinoid process (ACP), greater wing of sphenoid (GWS), and pterygoid process (PP', 'ACP, GWS, and PP pneumatization', 'ICA, ON, and MN protrusions', 'rate of complications', 'Protrusion and dehiscence of ICA, ON, MN, and VN', 'ICA, ON, MN, and VN dehiscence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0201519', 'cui_str': 'Islet cell antibody measurement'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0230053', 'cui_str': 'Structure of anterior clinoid process'}, {'cui': 'C0222728', 'cui_str': 'Structure of greater wing of sphenoid bone'}, {'cui': 'C0222730', 'cui_str': 'Structure of pterygoid process of sphenoid bone'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}]",1003.0,0.0264324,"ICA, ON, and MN protrusions were not seen in patients with the type I or II SS on both sides.","[{'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Fatihoglu', 'Affiliation': 'Department of Radiology, Erzincan University, Erzincan, Turkey.'}, {'ForeName': 'Sonay', 'Initials': 'S', 'LastName': 'Aydin', 'Affiliation': 'Department of Radiology, Erzincan University, Erzincan, Turkey. Electronic address: sonay.aydin@erzincan.edu.tr.'}, {'ForeName': 'Erdal', 'Initials': 'E', 'LastName': 'Karavas', 'Affiliation': 'Department of Radiology, Erzincan University, Erzincan, Turkey.'}, {'ForeName': 'Mecit', 'Initials': 'M', 'LastName': 'Kantarci', 'Affiliation': 'Department of Radiology, Erzincan University, Erzincan, Turkey; Department of Radiology, Atatürk University, Erzurum, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.102958']
239,33618123,Evaluation of the cognitive benefits of intrathecal baclofen pump implantation in people with intractable multiple sclerosis related spasticity.,"BACKGROUND


Spasticity is a common problematic symptom in Multiple Sclerosis with over one third of patients failing first line therapies. Intrathecal baclofen is a safe and efficacious option for treatment resistant spasticity. Anecdotally patients report improved concentration/cognitive performance when switching to intrathecal baclofen (ITB) from systemic medications.
AIM


To explore whether subjects who proceed with ITB pump implantation for spasticity management and reduce oral anti-spasticity agents will have improved cognitive function.
METHODS


Subjects were admitted for trial of ITB via lumbar puncture and subsequent pump implantation. Spasticity and cognitive measures before ITB trial and 3 months post implant were recorded. Paired t-test or Wilcoxon Signed Ranks test was used for within subject change and effect sizes (Cohen's d z ) were calculated. Subgroup analysis of those on ≥2, or ≤ 1 spasticity medications at baseline was performed.
RESULTS


27 subjects with MS completed per protocol. Mean age 46 years [26 - 56], disease duration 15 years [6 - 26], RRMS = 3, SPMS = 17 and PPMS=7. The majority were on multiple spasticity medications. Spasticity scores significantly improved post pump implant. Mean ITB dose at 3 months was 143 mcg / day and 19 discontinued all other treatments for spasticity. There was no deterioration on any cognitive or mood measure. An improvement of moderate effect size was found in Backwards Digit Span (d=0.41, p=0.059) and HADS - anxiety (d=0.37, p=0.097). Fatigue Severity Scale score decreased substantially (d=0.81, p=0.005). Small improvements in Symbol Digit Modalities Test score (d=0.24) and Sustained Attention to Response Task response time (d=0.23) were non-significant. Performance on other measures did not change. Effect sizes were larger in subgroup on ≥2 oral spasticity medications at baseline, compared to the group on ≤1 medication (SDMT, d=0.42 vs d=0.07; Backwards digit span 0.45 vs 0.28; HADS-anxiety 0.39 vs 0.32; HADS-depression d=0.32 vs 0.05 and FSS, d= 1.14 vs 0.42).
CONCLUSIONS


In a pilot study exploring the impact of ITB on cognition, spasticity scores improved universally and beneficial effects on some measures of fatigue, anxiety, auditory attention and verbal working memory were found. Improvement of speed of processing in those withdrawing higher doses of oral medication was also demonstrated suggesting that switching to ITB has added cognitive and psychological benefits for people with MS.",2021,Small improvements in Symbol Digit Modalities Test score (d=0.24) and Sustained Attention to Response Task response time (d=0.23) were non-significant.,"['27 subjects with MS completed per protocol', 'people with intractable multiple sclerosis related spasticity', 'Subjects were admitted for trial of ITB via lumbar puncture and subsequent pump implantation', 'Mean age 46 years [26 - 56], disease duration 15 years [6 - 26], RRMS\xa0=\xa03, SPMS\xa0=\xa017 and PPMS=7']","['ITB pump implantation', 'intrathecal baclofen pump implantation', 'Intrathecal baclofen']","['cognition, spasticity scores', 'fatigue, anxiety, auditory attention and verbal working memory', 'Backwards Digit Span', 'Fatigue Severity Scale score', 'HADS - anxiety', 'concentration/cognitive performance', 'Symbol Digit Modalities Test score (d=0.24) and Sustained Attention to Response Task response time', 'cognitive or mood measure', 'Spasticity scores', 'moderate effect size', 'oral spasticity medications', 'Spasticity and cognitive measures']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0038111', 'cui_str': 'Saint Pierre and Miquelon'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",27.0,0.0685907,Small improvements in Symbol Digit Modalities Test score (d=0.24) and Sustained Attention to Response Task response time (d=0.23) were non-significant.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Farrell', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London; Department of Neuroinflammation, Queen Square, Institute of Neurology, University College London; NIHR University College London Hospitals, Biomedical Research Centre. Electronic address: rachel.farrell@ucl.ac.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Summers', 'Affiliation': 'Department of Clinical Neuropsychology, National Hospital for Neurology & Neurosurgery, London, United Kingdom.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Doogan', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mulhert', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, University of Manchester, United Kingdom.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Keenan', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Buchanan', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Padilla', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London.'}, {'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Stevenson', 'Affiliation': 'Department of Rehabilitation, The National Hospital for Neurology & Neurosurgery, University College London Hospitals (UCLH), London.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102831']
240,33610123,Cediranib in addition to chemotherapy for women with relapsed platinum-sensitive ovarian cancer (ICON6): overall survival results of a phase III randomised trial.,"BACKGROUND


Cediranib, an oral anti-angiogenic VEGFR 1-3 inhibitor, was studied at a daily dose of 20 mg in combination with platinum-based chemotherapy and as maintenance in a randomised trial in patients with first relapse of 'platinum-sensitive' ovarian cancer and has been shown to improve progression-free survival (PFS).
PATIENTS AND METHODS


ICON6 (NCT00532194) was an international three-arm, double-blind, placebo-controlled randomised trial. Between December 2007 and December 2011, 456 women were randomised, using stratification, to receive either chemotherapy with placebo throughout (arm A, reference); chemotherapy with concurrent cediranib, followed by maintenance placebo (arm B, concurrent); or chemotherapy with concurrent cediranib, followed by maintenance cediranib (arm C, maintenance). Due to an enforced redesign of the trial in September 2011, the primary endpoint became PFS between arms A and C which we have previously published, and the overall survival (OS) was defined as a secondary endpoint, which is reported here.
RESULTS


After a median follow-up of 25.6 months, strong evidence of an effect of concurrent plus maintenance cediranib on PFS was observed [hazard ratio (HR) 0.56, 95% confidence interval (CI) 0.44-0.72, P < 0.0001]. In this final update of the survival analysis, 90% of patients have died. There was a 7.4-month difference in median survival and an HR of 0.86 (95% CI: 0.67-1.11, P = 0.24) in favour of arm C. There was strong evidence of a departure from the assumption of non-proportionality using the Grambsch-Therneau test (P = 0.0031), making the HR difficult to interpret. Consequently, the restricted mean survival time (RMST) was used and the estimated difference over 6 years by the RMST was 4.8 months (95% CI: -0.09 to 9.74 months).
CONCLUSIONS


Although a statistically significant difference in time to progression was seen, the enforced curtailment in recruitment meant that the secondary analysis of OS was underpowered. The relative reduction in the risk of death of 14% risk of death was not conventionally statistically significant, but this improvement and the increase in the mean survival time in this analysis suggest that cediranib may have worthwhile activity in the treatment of recurrent ovarian cancer and that further research should be undertaken.",2021,"The relative reduction in the risk of death of 14% risk of death was not conventionally statistically significant, but this improvement and the increase in the mean survival time in this analysis suggest that cediranib may have worthwhile activity in the treatment of recurrent ovarian cancer and that further research should be undertaken.","[""patients with first relapse of 'platinum-sensitive' ovarian cancer"", 'Between December 2007 and December 2011, 456 women', 'women with relapsed platinum-sensitive ovarian cancer (ICON6']","['placebo', 'chemotherapy with concurrent cediranib, followed by maintenance placebo (arm B, concurrent); or chemotherapy with concurrent cediranib, followed by maintenance cediranib', 'chemotherapy with placebo', 'chemotherapy', 'platinum-based chemotherapy', 'cediranib', 'Cediranib']","['time to progression', 'overall survival (OS', 'median survival', 'mean survival time (RMST', 'hazard ratio (HR', 'mean survival time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1698364', 'cui_str': 'cediranib'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",456.0,0.635554,"The relative reduction in the risk of death of 14% risk of death was not conventionally statistically significant, but this improvement and the increase in the mean survival time in this analysis suggest that cediranib may have worthwhile activity in the treatment of recurrent ovarian cancer and that further research should be undertaken.","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Institute, Cancer Research UK & UCL Trials Centre, London, UK. Electronic address: j.ledermann@ucl.ac.uk.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Embleton-Thirsk', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit, London, UK.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Perren', 'Affiliation': ""Leeds Institute of Medical Research at St James's, Leeds, UK.""}, {'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'Jayson', 'Affiliation': 'Christie Hospital and University of Manchester, Manchester, UK.'}, {'ForeName': 'G J S', 'Initials': 'GJS', 'LastName': 'Rustin', 'Affiliation': 'Mount Vernon Cancer Centre, London, UK.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kaye', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hirte', 'Affiliation': 'Juravinski Cancer Centre, Hamilton, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vaughan', 'Affiliation': 'Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Prince of Wales Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'González-Martín', 'Affiliation': 'Clínica Universidad de Navarra, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Deane', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit, London, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Popoola', 'Affiliation': 'Medical Research Council Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Farrelly', 'Affiliation': 'UCL Cancer Institute, Cancer Research UK & UCL Trials Centre, London, UK.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Swart', 'Affiliation': 'University of East Anglia, Norwich, UK.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Kaplan', 'Affiliation': 'Medical Research Council Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'M K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'Medical Research Council Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ESMO open,['10.1016/j.esmoop.2020.100043']
241,33611761,MMSE is an independent prognostic factor for survival in primary central nervous system lymphoma.,"INTRODUCTION


To assess the value of the Mini-Mental State Examination (MMSE)-score at baseline in predicting survival in adult primary central nervous system lymphoma (PCNSL) patients.
METHODS


In the HOVON 105/ ALLG NHL 24 phase III study patients with newly-diagnosed PCNSL were randomized between high-dose methotrexate-based chemotherapy with or without rituximab. Data on potential (MMSE-score), and known baseline prognostic factors (age, performance status, serum LDH, cerebrospinal fluid total protein, involvement of deep brain structures, multiple cerebral lesions, and the IELSG-score) were collected prospectively. Multivariable stepwise Cox regression analyses were used to assess the prognostic value of all factors on progression-free survival (PFS) and overall survival (OS) among patients with available MMSE score at baseline. Age was analyzed as continuous variable, the MMSE-score both as a continuous and as a categorical variable.
RESULTS


In univariable analysis, age, MMSE-score and whether the patient received rituximab were statistically significantly prognostic factors for PFS. Age and MMSE-score were statistically significantly associated with OS. In a multivariable analysis of the univariately significant factors only MMSE-score was independently associated with the survival endpoints, as a continuous variable (HR for PFS 1.04, 95% CI 1.01-1.08; OS 1.06 (95% CI 1.02-1.10) and as categorical variable HR (< 27 versus ≥ 27 for PFS 1.55 (1.02-2.35); OS 1.68 (1.05-2.70). In our population, performance status, serum LDH, and CSF protein level were not of prognostic value.
CONCLUSION


Neurocognitive disturbances, measured with the MMSE at baseline, are an unfavorable prognostic factor for both PFS and OS in adult PCNSL patients up to 70 years-old.",2021,"In univariable analysis, age, MMSE-score and whether the patient received rituximab were statistically significantly prognostic factors for PFS.","['patients with newly-diagnosed PCNSL', 'adult primary central nervous system lymphoma (PCNSL) patients']","['Mini-Mental State Examination (MMSE)-score at baseline', 'MMSE', 'methotrexate-based chemotherapy with or without rituximab']","['performance status, serum LDH, and CSF protein level', 'survival endpoints', 'potential (MMSE-score), and known baseline prognostic factors (age, performance status, serum LDH, cerebrospinal fluid total protein, involvement of deep brain structures, multiple cerebral lesions, and the IELSG-score', 'categorical variable HR', 'progression-free survival (PFS) and overall survival (OS', 'Age and MMSE-score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0280803', 'cui_str': 'Primary central nervous system lymphoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0201943', 'cui_str': 'Measurement of protein in cerebrospinal fluid specimen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.236234,"In univariable analysis, age, MMSE-score and whether the patient received rituximab were statistically significantly prognostic factors for PFS.","[{'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'van der Meulen', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015 GD, Rotterdam, Netherlands. m.vandermeulen.2@erasmusmc.nl.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Dirven', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Bakunina', 'Affiliation': 'Department of Hematology, HOVON Data Center, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015 GD, Rotterdam, Netherlands.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Issa', 'Affiliation': 'Department of Hematology, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jeanette K', 'Initials': 'JK', 'LastName': 'Doorduijn', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Jacoline E C', 'Initials': 'JEC', 'LastName': 'Bromberg', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015 GD, Rotterdam, Netherlands.'}]",Journal of neuro-oncology,['10.1007/s11060-021-03708-8']
242,33618149,"Trajectories of post-traumatic stress symptoms, anxiety, and depression in hospitalized COVID-19 patients: A one-month follow-up.","OBJECTIVES


Little is known about the mental health outcomes of hospitalized COVID-19 patients. The aims of the study were: (1) to examine the trajectories of anxiety, depression, and pandemic-related stress factors (PRSF) of COVID-19 hospitalized patients one-month following hospitalization; (2) to assess the presence of post-traumatic stress symptoms (PTSS) a month after hospitalization; (3) to identify baseline risk and protective factors that would predict PTSS one month after hospitalization.
METHODS


We contacted hospitalized COVID-19 patients (n = 64) by phone, at three time-points: during the first days after admission to the hospital (T1); after ~two weeks from the beginning of hospitalization (T2), and one month after hospitalization (T3). At all time-points we assessed the levels of anxiety and depression symptoms, as well as PRSF. At T3, PTSS were assessed.
RESULTS


The levels of depressive and anxiety symptoms decreased one-month following hospitalization. Moreover, higher levels of anxiety (standardized β = 1.15, 95% CI = 0.81-1.49, p < 0.001) and depression (β = 0.97, 95% CI = 0.63-1.31 p < 0.001) symptoms during the first week of hospitalization, feeling socially disconnected (β = 0.59, 95% CI = 0.37-0.81 p < 0.001) and experiencing a longer hospitalization period (β = 0.25, 95% CI = 0.03-0.47 p = 0.026) predicted higher PTSS scores a month post-hospitalization.
CONCLUSIONS


We identified early hospitalization risk factors for the development of PTSS one month after hospitalization that should be targeted to reduce the risk for PTSS.",2021,"Moreover, higher levels of anxiety (standardized β = 1.15, 95% CI = 0.81-1.49, p < 0.001) and depression (β = 0.97, 95% CI = 0.63-1.31 p < 0.001) symptoms during the first week of hospitalization, feeling socially disconnected (β = 0.59, 95% CI = 0.37-0.81 p < 0.001) and experiencing a longer hospitalization period (β = 0.25, 95% CI = 0.03-0.47",['hospitalized COVID-19 patients'],[],"['trajectories of anxiety, depression, and pandemic-related stress factors (PRSF', 'PTSS scores', 'levels of anxiety and depression symptoms', 'levels of depressive and anxiety symptoms', 'higher levels of anxiety', 'depression']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.09252,"Moreover, higher levels of anxiety (standardized β = 1.15, 95% CI = 0.81-1.49, p < 0.001) and depression (β = 0.97, 95% CI = 0.63-1.31 p < 0.001) symptoms during the first week of hospitalization, feeling socially disconnected (β = 0.59, 95% CI = 0.37-0.81 p < 0.001) and experiencing a longer hospitalization period (β = 0.25, 95% CI = 0.03-0.47","[{'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Matalon', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Sheba Medical Center, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Shirel', 'Initials': 'S', 'LastName': 'Dorman-Ilan', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Ilanit', 'Initials': 'I', 'LastName': 'Hasson-Ohayon', 'Affiliation': 'The Psychology Department, Bar-Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Nimrod', 'Initials': 'N', 'LastName': 'Hertz-Palmor', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Sheba Medical Center, Ramat Gan, Israel; School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Shachar', 'Initials': 'S', 'LastName': 'Shani', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Sheba Medical Center, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Basel', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Sheba Medical Center, Ramat Gan, Israel; School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Raz', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Division of Psychiatry, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Social Work, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Ayelet', 'Initials': 'A', 'LastName': 'Abramovich', 'Affiliation': 'Department of Social Work, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Arnon', 'Initials': 'A', 'LastName': 'Afek', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Medical Management, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Amitai', 'Initials': 'A', 'LastName': 'Ziv', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Medical Management, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Yitshak', 'Initials': 'Y', 'LastName': 'Kreiss', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Medical Management, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Itai M', 'Initials': 'IM', 'LastName': 'Pessach', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Medical Management, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Gothelf', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Sheba Medical Center, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: gothelf@tauex.tau.ac.il.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2021.110399']
243,33610954,Comparative effects of CPAP and mandibular advancement splint therapy on blood pressure variability in moderate to severe obstructive sleep apnoea.,"BACKGROUND


Obstructive sleep apnoea (OSA) is associated with increased blood pressure variability (BPV) and are risk factors for cardiovascular disease. We aimed to assess the comparative effects of two OSA therapies, continuous positive airway pressure (CPAP) and mandibular advancement splint (MAS), on BPV.
METHODS


This is a secondary analysis of data collected as part of a previously published randomised crossover trial of one month each of CPAP and MAS therapy. BPV was determined from 24-h-ambulatory blood pressure recordings in 92 patients with moderate to severe OSA at baseline and after one month of optimised treatment with each modality. BPV was assessed by three measures: Standard deviation of the mean (SD), Coefficient of variation (CoV), and the Average Real Variability (ARV) index.
RESULTS


Neither CPAP nor MAS therapy improved BPV, with no difference between treatments. BPV did not change in hypertensive OSA patients, however, there was a reduction in ARV of diastolic blood pressure in the effectively treated compared to ineffectively treated CPAP patients, Δ ARV 24-h-DBP (mmHg), -0.72 ± 2.14, 0.34 ± 1.52, P = 0.02, respectively. There was no difference between effective versus ineffective MAS treatment, Δ ARV 24-h-DBP (mmHg), -0.04 ± 2.4, 0.02 ± 1.9, P = 1.00, respectively.
CONCLUSIONS


One month of optimised CPAP or MAS therapy did not improve short term BPV in patients with moderate to severe OSA. The subgroup of patients on effective CPAP showed some improvement in BPV with CPAP but not MAS. Further work on the effect of OSA therapy on BPV following long-term therapy is needed.",2021,"BPV did not change in hypertensive OSA patients, however, there was a reduction in ARV of diastolic blood pressure in the effectively treated compared to ineffectively treated CPAP patients, Δ ARV 24-h-DBP (mmHg), -0.72 ± 2.14, 0.34 ± 1.52, P = 0.02, respectively.","['Obstructive sleep apnoea (OSA', 'moderate to severe obstructive sleep apnoea', 'hypertensive OSA patients', 'patients with moderate to severe OSA', '92 patients with moderate to severe OSA']","['CPAP and mandibular advancement splint therapy', 'OSA therapy', 'CPAP or MAS therapy', 'CPAP and MAS therapy', 'OSA therapies, continuous positive airway pressure (CPAP) and mandibular advancement splint (MAS']","['BPV', 'short term BPV', 'blood pressure variability (BPV', 'blood pressure variability', 'mean (SD), Coefficient of variation (CoV), and the Average Real Variability (ARV) index', 'ARV of diastolic blood pressure']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C5200825', 'cui_str': 'Mandibular Advancement Splints'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",92.0,0.0205561,"BPV did not change in hypertensive OSA patients, however, there was a reduction in ARV of diastolic blood pressure in the effectively treated compared to ineffectively treated CPAP patients, Δ ARV 24-h-DBP (mmHg), -0.72 ± 2.14, 0.34 ± 1.52, P = 0.02, respectively.","[{'ForeName': 'Hasthi U', 'Initials': 'HU', 'LastName': 'Dissanayake', 'Affiliation': 'Sleep Research Group, D 17 - Charles Perkins Centre, The University of Sydney, Australia; Faculty of Medicine and Health, Sydney Medical School, Northern Clinical School, The University of Sydney, Australia. Electronic address: hasthi.dissanayake@sydney.edu.au.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sutherland', 'Affiliation': 'Sleep Research Group, D 17 - Charles Perkins Centre, The University of Sydney, Australia; Faculty of Medicine and Health, Sydney Medical School, Northern Clinical School, The University of Sydney, Australia; Centre for Sleep Health & Research, Department of Respiratory Medicine, Royal North Shore Hospital, Australia.'}, {'ForeName': 'Craig L', 'Initials': 'CL', 'LastName': 'Phillips', 'Affiliation': 'Faculty of Medicine and Health, Sydney Medical School, Northern Clinical School, The University of Sydney, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Faculty of Medicine and Health, Sydney Medical School, Northern Clinical School, The University of Sydney, Australia; Woolcock Institute of Medical Research, Sydney, Australia.'}, {'ForeName': 'Anastasia S', 'Initials': 'AS', 'LastName': 'Mihailidou', 'Affiliation': 'Department of Cardiology and Kolling Institute, Royal North Shore Hospital, St Leonards, Australia; Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Cistulli', 'Affiliation': 'Sleep Research Group, D 17 - Charles Perkins Centre, The University of Sydney, Australia; Faculty of Medicine and Health, Sydney Medical School, Northern Clinical School, The University of Sydney, Australia; Centre for Sleep Health & Research, Department of Respiratory Medicine, Royal North Shore Hospital, Australia.'}]",Sleep medicine,['10.1016/j.sleep.2021.01.059']
244,33618033,Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia - Study design and protocol.,"OBJECTIVE


Juvenile-onset fibromyalgia (JFM) is a chronic debilitating pain condition that negatively impacts physical, social and academic functioning. Cognitive-behavioral therapy (CBT) is beneficial in reducing functional disability among adolescents with JFM but has only a modest impact on pain reduction and does not improve physical exercise participation. This randomized controlled trial (RCT) aims to test whether a novel intervention that combines CBT with specialized neuromuscular exercise training (the Fibromyalgia Integrative Training program for Teens ""FIT Teens"") is superior to CBT alone or a graded aerobic exercise (GAE) program.
DESIGN/METHODS


This 3-arm multi-site RCT will examine the efficacy of the FIT Teens intervention in reducing functional disability (primary outcome) and pain intensity (secondary outcome), relative to CBT or GAE. All interventions are 8-weeks (16 sessions) in duration and are delivered in small groups of 4-6 adolescents with JFM. A total of 420 participants are anticipated to be enrolled across seven sites with approximately equal allocation to each treatment arm. Functional disability and average pain intensity in the past week will be assessed at baseline, post-treatment and at 3-, 6-, 9- and 12-month follow-up. The 3-month follow-up is the primary endpoint to evaluate treatment efficacy; longitudinal assessments will determine maintenance of treatment gains. Changes in coping, fear of movement, biomechanical changes and physical fitness will also be evaluated.
CONCLUSIONS


This multi-site RCT is designed to evaluate whether the combined FIT Teens intervention will have significantly greater effects on disability and pain reduction than CBT or GAE alone for youth with JFM. Clinical trials.gov registration: NCT03268421.",2021,All interventions are 8-weeks,"['Teens ""FIT Teens', 'adolescents with JFM', '420 participants are anticipated to be enrolled across seven sites with approximately equal allocation to each treatment arm', 'adolescents with juvenile fibromyalgia - Study design and protocol', 'Juvenile-onset fibromyalgia (JFM']","['fibromyalgia integrative training (FIT teens', 'CBT with specialized neuromuscular exercise training (the Fibromyalgia Integrative Training program', 'CBT alone or a graded aerobic exercise (GAE) program', 'Cognitive-behavioral therapy (CBT']","['Functional disability and average pain intensity', 'functional disability', 'disability and pain reduction', 'Changes in coping, fear of movement, biomechanical changes and physical fitness', 'pain intensity (secondary outcome), relative to CBT or GAE']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]",420.0,0.0985581,All interventions are 8-weeks,"[{'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Kashikar-Zuck', 'Affiliation': ""Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. Electronic address: susmita.kashikar-zuck@cchmc.org.""}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Briggs', 'Affiliation': 'Sports Medicine Research Institute, and Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Bout-Tabaku', 'Affiliation': 'Department of Pediatric Medicine, Sidra Medicine, Doha, Qatar; Weill Cornell Medicine, Doha, Qatar.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Connelly', 'Affiliation': ""Division of Developmental and Behavioral Sciences, Children's Mercy Hospital, Kansas City, KS, USA.""}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Daffin', 'Affiliation': ""Department of Pediatrics, University of Louisville, School of Medicine, Norton Children's Hospital, Louisville, KY, USA.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Guite', 'Affiliation': 'Department of Pediatrics and Nursing, University of Connecticut, Hartford, CT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ittenbach', 'Affiliation': ""Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Deirdre E', 'Initials': 'DE', 'LastName': 'Logan', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesia, Boston Children's Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Lynch-Jordan', 'Affiliation': ""Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Myer', 'Affiliation': 'Sports Performance and Research Center, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Ounpuu', 'Affiliation': ""Center for Motion Analysis, Connecticut Children's Medical Center, Department of Orthopedic Surgery, University of Connecticut School of Medicine, Hartford, CT, USA.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peugh', 'Affiliation': ""Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Schikler', 'Affiliation': ""Department of Pediatrics, University of Louisville, School of Medicine, Norton Children's Hospital, Louisville, KY, USA.""}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Sugimoto', 'Affiliation': 'Sport Sciences, Waseda University, Tokyo, Japan; The Micheli Center for Sports Injury Prevention, Waltham, MA, USA.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Stinson', 'Affiliation': 'Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, Toronto, Canada; Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Tracy V', 'Initials': 'TV', 'LastName': 'Ting', 'Affiliation': ""Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Staci', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': ""Division of Sports Medicine, SPORT Center, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Williams', 'Affiliation': ""Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Zempsky', 'Affiliation': ""Department of Pediatrics and Nursing, University of Connecticut, Hartford, CT, USA; Division of Pain and Palliative Medicine, Connecticut Children's Medical Center, Hartford, CT, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2021.106321']
245,33610076,Impact of a brief behavioral treatment for insomnia (BBTi) on metacognition in older adults.,"INTRODUCTION


Brief (≤4 sessions) behavioral treatment for insomnia (BBTi) improves insomnia symptoms in older adults. Findings for BBTi-related improvements in objective cognition are mixed, with our recent trial reporting no effects. Metacognition (appraisal of one's own performance) has not been examined. This study examined the effects of BBTi on metacognition in older adults with insomnia.
METHODS


Older adults with insomnia [N = 62, Mage = 69.45 (SD = 7.71)] were randomized to 4-weeks of BBTi (n = 32; psychoeducation, sleep hygiene, stimulus control, sleep restriction, relaxation, review/maintenance) or self-monitoring control (SMC; n = 30; social conversations). Throughout the study (2 week baseline, 4 week treatment, 2 week post-treament, 2 week 3-month followup), participants completed daily paper/pencil cognitive tasks (measuring verbal memory, attention, processing speed and reasoning) and provided daily metacognition ratings of their performance in four areas: quality, satisfaction, compared to same age peers, compared to own ability. Two-week averages of metacognitive ratings were calculated for baseline, treatment-first half, treatment-second half, post-treatment, and 3-month follow-up. Multilevel Modeling examined treatment effects (BBTi/SMC) over time on metacognition, controlling for age and sex.
RESULTS


A significant group by time interaction (p = 0.05) revealed consistent improvements over time in better metacognitive ratings relative to same age peers for BBTi. Specifically, baseline ratings [mean (M) = 51.21, standard error (SE) = 3.15] improved at first half of treatment (M = 56.65, SE = 3.15, p < 0.001), maintained improvement at second-half of treatment (p = 0.18), showed additional improvement at post-treatment (M = 60.79, SE = 3.15, p = 0.02), and maintained improvement at follow-up (M = 62.30, SE = 3.15; p = 0.02). SMC prompted inconsistent and smaller improvements between baseline (M = 53.24, SE = 3.29) and first-half of treatment (M = 56.62, SE = 3.28; p = 0.004), with additional improvement at second-half of treatment (M = 59.39, SE = 3.28; p = 0.02) that was maintained at post-treatment (p = 0.73) and returned to levels observed at first-half of treatment (M = 57.78, SE = 3.21; p = 0.55). Significant main effects of time (all ps < 0.001) for other metacognition variables (Quality, Satisfaction, Compared to own ability) indicated general improvements over time for both groups.
DISCUSSION


Metacognition generally improved over time regardless of treatment. BBTi selectively improved ratings of performance relative to same age peers. Repeated objective testing alone may improve metacognition in older adults with insomnia. Better understanding of metacognition and how to improve it has important implications for older adults as metacognitive complaints have been associated with mild cognitive impairment.",2021,A significant group by time interaction (p = 0.05) revealed consistent improvements over time in better metacognitive ratings relative to same age peers for BBTi.,"['62, Mage\xa0', 'n\xa0=\xa032', 'older adults', 'Older adults with insomnia', 'older adults with insomnia']","['BBTi ', 'psychoeducation, sleep hygiene, stimulus control, sleep restriction, relaxation, review/maintenance) or self-monitoring control (SMC; n\xa0=\xa030; social conversations', 'BBTi', 'Brief (≤4 sessions) behavioral treatment for insomnia (BBTi', 'brief behavioral treatment']","['time interaction', 'metacognitive ratings', 'insomnia symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0871436', 'cui_str': 'Stimulus control'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0198712,A significant group by time interaction (p = 0.05) revealed consistent improvements over time in better metacognitive ratings relative to same age peers for BBTi.,"[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'Department of Psychiatry, University of Missouri-Columbia, Columbia, MO, USA. Electronic address: mccraec@health.missouri.edu.'}, {'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'Curtis', 'Affiliation': 'Department of Psychiatry, University of Missouri-Columbia, Columbia, MO, USA; Department of Psychological Sciences, University of Missouri-Columbia, Columbia, MO, USA.'}, {'ForeName': 'Neetu', 'Initials': 'N', 'LastName': 'Nair', 'Affiliation': 'Department of Psychiatry, University of Missouri-Columbia, Columbia, MO, USA.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Berry', 'Affiliation': 'Department of Psychological Sciences, University of Missouri-Columbia, Columbia, MO, USA.'}, {'ForeName': 'Mattina', 'Initials': 'M', 'LastName': 'Davenport', 'Affiliation': 'Department of Psychiatry, University of Missouri-Columbia, Columbia, MO, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McGovney', 'Affiliation': 'Department of Psychological Sciences, University of Missouri-Columbia, Columbia, MO, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Berry', 'Affiliation': 'College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'McCoy', 'Affiliation': 'Neuropsychology Service, South Texas Veterans Health Care System, San Antonio, TX, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marsiske', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}]",Sleep medicine,['10.1016/j.sleep.2021.01.039']
246,33609973,Impact of high-risk features for stage II adenocarcinoma of the appendix.,"BACKGROUND


Clinico-pathological high-risk features are frequently utilized in adjuvant chemotherapy (AC) decisions in stage II colorectal cancer and their utility in stage II appendiceal adenocarcinoma (AA) is not established. The aim of this study is to determine the impact of high-risk features in clinical outcomes and whether high risk features are predictive of AC benefit in stage II AA.
METHODS


Patients with pathological stage II AA between 2010 and 2015 were identified from the National Cancer Database (NCDB) using ICD-O-3 morphology and topography codes: 8140, 8480 and C18.1. High risk stage II AA was defined as having at least one of the following clinicopathological features: T4 tumor, <12 lymph nodes examined, poorly differentiated histology, positive margins, or lymphovascular invasion. Patients with none of these features were defined as low-risk.
RESULTS


A total of 1040 patients with pathological stage II AA were identified. 51.0% males, 84.5% Caucasian; median age 61 (range, 19-90). 46.4% were determined to have high-risk stage II AA. High-risk status was associated with worse OS compared to low-risk in univariate (HR 1.55; 95% CI 1.18-2.02; p = 0.001) and multivariable analyses (HR 1.36; 95% CI 1.03-1.79; p = 0.028). High-risk stage II AA patients had significantly worse 5-year OS compared to low-risk patients (67.1% vs. 74.5%, p = 0.0013). AC was administered in 34.4% (n = 166) of high-risk patients and in 36.5% (n = 203) of low-risk patients. Among high-risk patients, AC was not associated with better OS in univariate (HR 0.86; 95% CI 0.59-1.26; p = 0.448) and multivariable analyses (HR 1.35; 95% CI 0.90-2.04; p = 0.151) compared to no AC. Similarly, among low-risk patients, AC was not associated with better OS in univariate (HR 0.92; 95% CI 0.60-1.39; p = 0.679) and multivariable analyses (HR 1.27; 95% CI 0.81-2.02; p = 0.299) compared to no AC. For high-risk patients, 5-year OS was 68.3% in patients that received AC vs. 66.5% in patients that did not (p = 0.722). For low-risk patients, 5-year OS was 74.0% in patients that received AC vs. 76.3% in patients that did not (p = 0.813).
CONCLUSION


High-risk stage II AA patients had significantly worse 5-year OS compared to low-risk patients. AC did not improve survival regardless of high-risk features in stage II AA in this retrospective study. A prospective randomized clinical trial would be required to determine the impact of high-risk features on AC in stage II AA.",2021,"For high-risk patients, 5-year OS was 68.3% in patients that received AC vs. 66.5% in patients that did not (p = 0.722).","['203) of low-risk patients', '51.0% males, 84.5% Caucasian; median age 61 (range, 19-90', '1040 patients with pathological stage II AA', 'stage II adenocarcinoma of the appendix', 'Patients with pathological stage II AA between 2010 and 2015 were identified from the National Cancer Database (NCDB) using ICD-O-3 morphology and topography codes: 8140, 8480 and C18.1']",[],"['High risk stage II AA', '5-year OS', 'High-risk stage']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0238003', 'cui_str': 'Adenocarcinoma of appendix'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0009219', 'cui_str': 'Coding'}]",[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",1040.0,0.29023,"For high-risk patients, 5-year OS was 68.3% in patients that received AC vs. 66.5% in patients that did not (p = 0.722).","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Akce', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA. Electronic address: mehmet.akce@emory.edu.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Zakka', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'McKenna', 'Initials': 'M', 'LastName': 'Penley', 'Affiliation': 'Winship Research Informatics, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Renjian', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Winship Research Informatics, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Khalil', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Olatunji B', 'Initials': 'OB', 'LastName': 'Alese', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Walid L', 'Initials': 'WL', 'LastName': 'Shaib', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Behera', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA; Winship Research Informatics, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Bassel F', 'Initials': 'BF', 'LastName': 'El-Rayes', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2021.100329']
247,33617181,Subcostal Anterior Quadratus Lumborum Block Versus Epidural Block for Analgesia in Open Nephrectomy: A Randomized Clinical Trial.,"BACKGROUND


Epidural block are often used for analgesia after open nephrectomy surgery. Subcostal anterior quadratus lumborum block may be an alternative. We therefore tested the hypothesis that the continuous subcostal anterior quadratus lumborum block is noninferior to epidural block for analgesia in patients having open partial nephrectomies.
METHODS


Adults having open partial nephrectomies were randomly allocated to epidural or unilateral subcostal anterior quadratus lumborum block. The joint primary outcomes were opioid consumption measured in morphine equivalents and pain measured on a numeric rating scale (0-10) from postanesthesia care unit (PACU) until 72 hours after surgery. The noninferiority deltas were 30% for opioid consumption and 1 point on a 0-10 scale for pain. Secondary outcomes included patient global assessment of pain management on the third postoperative day, the number of antiemetic medication doses through the third postoperative day, duration of PACU stay, and postoperative duration of hospitalization.
RESULTS


Twenty-six patients were randomized to anterior quadratus lumborum block and 29 to epidural analgesia. Neither pain scores nor opioid consumption in the quadratus lumborum patients were noninferior to epidural analgesia. At 72 hours, mean ± standard deviation pain scores in subcoastal anterior quadratus lumborum block and epidural group were 4.7 ± 1.8 and 4.1 ± 1.7, with an estimated difference in pain scores of 0.62 (95% confidence interval [CI], 0.74-1.99; noninferiority P = .21). The median [Q1, Q3] opioid consumption was more than doubled in quadratus lumborum patients at 70 mg [43, 125] versus 30 mg [18, 75] in the epidural group with an estimated ratio of geometric means of 1.69 (95% CI, 0.66-4.33; noninferiority P = .80). Patient global assessment and duration of PACU and hospital stays did not differ significantly in the 2 groups.
CONCLUSIONS


We were unable to show that subcostal anterior quadratus lumborum block are noninferior to epidural analgesia in terms of pain scores and opioid consumption for open partial nephrectomies. Effectiveness of novel blocks should be rigorously tested in specific surgical setting before widespread adoption.",2021,"Patient global assessment and duration of PACU and hospital stays did not differ significantly in the 2 groups.
","['Open Nephrectomy', 'Adults having open partial nephrectomies', 'Twenty-six patients', 'patients having open partial nephrectomies']","['epidural or unilateral subcostal anterior quadratus lumborum block', 'Subcostal Anterior Quadratus Lumborum Block Versus Epidural Block', 'anterior quadratus lumborum block and 29 to epidural analgesia']","['patient global assessment of pain management on the third postoperative day, the number of antiemetic medication doses through the third postoperative day, duration of PACU stay, and postoperative duration of hospitalization', 'median [Q1, Q3] opioid consumption', 'opioid consumption measured in morphine equivalents and pain measured on a numeric rating scale (0-10) from postanesthesia care unit (PACU', 'Patient global assessment and duration of PACU and hospital stays', 'pain scores', 'pain scores nor opioid consumption', 'mean ± standard deviation pain scores']","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0442184', 'cui_str': 'Subcostal'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",26.0,0.189898,"Patient global assessment and duration of PACU and hospital stays did not differ significantly in the 2 groups.
","[{'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Elsharkawy', 'Affiliation': 'From the Department of Anesthesiology, Pain and Healing Center, Case Western Reserve University, MetroHealth, Cleveland, Ohio.'}, {'ForeName': 'Sanchit', 'Initials': 'S', 'LastName': 'Ahuja', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Guangmei', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Wael Ali', 'Initials': 'WA', 'LastName': 'Sakr Esa', 'Affiliation': 'Department of General Anesthesiology and.'}, {'ForeName': 'Loran Mounir', 'Initials': 'LM', 'LastName': 'Soliman', 'Affiliation': 'Department of General Anesthesiology and.'}, {'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Dilara', 'Initials': 'D', 'LastName': 'Khoshknabi', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Mohammad Zafeer', 'Initials': 'MZ', 'LastName': 'Khan', 'Affiliation': 'Department of Anesthesiology, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Raza', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'DeGrande', 'Affiliation': 'Department of Anesthesia, Seven Hills Anesthesia, Edgewood, Kentucky.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005382']
248,33609624,"Benralizumab for adolescent patients with severe, eosinophilic asthma: Safety and efficacy after 3 years of treatment.","BACKGROUND


Adults and adolescents with severe asthma who completed the 48-week SIROCCO and 56-week CALIMA phase III benralizumab trials entered the safety extension study BORA (NCT02258542). The continued safety and efficacy of benralizumab in the first year of BORA (year 2 of treatment) have been reported.
OBJECTIVE


We sought to report outcomes for adolescents during years 2 and 3 of treatment in BORA.
METHODS


Patients on benralizumab 30 mg every 4 weeks (Q4W) or every 8 weeks (Q8W) in SIROCCO/CALIMA continued their regimens in BORA (Q4W/Q4W and Q8W/Q8W, respectively), whereas placebo patients were rerandomized 1:1 to benralizumab (placebo/Q4W and placebo/Q8W, respectively) for 108 weeks. The primary outcome was safety; secondary outcomes included reduction in annual asthma exacerbation rate and change from baseline in prebronchodilator FEV 1 .
RESULTS


Adolescents (N = 86) were treated with benralizumab Q8W (n = 61) or Q4W (n = 25); 69 completed treatment (Q8W: n = 51; Q4W: n = 18). For Q4W and Q8W regimens, rates of treatment-emergent adverse events were 68% (17 of 25) and 74% (45 of 61), respectively, rates of treatment-emergent adverse events (TEAEs) were 68% (17/25) and 74% (45/61), TEAEs leading to discontinuation were 4% (1/25) and 0%, serious AEs were 8% (2/25) and 7% (4/61), and no deaths occurred. In efficacy analyses, 69% (42 of 61) Q8W patients were exacerbation-free (placebo/Q8W: 62% [18 of 29], Q8W/Q8W: 75% [24 of 32]). Mean ± SD change in FEV 1  at week 108 versus BORA baseline was 0.327 ± 0.452 L (placebo/Q8W) and 0.323 ± 0.558 L (Q8W/Q8W).
CONCLUSIONS


Safety and efficacy profiles in this 2-year extension study (up to 3 years of benralizumab treatment in adolescents) were consistent with previous findings.",2021,"Mean ± SD change in FEV 1  at Week 108 vs. BORA baseline was 0.327 ± 0.452 L (placebo/Q8W) and 0.323 ± 0.558 L (Q8W/Q8W).
","['Adolescents (N=86) were treated with', 'Adolescent Patients with Severe, Eosinophilic Asthma', 'n=61) or Q4W (n=25); 69 completed treatment (Q8W: n=51; Q4W: n=18', 'Adults and adolescents with severe asthma', 'adolescents during Years 2 and 3 of treatment in BORA', 'treatment in adolescents', 'Patients on']","['benralizumab Q8W', 'Benralizumab', 'BORA', 'benralizumab', 'benralizumab 30 mg every 4 weeks (Q4W) or every 8 weeks (Q8W) in SIROCCO', 'benralizumab (placebo/Q4W and placebo']","['Mean ± SD change', 'rates of treatment-emergent adverse event (TEAEs', 'reduction of annual asthma exacerbation rate and change from baseline in prebronchodilator forced expiratory volume in 1 second (FEV 1 ', 'serious AEs', 'exacerbation-free']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2982078', 'cui_str': 'benralizumab'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0585337', 'cui_str': 'Bimonthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.301583,"Mean ± SD change in FEV 1  at Week 108 vs. BORA baseline was 0.327 ± 0.452 L (placebo/Q8W) and 0.323 ± 0.558 L (Q8W/Q8W).
","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wis. Electronic address: wwb@medicine.wisc.edu.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'University of Arizona College of Medicine, Tucson, Ariz.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'FitzGerald', 'Affiliation': 'The Lung Centre, Vancouver General Hospital, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Mich.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Barker', 'Affiliation': 'AstraZeneca, Gaithersburg, Md.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brooks', 'Affiliation': 'AstraZeneca, Gaithersburg, Md.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Olsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Ubaldo J', 'Initials': 'UJ', 'LastName': 'Martin', 'Affiliation': 'AstraZeneca, Gaithersburg, Md.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Goldman', 'Affiliation': 'AstraZeneca, Gaithersburg, Md.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2021.02.009']
249,33611164,Metronomic oral vinorelbine in previously untreated advanced non-small-cell lung cancer patients unfit for platinum-based chemotherapy: results of the randomized phase II Tempo Lung trial.,"BACKGROUND


To assess the efficacy and safety of a metronomic schedule of oral vinorelbine (mVNR) in advanced non-small-cell lung cancer (NSCLC) in patients unfit for platinum-based combination chemotherapy.
PATIENTS AND METHODS


This was a multicenter, prospective, randomized, open-label phase II study in treatment-naive patients with TNM stage IIIB/IV NSCLC. Patients received mVNR at a fixed dose of 50 mg × 3 or standard schedule 60-80 mg/m 2  weekly until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) without grade 4 toxicity (G4PFS; NCI-CTC v4). Main secondary objectives were safety, disease control rate (DCR) without grade 4 toxicity (G4DCR), DCR, PFS, overall survival (OS) and quality of life (QoL).
RESULTS


A total of 167 patients were included, 83 and 84 patients in the mVNR and standard arms, respectively. The median G4PFS was 4.0 months [95% confidence interval (CI): 2.6-4.3] and 2.2 months (95% CI: 1.5-2.9), hazard ration (HR) = 0.63 (95% CI: 0.45-0.88), P = 0.0068 in favor of metronomic arm; G4DCR was 45.8% and 26.8% in the mVNR and standard arms, respectively. Grade 3-4 treatment-related adverse events were less frequent in the mVNR arm (25.3% versus 54.4%) mainly owing to a reduction in all grades (15.7% versus 51.9%) and grade 3-4 neutropenia (10.8% versus 42%). PFS was 4.3 (95% CI: 3.3-5.1) and 3.9 months (95% CI: 2.8-5.2) in mVNR and standard arms, respectively. No difference in median OS was observed. QoL was comparable between arms.
CONCLUSIONS


Metronomic oral vinorelbine significantly prolonged median G4PFS in advanced NSCLC patients unfit for platinum combinations as first-line treatment. It was associated with a clear reduction in toxicity and may be considered as an important option in this challenging population.",2021,"PFS was 4.3 (95% CI: 3.3-5.1) and 3.9 months (95% CI: 2.8-5.2) in mVNR and standard arms, respectively.","['A total of 167 patients were included, 83 and 84 patients in the mVNR and standard arms, respectively', 'treatment-naive patients with TNM stage IIIB/IV NSCLC', 'previously untreated advanced non-small-cell lung cancer patients unfit for', 'advanced non-small-cell lung cancer (NSCLC) in patients unfit for platinum-based combination chemotherapy', 'advanced NSCLC patients']","['oral vinorelbine (mVNR', 'platinum-based chemotherapy', 'Metronomic oral vinorelbine', 'mVNR']","['median G4PFS', 'PFS', 'progression-free survival (PFS) without grade 4 toxicity (G4PFS; NCI-CTC v4', 'grade 3-4 neutropenia', 'efficacy and safety', 'toxicity', 'median OS', 'adverse events', 'QoL', 'safety, disease control rate (DCR) without grade 4 toxicity (G4DCR), DCR, PFS, overall survival (OS) and quality of life (QoL']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",167.0,0.16936,"PFS was 4.3 (95% CI: 3.3-5.1) and 3.9 months (95% CI: 2.8-5.2) in mVNR and standard arms, respectively.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Camerini', 'Affiliation': 'Medical Oncology Department, Versilia Hospital, Lido di Camaiore, Italy. Electronic address: andrea.camerini@uslnordovest.toscana.it.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morabito', 'Affiliation': 'Thoracic Medical Oncology, Istituto Nazionale Tumori, ""Fondazione G. Pascale"", IRCCS, Napoli, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Montanino', 'Affiliation': 'Thoracic Medical Oncology, Istituto Nazionale Tumori, ""Fondazione G. Pascale"", IRCCS, Napoli, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bernabé', 'Affiliation': 'Medical Oncology Department, Hospital Virgen del Rocio, Institute for Biomedical Research, Seville, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Grossi', 'Affiliation': ""Division of Medical Oncology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ramlau', 'Affiliation': 'Oncology Department, Poznan University of Medical Sciences, Poland.'}, {'ForeName': 'T-E', 'Initials': 'TE', 'LastName': 'Ciuleanu', 'Affiliation': 'Oncology Institute ""Pr Dr Ion Chiricuta"", Cluj-Napoca, Romania.'}, {'ForeName': 'G-L', 'Initials': 'GL', 'LastName': 'Ceresoli', 'Affiliation': 'Oncology Department, Cliniche Humanitas Gavazzeni, Bergamo, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pasello', 'Affiliation': 'Oncology 2, Istituto Oncologico Veneto IRCCS, Padova, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'de Marinis', 'Affiliation': 'Thoracic Oncology Division, European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bosch-Barrera', 'Affiliation': 'Lung Cancer Unit, Catalan Institute of Oncology, Hospital Universitari Dr Josep Trueta, Girona, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Laundreau', 'Affiliation': 'Medical Affairs Oncology, Pierre Fabre Médicament, Boulogne, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gautier', 'Affiliation': 'IRPF, Pierre Fabre Médicament, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ta Thanh Minh', 'Affiliation': 'Medical Affairs Oncology, Pierre Fabre Médicament, Boulogne, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kowalski', 'Affiliation': 'Lung Cancer and Chest Tumours Department, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}]",ESMO open,['10.1016/j.esmoop.2021.100051']
250,33616875,"A Pragmatic Study of Basal and Mid-Mixture Insulins as Starter Insulins in Chinese Patients With Type 2 Diabetes: Observations From Long-Term, Real-World Experience.","INTRODUCTION


According to Chinese guidelines, basal insulin (BI) or premixed insulins are recommended insulin starters following the failure of oral antihyperglycemic medication (OAM) in Chinese patients with type 2 diabetes (T2D). This pragmatic study investigated the long-term effectiveness, safety, and cost of add-on BI and mid-mixture insulin analog (MMI) regimens in Chinese patients with T2D.
METHODS


This multicenter, open-label, pragmatic study randomized patients 1:1 to receive either BI or MMI with OAMs adjusted according to current standards of care. We evaluated the change in glycated hemoglobin (HbA1c) from baseline, safety parameters, and antidiabetic medication costs.
RESULTS


Change in HbA1c from baseline showed a statistically greater decrease at week 48 in the MMI group (MMI: - 2.03% [0.06] vs. BI: - 1.82% [0.06]; P < 0.05). Both groups showed decreases in fasting plasma glucose (mmol/L) (MMI: - 2.53 [0.14] vs. BI: - 3.19 [0.14]; P < 0.01) and postprandial glucose (mmol/L) (MMI: - 4.35 [0.22] vs. BI: - 4.33 [0.23]). More patients in the BI group showed increases in OAM use, while OAM use decreased in the MMI group. Both groups showed stable glycemic control with a very limited insulin dose change from week 24 to week 48. The incidence of total hypoglycemia was higher in the MMI group (MMI: 124% [30.7] vs. BI: 76% [18.5], P < 0.0001), but no incidence of severe hypoglycemia was reported in either group. Treatment costs, in terms of average daily cost and cost of glycemic control, were higher in the BI group.
CONCLUSION


In long-term real-world use, the MMI and BI groups demonstrated improved glycemic control, with the MMI group showing more significant improvement than the BI group. Hypoglycemia incidence was higher in the MMI group, with no major safety issues through week 48. MMI is likely to provide better price value than BI for the treatment of T2D in Chinese patients.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03018938.",2021,"More patients in the BI group showed increases in OAM use, while OAM use decreased in the MMI group.","['Chinese patients', 'Chinese Patients With Type 2 Diabetes', 'Chinese patients with T2D.\nMETHODS', 'Chinese patients with type 2 diabetes (T2D']","['BI or MMI with OAMs', 'BI and mid-mixture insulin analog (MMI) regimens', 'Basal and Mid-Mixture Insulins']","['average daily cost and cost of glycemic control', 'severe hypoglycemia', 'incidence of total hypoglycemia', 'postprandial glucose', 'Hypoglycemia incidence', 'fasting plasma glucose', 'stable glycemic control', 'glycemic control', 'OAM use, while OAM use', 'glycated hemoglobin (HbA1c) from baseline, safety parameters, and antidiabetic medication costs']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]",,0.0243322,"More patients in the BI group showed increases in OAM use, while OAM use decreased in the MMI group.","[{'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Zeng', 'Affiliation': 'Department of Endocrinology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': ""Department of Endocrinology, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Henan, China.""}, {'ForeName': 'Jiangong', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Department of Endocrinology, Lanzhou University Second Hospital, Gansu, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.'}, {'ForeName': 'Jiankun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. cheria_chen@126.com.'}, {'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China. jiln@bjmu.edu.cn.""}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-021-01007-z']
251,33624377,Lung cancer stigma is a predictor for psychological distress: A longitudinal study. Lung cancer stigma is a predictor for psychological distress.,"OBJECTIVES


To examine if baseline stigma predicts psychological distress at 3 and 6 months follow-up among patients newly diagnosed with lung cancer.
METHODS


This longitudinal study was nested within a larger randomised controlled trial. Eligible participants were recruited via respiratory and oncology out-patient clinics in Australia (n = 194). Consenting participants were asked to complete surveys at baseline, 3 and 6 months post-recruitment. Measures included lung cancer stigma (Cataldo Lung Cancer Stigma Scale) and psychological distress (General Health Questionnaire-12 [GHQ-12]).
RESULTS


One-hundred and ninety-four participants were included for analysis. Most were male (57.7%) with a mean age of 68 years (SD = 8.8). A significant relationship between baseline lung cancer stigma and psychological distress at 6 months was found, where a one unit increase in lung cancer stigma increases psychological distress by 0.044 when adjusting for age, gender, smoking status, baseline GHQ-12 scores and intervention allocation (as part of the larger trial; p = 0.001; β = 0.044, 95% CI = 0.010, 0.079).
CONCLUSION


Temporal links between lung cancer stigma and psychological distress was found at 6 months, suggesting stigma-related experiences may have a delayed impact. Development of routine lung cancer stigma assessments is recommended to identify those at risk of psychological distress.",2021,"To examine if baseline stigma predicts psychological distress at 3 months and 6 months follow-up among patients newly diagnosed with lung cancer.
","['Eligible participants were recruited via respiratory and oncology out-patient clinics in Australia (n=194', 'Most were male (57.7%) with a mean age of 68 years (SD=8.8', 'One-hundred and ninety-four participants were included for analysis', 'psychological distress', 'patients newly diagnosed with lung cancer']",[],"['lung cancer stigma (Cataldo Lung Cancer Stigma Scale) and psychological distress (General Health Questionnaire 12', 'lung cancer stigma and psychological distress', 'lung cancer stigma increases psychological distress', 'baseline lung cancer stigma and psychological distress']","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]",[],"[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",194.0,0.0621412,"To examine if baseline stigma predicts psychological distress at 3 months and 6 months follow-up among patients newly diagnosed with lung cancer.
","[{'ForeName': 'Shiho', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Boyes', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kelly', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Cox', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Kerrin', 'Initials': 'K', 'LastName': 'Palazzi', 'Affiliation': 'Clinical Research, Information Technology and Statistical Support Unit, Hunter Medical Research Institute, New Lambton, New South Wales, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia.'}]",Psycho-oncology,['10.1002/pon.5665']
252,33626934,Matching-adjusted indirect comparison of palbociclib versus ribociclib and abemaciclib in hormone receptor-positive/HER2-negative advanced breast cancer.,"Aim:  Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM), in combination with fulvestrant (FUL), are approved for the treatment of hormone receptor-positive, HER2-negative advanced breast cancer. This study aims to determine relative efficacy of PAL+FUL versus RIB+FUL and ABM+FUL using matching-adjusted indirect treatment comparisons.  Patients & methods:  Anchored matching-adjusted indirect treatment comparisons were conducted using individual patient data from PALOMA-3 and published summary-level data from MONARCH 2 and MONALEESA-3. The primary outcome was overall survival (OS).  Results:  OS was similar for PAL+FUL versus ABM+FUL (hazard ratio: 0.87; 95% CI: 0.54-1.40) and RIB+FUL (hazard ratio: 0.89; 95% CI: 0.48-1.63).  Conclusion:  Adjusting for cross-trial differences suggests similar OS between treatments, underscoring the importance of accounting for these differences when indirectly comparing treatments.",2021,Results:  OS was similar for PAL+FUL versus ABM+FUL (hazard ratio: 0.87; 95% CI: 0.54-1.40) and RIB+FUL (hazard ratio: 0.89; 95% CI: 0.48-1.63).  ,['hormone receptor-positive/HER2-negative advanced breast cancer'],"['PAL+FUL versus RIB+FUL and ABM+FUL', 'palbociclib versus ribociclib and abemaciclib', 'Palbociclib (PAL), ribociclib (RIB)\xa0and abemaciclib (ABM), in combination with fulvestrant (FUL']",['overall survival (OS'],"[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.448828,Results:  OS was similar for PAL+FUL versus ABM+FUL (hazard ratio: 0.87; 95% CI: 0.54-1.40) and RIB+FUL (hazard ratio: 0.89; 95% CI: 0.48-1.63).  ,"[{'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco Comprehensive Cancer Center, San Francisco, CA 94143, USA.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Haltner', 'Affiliation': 'EVERSANA, Sydney, Nova Scotia B1P 1C6, Canada.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhan', 'Affiliation': 'Pfizer, Inc., NY\xa010017, USA.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': 'EVERSANA, Sydney, Nova Scotia B1P 1C6, Canada.'}, {'ForeName': 'Eustratios', 'Initials': 'E', 'LastName': 'Bananis', 'Affiliation': 'Pfizer, Inc., NY\xa010017, USA.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Hooper', 'Affiliation': 'EVERSANA, Sydney, Nova Scotia B1P 1C6, Canada.'}, {'ForeName': 'Debanjali', 'Initials': 'D', 'LastName': 'Mitra', 'Affiliation': 'Pfizer, Inc., NY\xa010017, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Cameron', 'Affiliation': 'EVERSANA, Sydney, Nova Scotia B1P 1C6, Canada.'}]",Journal of comparative effectiveness research,['10.2217/cer-2020-0272']
253,33617910,Two-year toxicity of simultaneous integrated boost in hypofractionated prone breast cancer irradiation: Comparison with sequential boost in a randomized trial.,"INTRODUCTION


A simultaneous integrated boost (SIB) leads to less acute toxicity. Less is known for late toxicity due to SIB. In this first and only randomized trial, two-years toxicity is analysed.
MATERIALS AND METHODS


Physician-assessed toxicity, using the LENT SOMA scale, and photographs, analysed with the BCCT.core software, was examined for 150 patients, randomized between SIB and sequential boost (SEB).
RESULTS


Differences in physician-assessed two-years toxicity and photographic analysis between SIB and SEB are very small and not significant.
CONCLUSION


There is no indication that a SIB leads to an excess in toxicity or worse cosmetic outcome at 2 years.",2021,"RESULTS


Differences in physician-assessed two-years toxicity and photographic analysis between SIB and SEB are very small and not signicant.
","['hypofractionated prone breast cancer irradiation', '150 patients, randomized between SIB and sequential boost (SEB']",[],['acute toxicity'],"[{'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]",[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.0294634,"RESULTS


Differences in physician-assessed two-years toxicity and photographic analysis between SIB and SEB are very small and not signicant.
","[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Van Hulle', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium. Electronic address: Hans.VanHulle@Ugent.be.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Desaunois', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium. Electronic address: Eline.Desaunois@Ugent.be.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vakaet', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium; Department of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: Vincent.Vakaet@Ugent.be.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Paelinck', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: Leen.Paelinck@Uzgent.be.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Schoepen', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium; Department of Industrial Systems Engineering and Product Design, Kortrijk, Belgium. Electronic address: Max.Schoepen@Ugent.be.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Post', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium. Electronic address: Giselle.Post@Ugent.be.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Van Greveling', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: Annick.VanGreveling@Uzgent.be.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Speleers', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium. Electronic address: Bruno.Speleers@Ugent.be.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Mareel', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium. Electronic address: Marc.Mareel@Ugent.be.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'De Neve', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium. Electronic address: Wilfried.DeNeve@Ugent.be.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Monten', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium; Department of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: Chris.Monten@Uzgent.be.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Deseyne', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium; Department of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: Pieter.Deseyne@Uzgent.be.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Veldeman', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Belgium; Department of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: Liv.Veldeman@Uzgent.be.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2021.02.010']
254,33621631,Stanford Pragmatiec Effectiveness Comparison (SPEC) protocol: Comparing long-term effectiveness of high-frequency and burst spinal cord stimulation in real-world application.,"OBJECTIVES


High-frequency and burst stimulation are newer waveforms that have demonstrated promise compared to traditional tonic spinal cord stimulation (SCS), but more studies are needed to compare their effectiveness. We report the study methods for an ongoing, single center, pragmatic randomized clinical trial to compare the effectiveness of high-frequency and burst SCS in patients with chronic back and/or leg pain.
MATERIALS AND METHODS


Participants who are candidates for spinal cord stimulation are enrolled and screened. Participants will be randomly assigned using point-of-care randomization to receive either high-frequency or burst SCS. Data collection will be through Stanford Pain Management Center's learning healthcare system: CHOIR. CHOIR surveys include National Institutes of Health Patient Reported Outcomes Measurement Information System item banks, a body map, questions about pain intensity, pain catastrophizing scale, and questions about patients' pain experience and healthcare utilization. Participants will complete online surveys at baseline and then 1, 3, 6, 12, 18, 24 and 36 months after their device implant. All participants will use our routine process of trial and implant. Reported adverse events are monitored throughout the study. Our primary outcome is change from baseline in pain intensity at 12 months.
RESULTS


We hypothesize that high-frequency SCS is more effective than burst SCS in improving pain, physical function and pain interference in participants with chronic low back and/or leg pain.
CONCLUSIONS


The pragmatic nature of our proposed trial enables us to recruit a larger participant cohort faster and to follow up these participants longer than currently published clinical trials.",2021,"We hypothesize that high-frequency SCS is more effective than burst SCS in improving pain, physical function and pain interference in participants with chronic low back and/or leg pain.
","['patients with chronic back and/or leg pain', 'Participants who are candidates for spinal cord stimulation are enrolled and screened', 'participants with chronic low back and/or leg pain']","['high-frequency and burst spinal cord stimulation', 'high-frequency and burst SCS', 'Stanford pragmatic effectiveness comparison (SPEC) protocol']","['pain intensity', ""pain intensity, pain catastrophizing scale, and questions about patients' pain experience and healthcare utilization"", 'pain, physical function and pain interference', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.212619,"We hypothesize that high-frequency SCS is more effective than burst SCS in improving pain, physical function and pain interference in participants with chronic low back and/or leg pain.
","[{'ForeName': 'Philip Anthony', 'Initials': 'PA', 'LastName': 'Petrou', 'Affiliation': 'Stanford University School of Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Leong', 'Affiliation': 'Stanford University School of Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, USA.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Mackey', 'Affiliation': 'Stanford University School of Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, USA.'}, {'ForeName': 'Vafi', 'Initials': 'V', 'LastName': 'Salmasi', 'Affiliation': 'Stanford University School of Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, USA. Electronic address: vsalmasi@stanford.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106324']
255,33625578,"Reply to Andreas Boehle, Frank Kahmann, Thomas Oliver Henkel, Joerg Zimmermann and Stefan Machten's to the Letter to the editor Re: results of a randomized trial of treatment modalities in patients with low or early-intermediate risk prostate cancer (PREFERE trial).",,2021,,['patients with low or early-intermediate risk prostate cancer (PREFERE trial'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],,0.0179056,,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wiegel', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany. thomas.wiegel@uniklinik-ulm.de.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Albers', 'Affiliation': 'Department of Urology, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Bartkowiak', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}, {'ForeName': 'Roswitha', 'Initials': 'R', 'LastName': 'Bussar-Maatz', 'Affiliation': 'PREFERE Project Management, German Cancer Society, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Kristiansen', 'Affiliation': 'Institute of Pathology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Department of Clinical Epidemiology and Applied Biostatistics, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wellek', 'Affiliation': 'Department of Medical Biostatistics, Epidemiology and Informatics, University of Mainz, Mainz, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Schmidberger', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Grozinger', 'Affiliation': 'Department of Urology, Klinikum Leverkusen, Leverkusen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Renner', 'Affiliation': 'Center for Urology, Lübeck, Germany.'}, {'ForeName': 'Fried', 'Initials': 'F', 'LastName': 'Schneider', 'Affiliation': 'Department of Urology, Klinikum Lippe Detmold, Detmold, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Burmester', 'Affiliation': 'Department of Urology, Vinzenzkrankenhaus, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stöckle', 'Affiliation': 'Department of Urology, University Hospital Homburg/Saar, Homburg, Germany.'}]",Journal of cancer research and clinical oncology,['10.1007/s00432-021-03549-y']
256,33626326,Topical Oxygen Jet Therapy (TOJT) for treating infected chronic surgical wounds.,"OBJECTIVES


To evaluate the effectiveness of Topical Oxygen Jet Therapy (TOJT) in the treatment of surgical wounds in adult patients who has clinical signs of infection for over 30 days; and to identify the pathogens causing complicated skin and soft tissue infections.
METHOD


Parallel, randomized clinical trials randomly divided into ""Control Group"" (CG) and ""Treatment Group"" (TG), which were followed up for 10 consecutive days. Venous antibiotics and dressings were used in both groups. In addition, TOJT were used on the wounds in the TG. The outcome criteria were based on clinical indicators: Pressure Ulcer Scale for Healing (PUSH) and Visual Analog Scale Pain (VAS). The paired t-test or Wilcoxon, chi-squared or Fisher's exact test, and Student's t-test or Mann-Whitney tests were used with a significance level of 5%.
RESULTS


73 inpatients were included and followed up: 39 in TG and 34, CG. There were no significant differences in socio-demographic variables or of initial laboratory tests, except for blood glucose that was higher in TG than in CG (p = 0.044). Ten days into treatment, both the area of PUSH wounds (p < 0.001) and the pain scale (p = 0.029) were significantly reduced in TG. Staphylococcus aureus was the most prevalent pathogen (40%) with no significant difference between the two groups.
DISCUSSION


Although the follow-up time was of only ten days, a significant improvement was observed in TG. As a limitation of the study, the small sample size precluded the comparison of S. aureus infections between the two groups.
CONCLUSION


TOJT accelerated the healing process, reduced pain and contributed to an improvement in the clinical status of the wounds when compared to CG. These findings demonstrate the effectiveness and relevance of the employed technique. It can be easily incorporated as a routine procedure in hospitals without extra investment.",2021,"Ten days into treatment, both the area of PUSH wounds (p < 0.001) and the pain scale (p = 0.029) were significantly reduced in TG.","['73 inpatients were included and followed up: 39 in TG and 34, CG', 'surgical wounds in adult patients who has clinical signs of infection for over 30 days', 'treating infected chronic surgical wounds']","['Topical Oxygen Jet Therapy (TOJT', 'Control Group"" (CG) and ""Treatment Group"" (TG']","['pain scale', 'clinical indicators: Pressure Ulcer Scale for Healing (PUSH) and Visual Analog Scale Pain (VAS', 'socio-demographic variables or of initial laboratory tests, except for blood glucose', 'TG', 'healing process, reduced pain']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",73.0,0.019121,"Ten days into treatment, both the area of PUSH wounds (p < 0.001) and the pain scale (p = 0.029) were significantly reduced in TG.","[{'ForeName': 'Maria Helena', 'Initials': 'MH', 'LastName': 'Otaviano', 'Affiliation': 'Faculdade de Ciências Medicas da Santa Casa de São Paulo, São Paulo, SP, Brazil. Electronic address: mariahelena1957@hotmail.com.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Salles', 'Affiliation': 'Faculdade de Ciências Medicas da Santa Casa de São Paulo, São Paulo, SP, Brazil. Electronic address: salles.infecto@gmail.com.'}, {'ForeName': 'Ting Hui', 'Initials': 'TH', 'LastName': 'Ching', 'Affiliation': 'Faculdade de Ciências Medicas da Santa Casa de São Paulo, São Paulo, SP, Brazil. Electronic address: jthc8720@gmail.com.'}, {'ForeName': 'Josilene Lopes', 'Initials': 'JL', 'LastName': 'Dettoni', 'Affiliation': 'Universidade Federal de Rondônia, Porto Velho, RO, Brazil. Electronic address: josilenedettoni@gmail.com.'}, {'ForeName': 'Ieda Guedes Simões', 'Initials': 'IGS', 'LastName': 'Coulibaly', 'Affiliation': 'EBRAMEC - Escola Brasileira de Medicina Chinesa, São Paulo, SP, Brazil. Electronic address: ieda9182@gmail.com.'}, {'ForeName': 'Erika Tiemi', 'Initials': 'ET', 'LastName': 'Fukunaga', 'Affiliation': 'Faculdade de Ciências Medicas da Santa Casa de São Paulo, São Paulo, SP, Brazil. Electronic address: erika.fukunaga@gmail.com.'}, {'ForeName': 'Mônica Antar', 'Initials': 'MA', 'LastName': 'Gamba', 'Affiliation': 'Universidade Federal de São Paulo, São Paulo, SP, Brazil. Electronic address: antar.gamba@unifesp.com.'}, {'ForeName': 'José Cássio de', 'Initials': 'JC', 'LastName': 'Moraes', 'Affiliation': 'Faculdade de Ciências Medicas da Santa Casa de São Paulo, São Paulo, SP, Brazil. Electronic address: jcassiom@uol.com.br.'}]",The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases,['10.1016/j.bjid.2021.101547']
257,33621762,Comparison of efficacy of endoscopic versus microscopic transcanal inlay butterfly cartilage myringoplasty.,"BACKGROUND AND OBJECTIVES


Butterfly cartilage myringoplasty has been widely practiced over two decades due to its simplicity and feasibility. The present study is aimed to compare the efficacy of endoscopic versus microscopic transcanal inlay butterfly cartilage myringoplasty.
SUBJECTS AND METHODS


In this randomised control trial, fifty patients with small to medium sized perforation were included. The first group underwent butterfly cartilage myringoplasty using endoscope and the second group using microscope and, outcomes were compared.
RESULTS


Graft success rates in the endoscopic group was 96% ± 4% and in the microscopic group was 92% ± 8%. The improvement in the Air-Bone Gap was 11.00 ± 7.21 dB in the endoscopic group and 10.8 ± 7.59 dB in the microscopic group. The difference was not statistically significant.
CONCLUSIONS


The overall success rates and hearing outcomes were similar in the endoscopic and microscopic group with added advantages of less pain, shorter operative time and better field of vision in the endoscopic group.",2021,"The overall success rates and hearing outcomes were similar in the endoscopic and microscopic group with added advantages of less pain, shorter operative time and better field of vision in the endoscopic group.",['fifty patients with small to medium sized perforation were included'],"['butterfly cartilage myringoplasty using endoscope', 'endoscopic versus microscopic transcanal']","['Air-Bone Gap', 'overall success rates and hearing outcomes', 'pain, shorter operative time and better field of vision', 'Graft success rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0006496', 'cui_str': 'Butterfly'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]",50.0,0.0458088,"The overall success rates and hearing outcomes were similar in the endoscopic and microscopic group with added advantages of less pain, shorter operative time and better field of vision in the endoscopic group.","[{'ForeName': 'Nimisha', 'Initials': 'N', 'LastName': 'Ravi', 'Affiliation': 'Department of ENT Maulana Azad Medical College, New Delhi 110002, India.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Meher', 'Affiliation': 'Department of ENT Maulana Azad Medical College, New Delhi 110002, India. Electronic address: ravimeher@gmail.com.'}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Rathore', 'Affiliation': 'Department of ENT Maulana Azad Medical College, New Delhi 110002, India.'}, {'ForeName': 'Ishwar', 'Initials': 'I', 'LastName': 'Singh', 'Affiliation': 'Department of ENT Maulana Azad Medical College, New Delhi 110002, India.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.102978']
258,33621632,Integration of a smartwatch within an internet-delivered intervention for depression: Protocol for a feasibility randomized controlled trial on acceptance.,"BACKGROUND


Mood tracking is commonly employed within a range of mental health interventions. Physical activity and sleep are also important for contextualizing mood data but can be difficult to track manually and rely on retrospective recall. Smartwatches could enhance self-monitoring by addressing difficulties in recall of sleep and physical activity and reducing the burden on patients in terms of remembering to track and the effort of tracking. This feasibility study will explore the acceptance of a smartwatch app for self-monitoring of mood, sleep, and physical activity, in an internet-based cognitive-behavioral therapy (iCBT) for depression offered in a routine care setting.
METHODS


Seventy participants will be randomly allocated to (i) iCBT intervention plus smartwatch app or (ii) iCBT intervention alone. Patient acceptance will be measured longitudinally using a theory-based acceptance questionnaire to understand and compare the evolution of acceptance of the technology-delivered self-report in the two groups. A post-treatment interview will explore participants subjective experience of using the smartwatch. Engagement with the intervention, including self-report, and clinical outcomes, will be measured across both groups to assess for any differences.
IMPLICATIONS


This is the first study investigating the evolution of patient acceptance of smartwatch self-report in an iCBT delivered intervention in a clinical sample. Through an engaging and convenient means of capturing ecologically valid mood data, the study has the potential to show that smartwatches are an acceptable means for patient self-monitoring within iCBT interventions for depression and support potential use-cases for smartwatches in the context of mental health interventions in general. Prospectively registered at ClinicalTrials.gov (NCT04568317).",2021,"This feasibility study will explore the acceptance of a smartwatch app for self-monitoring of mood, sleep, and physical activity, in an internet-based cognitive-behavioral therapy (iCBT) for depression offered in a routine care setting.
",['Seventy participants will be randomly allocated to'],"['iCBT intervention plus smartwatch app or (ii) iCBT intervention alone', 'internet-based cognitive-behavioral therapy (iCBT']",['Physical activity and sleep'],"[{'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",70.0,0.0743286,"This feasibility study will explore the acceptance of a smartwatch app for self-monitoring of mood, sleep, and physical activity, in an internet-based cognitive-behavioral therapy (iCBT) for depression offered in a routine care setting.
","[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Nadal', 'Affiliation': 'School of Computer Science and Statistics, Trinity College Dublin, College Green, Dublin, Ireland. Electronic address: nadalc@tcd.ie.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Earley', 'Affiliation': 'E-mental Health Research Group, School of Psychology, Trinity College Dublin, Dublin, Ireland; SilverCloud Health, 1 Stephen Street Upper, Dublin, Ireland. Electronic address: caroline.earley@silvercloudhealth.com.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Enrique', 'Affiliation': 'E-mental Health Research Group, School of Psychology, Trinity College Dublin, Dublin, Ireland; SilverCloud Health, 1 Stephen Street Upper, Dublin, Ireland. Electronic address: angel.enrique@silvercloudhealth.com.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Vigano', 'Affiliation': 'SilverCloud Health, 1 Stephen Street Upper, Dublin, Ireland. Electronic address: noemi.vigano@silvercloudhealth.com.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Sas', 'Affiliation': 'Lancaster University, School of Computing and Communications, Lancaster, UK. Electronic address: c.sas@lancaster.ac.uk.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'E-mental Health Research Group, School of Psychology, Trinity College Dublin, Dublin, Ireland; SilverCloud Health, 1 Stephen Street Upper, Dublin, Ireland. Electronic address: derek.richards@tcd.ie.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Doherty', 'Affiliation': 'School of Computer Science and Statistics, Trinity College Dublin, College Green, Dublin, Ireland. Electronic address: gavin.doherty@tcd.ie.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106323']
259,33621942,The effect of laboratory and real world gait training with vibration feedback on center of pressure during gait in people with chronic ankle instability.,"BACKGROUND


External feedback has can medially shift the center of pressure (COP) location in people with chronic ankle instability(CAI) during walking. However, previous modalities are restricted to controlled environments which limits motor learning. Vibration feedback during gait may maximize motor learning by allowing for training in the laboratory and real world (RW) but has not been investigated in those with CAI.
RESEARCH QUESTION


Does vibration feedback change COP location in people with CAI following laboratory and RW training?
METHODS


Nineteen CAI participants walked for 10 min on a treadmill (lab training) and a one mile loop on a sidewalk (RW training) with vibration feedback. When pressure under the 5th metatarsal exceeded a threshold, a vibration stimulus was applied to the lateral malleolus encouraging the participant to medially shift the COP. One minute baseline, posttest, and short term retention gait assessments were taken for each environment. The stance phase of gait was divided into 10 subphases and data were averaged within each subphase. Repeated measures ANOVAs were completed for each subphase to compare COP location over time.
RESULTS


After lab based training the COP was more medial at posttest for the first 90 % of stance versus baseline (Mean differences (MD): -0.57 to -5.12 mm, p < 0.023). Relative to baseline, the COP remained more medial at retention from 20 to 90% of stance (MD: -1.69 to -4.40 mm, p < 0.049). For RW training, the COP was more medial at posttest for the first 70 % of stance versus baseline (MD: -4.24 to -8.27 mm, p < 0.017) and the first 60 % of stance at retention versus baseline (MD: -4.14 to -6.42 mm, p < 0.049).
SIGNIFICANCE


Vibration feedback during laboratory and RW gait training has the ability to immediately shift the COP location medially and retain this shift for a short period in individuals with CAI.",2021,After lab based training the COP was more medial at posttest for the first 90 % of stance versus baseline,"['people with chronic ankle instability', 'people with CAI following laboratory and RW training', 'people with chronic ankle instability(CAI', 'Nineteen CAI participants walked for 10\u2009min on a', 'individuals with CAI']","['laboratory and real world gait training with vibration feedback', 'RW gait training', 'treadmill (lab training) and a one mile loop on a sidewalk (RW training) with vibration feedback']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0331865', 'cui_str': 'miles'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0557772', 'cui_str': 'Sidewalk'}]",[],19.0,0.0183191,After lab based training the COP was more medial at posttest for the first 90 % of stance versus baseline,"[{'ForeName': 'Kimmery G', 'Initials': 'KG', 'LastName': 'Migel', 'Affiliation': 'MOTION Science Institute, University of North Carolina at Chapel Hill, 209 Fetzer Hall, CB8700, Chapel Hill, NC, 27599, United States. Electronic address: kmigel@live.unc.edu.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Wikstrom', 'Affiliation': 'MOTION Science Institute, University of North Carolina at Chapel Hill, 209 Fetzer Hall, CB8700, Chapel Hill, NC, 27599, United States. Electronic address: wikstrom@unc.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2021.02.011']
260,33629227,Phase 2 Randomized Clinical Study of Netarsudil Ophthalmic Solution in Japanese Patients with Primary Open-Angle Glaucoma or Ocular Hypertension.,"INTRODUCTION


Netarsudil reduces intraocular pressure (IOP) by increasing aqueous outflow through the trabecular meshwork (TM) pathway and decreasing episcleral venous pressure. The primary objective of this phase 2 study was to evaluate ocular hypotensive efficacy and safety of three netarsudil concentrations (0.01%, 0.02%, and 0.04%) relative to its placebo over 4 weeks in Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
METHODS


Patients were randomized to one of four treatment arms, netarsudil ophthalmic solution 0.01%, 0.02%, 0.04%, or placebo, and treated once-daily (QD) in the evening (P.M.) for 4 weeks. The primary efficacy variable was mean diurnal IOP (average of diurnal time points at 9 A.M., 11 A.M., and 4 P.M.) at week 4.
RESULTS


A total of 215 patients were randomized and 207 (96.3%) completed the study. The mean of mean diurnal IOP at baseline ranged from 20.28 to 21.14 mmHg across groups. At week 4, least squares (LS) mean of mean diurnal IOP adjusted for baseline was 16.53, 15.82, 16.06, and 18.94 mmHg in the netarsudil 0.01%, 0.02%, 0.04%, and placebo groups, respectively, demonstrating the superiority of netarsudil (all concentrations) over placebo. At week 4, mean reduction (mean percentage reduction) from baseline in mean diurnal IOP was 4.10 (19.8%), 4.80 (23.5%), 4.81 (23.8%), and 1.73 mmHg (8.2%), respectively, demonstrating statistically significant reductions (p < 0.0001) in all netarsudil concentrations over placebo. Adverse events (AEs) occurred in a concentration-dependent manner, and the incidence of ocular AEs was 34.5%, 42.6%, 68.6%, and 9.1% in the netarsudil 0.01%, 0.02%, 0.04%, and placebo groups, respectively. The most frequently reported AE was conjunctival hyperemia, with an incidence of 23.6%, 37.0%, 56.9%, and 1.8%, respectively. No serious AEs were reported.
CONCLUSION


Netarsudil ophthalmic solutions 0.01%, 0.02%, and 0.04% dosed QD (P.M.) demonstrated superiority to placebo in terms of hypotensive effectiveness at week 4 and were found to be safe and generally well tolerated. Netarsudil 0.02% QD provided an optimal efficacy and safety profile for the treatment of Japanese patients with POAG or OHT.
TRIAL REGISTRATION


NCT03844945.",2021,"Adverse events (AEs) occurred in a concentration-dependent manner, and the incidence of ocular AEs was 34.5%, 42.6%, 68.6%, and 9.1% in the netarsudil 0.01%, 0.02%, 0.04%, and placebo groups, respectively.","['Patients', 'Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT', 'A total of 215 patients were randomized and 207 (96.3%) completed the study', 'Japanese Patients with Primary Open-Angle Glaucoma or Ocular Hypertension', 'Japanese patients with POAG or OHT']","['trabecular meshwork (TM', 'netarsudil ophthalmic solution', 'Netarsudil Ophthalmic Solution', 'placebo']","['hypotensive effectiveness', 'mean diurnal IOP (average of diurnal time points', 'incidence of ocular AEs', 'Adverse events (AEs', 'episcleral venous pressure', 'mean diurnal IOP', 'conjunctival hyperemia', 'optimal efficacy and safety profile', 'mean of mean diurnal IOP', 'Netarsudil reduces intraocular pressure (IOP', 'safe and generally well tolerated', 'ocular hypotensive efficacy and safety of three netarsudil concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040573', 'cui_str': 'Trabecular meshwork structure'}, {'cui': 'C4535721', 'cui_str': 'netarsudil Ophthalmic Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1827744', 'cui_str': 'Episcleral venous pressure'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",215.0,0.447732,"Adverse events (AEs) occurred in a concentration-dependent manner, and the incidence of ocular AEs was 34.5%, 42.6%, 68.6%, and 9.1% in the netarsudil 0.01%, 0.02%, 0.04%, and placebo groups, respectively.","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Araie', 'Affiliation': 'Kanto Central Hospital of the Mutual Aid Association of Public School Teachers, Tokyo, Japan. m.araie-tky@nifty.com.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Aso', 'Affiliation': 'Aerie Pharmaceuticals Ireland Ltd. (Japan Branch), Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kanemoto', 'Affiliation': 'Aerie Pharmaceuticals Ireland Ltd. (Japan Branch), Tokyo, Japan.'}, {'ForeName': 'Kalyani', 'Initials': 'K', 'LastName': 'Kothapalli', 'Affiliation': 'Statistics and Data Corporation, Tempe, AZ, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Kopczynski', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Senchyna', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hollander', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA, USA.'}]",Advances in therapy,['10.1007/s12325-021-01634-9']
261,33633016,Phentolamine Eye Drops Reverse Pharmacologically Induced Mydriasis in a Randomized Phase 2b Trial.,"SIGNIFICANCE


After a dilated eye examination, many patients experience symptoms of prolonged light sensitivity, blurred vision, and cycloplegia associated with pharmacological mydriasis. Phentolamine mesylate ophthalmic solution (PMOS) may expedite the reversal of mydriasis in patients, potentially facilitating return to functional vision and reducing barriers to obtaining dilated eye examinations.
PURPOSE


The protracted reversal time after pharmacologically induced pupil dilation impairs vision. We tested the hypothesis that PMOS rapidly reduces pupil diameter in this acute indication.
METHODS


In this double-masked placebo-controlled, randomized, two-arm crossover phase 2b trial, we evaluated the effects of one drop of 1% PMOS applied bilaterally in subjects who had their pupils dilated by one of two common mydriatic agents: 2.5% phenylephrine or 1% tropicamide. End points included change in pupil diameter, percent of subjects returning to baseline pupil diameter, and accommodative function at multiple time points.
RESULTS


Thirty-one subjects completed the study (15 dilated with phenylephrine and 16 with tropicamide). Change in pupil diameter from baseline at 2 hours after maximal dilation with 1% PMOS was -1.69 mm and was significantly greater in magnitude compared with placebo for every time point beyond 30 minutes (P < .05). At 2 hours, a greater percentage of study eyes given 1% PMOS returned to baseline pupil diameter compared with placebo (29 vs. 13%, P = .03), which was this also seen at 4 hours (P < .001). More subjects treated with PMOS in the tropicamide subgroup had at least one eye returning to baseline accommodative amplitude at 2 hours (63 vs. 38%, P = .01). There were no severe adverse events, with only mild to moderate conjunctival hyperemia that resolved in most patients by 6 hours.
CONCLUSIONS


Phentolamine mesylate ophthalmic solution at 1% reversed medically induced pupil dilation more rapidly than placebo treatment regardless of which mydriatic was used (adrenergic agonists and cholinergic blockers) with a tolerable safety profile.",2021,"At 2 hours, a greater percentage of study eyes given 1% PMOS returned to baseline pupil diameter compared with placebo (29 vs. 13%, P = .03), which was this also seen at 4 hours (P < .001).","['subjects who had their pupils dilated by one of two common mydriatic agents: 2.5', 'Thirty-one subjects completed the study (15 dilated with phenylephrine and 16 with tropicamide']","['phenylephrine or 1% tropicamide', 'placebo', 'PMOS', 'Phentolamine mesylate ophthalmic solution (PMOS', 'Phentolamine Eye Drops Reverse Pharmacologically Induced Mydriasis', 'Phentolamine mesylate ophthalmic solution']","['change in pupil diameter, percent of subjects returning to baseline pupil diameter, and accommodative function at multiple time points', 'severe adverse events', 'pupil diameter', 'moderate conjunctival hyperemia', 'eye returning to baseline accommodative amplitude', 'Change in pupil diameter', 'pupil dilation']","[{'cui': 'C0026961', 'cui_str': 'Dilated pupil'}, {'cui': 'C0026964', 'cui_str': 'Mydriatic agent'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0041190', 'cui_str': 'Tropicamide'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0041190', 'cui_str': 'Tropicamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0733398', 'cui_str': 'Phentolamine mesylate'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0031448', 'cui_str': 'Phentolamine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1627880', 'cui_str': 'Accommodative amplitude'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}]",15.0,0.417326,"At 2 hours, a greater percentage of study eyes given 1% PMOS returned to baseline pupil diameter compared with placebo (29 vs. 13%, P = .03), which was this also seen at 4 hours (P < .001).","[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Karpecki', 'Affiliation': 'Kentucky College of Optometry, Pikeville, Kentucky.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Foster', 'Affiliation': 'Athens Eye Care, Athens, Ohio.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Montaquila', 'Affiliation': 'West Bay Eye Associates, Warwick, Rhode Island.'}, {'ForeName': 'Shane R', 'Initials': 'SR', 'LastName': 'Kannarr', 'Affiliation': 'Kannarr Eye Care, Pittsburg, Kansas.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Slonim', 'Affiliation': 'Oculos Development Services, LLC, Tampa, Florida.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Meyer', 'Affiliation': 'Ocuphire Pharma, Farmington Hills, Michigan.'}, {'ForeName': 'Mina P', 'Initials': 'MP', 'LastName': 'Sooch', 'Affiliation': 'Ocuphire Pharma, Farmington Hills, Michigan.'}, {'ForeName': 'Reda M', 'Initials': 'RM', 'LastName': 'Jaber', 'Affiliation': 'Ocuphire Pharma, Farmington Hills, Michigan.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Charizanis', 'Affiliation': ''}, {'ForeName': 'Jonah E', 'Initials': 'JE', 'LastName': 'Yousif', 'Affiliation': 'Ocuphire Pharma, Farmington Hills, Michigan.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Klapman', 'Affiliation': 'Ocuphire Pharma, Farmington Hills, Michigan.'}, {'ForeName': 'Arin T', 'Initials': 'AT', 'LastName': 'Amin', 'Affiliation': 'Ocuphire Pharma, Farmington Hills, Michigan.'}, {'ForeName': 'Marguerite B', 'Initials': 'MB', 'LastName': 'McDonald', 'Affiliation': 'New York University Langone Medical Center, New York, New York.'}, {'ForeName': 'Gerald D', 'Initials': 'GD', 'LastName': 'Horn', 'Affiliation': 'LasikPlus, Cincinnati, Ohio.'}, {'ForeName': 'Eliot S', 'Initials': 'ES', 'LastName': 'Lazar', 'Affiliation': 'elCON Medical, Buffalo, New York.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Pepose', 'Affiliation': ''}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001656']
262,33631360,Study protocol for a randomized controlled trial comparing two low-intensity weight loss maintenance interventions based on acceptance and commitment therapy or self-regulation.,"BACKGROUND


Weight regain is common following behavioral obesity treatment and attenuates many of the benefits of initial weight loss. This paper describes a randomized controlled trial that will evaluate the efficacy of two low-contact weight loss maintenance interventions based on Acceptance and Commitment Therapy (ACT) and self-regulation (SR). Potential mechanisms of action and moderators of treatment effects will also be evaluated.
METHODS


Adults (anticipated N = 480) with overweight or obesity will complete an initial 3-month online weight loss program (Phase 1). Participants who achieve ≥4 kg weight loss (anticipated N = 288) will then be randomized to an ACT or SR weight loss maintenance intervention. Both interventions will entail four 2.5 h, face-to-face, group-based workshop sessions and 6 months of email contact. Assessments will be conducted at phase 1 baseline, phase 1 completion/pre-randomization, and 6, 12, 18, 24, and 30 months post-randomization. The primary outcome will be weight change for the period from randomization to 30 months. Potential process measures including ACT-based constructs (e.g., psychological acceptance, values-consistent behavior), self-weighing frequency, and motivation will be also be assessed, as will potential moderators (e.g., initial weight loss).
CONCLUSIONS


This study will compare the efficacy of two intervention approaches (ACT and SR) delivered in a scalable workshop format for long-term weight loss maintenance. Future research could examine efficacy and cost-effectiveness of these approaches in real world settings.",2021,This study will compare the efficacy of two intervention approaches (ACT and SR) delivered in a scalable workshop format for long-term weight loss maintenance.,"['Adults (anticipated N\u202f=\u202f480) with overweight or obesity will complete an initial 3-month online weight loss program (Phase 1', 'Participants who achieve ≥4\u202fkg weight loss (anticipated N\u202f=\u202f288']","['intervention approaches (ACT and SR', 'low-contact weight loss maintenance interventions', 'ACT or SR weight loss maintenance intervention', 'low-intensity weight loss maintenance interventions']","['ACT-based constructs (e.g., psychological acceptance, values-consistent behavior), self-weighing frequency, and motivation', 'Acceptance and Commitment Therapy (ACT) and self-regulation (SR', 'weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",480.0,0.0980461,This study will compare the efficacy of two intervention approaches (ACT and SR) delivered in a scalable workshop format for long-term weight loss maintenance.,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lillis', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA. Electronic address: jasonlillis22@gmail.com.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Schumacher', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.'}, {'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Levin', 'Affiliation': 'Department of Psychology, Utah State University, Logan, UT, USA.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University, School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Unick', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Evans', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.'}, {'ForeName': 'Jacqueline F', 'Initials': 'JF', 'LastName': 'Hayes', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106327']
263,33631359,"Incorporating nutrition, vests, education, and strength training (INVEST) in bone health: Trial design and methods.","BACKGROUND


Achievement of 5-10% weight loss (WL) among older adults living with obesity considerably improves prognosis of health-related outcomes; however, concomitant declines in bone mineral density (BMD) limit overall benefit by increasing fracture risk. Declines in mechanical loading contribute to WL-associated BMD loss, with pilot data signaling the addition of external weight replacement (via weighted vest use) during intentional WL mitigates bone loss at weight bearing sites to a similar degree as resistance exercise training (RT). Definitive data in support of weighted vest use as a potential strategy to mitigate WL-associated bone loss in this population are needed.
METHODS


In the Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health trial (NCT04076618), 192 older adults (60-85 years) who are overweight (BMI ≥ 27 kg/m 2 ) with at least one obesity-related risk factor or obese (BMI = 30-40 kg/m 2 ) will be randomly assigned to participate in one of three 12-month intervention groups: WL alone, WL + weighted vest use (WL + VEST), or WL + RT. The primary aim is to determine the effects of WL + VEST compared to WL alone and WL + RT on indicators of bone health and subsequent fracture risk.
DISCUSSION


Determining effective, translatable strategies that minimize bone loss during intentional WL among older adults holds public health potential. The INVEST in Bone Health trial offers an innovative approach for increasing mechanical stress during intentional WL in the absence of RT. If successful, findings from this study will provide evidence in support of a scalable solution to minimize bone loss during intentional WL among older adults with obesity.",2021,"The primary aim is to determine the effects of WL + VEST compared to WL alone and WL + RT on indicators of bone health and subsequent fracture risk.
","['older adults living with obesity', 'older adults with obesity', '192 older adults (60-85\u202fyears) who are overweight (BMI\u202f≥\u202f27\u202fkg/m 2 ) with at least one obesity-related risk factor or obese (BMI\u202f=\u202f30-40\u202fkg/m 2 ']","['Incorporating nutrition, vests, education, and strength training (INVEST', 'WL\u202f+\u202fVEST', 'WL alone, WL\u202f+\u202fweighted vest use (WL\u202f+\u202fVEST), or WL\u202f+\u202fRT', 'WL alone and WL\u202f+\u202fRT']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]",[],192.0,0.0738632,"The primary aim is to determine the effects of WL + VEST compared to WL alone and WL + RT on indicators of bone health and subsequent fracture risk.
","[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Department of Internal Medicine-Geriatrics and Gerontology, Wake Forest School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Peggy M', 'Initials': 'PM', 'LastName': 'Cawthon', 'Affiliation': 'Research Institute, California Pacific Medical Center, San Francisco, CA, United States of America; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Crotts', 'Affiliation': 'Department of Internal Medicine-Geriatrics and Gerontology, Wake Forest School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fanning', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gerosa', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Greene', 'Affiliation': 'Department of Biomedical Engineering, Wake Forest School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Internal Medicine-Geriatrics and Gerontology, Wake Forest School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kiel', 'Affiliation': 'Department of Scientific and Clinical Affairs, Medifast, Inc., Baltimore, MD, United States of America.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Lawrence', 'Affiliation': 'Department of Internal Medicine-Geriatrics and Gerontology, Wake Forest School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Lenchik', 'Affiliation': 'Department of Diagnostic Radiology, Wake Forest School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'S Delanie', 'Initials': 'SD', 'LastName': 'Lynch', 'Affiliation': 'Department of Biomedical Engineering, Wake Forest School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Beverly A', 'Initials': 'BA', 'LastName': 'Nesbit', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'Department of Internal Medicine-Geriatrics and Gerontology, Wake Forest School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Weaver', 'Affiliation': 'Department of Biomedical Engineering, Wake Forest School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Beavers', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America. Electronic address: beaverkm@wfu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106326']
264,33631357,"RAMIC: Design of a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of ramipril in patients with COVID-19.","BACKGROUND AND AIMS


Retrospective studies have shown that angiotensin-converting-enzyme (ACE) inhibitors are associated with a reduced risk of complications and mortality in persons with novel coronavirus disease 2019 (COVID-19). Thus, we aimed to examine the efficacy of ramipril, an ACE-inhibitor, in preventing ICU admission, mechanical ventilation and/or mortality while also minimizing the risk of transmission and use of personal protective equipment (PPE).
METHODS


RAMIC is a multicenter, randomized, double-blind, allocation-concealed, placebo-controlled trial comparing the efficacy of treatment with ramipril 2.5 mg orally daily compared to placebo for 14 days. The study population includes adult patients with COVID-19 who were admitted to a hospital or assessed in an emergency department or ambulatory clinic. Key exclusion criteria include ICU admission or need for mechanical ventilation at screening, use of an ACE inhibitor or angiotensin-receptor-II blocker within 7 days, glomerular filtration rate < 40 mL/min or a systolic blood pressure (BP) < 100 mmHg or diastolic BP < 65 mmHg. Patients are randomized 2:1 to receive ramipril (2.5 mg) or placebo daily. Informed consent and study visits occur virtually to minimize the risk of SARS-CoV-2 transmission and preserve PPE. The primary composite endpoint of ICU admission, invasive mechanical ventilation and death are adjudicated virtually.
CONCLUSIONS


RAMIC is designed to assess the efficacy of treatment with ramipril for 14 days to decrease ICU admission, mechanical ventilator use and mortality in patients with COVID-19 and leverages virtual study visits and endpoint adjudication to mitigate risk of infection and to preserve PPE (ClinicalTrials.gov, NCT04366050).",2021,Informed consent and study visits occur virtually to minimize the risk of SARS-CoV-2 transmission and preserve PPE.,"['adult patients with COVID-19 who were admitted to a hospital or assessed in an emergency department or ambulatory clinic', 'persons with novel coronavirus disease 2019 (COVID-19', 'patients with COVID-19']","['RAMIC', 'placebo', 'ACE inhibitor or angiotensin-receptor-II blocker', 'ramipril 2.5\u202fmg orally daily compared to placebo', 'ramipril', 'angiotensin-converting-enzyme (ACE) inhibitors']","['systolic blood pressure (BP', 'ICU admission, mechanical ventilator use and mortality', 'ICU admission, invasive mechanical ventilation and death are adjudicated virtually']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0003011', 'cui_str': 'Angiotensin II Receptor'}, {'cui': 'C0989605', 'cui_str': 'Ramipril 2.5 MG'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0042497', 'cui_str': 'Mechanical ventilator'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.362811,Informed consent and study visits occur virtually to minimize the risk of SARS-CoV-2 transmission and preserve PPE.,"[{'ForeName': 'Veeral', 'Initials': 'V', 'LastName': 'Ajmera', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California, United States of America; NAFLD Research Center, Department of Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Wesley K', 'Initials': 'WK', 'LastName': 'Thompson', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Davey M', 'Initials': 'DM', 'LastName': 'Smith', 'Affiliation': 'Division of Infectious Diseases and Global Public Health, Department of Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care & Sleep Medicine, Department of Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Ravindra L', 'Initials': 'RL', 'LastName': 'Mehta', 'Affiliation': 'Division of Nephrology-Hypertension, Department of Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Vaishal', 'Initials': 'V', 'LastName': 'Tolia', 'Affiliation': 'Department of Emergency Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Department of Pharmacy, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Sriram', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Insel', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, California, United States of America; Division of Endocrinology and Metabolism, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Collier', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Richards', 'Affiliation': 'NAFLD Research Center, Department of Medicine, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California, United States of America; NAFLD Research Center, Department of Medicine, University of California San Diego, La Jolla, California, United States of America. Electronic address: roloomba@ucsd.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106330']
265,33631356,Collaborative care in the treatment of opioid use disorder and mental health conditions in primary care: A clinical study protocol.,"BACKGROUND


People with opioid use disorder (OUD) often have a co-occurring psychiatric disorder, which elevates the risk of morbidity and mortality. Promising evidence supports the use of collaborative care for treating people with OUD in primary care. Whether collaborative care interventions that treat both OUD and psychiatric disorders will result in better outcomes is presently unknown.
METHODS


The Whole Health Study is a 3-arm randomized controlled trial designed to test collaborative care treatment for OUD and the psychiatric disorders that commonly accompany OUD. Approximately 1200 primary care patients aged ≥18 years with OUD and depression, anxiety, or PTSD will be randomized to one of three conditions: (1) Augmented Usual Care, which consists of a primary care physician (PCP) waivered to prescribe buprenorphine and an addiction psychiatrist to consult on medication-assisted treatment; (2) Collaborative Care, which consists of a waivered PCP, a mental health care manager trained in psychosocial treatments for OUD and psychiatric disorders, and an addiction psychiatrist who provides consultation for OUD and mental health; or (3) Collaborative Care Plus, which consists of all the elements of the Collaborative Care arm plus a Certified Recovery Specialist to help with treatment engagement and retention. Primary outcomes are six-month rates of opioid use and six-month rates of remission of co-occurring psychiatric disorders.
DISCUSSION


The Whole Health Study will investigate whether collaborative care models that address OUD and co-occurring depression, anxiety, or PTSD will result in better patient outcomes. The results will inform clinical care delivery during the current opioid crisis.
CLINICAL TRIALS REGISTRATION


www.clinicaltrials.gov registration: NCT04245423.",2021,"Primary outcomes are six-month rates of opioid use and six-month rates of remission of co-occurring psychiatric disorders.
","['primary care', 'People with opioid use disorder (OUD', 'Approximately 1200 primary care patients aged ≥18\u202fyears with OUD and depression, anxiety, or PTSD will be randomized to one of three conditions']","['buprenorphine and an addiction psychiatrist to consult on medication-assisted treatment', 'addiction psychiatrist who provides consultation for OUD and mental health; or (3) Collaborative Care Plus, which consists of all the elements of the Collaborative Care arm plus a Certified Recovery Specialist']",['six-month rates of opioid use and six-month rates of remission of co-occurring psychiatric disorders'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",,0.14883,"Primary outcomes are six-month rates of opioid use and six-month rates of remission of co-occurring psychiatric disorders.
","[{'ForeName': 'Rebecca Arden', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Leonard Davis Institute for Health Economics, University of Pennsylvania, Philadelphia, PA 19104, USA. Electronic address: Rebecca.Harris@pennmedicine.upenn.edu.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Mandell', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Kampman', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medicine, New York, NY 10065, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Zuleyha', 'Initials': 'Z', 'LastName': 'Cidav', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Coviello', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'French', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Livesey', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Lowenstein', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Lynch', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'McKay', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA 19104, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Oslin', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Courtney Benjamin', 'Initials': 'CB', 'LastName': 'Wolk', 'Affiliation': 'Leonard Davis Institute for Health Economics, University of Pennsylvania, Philadelphia, PA 19104, USA; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Hillary R', 'Initials': 'HR', 'LastName': 'Bogner', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Leonard Davis Institute for Health Economics, University of Pennsylvania, Philadelphia, PA 19104, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106325']
266,33631355,Denosumab versus alendronate in long-term glucocorticoid users: A 12-month randomized controlled trial.,"OBJECTIVES


To compare the efficacy of denosumab and alendronate on raising spine bone mineral density (BMD) in long-term glucocorticoid (GC) users.
METHODS


Adult patients receiving long-term prednisolone (≥2.5 mg/day for ≥1 year) were recruited and randomized to either subcutaneous denosumab (60 mg/6 months) or oral alendronate (70 mg/week). BMD (lumbar spine, femoral neck, hip) and bone markers (serum P1NP and CTX) were measured at month 0, 6 and 12. The difference in spine BMD (primary outcome) at month 12 was compared between the two groups.
RESULTS


139 subjects were recruited (age 50.0 ± 12.7 years; 96% women): 69 assigned denosumab and 70 assigned alendronate. At entry, 73(53%) patients were osteoporotic and 82(59%) patients were naive to the bisphosphonates. Baseline clinical characteristics and BMD values were similar in the two groups. At month 12, a significant gain in mean BMD at the lumbar spine (+3.5 ± 2.5%; p<0.001), hip (+0.9 ± 2.8%; p=0.01) and femoral neck (+1.04 ± 4.1%; p=0.047); was observed in denosumab-treated patients, whereas the corresponding change was +2.5 ± 2.9% (p<0.001), +1.6 ± 2.7% (p<0.001) and + 1.5 ± 3.9% (p=0.002) in the alendronate group. The spine, but not the hip or femoral neck, BMD at month 12 was significantly higher in the denosumab than alendronate group after adjustment for baseline BMD values, age, sex, osteoporosis risk factors and the cumulative prednisolone doses received in one year. The drop in P1NP and CTX was significantly higher in the denosumab than alendronate group. Frequency of adverse events (AEs), including infections, was similar in the two treatment arms. Seven patients withdrew from the study but not related to AEs.
CONCLUSIONS


In patients receiving long-term GCs, denosumab is superior to alendronate in raising the spine BMD after 12 months. Both drugs are well-tolerated.",2021,The drop in P1NP and CTX was significantly higher in the denosumab than alendronate group.,"['≥2.5\u202fmg/day for ≥1\u202fyear', '139 subjects were recruited (age 50.0\u202f±\u202f12.7\u202fyears; 96% women): 69 assigned', 'Adult patients receiving', 'long-term glucocorticoid users']","['Denosumab versus alendronate', 'alendronate', 'subcutaneous denosumab', 'oral alendronate', 'denosumab', 'long-term prednisolone', 'denosumab and alendronate']","['mean BMD at the lumbar spine', 'Frequency of adverse events (AEs), including infections', 'BMD (lumbar spine, femoral neck, hip) and bone markers (serum P1NP and CTX', 'P1NP and CTX', 'spine BMD', 'femoral neck', 'hip or femoral neck, BMD', 'raising spine bone mineral density (BMD', 'BMD values']","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",139.0,0.109833,The drop in P1NP and CTX was significantly higher in the denosumab than alendronate group.,"[{'ForeName': 'Chi Chiu', 'Initials': 'CC', 'LastName': 'Mok', 'Affiliation': 'Department of Medicine, Tuen Mun Hospital, Hong Kong. Electronic address: ccmok2005@yahoo.com.'}, {'ForeName': 'Ling Yin', 'Initials': 'LY', 'LastName': 'Ho', 'Affiliation': 'Department of Medicine, Tuen Mun Hospital, Hong Kong.'}, {'ForeName': 'Stella Mei Tik', 'Initials': 'SMT', 'LastName': 'Leung', 'Affiliation': 'Department of Pathology, Queen Elizabeth Hospital, Tuen Mun Hospital, Hong Kong.'}, {'ForeName': 'Hoi Ning', 'Initials': 'HN', 'LastName': 'Cheung', 'Affiliation': 'Department of Pathology, Queen Elizabeth Hospital, Tuen Mun Hospital, Hong Kong.'}, {'ForeName': 'Sammy Pak Lam', 'Initials': 'SPL', 'LastName': 'Chen', 'Affiliation': 'Department of Pathology, Queen Elizabeth Hospital, Tuen Mun Hospital, Hong Kong.'}, {'ForeName': 'Kwok Man', 'Initials': 'KM', 'LastName': 'Ma', 'Affiliation': 'Department of Nuclear Medicine, Tuen Mun Hospital, Hong Kong.'}]",Bone,['10.1016/j.bone.2021.115902']
267,33631112,"Ublituximab plus ibrutinib versus ibrutinib alone for patients with relapsed or refractory high-risk chronic lymphocytic leukaemia (GENUINE): a phase 3, multicentre, open-label, randomised trial.","BACKGROUND


Patients with chronic lymphocytic leukaemia and high-risk features have poorer outcomes on ibrutinib than those without high-risk features. The aim of this study was to assess the benefit of adding ublituximab, an anti-CD20 monoclonal antibody, to ibrutinib therapy in this population.
METHODS


We did a randomised, phase 3, multicentre study (GENUINE) of patients aged 18 years or older with relapsed or refractory chronic lymphocytic leukaemia with at least one of 17p deletion, 11q deletion, or TP53 mutation, at 119 clinics in the USA and Israel. Eligible patients had received at least one previous chronic lymphocytic leukaemia therapy and had an Eastern Cooperative Oncology Group performance status of 2 or lower. We randomised patients (1:1) using permuted block randomisation with a block size of four and stratified by previous lines of therapy (one vs two or more) to receive ibrutinib alone or ibrutinib in combination with ublituximab. Treatment allocation was not masked to patients or investigators. Ibrutinib was given orally daily at 420 mg for all cycles. Ublituximab was given intravenously in 28-day cycles, with increasing doses during cycle 1 (≤150 mg on day 1, 750 mg on day 2, and 900 mg on days 8 and 15) and continuing at 900 mg on day 1 of cycles 2-6. After cycle 6, ublituximab was given at 900 mg every three cycles. The study was initially designed with co-primary endpoints of progression-free survival and overall response rate but due to protracted patient accrual, the protocol was amended to have a single primary endpoint of independent review committee-assessed overall response rate (defined as the proportion of patients who had a partial response, complete response, or complete response with incomplete marrow recovery according to the 2008 International Workshop on CLL criteria) in the intention-to-treat population. Safety was evaluated in the population of patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, NCT02301156, and the final analysis is presented.
FINDINGS


224 patients were assessed for eligibility, of whom 126 patients were enrolled and randomly assigned to receive ublituximab plus ibrutinib (n=64) or ibrutinib alone (n=62) between Feb 6, 2015, and Dec 19, 2016. After a median follow-up of 41·6 months (IQR 36·7-47·3), the overall response rate was 53 (83%) of 64 patients in the ublituximab plus ibrutinib group and 40 (65%) of 62 patients in the ibrutinib group (p=0·020). 117 patients, including 59 in the ublituximab plus ibrutinib group and 58 in the ibrutinib group, received at least one dose of treatment and were included in safety analyses. Most adverse events were grade 1 or 2. The most common grade 3 and 4 adverse events were neutropenia (11 [19%] patients in the ublituximab plus ibrutinib group and seven [12%] in the ibrutinib group), anaemia (five [8%] and five [9%]), and diarrhoea (six [10%] and three [5%]). The most common serious adverse events were pneumonia (six [10%] in the ublituximab plus ibrutinib group and four [7%] in the ibrutinib group), atrial fibrillation (four [7%] and one [2%]), sepsis (four [7%] and one [2%]), and febrile neutropenia (three [5%] and one [2%]). Two patients in the ublituximab plus ibrutinib group died due to adverse events (one cardiac arrest and one failure to thrive), neither of which were treatment-related. Five patients in the ibrutinib group died due to adverse events, including one cardiac arrest, one cerebral infarction, one intracranial haemorrhage, one Pneumocystis jirovecii pneumonia infection, and one unexplained death; the death due to cardiac arrest was considered to be treatment-related.
INTERPRETATION


The addition of ublituximab to ibrutinib resulted in a statistically higher overall response rate without affecting the safety profile of ibrutinib monotherapy in patients with relapsed or refractory high-risk chronic lymphocytic leukaemia. These findings provide support for the addition of ublituximab to Bruton tyrosine kinase inhibitors for the treatment of these patients.
FUNDING


TG Therapeutics.",2021,The addition of ublituximab to ibrutinib resulted in a statistically higher overall response rate without affecting the safety profile of ibrutinib monotherapy in patients with relapsed or refractory high-risk chronic lymphocytic leukaemia.,"['Eligible patients had received at least one previous chronic lymphocytic leukaemia therapy and had an Eastern Cooperative Oncology Group performance status of 2 or lower', 'patients with relapsed or refractory high-risk chronic lymphocytic leukaemia (GENUINE', 'Patients with chronic lymphocytic leukaemia and high-risk features', 'patients aged 18 years or older with relapsed or refractory chronic lymphocytic leukaemia with at least one of 17p deletion, 11q deletion, or TP53 mutation, at 119 clinics in the USA and Israel', '224 patients were assessed for eligibility, of whom 126 patients', 'patients with relapsed or refractory high-risk chronic lymphocytic leukaemia', '117 patients, including 59 in the ublituximab plus ibrutinib group and 58 in the ibrutinib group']","['ublituximab plus ibrutinib (n=64) or ibrutinib alone', 'ibrutinib alone or ibrutinib in combination with ublituximab', 'Ublituximab', 'Ublituximab plus ibrutinib versus ibrutinib alone']","['sepsis', 'overall response rate', 'adverse events, including one cardiac arrest, one cerebral infarction, one intracranial haemorrhage, one Pneumocystis jirovecii pneumonia infection, and one unexplained death; the death due to cardiac arrest', 'partial response, complete response, or complete response with incomplete marrow recovery', 'anaemia', 'atrial fibrillation', 'febrile neutropenia', 'died due to adverse events (one cardiac arrest and one failure to thrive', 'progression-free survival and overall response rate', 'Safety', 'neutropenia', 'diarrhoea']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4083151', 'cui_str': 'ublituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4083151', 'cui_str': 'ublituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}]","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C1535939', 'cui_str': 'Pneumocystosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0277589', 'cui_str': 'Death of unknown cause'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0015544', 'cui_str': 'Failure to thrive'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",224.0,0.218284,The addition of ublituximab to ibrutinib resulted in a statistically higher overall response rate without affecting the safety profile of ibrutinib monotherapy in patients with relapsed or refractory high-risk chronic lymphocytic leukaemia.,"[{'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': 'Willamette Valley Cancer Institute, US Oncology Research, Eugene, OR, USA. Electronic address: jeff.sharman@usoncology.com.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Brander', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University Health System, Durham, NC, USA.'}, {'ForeName': 'Anthony R', 'Initials': 'AR', 'LastName': 'Mato', 'Affiliation': 'Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Nilanjan', 'Initials': 'N', 'LastName': 'Ghosh', 'Affiliation': 'Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Schuster', 'Affiliation': 'Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Kambhampati', 'Affiliation': 'Sarah Cannon Cancer Center at Research Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Burke', 'Affiliation': 'Rocky Mountain Cancer Centers, US Oncology Research, Aurora, CO, USA.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Lansigan', 'Affiliation': 'Hematology/Oncology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Marshall T', 'Initials': 'MT', 'LastName': 'Schreeder', 'Affiliation': 'Clearview Cancer Institute, Huntsville, AL, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Lunin', 'Affiliation': 'Florida Cancer Specialists, Sarasota, FL, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zweibach', 'Affiliation': 'Cancer Care Centers of South Texas, US Oncology Research, New Braunfels, TX, USA.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Shtivelband', 'Affiliation': 'Ironwood Cancer and Research Center, Chandler, AZ, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Travis', 'Affiliation': 'Highlands Oncology Group, Fayetteville, AR, USA.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Chandler', 'Affiliation': 'West Cancer Center, Memphis, TN, USA.'}, {'ForeName': 'Kathryn S', 'Initials': 'KS', 'LastName': 'Kolibaba', 'Affiliation': 'Compass Oncology, US Oncology Research, Vancouver, WA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sportelli', 'Affiliation': 'TG Therapeutics, New York, NY, USA.'}, {'ForeName': 'Hari P', 'Initials': 'HP', 'LastName': 'Miskin', 'Affiliation': 'TG Therapeutics, New York, NY, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Weiss', 'Affiliation': 'TG Therapeutics, New York, NY, USA.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, TN, USA.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30433-6']
268,33637429,Improving Handoff by Deliberate Cognitive Processing: Results from a Randomized Controlled Experimental Study.,"BACKGROUND


Although a number of successful handoff interventions have been reported, the handoff process remains vulnerable because it relies on memory. The aim of this study was to investigate the effect of deliberate cognitive processing (i.e., analytical, conscious, and effortful thinking) on recall of information from a simulated handoff.
METHODS


This two-phased experiment was executed in the Netherlands in 2015. A total of 78 pediatric residents were randomly divided into an intervention group (n = 37) and a control group (n = 41). In phase 1, participants received written handoffs from 8 patients. The intervention group was asked to develop a contingency plan for each patient, deliberately processing the information. The control group received no specific instructions. In phase 2, all participants were asked to write down as much as they recalled from the handoffs. The outcome was the amount and accuracy of recalled information, calculated by scoring for idea units (single information elements) and inferences (conclusions computed by participants based on two or more idea units).
RESULTS


Participants in the intervention group recalled significantly more inferences (7.24 vs. 3.22) but fewer correct idea units (21.1% vs. 25.3%) than those in the control group. There was no difference with regard to incorrectly recalled information.
CONCLUSION


Our study revealed that deliberate cognitive processing leads to creation of more correct inferences, but fewer idea units. This suggests that deliberate cognitive processing results in interpretation of the information into higher level concepts, rather than remembering specific pieces of information separately. This implies better understanding of patients' problems.",2021,"RESULTS


Participants in the intervention group recalled significantly more inferences (7.24 vs. 3.22) but fewer correct idea units (21.1% vs. 25.3%) than those in the control group.",['78 pediatric residents'],"['no specific instructions', 'deliberate cognitive processing (i.e., analytical, conscious, and effortful thinking', 'Deliberate Cognitive Processing']",['correct idea units'],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",78.0,0.0520658,"RESULTS


Participants in the intervention group recalled significantly more inferences (7.24 vs. 3.22) but fewer correct idea units (21.1% vs. 25.3%) than those in the control group.","[{'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'van Heesch', 'Affiliation': ''}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Frenkel', 'Affiliation': ''}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Kollen', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zwaan', 'Affiliation': ''}, {'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Mamede', 'Affiliation': ''}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'de Hoog', 'Affiliation': ''}]",Joint Commission journal on quality and patient safety,['10.1016/j.jcjq.2020.11.008']
269,33638801,Safety and Efficacy of Perioperative Use of Evolocumab in Myocardial Infarction Patients: Study Protocol for a Multicentre Randomized Controlled Trial.,"INTRODUCTION


The SECURE-PCI study supports a perioperative loading dose of statins, although whether an intensive lipid-lowering strategy prior to percutaneous coronary intervention further benefits acute coronary syndrome patients remains controversial. Evolocumab, a proprotein-converting enzyme subtilisin/kexin type 9 (PCSK9) inhibitor, acts more quickly and effectively than statins and reduces the risk of cardiovascular events in post-myocardial infarction (MI) patients. Nonetheless, whether it can be safely used in perioperative MI patients and whether perioperative application can benefit patients are still unknown. This study aims to evaluate the safety and efficacy of this treatment regimen.
METHODS


A multicentre, prospective, randomized, controlled superiority trial will be conducted in 530 statin-naïve MI patients. All eligible patients will be randomized to the evolocumab group (140 mg subcutaneously injected once before revascularization + 14 days after the first dose) or the control group (no evolocumab injection). Evolocumab will then be administered depending on the patient's lipid profile. Both groups will be treated simultaneously with standardized secondary preventive medications. The primary end points are major adverse cardiovascular events (a composite of death, recurrent MI, unanticipated revascularization, stroke and any rehospitalization for ischaemic causes) within 12 months. The secondary end point is post-infarction angina after pain relief. The safety end points include myopathy, impaired liver or renal function, and other adverse events during the follow-up period.
OUTCOMES


This is the first trial to evaluate the safety and efficacy of evolocumab pre-treatment on prognosis in MI patients. Perioperative evolocumab injection may be a new, safe way to improve prognosis.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ( http://www.chictr.org.cn ; ChiCTR1900024526). Registered on 13 July 2019 and updated on 31 May 2020. The study is currently recruiting patients.",2021,"Evolocumab, a proprotein-converting enzyme subtilisin/kexin type 9 (PCSK9) inhibitor, acts more quickly and effectively than statins and reduces the risk of cardiovascular events in post-myocardial infarction (MI) patients.","['Myocardial Infarction Patients', '530 statin-naïve MI patients', 'MI patients']","['Evolocumab', 'evolocumab', 'control group (no evolocumab injection', 'Evolocumab, a proprotein-converting enzyme subtilisin/kexin type 9 (PCSK9) inhibitor', 'evolocumab pre-treatment']","['major adverse cardiovascular events (a composite of death, recurrent MI, unanticipated revascularization, stroke and any rehospitalization for ischaemic causes', 'post-infarction angina after pain relief', 'safety and efficacy', 'safety end points include myopathy, impaired liver or renal function, and other adverse events', 'Safety and Efficacy']","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'Kexin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0423732', 'cui_str': 'After pains'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.122515,"Evolocumab, a proprotein-converting enzyme subtilisin/kexin type 9 (PCSK9) inhibitor, acts more quickly and effectively than statins and reduces the risk of cardiovascular events in post-myocardial infarction (MI) patients.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luan', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China. ryan1218@zju.edu.cn.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.""}, {'ForeName': 'Liding', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.""}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China. fugs@zju.edu.cn.""}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China. 3313011@zju.edu.cn.""}]",Advances in therapy,['10.1007/s12325-021-01662-5']
270,33640376,"Italian breakfast in mind: The effect of caffeine, carbohydrate and protein on physiological state, mood and cognitive performance.","Due to the bidirectional influence between eating and mental activity, there is a growing interest in the neurosciences in the potential of food to influence mental states. Breakfast is the most investigated meal since it is supposed to influence satiety, mood and cognitive performance for the rest of the day. However, there is insufficient consistency among studies to draw firm conclusions about the short-term influence of carbohydrates and proteins on self-reported physiological state and mood. In order to shed light on this topic, 40 young Italian adults were involved in a single-blind randomized counterbalanced crossover experiment, in which we asked them to report on a series of visuo-analogue scales their physiological (i.e., hunger, tiredness and thirst) and affective states (i.e., happiness, excitement, activeness and relaxation) and perform 2 computer-administered cognitive tasks (simple reaction time and forward digit span) before and after having breakfast with a bitter espresso coffee and a whole wheat or a protein croissant. Our data show that breakfast improves the self-reported mood and physiological state, and also short-term verbal memory assessed by means of the forward digit span: we suppose that both croissants and caffeine played an important role in such findings. As for the reaction times, the whole wheat croissant intake determined slower reaction time compared with the protein croissant, maybe due to the higher glycemic response induced by carbohydrate ingestion. Confirming the bidirectional relationship between mind and food intake, the present findings are significant for nutrition science, since mood, physiological state and cognitive performance play a substantial role in general well-being as well as in eating behavior.",2021,"Our data show that breakfast improves the self-reported mood and physiological state, and also short-term verbal memory assessed by means of the forward digit span: we suppose that both croissants and caffeine played an important role in such findings.","['40 young Italian adults', 'Italian breakfast in mind']","['2 computer-administered cognitive tasks (simple reaction time and forward digit span) before and after having breakfast with a bitter espresso coffee and a whole wheat or a protein croissant', 'caffeine, carbohydrate and protein']","['reaction time', 'physiological state, mood and cognitive performance']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",40.0,0.0189784,"Our data show that breakfast improves the self-reported mood and physiological state, and also short-term verbal memory assessed by means of the forward digit span: we suppose that both croissants and caffeine played an important role in such findings.","[{'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Manippa', 'Affiliation': 'Department of Psychological, Health and Territorial Sciences, University G. ""d\'Annunzio"" of Chieti-Pescara, Chieti, Italy. Electronic address: valerio.manippa@unich.it.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Lupo', 'Affiliation': 'Department of Psychological, Health and Territorial Sciences, University G. ""d\'Annunzio"" of Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Tommasi', 'Affiliation': 'Department of Psychological, Health and Territorial Sciences, University G. ""d\'Annunzio"" of Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Afredo', 'Initials': 'A', 'LastName': 'Brancucci', 'Affiliation': 'Department of Psychological, Health and Territorial Sciences, University G. ""d\'Annunzio"" of Chieti-Pescara, Chieti, Italy.'}]",Physiology & behavior,['10.1016/j.physbeh.2021.113371']
271,33636650,Effects of self-healing intervention on quality of life and mother-child interaction among female breadwinners.,"OBJECTIVES


This study aimed to investigate the effectiveness of self-healing (the healing codes) intervention on quality of life (QoL) and mother-child interaction among female breadwinners.
METHODS


The study population comprised all female breadwinners who referred to the welfare centers of Isfahan in 2020; using convenience sampling, we selected 30 women and divided them into experimental and control groups (n = 15 per group). The experimental group underwent fourteen sessions (90-min sessions per week) of self-healing training.
RESULTS


The mean ± SD of QoL and mother-child interaction for experimental and control groups in the post-test stage were 84.33 ± 3.92 and 160.86 ± 8.74 respectively. Self-healing intervention had significant effects on QoL and mother-child interaction among female breadwinners. The intervention program improved the components of QoL and mother-child interaction among female breadwinners (p < 0.01).
CONCLUSIONS


Self-healing training can be used as a novel approach to enhance QoL and mother-child interaction in this group of women.",2021,"The intervention program improved the components of QoL and mother-child interaction among female breadwinners (p < 0.01).
","['study population comprised all female breadwinners who referred to the welfare centers of Isfahan in 2020; using', 'female breadwinners']","['self-healing intervention', 'Self-healing intervention', 'self-healing (the healing codes) intervention', 'convenience sampling', 'self-healing training']","['quality of life (QoL', 'mean\xa0±\xa0SD of QoL and mother-child interaction', 'QoL and mother-child interaction', 'quality of life and mother-child interaction']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0885003', 'cui_str': 'Xiakucao'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}]",30.0,0.0108561,"The intervention program improved the components of QoL and mother-child interaction among female breadwinners (p < 0.01).
","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Zarean', 'Affiliation': 'Department of Education and Psychology, University of Mohaghegh Ardabili, Ardabil, Iran. Electronic address: zareanfah@gmail.com.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101334']
272,33631500,"Efficacy and safety of modafinil in patients with idiopathic hypersomnia without long sleep time: a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study.","BACKGROUND


Few treatments are available for patients with idiopathic hypersomnia (IH). Modafinil, an established treatment for narcolepsy, was tested for efficacy and safety in Japanese patients with IH without long sleep time.
METHODS


This multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study was conducted at 20 institutions in Japan. Patients who met the diagnostic criteria of IH in the International Classification of Sleep Disorders (second edition) were included. The study comprised a ≥17-day observation period and a 3-week treatment period during which modafinil (200 mg) or placebo was administered orally once daily (in the morning). The primary efficacy endpoint was change in mean sleep latency on the Maintenance of Wakefulness Test (MWT). Adverse events (AEs) were also recorded to evaluate safety.
RESULTS


In total, 123 patients were screened and 71 were randomized to receive modafinil (N = 34) or placebo (N = 37). Patients treated with modafinil experienced a significantly prolonged mean sleep latency on the MWT at the end of the study compared with placebo (5.02 min, 95% confidence interval: 3.26-6.77 min; p < 0.001). AEs occurred in 58.8% (20/34) and 27.0% (10/37) of patients in the modafinil and placebo groups, respectively. Frequent AEs in the modafinil group were headache (n = 6), dry mouth (n = 3), and nausea (n = 3); no clinically significant AEs occurred.
CONCLUSION


Modafinil was shown to be an effective and safe treatment for excessive daytime sleepiness in patients with IH without long sleep time.
CLINICAL TRIAL REGISTRATION


JapicCTI; 142539.",2021,"AEs occurred in 58.8% (20/34) and 27.0% (10/37) of patients in the modafinil and placebo groups, respectively.","['patients with IH without long sleep time', '20 institutions in Japan', 'Patients who met the diagnostic criteria of IH in the International Classification of Sleep Disorders (second edition) were included', 'patients with idiopathic hypersomnia (IH', 'Japanese patients with IH without long sleep time', 'patients with idiopathic hypersomnia without long sleep time', '123 patients were screened and 71']","['Modafinil', 'modafinil', 'placebo']","['Efficacy and safety', 'Adverse events (AEs', 'AEs', 'nausea', 'efficacy and safety', 'excessive daytime sleepiness', 'mean sleep latency on the Maintenance of Wakefulness Test (MWT', 'mean sleep latency', 'headache']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561855', 'cui_str': 'Idiopathic hypersomnia without long sleep time'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033138', 'cui_str': 'Primary hypersomnia'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",123.0,0.65674,"AEs occurred in 58.8% (20/34) and 27.0% (10/37) of patients in the modafinil and placebo groups, respectively.","[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Japan Somnology Center, Institute of Neuropsychiatry, 5-10-10 Yoyogi, Shibuya-ku, Tokyo, 151-0053, Japan; Department of Somnology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. Electronic address: inoue@somnology.com.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Tabata', 'Affiliation': 'Research and Development Headquarters, Alfresa Pharma Corporation, 2-2-9 Koku-machi, Chuo-ku, Osaka, 540-8575, Japan.'}, {'ForeName': 'Naoji', 'Initials': 'N', 'LastName': 'Tsukimori', 'Affiliation': 'Medical Affairs Headquarters, Alfresa Pharma Corporation, 2-2-9 Koku-machi, Chuo-ku, Osaka, 540-8575, Japan.'}]",Sleep medicine,['10.1016/j.sleep.2021.01.018']
273,33647676,"Effect of guided imagery on anxiety, muscle pain, and vital signs in patients with COVID-19: A randomized controlled trial.","BACKGROUND


COVID-19 can lead to anxiety due to its high mortality rate. Patients with COVID-19 may suffer from muscle pain. This study aimed to determine the effect of guided imagery on anxiety, muscle pain, and vital signs in patients with COVID-19.
METHODS


110 patients with COVID-19 were recruited and randomly assigned to two control and intervention groups. Data were collected using the Spielberger Anxiety Inventory, the McGill Pain Questionnaire, and the Visual Analogue Scale. The intervention group received ten training sessions of guided imagery.
RESULTS


The results indicated a significant difference in the mean scores of state (t = -3.829, p < .001), trait anxiety (t = -2.946, p = .004), pain quality (t = -4.223, p < .001), pain intensity (t = -3.068, p = .003), and heart rate, systolic blood pressure, and oxygen saturation (p < .001) between the two groups after the intervention.
CONCLUSIONS


Guided imagery as a cost-effective method of complementary medicine is recommended to manage anxiety and pain in patients with COVID-19.",2021,"Data were collected using the Spielberger Anxiety Inventory, the McGill Pain Questionnaire, and the Visual Analogue Scale.","['110 patients with COVID-19', 'patients with COVID-19', 'Patients with COVID-19 may suffer from muscle pain']","['guided imagery', 'training sessions of guided imagery']","['trait anxiety', 'Spielberger Anxiety Inventory, the McGill Pain Questionnaire, and the Visual Analogue Scale', 'pain intensity', 'anxiety, muscle pain, and vital signs', 'mean scores of state', 'pain quality', 'heart rate, systolic blood pressure, and oxygen saturation']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",110.0,0.109641,"Data were collected using the Spielberger Anxiety Inventory, the McGill Pain Questionnaire, and the Visual Analogue Scale.","[{'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Parizad', 'Affiliation': 'Patient Safety Research Center, Clinical Research Institute, Nursing & Midwifery School, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Goli', 'Affiliation': 'Department of Medical-surgical Nursing, School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran. Electronic address: rasoulgoli94@gmail.com.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Faraji', 'Affiliation': 'Department of Medical-surgical Nursing, School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mam-Qaderi', 'Affiliation': 'Department of Medical-surgical Nursing, School of Nursing and Midwifery, Islamic Azad University, Urmia Branch, Urmia, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Mirzaee', 'Affiliation': 'Department of Psychiatric Nursing, School of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Gharebaghi', 'Affiliation': 'Department of Infectious Diseases, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Baghaie', 'Affiliation': 'Patient Safety Research Center, Clinical Research Institute, Nursing & Midwifery School, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Haedeh', 'Initials': 'H', 'LastName': 'Feizipour', 'Affiliation': 'Department of Medical Sicences, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mah-Monir', 'Initials': 'MM', 'LastName': 'Haghighi', 'Affiliation': 'Department of Medical Sicences, Urmia University of Medical Sciences, Urmia, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101335']
274,33647384,Physiological responses to acute psychosocial stress in women with menopausal insomnia.,"INTRODUCTION


Insomnia disorder is a common sleep disorder and frequently emerges in the context of menopause, being associated with menopause-specific factors such as hot flashes and other psychosocial variables. Increased vulnerability to stress may also contribute to the development of insomnia in midlife women. Here, we aimed to investigate whether there are differences in physiological reactivity to acute psychosocial stress in women with menopausal insomnia compared with controls.
METHODS


We investigated cortisol and heart rate [HR] responses to an acute experimental psychosocial stress (Trier Social Stress Test, TSST) approximately 1 h after waking in the morning in midlife women with (n = 22) and without (n = 16) DSM-IV insomnia disorder (Age: 50.05 ± 3.10 years), developed in the context of menopause.
RESULTS


Despite similar perceived stress levels, women with insomnia showed blunted HR increases (~29% HR acceleration) to the TSST compared to controls (~44% HR acceleration) (p = 0.026). No group differences in HR were detected at baseline or during post-task recovery. Cortisol stress responses were inconclusive, with most of the women (60%) failing to exhibit significant cortisol increases in response to the TSST. A greater magnitude of the cortisol awakening response (CAR) predicted the likelihood of being a non-responder (p = 0.036), showing the confounding effect of CAR on cortisol stress responses.
DISCUSSION


Women with menopausal insomnia show blunted cardiac responses to stress, suggesting alterations in the autonomic reactivity to acute stress. Whether these alterations are pre-existing or are a consequence of insomnia, needs to be determined.",2021,"Despite similar perceived stress levels, women with insomnia showed blunted HR increases (~29% HR acceleration) to the TSST compared to controls (~44% HR acceleration) (p = 0.026).","['midlife women with (n\u202f=\u202f22) and without (n\u202f=\u202f16) DSM-IV insomnia disorder (Age: 50.05\u202f±\u202f3.10\u202fyears), developed in the context of menopause', 'women with menopausal insomnia compared with controls', 'women with menopausal insomnia', 'midlife women']","['acute experimental psychosocial stress (Trier Social Stress Test, TSST', 'TSST']","['HR', 'blunted HR increases', 'Cortisol stress responses', 'cortisol and heart rate [HR] responses', 'cortisol awakening response (CAR']","[{'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0341866', 'cui_str': 'Menopausal sleeplessness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}]",,0.0827947,"Despite similar perceived stress levels, women with insomnia showed blunted HR increases (~29% HR acceleration) to the TSST compared to controls (~44% HR acceleration) (p = 0.026).","[{'ForeName': 'Dilara', 'Initials': 'D', 'LastName': 'Yuksel', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA 94025, USA.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'de Zambotti', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA 94025, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sugarbaker', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA 94025, USA.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Schulte', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA 94025, USA; Department of Psychology, Palo Alto University, 1791 Arastradero Rd, Palo Alto, CA 94304, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Colrain', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA 94025, USA; Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, VIC 3010, Australia.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Baker', 'Affiliation': 'Center for Health Sciences, SRI International, Menlo Park, CA 94025, USA; Brain Function Research Group, School of Physiology, University of the Witwatersrand, Johannesburg 2000, South Africa. Electronic address: fiona.baker@sri.com.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2021.02.019']
275,33636344,The protocol of the Application of Economics & Social psychology to improve Opioid Prescribing Safety Trial 1 (AESOPS-1): Electronic health record nudges.,"BACKGROUND


There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. Despite clinical guidelines and education, prescribing continues at a higher rate than before the opioids crisis. The objective of trial 1 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-1) is to discourage unnecessary opioid prescribing in primary care by applying ""behavioral insights""-empirically-tested social and psychological interventions that affect choice.
METHODS


AESOPS-1 randomizes primary care clinics in Illinois and California to behavioral intervention or control. Both arms receive opioid guideline education. Clinics randomized to the behavioral intervention arm receive nudges within the electronic health record (EHR) including: 1) an ""accountable justification"" entered in the chart, 2) a precommitment to address high-risk prescriptions, and 3) a ""PainTracker"" that broadens discussions about pain. The control arm receives no EHR-based intervention. The primary outcome is the change in weekly milligram morphine equivalents (MME) prescribed. The secondary outcome is the change in the proportion of patients prescribed at least 50 daily MME. To evaluate these outcomes, we will use a difference-in-differences mixed-effects regression model on clinician MME weekly or daily dose. The analysis will be ""intent-to-treat."" The intervention period is 18-months, with a 6-month follow-up period to measure persistence of effects.
DISCUSSION


The AESOPS-1 trial will evaluate the effect of EHR-based interventions in reducing noncancer opioid prescribing in primary care. AESOPS-1 may demonstrate practical and scalable strategies to lower unnecessary population exposure to opioids.",2021,"The objective of trial 1 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-1) is to discourage unnecessary opioid prescribing in primary care by applying ""behavioral insights""-empirically-tested social and psychological interventions that affect choice.","['primary care', 'Methods AESOPS-1 randomizes primary care clinics in Illinois and California to behavioral intervention or control']","['EHR-based interventions', 'behavioral intervention arm receive nudges within the electronic health record (EHR) including: 1) an ""accountable justification"" entered in the chart, 2) a precommitment to address high-risk prescriptions, and 3) a ""PainTracker"" that broadens discussions about pain']","['change in the proportion of patients prescribed at least 50 daily MME', 'change in weekly milligram morphine equivalents (MME) prescribed']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0066662', 'cui_str': '1,2,3,4,9,9-hexachloro-1,4,4a,5,8,8a-hexahydro-6- methyl-6,7-epoxy-1,4-methanonaphthalene'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]",,0.103082,"The objective of trial 1 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-1) is to discourage unnecessary opioid prescribing in primary care by applying ""behavioral insights""-empirically-tested social and psychological interventions that affect choice.","[{'ForeName': 'Marcella A', 'Initials': 'MA', 'LastName': 'Kelley', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America; School of Pharmacy, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Persell', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Linder', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Friedberg', 'Affiliation': 'Blue Cross Blue Shield of Massachusetts, Boston, MA, United States of America.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Meeker', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America; Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Fox', 'Affiliation': 'Anderson School of Management, University of California at Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Noah J', 'Initials': 'NJ', 'LastName': 'Goldstein', 'Affiliation': 'Anderson School of Management, University of California at Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Tara K', 'Initials': 'TK', 'LastName': 'Knight', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America; Sol Price School of Public Policy, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Zein', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Rowe', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of Washington, School of Medicine, Seattle, WA, United States of America.'}, {'ForeName': 'Jason N', 'Initials': 'JN', 'LastName': 'Doctor', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America; School of Pharmacy, University of Southern California, Los Angeles, CA, United States of America; Sol Price School of Public Policy, University of Southern California, Los Angeles, CA, United States of America. Electronic address: jdoctor@usc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106329']
276,33639518,Effects of progressive muscle relaxation training with music therapy on sleep and anger of patients at Community Mental Health Center.,"OBJECTIVE


The objective is to examine the effects of progressive muscle relaxation training and music therapy applied to chronic psychiatric patients attending the Community Mental Health Center (CMHC) on their anger level and sleep quality.
METHODS


The sample of the study consisted of 66 chronic psychiatric patients (n = 32 in the control group; n = 34 in the intervention group). Progressive muscle relaxation training with music therapy were implemented in the intervention group as 2 sessions per week for 3 months.
RESULTS


A statistically significant difference was found between the pre-test and post-test mean scores of the intervention group (p ≤ .001). After the intervention, a statistically significant difference was found between the PSQI, anger-in, anger-out, anger-control, and trait anger scale scores of the two groups (p ≤ .001).
CONCLUSION


Relaxation training and music therapy are effective in controlling anger and increasing sleep quality in chronic psychiatric patients.
CLINICAL TRIAL NUMBER


NCT04620122.",2021,"After the intervention, a statistically significant difference was found between the PSQI, anger-in, anger-out, anger-control, and trait anger scale scores of the two groups (p ≤ .001).
","['chronic psychiatric patients attending the Community Mental Health Center (CMHC) on their anger level and sleep quality', 'chronic psychiatric patients', '66 chronic psychiatric patients (n\xa0=\xa032 in the control group; n\xa0=\xa034 in the intervention group', 'patients at Community Mental Health Center']","['progressive muscle relaxation training with music therapy', 'Relaxation training and music therapy', 'progressive muscle relaxation training and music therapy', 'Progressive muscle relaxation training with music therapy']","['sleep quality', 'PSQI, anger-in, anger-out, anger-control, and trait anger scale scores', 'sleep and anger']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",66.0,0.0280356,"After the intervention, a statistically significant difference was found between the PSQI, anger-in, anger-out, anger-control, and trait anger scale scores of the two groups (p ≤ .001).
","[{'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'İçel', 'Affiliation': 'Gaziantep Islamic Science and Technology University, Faculty of Health Sciences, Midwifery Department, Gaziantep, Turkey. Electronic address: icelsema@gmail.com.'}, {'ForeName': 'Ceyda', 'Initials': 'C', 'LastName': 'Başoğul', 'Affiliation': 'Adıyaman University, Faculty of Health Sciences, Department of Psychiatric Nursing, Adıyaman, Turkey. Electronic address: cbasogul@adiyaman.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101338']
277,33640715,Influence of narrow-band imaging (NBI) and enhanced operator's attention during esophagus inspection on cervical inlet patches detection.,"PURPOSE


Heterotopic gastric mucosa in the upper esophagus (cervical inlet patches - CIP) may be easily missed during esophagogastroduodenoscopy (EGD) due to low awareness of this usually, but not invariably, benign lesion. Narrow-band imaging (NBI) emphasizes contrast between normal esophageal mucosa and CIP. The purpose of this study was to investigate how NBI use and enhanced attention of operator during inspection of upper esophagus impacts cervical inlet patch detection rate (CIPDR).
MATERIALS AND METHODS


This is a prospective, randomized study in which we enrolled 1000 patients, qualified for diagnostic EGD. The trial was divided into two parts; the first, when 6 operators performed EGD with standard attention (SA), and the second, when the same operators were asked to step up with attention at CIP (enhanced attention - EA). In both parts of the study, patients were randomized to NBI and white light endoscopy (WLE) in 1:1 ratio. The study is registered in ClinicalTrials.gov (No. NCT03015571).
RESULTS


Differences in CIPDR between WLE and NBI in SA and EA were not statistically different (5.6% vs 7.6%; p ​= ​0.3, and 7.6% vs 11.6%; p ​= ​0.1, respectively). In multivariate regression analysis, the only factors improving CIPDR were NBI with EA (NBI EA , OR 3.31; 95%CI 1.57-6.98; p ​= ​0.003) and sedation (OR 1.97; 95%CI 1.27-3.05; p ​= ​0.002).
CONCLUSIONS


The use of NBI combined with EA significantly improves CIPDR.",2021,"RESULTS


Differences in CIPDR between WLE and NBI in SA and EA were not statistically different (5.6% vs 7.6%; p ​= ​0.3, and 7.6% vs 11.6%; p ​= ​0.1, respectively).","['enrolled 1000 patients, qualified for diagnostic EGD', 'Heterotopic gastric mucosa in the upper esophagus (cervical inlet patches - CIP']","['EGD with standard attention (SA), and the second, when the same operators were asked to step up with attention at CIP (enhanced attention - EA', 'narrow-band imaging (NBI', 'NBI and white light endoscopy (WLE', 'NBI combined with EA']",['CIPDR'],"[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0574894', 'cui_str': 'Heterotopic'}, {'cui': 'C0017136', 'cui_str': 'Gastric mucous membrane structure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C3179046', 'cui_str': 'Inlets'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C1855739', 'cui_str': 'Indifference to Pain, Congenital, Autosomal Recessive'}]","[{'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C1855739', 'cui_str': 'Indifference to Pain, Congenital, Autosomal Recessive'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",[],1000.0,0.0855344,"RESULTS


Differences in CIPDR between WLE and NBI in SA and EA were not statistically different (5.6% vs 7.6%; p ​= ​0.3, and 7.6% vs 11.6%; p ​= ​0.1, respectively).","[{'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Romańczyk', 'Affiliation': 'Endoterapia, H-T. Centrum Medyczne, Tychy, Poland; Department of Gastroenterology and Hepatology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland. Electronic address: mromanczyk@sum.edu.pl.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Romańczyk', 'Affiliation': 'Endoterapia, H-T. Centrum Medyczne, Tychy, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Lesińska', 'Affiliation': 'Endoterapia, H-T. Centrum Medyczne, Tychy, Poland; Department of Gastroenterology and Hepatology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Romańczyk', 'Affiliation': 'Endoterapia, H-T. Centrum Medyczne, Tychy, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Hartleb', 'Affiliation': 'Department of Gastroenterology and Hepatology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Waluga', 'Affiliation': 'Endoterapia, H-T. Centrum Medyczne, Tychy, Poland; Department of Gastroenterology and Hepatology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland.'}]",Advances in medical sciences,['10.1016/j.advms.2021.02.002']
278,33639517,Therapeutic effects of auricular point acupressure on the recovery of patients after pterygium surgery: A pilot study.,"BACKGROUND


and purpose: Postoperative pain in the pterygium of the eye seriously affects patient recovery. This study was conducted to assess the efficacy of auricular point acupressure treatment on post-operative recovery in patients after pterygium surgery.
MATERIALS AND METHODS


This was a pilot, randomized controlled study. A total of 60 patients (60 eyes) were randomly assigned to two groups. After pterygium surgery, the auricular group was treated using ear acupressure (acupressure points with Cowherb seeds) and the control group was treated using sham auricular therapy (acupressure points without Cowherb seeds). Both groups were treated for one week. Outcome measures included pain score, corneal epithelial score, best-corrected visual acuity, and recurrence rate.
RESULTS


Fifty-three patients completed the study. The mean pain scores and corneal epithelial scores were significantly reduced over time in the auricular group compared with those in the control group (p < 0.05). The time-group interaction for both pain scores and corneal epithelial scores was significant between the two groups (p < 0.05). Simple main effect analysis showed the mean pain scores in the auricular group were significantly lower at each time point (the first 2-h, the first day, the third day and the first week, p < 0.05) than the control group. Mean corneal epithelial scores of the auricular group were significantly lower on the first day and third day respectively than the control group (p < 0.05). There was no significant difference in the best-corrected visual acuity or recurrence rate between the two groups (p > 0.05).
CONCLUSION


Auricular point acupressure accelerates corneal epithelium reconstruction and suppresses postoperative pain, making it an ideal adjunct treatment for postoperative pterygium recovery.
CLINICAL TRIAL REGISTRATION NUMBER


ChiCTR2000032490 on http://www.chictr.org.cn/.",2021,Mean corneal epithelial scores of the auricular group were significantly lower on the first day and third day respectively than the control group (p < 0.05).,"['60 patients (60 eyes', 'Fifty-three patients completed the study', 'patients after pterygium surgery']","['auricular point acupressure', 'ear acupressure (acupressure points with Cowherb seeds) and the control group was treated using sham auricular therapy (acupressure points without Cowherb seeds', 'Auricular point acupressure', 'auricular point acupressure treatment']","['Mean corneal epithelial scores', 'pain scores and corneal epithelial scores', 'mean pain scores and corneal epithelial scores', 'pain score, corneal epithelial score, best-corrected visual acuity, and recurrence rate', 'mean pain scores', 'best-corrected visual acuity or recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",60.0,0.0907746,Mean corneal epithelial scores of the auricular group were significantly lower on the first day and third day respectively than the control group (p < 0.05).,"[{'ForeName': 'Lusha', 'Initials': 'L', 'LastName': 'Cen', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Youdian Rd.54th, Hangzhou, 310006, China. Electronic address: 201811010712026@zcmu.edu.cn.'}, {'ForeName': 'Cao', 'Initials': 'C', 'LastName': 'Yi', 'Affiliation': 'Department of Dermatology, The First Affiliated Hospital of Zhejiang Chinese Medical University, China. Electronic address: 19873034@zcmu.edu.cn.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101339']
279,33252984,Lack of Bacterial Colonization Measure in Randomized Controlled Trial on Inhaled Corticosteroids Effect in Patients with Chronic Obstructive Pulmonary Disease.,,2021,,['Patients with Chronic Obstructive Pulmonary Disease'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",[],[],,0.176464,,"[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Martinez-Garcia', 'Affiliation': 'Hospital Universitario y Politécnico La Fe Valencia, Spain.'}, {'ForeName': 'Alvar', 'Initials': 'A', 'LastName': 'Agustí', 'Affiliation': 'Instituto de Salud Carlos III Madrid, Spain.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202011-4044LE']
280,33023304,Ivacaftor in Infants Aged 4 to <12 Months with Cystic Fibrosis and a Gating Mutation. Results of a Two-Part Phase 3 Clinical Trial.,"Rationale:  We previously reported that ivacaftor was safe and well tolerated in cohorts aged 12 to <24 months with cystic fibrosis and gating mutations in the ARRIVAL study; here, we report results for cohorts aged 4 to <12 months. Objectives:  To evaluate the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in infants aged 4 to <12 months with one or more gating mutations. Methods:  ARRIVAL is a single-arm phase 3 study. Infants received 25 mg or 50 mg ivacaftor every 12 hours on the basis of age and weight for 4 days in part A and 24 weeks in part B. Measurements and Main Results:  Primary endpoints were safety (parts A and B) and pharmacokinetics (part A). Secondary/tertiary endpoints (part B) included pharmacokinetics and changes in sweat chloride levels, growth, and markers of pancreatic function. Twenty-five infants received ivacaftor, 12 in part A and 17 in part B (four infants participated in both parts). Pharmacokinetics was consistent with that in older groups. Most adverse events were mild or moderate. In part B, cough was the most common adverse event ( n  = 10 [58.8%]). Five infants (part A,  n  = 1 [8.3%]; part B,  n  = 4 [23.5%]) had serious adverse events, all of which were considered to be not or unlikely related to ivacaftor. No deaths or treatment discontinuations occurred. One infant (5.9%) experienced an alanine transaminase elevation >3 to ≤5× the upper limit of normal at Week 24. No other adverse trends in laboratory tests, vital signs, or ECG parameters were reported. Sweat chloride concentrations and measures of pancreatic obstruction improved. Conclusions:  This study of ivacaftor in the first year of life supports treating the underlying cause of cystic fibrosis in children aged ≥4 months with one or more gating mutations.Clinical trial registered with clinicaltrials.gov (NCT02725567).",2021,One infant (5.9%) experienced an alanine transaminase elevation >3 to ≤5× the upper limit of normal at Week 24.,"['infants aged 4 to <12 months with one or more gating mutations', 'children aged ≥4 months with one or more gating mutations', 'cohorts aged 12 to <24 months with cystic fibrosis and gating mutations in the ARRIVAL study; here, we report results for cohorts aged 4 to <12 months', 'Infants Aged 4 to <12 Months with Cystic Fibrosis and a Gating Mutation']","['Ivacaftor', 'ivacaftor']","['serious adverse events', 'alanine transaminase elevation', 'safe and well tolerated', 'laboratory tests, vital signs, or ECG parameters', 'Secondary/tertiary endpoints (part B) included pharmacokinetics and changes in sweat chloride levels, growth, and markers of pancreatic function', 'safety (parts A and B) and pharmacokinetics (part A', 'safety, pharmacokinetics, and pharmacodynamics of ivacaftor']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}]","[{'cui': 'C3264621', 'cui_str': 'ivacaftor'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0232786', 'cui_str': 'Pancreatic function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}]",,0.0462653,One infant (5.9%) experienced an alanine transaminase elevation >3 to ≤5× the upper limit of normal at Week 24.,"[{'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Davies', 'Affiliation': 'National Heart & Lung Institute, Imperial College London and Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wainwright', 'Affiliation': ""Queensland Children's Hospital, University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Sawicki', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Higgins', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, Massachusetts; and.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, Massachusetts; and.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, Massachusetts; and.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Panorchan', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, Massachusetts; and.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Haseltine', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, Massachusetts; and.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, Massachusetts; and.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rosenfeld', 'Affiliation': ""Seattle Children's Hospital, University of Washington School of Medicine, Seattle, Washington.""}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202008-3177OC']
281,33636648,Long-term effectiveness and safety of lemborexant in adults with insomnia disorder: results from a phase 3 randomized clinical trial.,"OBJECTIVE/BACKGROUND


Lemborexant is a dual orexin receptor antagonist approved in the United States, Japan, and Canada for the treatment of insomnia in adults. We report effectiveness and safety outcomes in subjects with insomnia who received up to twelve months of continuous lemborexant treatment in Study E2006-G000-303 (Study 303; SUNRISE-2).
PATIENTS/METHODS


Study 303 was a twelve-month, global, multicenter, randomized, double-blind, parallel-group, Phase 3 study divided into two treatment periods. In Treatment Period 1 (first six months), subjects (n = 949, Full Analysis Set) were randomized to daily placebo, lemborexant 5 mg (LEM5) or lemborexant 10 mg (LEM10). In Treatment Period 2 (second six months), placebo subjects were rerandomized to LEM5 or LEM10, and subjects randomized to lemborexant continued their assigned treatment (LEM5, n = 251; LEM10, n = 226). Sleep onset and sleep maintenance endpoints were analyzed from daily electronic sleep diary data. Treatment-emergent adverse events (TEAEs) were monitored.
RESULTS


For all sleep parameters, the significant benefits observed with LEM5 and LEM10 versus placebo over six months were maintained at twelve months in subjects who received twelve continuous months of treatment. There was no evidence of rebound insomnia or withdrawal in either lemborexant group following treatment discontinuation. Over twelve months of lemborexant treatment, most TEAEs were mild/moderate; the most common TEAEs were nasopharyngitis, somnolence and headache.
CONCLUSIONS


LEM5 and LEM10 had significant benefit on sleep onset and sleep maintenance compared with placebo, and importantly, lemborexant effectiveness persisted at twelve months, suggesting that lemborexant may provide long-term benefits for subjects with insomnia.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39.",2021,"For all sleep parameters, the significant benefits observed with LEM5 and LEM10 versus placebo over six months were maintained at twelve months in subjects who received twelve continuous months of treatment.","['subjects with insomnia who received up to twelve months of continuous lemborexant treatment in Study E2006-G000-303 (Study 303; SUNRISE-2', 'subjects with insomnia', 'adults with insomnia disorder', 'insomnia in adults', 'Study 303 was a twelve-month, global, multicenter']","['placebo', 'lemborexant', 'placebo, lemborexant 5\xa0mg (LEM5) or lemborexant 10\xa0mg (LEM10', 'LEM5 or LEM10', 'LEM5 and LEM10 versus placebo']","['nasopharyngitis, somnolence and headache', 'sleep onset and sleep maintenance', 'rebound insomnia or withdrawal', 'Sleep onset and sleep maintenance endpoints']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0270541', 'cui_str': 'Rebound insomnia'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",,0.346373,"For all sleep parameters, the significant benefits observed with LEM5 and LEM10 versus placebo over six months were maintained at twelve months in subjects who received twelve continuous months of treatment.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Yardley', 'Affiliation': 'Eisai Ltd., Hatfield, UK.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Kärppä', 'Affiliation': 'Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pinner', 'Affiliation': 'Eisai Ltd., Hatfield, UK.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Perdomo', 'Affiliation': 'Eisai Inc., 100 Tice Boulevard, Woodcliff Lake, NJ 07677, USA.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Eisai Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Gleb', 'Initials': 'G', 'LastName': 'Filippov', 'Affiliation': 'Eisai Inc., 100 Tice Boulevard, Woodcliff Lake, NJ 07677, USA.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kubota', 'Affiliation': 'Eisai Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc., 100 Tice Boulevard, Woodcliff Lake, NJ 07677, USA. Electronic address: Margaret_Moline@eisai.com.'}]",Sleep medicine,['10.1016/j.sleep.2021.01.048']
282,33647273,Daily acute intermittent hypoxia combined with walking practice enhances walking performance but not intralimb motor coordination in persons with chronic incomplete spinal cord injury.,"Persons living with incomplete spinal cord injuries (SCI) often struggle to regain independent walking due to deficits in walking mechanics. They often dedicate many weeks of gait training before benefits to emerge, with additional training needed for benefits to persist. Recent studies in humans with SCI found that daily bouts of breathing low oxygen (acute intermittent hypoxia, AIH) prior to locomotor training elicited persistent (weeks) improvement in overground walking speed and endurance. AIH-induced improvements in overground walking may result from changes in control strategies that also enhance intralimb coordination; however, this possibility remains untested. Here, we examined the extent to which daily AIH combined with walking practice (AIH + WALK) improved overground walking performance and intralimb motor coordination in persons with chronic, incomplete SCI.
METHODS


We recruited 11 persons with chronic (> 1 year), incomplete SCI to participate in a randomized, double-blind, balanced, crossover study. Participants first received either daily (5 consecutive days) AIH (15, 90-s episodes of 10.0% O 2  with 60s intervals at 20.9% O 2 ) or SHAM (15, 90s episodes at 20.9% O 2  with 60s intervals at 20.9% O 2 ) followed by 30-min of overground walking practice. They received the second treatment after a minimum 2-week washout period. We quantified overground walking performance, in terms of speed and endurance, using the 10-Meter Walk Test (10MWT) and 6-Minute Walk Test (6MWT), respectively. We quantified intralimb motor coordination using kinematic variability measures of foot trajectory (i.e., endpoint variability, EV) and of inter-joint coupling between the hip and knee, as well as between the knee and ankle joints (i.e., angular coefficient of correspondence, ACC). We compared the changes in walking performance relative to baseline (BL) between daily AIH + WALK and daily SHAM+WALK on treatment day 5 (T 5 ), 1-week follow-up (F 1 ), and 2-weeks follow-up (F 2 ). We also compared these changes between participants who used bilateral walking aids (N = 5) and those who did not. To assess the effects of daily AIH + WALK on intralimb coordination, we compared potential treatment-induced changes in EV and ACC relative to BL at F 1  and F 2 .
RESULTS


Participants improved overground walking performance (speed and endurance) after daily AIH + WALK, but not SHAM+WALK. Following daily AIH + WALK, participants decreased their 10MWT time at T 5  by 28% (95% CI 0.2-10.1 s, p = 0.04), F 1  by 28% (95% CI 1.1-13.5 s, p = 0.01), and F 2  by 27% (95% CI 1.4-13.9 s, p = 0.01) relative to BL. The greatest decreases in the 10MWT occurred in participants who used bilateral walking aids (p < 0.05). We also found daily AIH + WALK resulted in an increase in 6MWT distance at T 5  by 22% (95% CI 13.3-72.6 m, p = 0.001), F 1  by 21% (95% CI 13.1-72.5 m, p = 0.001), and F 2  by 16% (95% CI 2.9-62.2 m, p = 0.02). However, measures of EV and ACC during self-selected walking conditions did not change following daily AIH + WALK (all p-values >0.50).
CONCLUSIONS


Consistent with prior studies, daily AIH + WALK triggered improvements in walking speed and endurance that persisted for weeks after treatment. Greatest improvements in speed occurred in participants who used bilateral walking aids. No change in EV and ACC may suggest that intralimb motor coordination was not a significant gait training priority during daily AIH + WALK.",2021,The greatest decreases in the 10MWT occurred in participants who used bilateral walking aids (p < 0.05).,"['11 persons with chronic (> 1\u202fyear', 'Persons living with incomplete spinal cord injuries (SCI', 'persons with chronic incomplete spinal cord injury', 'persons with chronic, incomplete SCI.\nMETHODS', 'participants who used bilateral walking aids (N\u202f=\u202f5) and those who did not']","['Daily acute intermittent hypoxia combined with walking practice enhances walking performance', 'SHAM', 'AIH combined with walking practice (AIH\u202f+\u202fWALK']","['10MWT time', 'overground walking speed and endurance', '10-Meter Walk Test (10MWT) and 6-Minute Walk Test (6MWT', 'overground walking performance (speed and endurance', '6MWT distance', '10MWT', 'walking speed and endurance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0556927', 'cui_str': 'Walking practice'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0021589', 'cui_str': 'Artificial insemination, homologous'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",11.0,0.0861545,The greatest decreases in the 10MWT occurred in participants who used bilateral walking aids (p < 0.05).,"[{'ForeName': 'Andrew Q', 'Initials': 'AQ', 'LastName': 'Tan', 'Affiliation': 'Department of Integrative Physiology, University of Colorado, Boulder, CO, USA.'}, {'ForeName': 'Won Joon', 'Initials': 'WJ', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, University of California, Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Avantika', 'Initials': 'A', 'LastName': 'Naidu', 'Affiliation': 'Spaulding Rehabilitation Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Randy D', 'Initials': 'RD', 'LastName': 'Trumbower', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA; Spaulding Rehabilitation Hospital, Charlestown, MA, USA. Electronic address: randy.trumbower@mgh.harvard.edu.'}]",Experimental neurology,['10.1016/j.expneurol.2021.113669']
283,33647373,A randomised controlled trial to compare the efficacy of an aluminium lactate/potassium nitrate/hydroxylapatite toothpaste with a control toothpaste for the prevention of dentine hypersensitivity.,"OBJECTIVES


To determine the efficacy of a cosmetic aluminium lactate/potassium nitrate/hydroxylapatite toothpaste for the reduction of dentine hypersensitivity (DH) pain as compared to a control toothpaste containing potassium nitrate.
METHODS


The study was a randomised, examiner-blind, two treatment arm, parallel controlled trial in healthy adults with at least 2 sensitive teeth (Schiff >2). At baseline, immediately after treatment and at 7 and 14 days of twice-daily brushing of the test or control toothpaste the sensitivity of 2 test teeth was measured following iced-water (Schiff and VAS) and tactile (Yeaple probe) stimuli, and a whole mouth plaque score was obtained. Participants also completed a whole-mouth VAS and DHEQ15 quality of life questionnaire at baseline, 7 and 14 days.
RESULTS


Both toothpastes reduced DH in test teeth, but pain reduction in the test group was significantly better at all timepoints and by all measures (p = 0.005, tooth-level VAS immediately after brushing; p < 0.001 all other comparisons). There was a relative risk reduction of Schiff sensitivity of 55 % immediately after brushing which rose to 81 % after 7 and 88.6 % after 14 days (all p < 0.001). There were no differences in plaque, whole mouth VAS or DHEQ15 scores at any time point.
CONCLUSION


This study demonstrated the efficacy of an aluminium lactate/potassium nitrate/hydroxylapatite toothpaste compared to a potassium nitrate control toothpaste for the prevention of dentine hypersensitivity both immediately and over a 2 week period. This agent appears to have potential for pain alleviation from the common oral pain condition of DH and further research is warranted.
CLINICAL SIGNIFICANCE


DH pain, whilst transient in nature, is arresting in magnitude, affecting quality of life. Daily application of efficacious toothpastes can relieve DH pain however, as yet, there is no gold standard treatment. The results of this study support further investigation of an aluminium lactate/potassium nitrate/hydroxylapatite toothpaste for DH management.",2021,"Both toothpastes reduced DH in test teeth, but pain reduction in the test group was significantly better at all timepoints and by all measures (p = 0.005, tooth-level VAS immediately after brushing; p < 0.001 all other comparisons).",['healthy adults with at least 2 sensitive teeth (Schiff >2'],"['aluminium lactate/potassium nitrate/hydroxylapatite toothpaste', 'aluminium lactate/potassium nitrate/hydroxylapatite toothpaste with a control toothpaste', 'potassium nitrate control toothpaste', 'cosmetic aluminium lactate/potassium nitrate/hydroxylapatite toothpaste']","['whole-mouth VAS and DHEQ15 quality of life questionnaire', 'dentine hypersensitivity (DH) pain', 'pain reduction', 'dentine hypersensitivity', 'DH pain', 'plaque, whole mouth VAS or DHEQ15 scores', 'relative risk reduction of Schiff sensitivity']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}]","[{'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0387411,"Both toothpastes reduced DH in test teeth, but pain reduction in the test group was significantly better at all timepoints and by all measures (p = 0.005, tooth-level VAS immediately after brushing; p < 0.001 all other comparisons).","[{'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Seong', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: J.Seong@bristol.ac.uk.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Newcombe', 'Affiliation': 'Cardiff University, Cardiff, CF10 3AT, UK. Electronic address: newcombe@cardiff.ac.uk.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Foskett', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: Helen.foskett@bristol.ac.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: maria.davies@bristol.ac.uk.'}, {'ForeName': 'Nicola X', 'Initials': 'NX', 'LastName': 'West', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: n.x.west@bristol.ac.uk.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103619']
284,33652127,Improving transition from inpatient rehabilitation following traumatic brain injury: Protocol for the BRITE pragmatic comparative effectiveness trial.,"Moderate to severe traumatic brain injury (TBI) is a common cause of long-term disability. Due to challenges that include inconsistent access to follow-up care, persons with TBI being discharged from inpatient rehabilitation facilities (IRFs) are at risk for rehospitalization, poor reintegration into the community, family stress, and other unfavorable outcomes resulting from unmet needs. In a six-center randomized pragmatic comparative effectiveness study, the BRITE trial (Brain Injury Rehabilitation: Improving the Transition Experience, ClinicalTrials.govNCT03422276), we compare the effectiveness of two existing methods for transition from IRF to community living or long-term nursing care. The Rehabilitation Discharge Plan (RDP) includes patient/family education and referrals for continued care. The Rehabilitation Transition Plan (RTP) provides RDP plus individualized, manualized care management via phone or videoconference, for 6 months. Nine hundred patients will be randomized (1:1) to RDP or RTP, with caregivers also invited to participate and contribute caregiver-reported outcomes. Extensive stakeholder input, including active participation of persons with TBI and their families, has informed all aspects of trial design and implementation planning. We hypothesize that RTP will result in better patient- and caregiver-reported outcomes (societal participation, quality of life, caregiver well-being) and more efficient use of healthcare resources at 6-months (primary outcome) and 12-months post-discharge, compared to RDP alone. Planned analyses will explore which participants benefit most from each transition model. With few exclusion criteria and other pragmatic features, the findings of this trial are expected to have a broad impact on improving transitions from inpatient TBI rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03422276.",2021,"We hypothesize that RTP will result in better patient- and caregiver-reported outcomes (societal participation, quality of life, caregiver well-being) and more efficient use of healthcare resources at 6-months (primary outcome) and 12-months post-discharge, compared to RDP alone.","['persons with TBI being discharged from inpatient rehabilitation facilities (IRFs', 'Nine hundred patients', 'persons with TBI and their families', 'Brain Injury Rehabilitation']","['RDP or RTP', 'RTP']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C4047961', 'cui_str': 'Discharge from inpatient rehabilitation facility'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C3845566', 'cui_str': 'Rehabilitation facility'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0012622', 'cui_str': 'Discharge planning'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]",[],900.0,0.108676,"We hypothesize that RTP will result in better patient- and caregiver-reported outcomes (societal participation, quality of life, caregiver well-being) and more efficient use of healthcare resources at 6-months (primary outcome) and 12-months post-discharge, compared to RDP alone.","[{'ForeName': 'Jesse R', 'Initials': 'JR', 'LastName': 'Fann', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 1959 NE Pacific Street, Box 356560, Seattle, WA 98195, United States of America. Electronic address: fann@uw.edu.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Hart', 'Affiliation': 'Moss Rehabilitation Research Institute, 50 Township Line Road, Elkins Park, PA 19027, United States of America. Electronic address: thart@einstein.edu.'}, {'ForeName': 'Marcia A', 'Initials': 'MA', 'LastName': 'Ciol', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine, 1959 NE Pacific Street, Box 356490, Seattle, WA 98195, United States of America. Electronic address: marciac@uw.edu.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'School of Social Work and Harborview Injury Prevention and Research Center, University of Washington, 4101 15(th) Avenue NE, Seattle, WA 98105, United States of America. Electronic address: mm99@uw.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bogner', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The Ohio State University, 480 Medical Center Drive, Columbus, OH 43210, United States of America. Electronic address: Jennifer.Bogner@osumc.edu.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Corrigan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The Ohio State University, 480 Medical Center Drive, Columbus, OH 43210, United States of America. Electronic address: John.Corrigan@osumc.edu.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': ""Dams-O'Connor"", 'Affiliation': ""Department of Rehabilitation Medicine, Department of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave Levy Place Box 1163, New York, NY 10029, United States of America. Electronic address: Kristen.dams-o'connor@mountsinai.org.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Driver', 'Affiliation': 'Department of Sports Therapy and Research, Baylor Scott and White Research Institute, 3434 Live Oak, Dallas, TX 75204, United States of America. Electronic address: simon.driver@bswhealth.org.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Dubiel', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Baylor Scott and White Institute for Rehabilitation, 909 N. Washington Avenue, Dallas, TX 75246, United States of America. Electronic address: rdubiel@bswrehab.com.'}, {'ForeName': 'Flora M', 'Initials': 'FM', 'LastName': 'Hammond', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Indian University School of Medicine, 4141 Shore Drive, Indianapolis, IN 46254, United States of America. Electronic address: Flora.hammond@rhin.com.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kajankova', 'Affiliation': 'Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai, One Gustave Levy Place Box 1163, New York, NY 10029, United States of America. Electronic address: Maria.kajankova@mountsinai.org.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Watanabe', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MossRehab at Elkins Park/Einstein Healthcare Network, 60 Township Line Road, Elkins Park, PA 19027, United States of America. Electronic address: watanabt@einstein.edu.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Hoffman', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine, 1959 NE Pacific Street, Box 356490, Seattle, WA 98195, United States of America. Electronic address: jeanneh@uw.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106332']
285,33652088,Theta burst stimulation over the prefrontal cortex: Effects on cerebral oximetry and cardiovascular measures in healthy humans.,"Theta Burst Stimulation (TBS) is a non-invasive neurophysiological technique, able to induce changes in synaptic activity. Research suggests that TBS may induce changes in cerebral oxygenation, cerebral blood flow, blood pressure and heart rate but there are conflicting results across studies. Thus, the objective of our sham-controlled study is to evaluate if TBS applied to the dorsolateral prefrontal cortex (DLPFC) of healthy volunteers produces changes in cerebral oximetry, heart rate and blood pressure. Forty-nine volunteers of both sexes were randomly allocated to one of five stimulation groups. Before and after real TBS or sham stimulation, blood pressure, heart rate, and cerebral oxygenation of the volunteers were measured. Cerebral oxygenation values were obtained with a near infra-red spectroscopy system. We found a significant reduction in left cortex oximetry after continuous TBS (cTBS) over the left DLPFC (p = 0.039) and a non-significant reduction in right cortex oximetry (p = 0.052). Right hemisphere inhibition (using cTBS) seemed to originate a significant reduction of 8 mmHg in systolic arterial pressure. No other changes were seen in oximetry, cardiac frequency and diastolic arterial pressure. In our group of normal subjects, cTBS applied to the left DLPFC was able to reduce oxygenation in the left cortex. Right hemisphere inhibition was associated with a significant reduction in systolic pressure.",2021,"No other changes were seen in oximetry, cardiac frequency and diastolic arterial pressure.","['healthy volunteers', 'healthy humans', 'Forty-nine volunteers of both sexes']","['TBS', 'Theta burst stimulation over the prefrontal cortex', 'Theta Burst Stimulation (TBS']","['left cortex oximetry', 'systolic pressure', 'systolic arterial pressure', 'oximetry, cardiac frequency and diastolic arterial pressure', 'cerebral oximetry and cardiovascular measures', 'cerebral oxygenation, cerebral blood flow, blood pressure and heart rate', 'right cortex oximetry', 'blood pressure, heart rate, and cerebral oxygenation', 'cerebral oximetry, heart rate and blood pressure', 'Cerebral oxygenation values']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]","[{'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",49.0,0.0192315,"No other changes were seen in oximetry, cardiac frequency and diastolic arterial pressure.","[{'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Pinto', 'Affiliation': 'Faculty of Health Sciences, University of Beira Interior, Covilhã, 6200-506, Portugal; CICS-Health Sciences Research Centre, University of Beira Interior, Covilhã, 6200-506, Portugal. Electronic address: nfcpinto@gmail.com.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gonçalves', 'Affiliation': 'Faculty of Health Sciences, University of Beira Interior, Covilhã, 6200-506, Portugal. Electronic address: helenasantosgoncalves@gmail.com.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Silva', 'Affiliation': 'Faculty of Health Sciences, University of Beira Interior, Covilhã, 6200-506, Portugal. Electronic address: ricardo.p.o.silva@gmail.com.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Duarte', 'Affiliation': 'Faculty of Health Sciences, University of Beira Interior, Covilhã, 6200-506, Portugal. Electronic address: martad@fcsaude.ubi.pt.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gama', 'Affiliation': 'Faculty of Health Sciences, University of Beira Interior, Covilhã, 6200-506, Portugal; University of Beira Interior, Department of Mathematics, Covilhã, 6200-506, Portugal. Electronic address: jgama@ubi.pt.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vaz Pato', 'Affiliation': 'Faculty of Health Sciences, University of Beira Interior, Covilhã, 6200-506, Portugal; CICS-Health Sciences Research Centre, University of Beira Interior, Covilhã, 6200-506, Portugal. Electronic address: mariavazpato@fcsaude.ubi.pt.'}]",Neuroscience letters,['10.1016/j.neulet.2021.135792']
286,33652129,Adherence rates during a randomized controlled trial evaluating the use of blinded acetaminophen and ibuprofen in children with asthma.,"BACKGROUND/AIMS


When conducting clinical trials comparing over-the-counter (OTC) medications, the wide availability of these treatments are a potential challenge to maintaining study integrity. We seek to describe adherence to a study protocol involving widely available OTC medications.
METHODS


To prospectively evaluate associations between acetaminophen use and asthma in 300 children aged 1-5 years, we conducted a double blind, randomized, controlled trial where parents administered blinded forms of either acetaminophen or ibuprofen as needed to their children over a 48 week period. Written and verbal instructions encouraged the exclusive use of the blinded study medication and discouraged OTC use. Adherence was determined by evaluating the frequency of use of per-protocol blinded study medication compared to off-protocol use of OTC medications.
RESULTS


4195 doses of acetaminophen or ibuprofen were received by children during the study which included 3664 doses (87.3%) of blinded study medication adhering to the protocol and 531 doses (12.7%) of OTC products deviating from the protocol with better adherence among those randomized to ibuprofen as compared to acetaminophen (89.5% vs. 85.5% of doses, p < 0.01). Individually, 227 participants (75.7%) remained fully adherent by not receiving any OTC medications. Pre-study preference for either acetaminophen or ibuprofen by the participants' families was not associated with differential rates of adherence to the blinded medication.
CONCLUSION


This parallel study demonstrated greater than 85% of acetaminophen or ibuprofen doses were blinded study medications adhering to the protocol while less than 15% were OTC deviations from the protocol. This successfully implemented study design provides a template to comparatively evaluate these and other OTC medications.",2021,"Pre-study preference for either acetaminophen or ibuprofen by the participants' families was not associated with differential rates of adherence to the blinded medication.
","['227 participants (75.7%) remained fully adherent by not receiving any OTC medications', '300 children aged 1-5\u202fyears', 'children with asthma']","['acetaminophen', 'acetaminophen or ibuprofen', 'ibuprofen', 'acetaminophen and ibuprofen']","['OTC deviations', 'Adherence', 'Adherence rates']","[{'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",300.0,0.306415,"Pre-study preference for either acetaminophen or ibuprofen by the participants' families was not associated with differential rates of adherence to the blinded medication.
","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sheehan', 'Affiliation': ""Boston Children's Hospital, Division of Allergy and Immunology, Harvard Medical School, Boston, MA, United States of America; Children's National Hospital, Division of Allergy and Immunology, George Washington University School of Medicine and Health Sciences, Washington DC, United States of America.""}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Paul', 'Affiliation': 'Penn State College of Medicine, Department of Pediatrics, Hershey, PA, United States of America.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Mauger', 'Affiliation': 'Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA, United States of America.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Moy', 'Affiliation': 'Stroger Hospital of Cook County, Department of Pediatrics, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Children's Hospital Colorado, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, United States of America.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Jackson', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Section of Allergy, Immunology, and Rheumatology, Department of Pediatrics, Madison, WI, United States of America.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fitzpatrick', 'Affiliation': 'Emory University, Department of Pediatrics, Atlanta, GA, United States of America.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Cabana', 'Affiliation': 'University of California, San Francisco, Department of Pediatrics, San Francisco, CA, United States of America.'}, {'ForeName': 'Ronina', 'Initials': 'R', 'LastName': 'Covar', 'Affiliation': 'National Jewish Health, Department of Pediatrics, Denver, CO, United States of America.'}, {'ForeName': 'Rachel G', 'Initials': 'RG', 'LastName': 'Robison', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital of Chicago, Division of Allergy and Immunology, Chicago, IL, United States of America.""}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Boston Children's Hospital, Division of Allergy and Immunology, Harvard Medical School, Boston, MA, United States of America. Electronic address: wanda.phipatanakul@childrens.harvard.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2021.106334']
287,33647827,Integrating cognitive dissonance and social consensus to reduce weight stigma.,"Weight stigma is pervasive and has a range of deleterious effects. Among the most promising approaches for modifying this form of stigma are cognitive dissonance and social consensus. Due to their theoretical connection, this study tested the effects of an experimental manipulation of cognitive dissonance blended with social consensus for targeting weight stigma. It also added to research investigating the effects of cognitive dissonance on weight stigma by investigating a broader range of stigma measures. Participants were university students aged 18-35 years (N = 98) who were randomly allocated to one of four experimental conditions: blended cognitive dissonance, standard cognitive dissonance, blended control or standard control. Stigma measures included the perceived characteristics of, affective reactions towards, social avoidance of, and blameworthiness attributed to a higher-weight individual, and general weight stigma. Results showed that those in the cognitive dissonance conditions reported significantly lower weight stigma than those in the non-dissonance, control conditions. Moreover, those in the blended cognitive dissonance condition with higher in-group identification reported less negative affective reactions than those with lower in-group identification. The results provide consistent support for cognitive dissonance as an approach for reducing weight stigma and some additive support for an integrated cognitive dissonance and social consensus approach.",2021,"Results showed that those in the cognitive dissonance conditions reported significantly lower weight stigma than those in the non-dissonance, control conditions.",['Participants were university students aged 18-35 years (N = 98'],"['blended cognitive dissonance, standard cognitive dissonance, blended control or standard control']","['negative affective reactions', 'perceived characteristics of, affective reactions towards, social avoidance of, and blameworthiness attributed to a higher-weight individual, and general weight stigma', 'weight stigma']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009242', 'cui_str': 'Cognitive Dissonance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",98.0,0.0235066,"Results showed that those in the cognitive dissonance conditions reported significantly lower weight stigma than those in the non-dissonance, control conditions.","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Meaney', 'Affiliation': 'Research School of Psychology, Australian National University, Canberra, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rieger', 'Affiliation': 'Research School of Psychology, Australian National University, Canberra, Australia. Electronic address: Elizabeth.Rieger@anu.edu.au.'}]",Body image,['10.1016/j.bodyim.2021.02.003']
288,33647748,Evaluation of different coatings of the tibial tray in uncemented total knee arthroplasty. A randomized controlled trial with 5 years follow-up with RSA and DEXA.,"BACKGROUND


Regenerex® is a porous titanium construct with a 3D interconnecting pore structure and biomechanical characteristics close to that of normal trabecular bone. This study aimed to compare the Regenerex (VR) to the non-interconnecting pore structure Porous Plasma Spray (VP) on tibial implants for total knee arthroplasty (TKA) at 5 years.
METHODS


We enrolled and randomized 61 patients (mean age = 63(49-71) years, Female/Male = 35/26) who were planned for an uncemented Vanguard TKA (Biomet, Warsaw, Indiana, USA) to receive either a VR or a VP coated tibial component (31/29). We performed radiostereometric analysis (RSA) and Dual Energy X-ray Absorptiometry (DEXA) postoperatively, and at three, six, 12, 24 and 60 months with measurements of migration. In total 55 patients attended the 5-year follow-up.
RESULTS


One patient died and four were reoperated during the 60-months period; none due to aseptic loosening. All reoperations were in the VR-group. The mean (range) 60-months MTPM was 1.4 mm (0.5-3.7) for the VP-group and 1.8 mm (0.4-4.9) for the VR-group (p = 0.8). The 24 to 60-months mean (range) MTPM was -0.3 mm (-5 to 1.24) in the VP-group and 0.2 mm (-0.4 to 3.5) in the VR-group (p = 0.8).
CONCLUSION


We did not find any statistically significant differences between the VP- and VR-group and both groups show recognizable migration. We will continue to follow the groups for years to come.",2021,We did not find any statistically significant differences between the VP- and VR-group and both groups show recognizable migration.,"['uncemented total knee arthroplasty', 'In total 55 patients attended the 5-year follow-up', 'tibial implants for total knee arthroplasty (TKA) at 5\xa0years', 'We enrolled and randomized 61 patients (mean age\xa0', '63(49-71) years, Female/Male\xa0=\xa035/26) who were planned for an uncemented Vanguard TKA (Biomet, Warsaw, Indiana, USA) to receive either a VR or a VP coated tibial component (31/29']","['Regenerex (VR) to the non-interconnecting pore structure Porous Plasma Spray (VP', 'tibial tray', 'RSA and DEXA']",['aseptic loosening'],"[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0085898', 'cui_str': 'Biomet'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C3178874', 'cui_str': 'Roentgen Stereophotogrammetry'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]","[{'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}]",61.0,0.0388195,We did not find any statistically significant differences between the VP- and VR-group and both groups show recognizable migration.,"[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dyreborg', 'Affiliation': 'Department of Orthopaedic Surgery, Centre of Head and Orthopaedics, Rigshospitalet, 2100 Copenhagen Ø, Denmark. Electronic address: karendyreborg@hotmail.com.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Winther', 'Affiliation': 'Department of Orthopaedic Surgery, Centre of Head and Orthopaedics, Rigshospitalet, 2100 Copenhagen Ø, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lind', 'Affiliation': 'Department of Orthopaedic Surgery, Clinic of Hip, Knee and Foot Surgery, Gentofte and Herlev Hospital, 2900 Hellerup, Denmark. Electronic address: thomas.lind@regionh.dk.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Flivik', 'Affiliation': 'Clinical Sciences, Lund University, Department of Orthopaedics, Skåne University Hospital, 221 85 Lund, Sweden. Electronic address: gunnar.flivik@med.lu.se.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mørk Petersen', 'Affiliation': 'Department of Orthopaedic Surgery, Centre of Head and Orthopaedics, Rigshospitalet, 2100 Copenhagen Ø, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. Electronic address: michael.moerk.petersen@regionh.dk.'}]",The Knee,['10.1016/j.knee.2021.02.002']
289,33647529,Comparison of blood flow restriction devices and their effect on quadriceps muscle activation.,"OBJECTIVES


Blood flow restriction training (BFRT) provides an alternative approach to traditional strength training. The purpose of this study was to determine differences in quadriceps muscle activation, subject reported pain, and perceived exertion between three exercise conditions: low-load resistance BFRT with (1) regulated and (2) standardized devices, and (3) high-load resistance exercise without BFRT.
DESIGN


Randomized cross over study.
SETTING


XX University Biomechanics laboratory.
PARTICIPANTS


Thirty-four healthy subjects (18 male/16 female) each completed three randomized sessions of knee extensions using Delfi's Personalized Tourniquet System (R) at 30% of 1 repetition maximum (1RM), the B-Strong™ device (S) at 30% 1RM, and high-load resistance exercise (HL) at 80% 1RM.
MAIN OUTCOME MEASURES


Quadriceps EMG activity, numeric pain rating scale (NPRS), and perceived exertion (OMNI-RES) were recorded.
RESULTS


Average and peak EMG were greater in HL sessions than both S and R (p < .001). NPRS was greater in the R sessions compared to both S (p < .001) and HL (p < .001). OMNI-RES was greater in the R sessions compared to S (p < .02) and HL (p < .001). No differences (p > .05) in average or peak EMG activation were found between S and R sessions.
CONCLUSIONS


Quadriceps EMG amplitude was greater during high-load resistance exercise versus low-load BFR exercise and there were no differences in EMG findings between BFRT devices.",2021,OMNI-RES was greater in the R sessions compared to S (p < .02) and HL (p < .001).,"['Thirty-four healthy subjects (18 male/16 female', 'XX University Biomechanics laboratory']","['Blood flow restriction training (BFRT', ""knee extensions using Delfi's Personalized Tourniquet System (R) at 30% of 1 repetition maximum (1RM), the B-Strong™ device (S) at 30% 1RM, and high-load resistance exercise (HL) at 80% 1RM"", 'blood flow restriction devices']","['quadriceps muscle activation', 'peak EMG', 'Quadriceps EMG amplitude', 'average or peak EMG activation', 'quadriceps muscle activation, subject reported pain, and perceived exertion', 'NPRS', 'OMNI-RES', 'Quadriceps EMG activity, numeric pain rating scale (NPRS), and perceived exertion (OMNI-RES']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",34.0,0.0736933,OMNI-RES was greater in the R sessions compared to S (p < .02) and HL (p < .001).,"[{'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Bordessa', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Mason C', 'Initials': 'MC', 'LastName': 'Hearn', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Alexander E', 'Initials': 'AE', 'LastName': 'Reinfeldt', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Tyler A', 'Initials': 'TA', 'LastName': 'Smith', 'Affiliation': 'San Diego State University, San Diego, CA, USA. Electronic address: Tyler.a.smith58@gmail.com.'}, {'ForeName': 'Harsimran S', 'Initials': 'HS', 'LastName': 'Baweja', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Levy', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Rosenthal', 'Affiliation': 'San Diego State University, San Diego, CA, USA. Electronic address: mrosenthal@unmc.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.02.005']
290,33657443,"The FALCON program: Two phase 2b randomized, double-blind, placebo-controlled studies to assess the efficacy and safety of pegbelfermin in the treatment of patients with nonalcoholic steatohepatitis and bridging fibrosis or compensated cirrhosis.","BACKGROUND


Nonalcoholic steatohepatitis (NASH) is the progressive form of nonalcoholic fatty liver disease (NAFLD); no approved therapies for NASH currently exist. Pegbelfermin (PGBF), a human fibroblast growth factor 21 analog, has metabolic effects that may provide benefit for patients with NASH.
DESIGN


The FALCON 1 and 2 studies are phase 2b, multicenter, double-blind, placebo-controlled, randomized trials to assess safety and efficacy of PGBF treatment in patients who have histologically-confirmed NASH with stage 3 liver fibrosis (FALCON 1; NCT03486899) or compensated cirrhosis (FALCON 2; NCT03486912). In both studies, randomized patients receive once weekly subcutaneous injections of PGBF (10, 20, or 40 mg) or placebo during a 48-week treatment period and are then followed for an additional 4 weeks.
ENDPOINTS


The primary efficacy endpoint for FALCON 1 is the proportion of patients who achieve ≥1 stage improvement in fibrosis (by NASH CRN fibrosis score) without NASH worsening or NASH improvement (≥2 point decrease in NAFLD Activity Score) without fibrosis worsening at Week 24. For FALCON 2, the primary efficacy endpoint is ≥1 stage improvement in fibrosis without NASH worsening at Week 48. Key safety endpoints for both studies include incidence and frequency of adverse events, bone mineral density and immunogenicity.
SUMMARY


Previous clinical trial data show that PGBF can reduce hepatic fat and improve metabolic factors and biomarkers of hepatic injury and fibrosis. The FALCON studies aim to evaluate PGBF treatment specifically in patients with NASH and advanced fibrosis, who are at greatest risk of poor clinical outcomes over time.",2021,The primary efficacy endpoint for FALCON 1 is the proportion of patients who achieve ≥1 stage improvement in fibrosis (by NASH CRN fibrosis score) without NASH worsening or NASH improvement (≥2 point decrease in NAFLD Activity Score) without fibrosis worsening at Week 24.,"['patients who have histologically-confirmed NASH with stage 3 liver fibrosis (FALCON 1; NCT03486899) or compensated cirrhosis ', 'patients with NASH', 'patients with nonalcoholic steatohepatitis and bridging fibrosis or compensated cirrhosis', 'patients with NASH and advanced fibrosis']","['Nonalcoholic steatohepatitis (NASH', 'Pegbelfermin (PGBF', 'placebo', 'PGBF', 'pegbelfermin']","['incidence and frequency of adverse events, bone mineral density and immunogenicity', 'safety and efficacy', 'NAFLD Activity Score) without fibrosis worsening', 'efficacy and safety', 'proportion of patients who achieve ≥1 stage improvement in fibrosis (by NASH CRN fibrosis score) without NASH worsening or NASH improvement', 'hepatic fat and improve metabolic factors and biomarkers of hepatic injury and fibrosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0999244', 'cui_str': 'Falco'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0334160', 'cui_str': 'Bridging fibrosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}]","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C5139693', 'cui_str': 'Pegbelfermin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver'}]",,0.507137,The primary efficacy endpoint for FALCON 1 is the proportion of patients who achieve ≥1 stage improvement in fibrosis (by NASH CRN fibrosis score) without NASH worsening or NASH improvement (≥2 point decrease in NAFLD Activity Score) without fibrosis worsening at Week 24.,"[{'ForeName': 'Manal F', 'Initials': 'MF', 'LastName': 'Abdelmalek', 'Affiliation': 'Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Edgar D', 'Initials': 'ED', 'LastName': 'Charles', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, United States of America. Electronic address: edgar.charles@bms.com.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Clinical Research, San Antonio, TX, United States of America.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Neuschwander-Tetri', 'Affiliation': 'Saint Louis University, St. Louis, MO, United States of America.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, VA, United States of America.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Ehman', 'Affiliation': 'Mayo Clinic College of Medicine, Rochester, MN, United States of America.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Karsdal', 'Affiliation': 'Nordic Bioscience, Herlev, Denmark.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Shuyan', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, United States of America.'}, {'ForeName': 'Giridhar S', 'Initials': 'GS', 'LastName': 'Tirucherai', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, United States of America.'}, {'ForeName': 'George H', 'Initials': 'GH', 'LastName': 'Klinger', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, United States of America.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Mora', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, United States of America.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Yamaguchi', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, United States of America.'}, {'ForeName': 'Diane E', 'Initials': 'DE', 'LastName': 'Shevell', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, United States of America.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'University of California at San Diego, San Diego, CA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106335']
291,33652233,Efficacy of core stability versus task oriented trainings on balance in ataxic persons with multiple sclerosis. A single blinded randomized controlled trial.,"BACKGROUND


Balance and ataxic symptoms are commonly encountered in people with multiple sclerosis (PwMS). Many intervention approaches have been proposed to address balance in PwMS. The purpose of this study was to investigate the efficacy of adding core stability versus task oriented trainings on traditional approaches on balance in ataxic PwMS.
METHODS


Forty five ataxic relapsing-remitting PwMS from both sexes were randomly assigned into three identical groups. Control group (CG) treated with conventional balance exercise program; study groups I (GI) and II (GII) received respectively additional training using core stability exercises and task oriented trainings. Outcome measures recorded pre and post study period included stability index (SI), anterior posterior stability index (APSI), and mediolateral stability index (MLSI) using Biodex stability system in addition to the Berg balance scale (BBS).
RESULTS


Post treatment, the results indicated significant improvement in (SI) and (APSI) (p<0.05), and non-significant improvement (p>0.05) in (MLSI) and BBS in CG. In GI and GII there was a significant improvement in all balance measures (p<0.05). Comparison of post treatment results between groups indicated a significant improvement of GII compared to CG in all study measures, GI showed non- significant difference in all balance measures compared to the CG(P>0.05).
CONCLUSION


In PwMS balance rehabilitation should be multimodal; core stability exercises and task-oriented training in addition to conventional balance training are effective to improve balance and should be considered as an essential part of the training program for balance rehabilitation in ataxic PwMS. Task-oriented training in addition to conventional balance rehabilitation seem to be a favorable approach.",2021,"Comparison of post treatment results between groups indicated a significant improvement of GII compared to CG in all study measures, GI showed non- significant difference in all balance measures compared to the CG(P>0.05).
","['people with multiple sclerosis (PwMS', 'Forty five ataxic relapsing-remitting PwMS from both sexes', 'ataxic persons with multiple sclerosis']","['Control group (CG) treated with conventional balance exercise program; study groups I (GI) and II (GII) received respectively additional training using core stability exercises and task oriented trainings', 'core stability versus task oriented trainings']","['SI) and (APSI) (p<0.05), and non-significant improvement (p>0.05) in (MLSI) and BBS', 'stability index (SI), anterior posterior stability index (APSI), and mediolateral stability index (MLSI) using Biodex stability system in addition to the Berg balance scale (BBS', 'GII']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0234366', 'cui_str': 'Ataxic'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332287', 'cui_str': 'With'}]",45.0,0.0271009,"Comparison of post treatment results between groups indicated a significant improvement of GII compared to CG in all study measures, GI showed non- significant difference in all balance measures compared to the CG(P>0.05).
","[{'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Ali', 'Affiliation': 'Department of Physical Therapy for Neuromuscular Disorders - Faculty of Physical therapy - Cairo University - Egypt; Department of Physical Therapy - Faculty of Health Sciences - Beirut Arab University - Lebanon. Electronic address: dr.shawky_2011@cu.edu.eg.'}, {'ForeName': 'Moshera H', 'Initials': 'MH', 'LastName': 'Darwish', 'Affiliation': 'Department of Physical Therapy for Neuromuscular Disorders - Faculty of Physical therapy - Cairo University - Egypt. Electronic address: dr.moshera11@yahoo.com.'}, {'ForeName': 'Nevin M', 'Initials': 'NM', 'LastName': 'Shalaby', 'Affiliation': 'Department of Neurology - Faculty of Medicine - Cairo University - Egypt. Electronic address: nevine.shalaby@kasralainy.edu.eg.'}, {'ForeName': 'Rami L', 'Initials': 'RL', 'LastName': 'Abbas', 'Affiliation': 'Department of Physical Therapy - Faculty of Health Sciences - Beirut Arab University - Lebanon. Electronic address: r.abbas@bau.edu.lb.'}, {'ForeName': 'Habiba Z', 'Initials': 'HZ', 'LastName': 'Soubhy', 'Affiliation': 'Department of Physical Therapy for Neuromuscular Disorders - Faculty of Physical therapy - Cairo University - Egypt. Electronic address: Habiba_future@yahoo.com.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102866']
292,33647762,Effects of manipulating body temperature on sleep in postmenopausal women.,"STUDY OBJECTIVES


A decline in sleep quality, slow wave sleep (SWS) and slow wave activity (SWA) are common in older adults. Prior studies have shown that manipulating body temperature during sleep can increase SWS/SWA. The aim of this study was to determine the effects of manipulation of body temperatures during sleep, using a high heat capacity mattress, on SWS/SWA and heart rate in post-menopausal women.
METHODS


Twenty-four healthy postmenopausal women between 40 and 75 years of age (mean age 62.4 ± 8.2 years, mean BMI 25.4 ± 3.5 kg/m 2 ) were randomized in a single-blind, counterbalanced, cross-over manner to sleep on either a high heat capacity mattress (HHCM) or a low heat capacity mattress (LHCM) a week apart. Sleep was recorded using polysomnography during an 8-h sleep opportunity. Core and peripheral temperature were recorded using an ingestible capsule and thermochron respectively.
RESULTS


In comparison to the LHCM, sleep on HHCM exhibited a selective increase in SWS (average increase in Stage N3 of 9.6 min (2.1%), p = 0.04) and in slow oscillatory (SO) activity (0.5-1 Hz) in the first NREM/REM cycle (p = 0.04). In addition, the HHCM induced a greater reduction in core body temperature (p = 0.002). The reduction in core body temperature (first 180 min after lights out) from LHCM to HHCM was associated (r = 0.5, p = 0.012) with the increase in SO activity (SO cycle 1 and 2/cycle 3 and 4). Average heart rate was 1.6 beats/minute lower across the night on the HHCM compared to the LHCM (p = 0.001).
CONCLUSIONS


The results of this study indicate that manipulation of body temperature during sleep may be a useful approach to enhance SWS sleep in postmenopausal women.",2021,"Average heart rate was 1.6 beats/minute lower across the night on the HHCM compared to the LHCM (p = 0.001).
","['postmenopausal women', 'older adults', 'Twenty-four healthy postmenopausal women between 40 and 75 years of age (mean age 62.4\xa0±\xa08.2 years, mean BMI 25.4\xa0±\xa03.5\xa0kg/m 2 ', 'post-menopausal women']","['counterbalanced, cross-over manner to sleep on either a high heat capacity mattress (HHCM) or a low heat capacity mattress (LHCM', 'HHCM', 'manipulating body temperature']","['sleep quality, slow wave sleep (SWS) and slow wave activity (SWA', 'SWS', 'Sleep', 'core body temperature', 'Average heart rate', 'Core and peripheral temperature', 'SO activity', 'reduction in core body temperature', 'slow oscillatory (SO) activity', 'SWS/SWA and heart rate']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",24.0,0.0301902,"Average heart rate was 1.6 beats/minute lower across the night on the HHCM compared to the LHCM (p = 0.001).
","[{'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Reid', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address: k-reid@northwestern.edu.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kräuchi', 'Affiliation': 'Psychiatric University Clinics, Basel, Switzerland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Grimaldi', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sbarboro', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Hrayr', 'Initials': 'H', 'LastName': 'Attarian', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Roneil', 'Initials': 'R', 'LastName': 'Malkani', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'Technogel Italia S.r.l. Pozzoleone (VI) Italy.'}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",Sleep medicine,['10.1016/j.sleep.2021.01.064']
293,33647734,Prognostic significance of early pyrexia in acute intracerebral haemorrhage: The INTERACT2 study.,"INTRODUCTION


Uncertainty exists over the prognostic significance of pyrexia in acute intracerebral haemorrhage (ICH). We aimed to determine the association of elevated body temperature with clinical and imaging outcomes among participants of the main Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2).
METHODS


Post-hoc analyses of INTERACT2, an international open, blinded outcome assessed, randomised trial of 2839 patients with spontaneous ICH (<6 h of onset) and elevated systolic blood pressure (SBP, 150-220 mmHg) randomly assigned to intensive (SBP target <140 mmHg) or guideline-recommended (SBP target < 180 mmHg) BP management. Multivariable logistic regression was used to determine associations of elevated baseline body temperature (<37.5 vs. ≥37.5 °C) and 90-day clinical outcome defined on the modified Rankin scale (mRS). Analysis of covariance determined relations of body temperature and haematoma and perihaematomal oedema (PHE) volumes, at baseline and 24 h post-randomisation.
RESULTS


Of 2792 participants with data available at admission, 39 (1.4%) patients had elevated body temperature ≥ 37.5 °C. Elevated body temperature was significantly associated with 90-day mortality (adjusted odds ratio 2.44; 95% confidence interval 1.02-5.82; P = .044) but not with major disability alone (mRS scores 3-5) and combination death or major disability (mRS scores 3-6). Elevated body temperature was also associated with larger PHE volume at baseline (10.89 vs. 3.14 cm 3 , P < .001;) and 24 h (12.43 vs 5.76 cm 3 , P = .018) but not with haematoma volumes at these time points.
CONCLUSION


Early pyrexia in mild to moderate ICH is associated with greater mortality and larger PHE volume, suggesting an early inflammatory-mediated reaction.
CLINICAL TRIAL REGISTRATION


www.clinicaltrials.gov (NCT00716079).",2021,Elevated body temperature was significantly associated with 90-day mortality (adjusted odds ratio 2.44; 95% confidence interval 1.02-5.82; P = .044) but not with major disability alone (mRS scores 3-5) and combination death or major disability (mRS scores 3-6).,"['acute intracerebral haemorrhage', 'participants of the main Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2', '2792 participants with data available at admission, 39 (1.4', '2839 patients with spontaneous ICH (<6\xa0h of onset) and elevated systolic blood pressure (SBP, 150-220\xa0mmHg) randomly assigned to', 'acute intracerebral haemorrhage (ICH', 'patients had elevated body temperature\xa0≥']",['intensive (SBP target <140\xa0mmHg) or guideline-recommended (SBP target\xa0<\xa0180\xa0mmHg'],"['larger PHE volume', 'body temperature and haematoma and perihaematomal oedema (PHE) volumes', '90-day mortality', 'Elevated body temperature', 'combination death or major disability', 'modified Rankin scale (mRS']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",2839.0,0.341944,Elevated body temperature was significantly associated with 90-day mortality (adjusted odds ratio 2.44; 95% confidence interval 1.02-5.82; P = .044) but not with major disability alone (mRS scores 3-5) and combination death or major disability (mRS scores 3-6).,"[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Shoujiang', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, PR China.'}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Discipline of Pharmacology, School of Medical Sciences, Faculty of Medicine and Health, Sydney, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, PR China; Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, Australia. Electronic address: canderson@georgeinstitute.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the neurological sciences,['10.1016/j.jns.2021.117364']
294,33657007,Associations with antibiotic prescribing for acute exacerbation of COPD in primary care: secondary analysis of a randomised controlled trial.,"BACKGROUND


C-reactive protein (CRP) point-of-care testing can reduce antibiotic use in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in primary care, without compromising patient care. Further safe reductions may be possible.
AIM


To investigate the associations between presenting features and antibiotic prescribing in patients with AECOPD in primary care.
DESIGN AND SETTING


Secondary analysis of a randomised controlled trial of participants presenting with AECOPD in primary care (the PACE trial).
METHOD


Clinicians collected participants' demographic features, comorbid illnesses, clinical signs, and symptoms. Antibiotic prescribing decisions were made after participants were randomised to receive a point-of-care CRP measurement or usual care. Multivariable regression models were fitted to explore the association between patient and clinical features and antibiotic prescribing, and extended to further explore any interactions with CRP measurement category (CRP not measured, CRP <20 mg/l, or CRP ≥20 mg/l).
RESULTS


A total of 649 participants from 86 general practices across England and Wales were included. Odds of antibiotic prescribing were higher in the presence of clinician-recorded crackles (adjusted odds ratio [AOR] = 5.22, 95% confidence interval [CI] = 3.24 to 8.41), wheeze (AOR = 1.64, 95% CI = 1.07 to 2.52), diminished vesicular breathing (AOR = 2.95, 95% CI = 1.70 to 5.10), or clinician-reported evidence of consolidation (AOR = 34.40, 95% CI = 2.84 to 417.27). Increased age was associated with lower odds of antibiotic prescribing (AOR per additional year increase = 0.98, 95% CI = 0.95 to 1.00), as was the presence of heart failure (AOR = 0.32, 95% CI = 0.12 to 0.85).
CONCLUSION


Several demographic features and clinical signs and symptoms are associated with antibiotic prescribing in AECOPD. Diagnostic and prognostic value of these features may help identify further safe reductions.",2021,"Increased age was associated with lower odds of antibiotic prescribing (AOR per-year increase =0.98,95","['patients with AECOPD in UK primary care', 'acute exacerbation of COPD in primary care', 'patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD', 'participants presenting with AECOPD in primary care', ""Clinicians collected participant's demographic features, comorbid illnesses, clinical signs, and symptoms"", '649 participants from 86 general practices across England and Wales']","['antibiotic prescribing', 'C-reactive protein point-of-care testing (CRP-POCT']","['vesicular breathing', 'heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}]","[{'cui': 'C0231857', 'cui_str': 'Vesicular breathing'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",649.0,0.151254,"Increased age was associated with lower odds of antibiotic prescribing (AOR per-year increase =0.98,95","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Bates', 'Affiliation': 'Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Hasse', 'Initials': 'H', 'LastName': 'Melbye', 'Affiliation': 'General Practice Research Unit, Department of Community Medicine, UIT the Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Cardiff School of Sport and Health Science, Cardiff Metropolitan University, Cardiff, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stanton', 'Affiliation': 'Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Mohammed Fasihul', 'Initials': 'MF', 'LastName': 'Alam', 'Affiliation': 'Department of Public Health, College of Health Sciences, QU-Health, Qatar University, Doha, Qatar.'}, {'ForeName': 'Jochen Wl', 'Initials': 'JW', 'LastName': 'Cals', 'Affiliation': 'Department of Family Medicine, School for Public Health and Primary Care, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Cochrane', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Kirby', 'Affiliation': 'Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Llor', 'Affiliation': 'Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark; University Institute in Primary Care Research Jordi Gol, Via Roma Health Centre, Barcelona, Spain.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Gurudutt', 'Initials': 'G', 'LastName': 'Naik', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Riga', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Oxford, UK.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Sewell', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas-Jones', 'Affiliation': 'Centre for Trials Research, School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'White', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Francis', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/BJGP.2020.0823']
295,33647599,The EMA review of trastuzumab emtansine (T-DM1) for the adjuvant treatment of adult patients with HER2-positive early breast cancer.,"Trastuzumab emtansine (T-DM1) is an antibody-drug conjugate of trastuzumab [a monoclonal antibody against human epidermal growth factor receptor 2 (HER2)] and DM1 (an inhibitor of tubulin polymerisation). It was initially approved in the European Union for the treatment of adult patients with HER2-positive unresectable locally advanced or metastatic breast cancer (BC) who had previously received trastuzumab and taxanes. On 18 December 2019, a variation of the marketing authorisation was approved extending this use to the adjuvant therapy of adult patients with HER2-positive early BC who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy. A phase III randomised, multicentre, open-label trial compared T-DM1 with trastuzumab as adjuvant therapy in patients with HER2-positive early BC who had received preoperative chemotherapy and HER2-targeted therapy followed by surgery, with a finding of invasive residual disease in the breast and/or axillary lymph nodes. The study met its primary endpoint by showing an increased 3-year invasive disease-free survival rate in the T-DM1 arm (88.3%) compared with the trastuzumab arm (77.0%), with an unstratified hazard ratio of 0.50 (95% confidence interval: 0.39-0.64). There was a higher incidence of hepatotoxicity (37.3% versus 10.6%), thrombocytopenia (28.5% versus 2.4%), peripheral neuropathy (32.3% versus 16.9%), haemorrhage (29.2% versus 9.6%) and pulmonary toxicity (2.8% versus 0.8%) in the T-DM1 arm compared with the control arm. The aim of this manuscript was to summarise the scientific review of the application leading to regulatory approval of this additional indication in the European Union.",2021,"There was a higher incidence of hepatotoxicity (37.3% versus 10.6%), thrombocytopenia (28.5% versus 2.4%), peripheral neuropathy (32.3% versus 16.9%), haemorrhage (29.2% versus 9.6%) and pulmonary toxicity (2.8% versus 0.8%) in the T-DM1 arm compared with the control arm.","['adult patients with HER2-positive early breast cancer', 'adult patients with HER2-positive early BC who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy', 'adult patients with HER2-positive unresectable locally advanced or metastatic breast cancer (BC) who had previously received', 'patients with HER2-positive early BC who had received preoperative chemotherapy and HER2-targeted therapy followed by surgery, with a finding of invasive residual disease in the breast and/or axillary lymph nodes']","['Trastuzumab emtansine (T-DM1', 'T-DM1 with trastuzumab', 'trastuzumab and taxanes', 'trastuzumab emtansine (T-DM1']","['pulmonary toxicity', 'thrombocytopenia', 'hepatotoxicity', 'peripheral neuropathy', 'haemorrhage', '3-year invasive disease-free survival rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}]","[{'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0919924', 'cui_str': 'Pulmonary toxicity'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.0845863,"There was a higher incidence of hepatotoxicity (37.3% versus 10.6%), thrombocytopenia (28.5% versus 2.4%), peripheral neuropathy (32.3% versus 16.9%), haemorrhage (29.2% versus 9.6%) and pulmonary toxicity (2.8% versus 0.8%) in the T-DM1 arm compared with the control arm.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Delgado', 'Affiliation': 'Oncology and Haematology Office, European Medicines Agency (EMA), Amsterdam, The Netherlands; Department of Haematology, Hospital Clinic, Barcelona, Spain. Electronic address: julio.delgado@ema.europa.eu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vleminckx', 'Affiliation': 'Oncology and Haematology Office, European Medicines Agency (EMA), Amsterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sarac', 'Affiliation': 'Danish Medicines Agency, Copenhagen, Denmark; Committe for Medicinal Products for Human Use (CHMP), EMA, Amsterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sosa', 'Affiliation': 'Danish Medicines Agency, Copenhagen, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bergh', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institute and Breast Cancer Centre, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Giuliani', 'Affiliation': 'The Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Enzmann', 'Affiliation': 'Committe for Medicinal Products for Human Use (CHMP), EMA, Amsterdam, The Netherlands; Bundesinstitut fur Arzneimittel und Medizinprodukte, Bonn, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pignatti', 'Affiliation': 'Oncology and Haematology Office, European Medicines Agency (EMA), Amsterdam, The Netherlands.'}]",ESMO open,['10.1016/j.esmoop.2021.100074']
296,33639484,Acoustic enhancement of slow wave sleep on consecutive nights improves alertness and attention in chronically short sleepers.,"INTRODUCTION


Chronic sleep restriction has been linked to occupational errors and motor vehicle crashes. Enhancing slow wave sleep may alleviate some of the cognitive deficits associated with chronic sleep restriction. However, the extent to which acoustic stimulation of slow wave activity (SWA) may improve alertness and attention is not well established, particularly with respect to consecutive nights of exposure.
METHODS


Twenty-five healthy adults (32.9 ± 8.2 years; 16 female) who self-restricted their sleep during workdays participated in a randomized, double-blind, cross-over study. Participants wore an automated acoustic stimulation device for two consecutive nights. Acoustic tones (50 ms long) were delivered on the up-phase of the slow wave first and then at constant 1-s inter-tone-intervals once N3 was identified (STIM), until an arousal or shift to another sleep stage occurred, or at inaudible decibels during equivalent stimulation periods (SHAM). Subjective alertness/fatigue (KSS, Samn-Perelli) was assessed across both days, and objective measures of alertness (MSLT) and attention (PVT) were assessed after two nights of stimulation.
RESULTS


After one night of acoustic stimulation, increased slow wave energy was observed in 68% of participants, with an average significant increase of 17.7% (p = 0.01), while Night 2 was associated with a 22.2% increase in SWA (p = 0.08). SWE was highly stable across the two nights of STIM (ICC 0.93, p < 0.001), and around half (56%) of participants were consistently classified as responders (11/25) or non-responders (3/25). Daytime testing showed that participants felt more alert and awake following each night of acoustic stimulation (p < 0.05), with improved objective attention across the day following two nights of acoustic stimulation.
DISCUSSION


Consecutive nights of acoustic stimulation enhanced SWA on both nights, and improved next day alertness and attention. Given large individual differences, we highlight the need to examine both the long-term effects of stimulation, and to identify inter-individual differences in acoustic stimulation response. Our findings suggest that the use of an acoustic device to enhance slow wave sleep may alleviate some of the deficits in alertness and attention typically associated with sleep restriction.",2021,"Daytime testing showed that participants felt more alert and awake following each night of acoustic stimulation (p < 0.05), with improved objective attention across the day following two nights of acoustic stimulation.
","['Twenty-five healthy adults (32.9\xa0±\xa08.2 years; 16 female) who self-restricted their sleep during workdays participated', 'chronically short sleepers']",['automated acoustic stimulation device'],"['Acoustic tones', 'objective attention', 'SWA', 'Daytime testing', 'Subjective alertness/fatigue (KSS, Samn-Perelli', 'SWE', 'objective measures of alertness (MSLT) and attention (PVT', 'slow wave energy']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0751509', 'cui_str': 'Short-sleeper'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Acoustic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",25.0,0.0783764,"Daytime testing showed that participants felt more alert and awake following each night of acoustic stimulation (p < 0.05), with improved objective attention across the day following two nights of acoustic stimulation.
","[{'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': 'Diep', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, 3800, Clayton, Australia; Cooperative Research Centre for Alertness, Safety and Productivity, 3800, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Garcia-Molina', 'Affiliation': 'Sleep and Respiratory Care, Philips, Pittsburgh, PA, USA; Department of Psychiatry, University of Wisconsin-Madison, WI, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Jasko', 'Affiliation': 'Sleep and Respiratory Care, Philips, Pittsburgh, PA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Manousakis', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, 3800, Clayton, Australia.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Ostrowski', 'Affiliation': 'Sleep and Respiratory Care, Philips, Pittsburgh, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Sleep and Respiratory Care, Philips, Pittsburgh, PA, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, 3800, Clayton, Australia; Cooperative Research Centre for Alertness, Safety and Productivity, 3800, Australia. Electronic address: clare.anderson@monash.edu.'}]",Sleep medicine,['10.1016/j.sleep.2021.01.044']
297,33636616,"Low vitamin D, but not tobacco use or high BMI, is associated with long-term disability progression in multiple sclerosis.","BACKGROUND


Low vitamin D levels, tobacco use and high body mass index (BMI) have been linked to adverse disease outcomes in multiple sclerosis (MS), but their influence on long-term disability progression remains unclear. Therefore, we explored whether these modifiable lifestyle factors were associated with 10-year clinical disability progression in patients with MS.
METHODS


In this prospective study, a cohort of 88 patients with relapsing-remitting MS completed a randomized controlled study on ω-3 fatty acids between 2004 and 2008. During 24 months, serum 25-hydroxyvitamin D (25(OH)D), serum cotinine (nicotine metabolite), and BMI were repeatedly measured. In 2017, a follow-up study was conducted among 80 of the participants, including disability assessment by the Expanded Disability Status Scale (EDSS). Linear regression was used to explore associations between the lifestyle factors and the EDSS change over 10 years.
RESULTS


Higher seasonally adjusted 25(OH)D levels were associated with lower 10-year EDSS progression (change in EDSS per 1 SD increase in 25(OH)D in a model adjusted for sex, age and baseline EDSS: -0.45 point, 95% CI: -0.75 to -0.16, p=0.003). Further adjustments for potential confounders related to lifestyle and disease status gave similar results. The association was mainly driven by low 25(OH)D levels during spring, as well as seasonally adjusted levels below 80 nmol/L. No clear association was found for BMI and cotinine.
CONCLUSION


Lower 25(OH)D levels, but apparently not tobacco use or higher BMI, were significantly associated with worse long-term disability progression in MS.",2021,"Lower 25(OH)D levels, but apparently not tobacco use or higher BMI, were significantly associated with worse long-term disability progression in MS.",['88 patients with relapsing-remitting MS completed a randomized controlled study on ω-3 fatty acids between 2004 and 2008'],['Low vitamin D'],"['Lower 25(OH)D levels', 'worse long-term disability progression', 'serum 25-hydroxyvitamin D (25(OH)D), serum cotinine (nicotine metabolite), and BMI', 'disability assessment by the Expanded Disability Status Scale (EDSS', '10-year EDSS progression', '10-year clinical disability progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C4285871', 'cui_str': 'Vitamin D low'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",88.0,0.0179158,"Lower 25(OH)D levels, but apparently not tobacco use or higher BMI, were significantly associated with worse long-term disability progression in MS.","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Wesnes', 'Affiliation': ""Department of Clinical Medicine, University of Bergen, Bergen, Norway; Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Neurology, St. Olav's University Hospital, Trondheim, Norway. Electronic address: kristin.wesnes@uib.no.""}, {'ForeName': 'Kjell-Morten', 'Initials': 'KM', 'LastName': 'Myhr', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway; Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Trond', 'Initials': 'T', 'LastName': 'Riise', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Silje Stokke', 'Initials': 'SS', 'LastName': 'Kvistad', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway; Department of Immunology and Transfusion medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Torkildsen', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway; Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Wergeland', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Norwegian Multiple Sclerosis Competence Center, Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Holmøy', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Neurology, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Midgard', 'Affiliation': 'Department of Neurology, Molde Hospital, Molde, Norway.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Bru', 'Affiliation': 'Department of Neurology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Edland', 'Affiliation': 'Department of Neurology, Vestre Viken Hospital Trust, Drammen, Norway.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Eikeland', 'Affiliation': 'Department of Neurology and Department of Paediatrics, Sørlandet Hospital Trust, Arendal, Norway.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Gosal', 'Affiliation': 'Department of Neurology, Østfold Hospital Kalnes, Grålum, Norway.'}, {'ForeName': 'Hanne F', 'Initials': 'HF', 'LastName': 'Harbo', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Neurology, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Kleveland', 'Affiliation': 'Department of Neurology, Innlandet Hospital Lillehammer, Lillehammer, Norway.'}, {'ForeName': 'Yvonne S', 'Initials': 'YS', 'LastName': 'Sørenes', 'Affiliation': 'Department of Neurology, Haugesund Hospital, Haugesund, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Øksendal', 'Affiliation': 'Department of Neurology, Nordland hospital trust, Bodø, Norway.'}, {'ForeName': 'Kjetil', 'Initials': 'K', 'LastName': 'Bjørnevik', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102801']
298,33636517,Predictors of Depressive Symptoms and Post Traumatic Stress Disorder Among Women Engaged in Commercial Sex Work in Southern Uganda.,"This study examined the factors associated with depressive symptoms and post traumatic depressive disorder (PTSD) among economically vulnerable women engaged in commercial sex work (WESW) in southern Uganda. Baseline data from a longitudinal cluster randomized study involving 542 self-identified WESW (18-55 years), recruited from 19 HIV hotspots were analyzed. Hierarchical linear regression modelling was utilized to estimate individual, family-level and economic-level predictors of depressive symptoms and PTSD. Family cohesion, sex work stigma, HIV status, financial distress, household assets, number of children and number of household income earners, were associated with PTSD. Similarly, family cohesion, number of people in the household, HIV status, sex work stigma, financial distress, and household assets, were associated with depressive symptoms. Women engaged in commercial sex work are at a higher risk of HIV and poor mental health outcomes. Sex work stigma and financial distress elevate levels of depressive symptoms and PTSD, over and above an individual's HIV status. Family and economic-level factors have the potential to mitigate the risk of poor mental health outcomes. As such, integrating stigma reduction and economic strengthening components in the programming targeting WESW-a key population, may be critical to address their mental health outcomes.",2021,"Family cohesion, sex work stigma, HIV status, financial distress, household assets, number of children and number of household income earners, were associated with PTSD.","['542 self-identified WESW (18-55 years), recruited from 19 HIV hotspots were analyzed', 'depressive symptoms and post traumatic depressive disorder (PTSD) among economically vulnerable women engaged in commercial sex work (WESW) in southern Uganda', 'Women', 'Engaged in Commercial Sex Work in Southern Uganda']",[],"['family cohesion, number of people in the household, HIV status, sex work stigma, financial distress', 'Family cohesion, sex work stigma, HIV status, financial distress, household assets, number of children and number of household income earners']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0033595', 'cui_str': 'Works as prostitute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]",[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0033595', 'cui_str': 'Works as prostitute'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0557163', 'cui_str': 'Household income'}]",542.0,0.0321672,"Family cohesion, sex work stigma, HIV status, financial distress, household assets, number of children and number of household income earners, were associated with PTSD.","[{'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: nabunyap@wustl.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: byansiw@wustl.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: damulirac@wustl.edu.'}, {'ForeName': 'Ozge Sensoy', 'Initials': 'OS', 'LastName': 'Bahar', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: ozge.sensoybahar@wustl.edu.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Jennings Mayo-Wilson', 'Affiliation': 'Indiana University School of Public Health, Department of Applied Health Science, 1025 E. 7(TH) Street, Bloomington, IN 47405, USA. Electronic address: ljmayowi@iu.edu.'}, {'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Tozan', 'Affiliation': 'New York University College of Global Public Health, 14 East 4(th) street, 3(rd) floor. New York, NY 10003, USA. Electronic address: yt23@nyu.edu.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kiyingi', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: j.kiyingi@wustl.edu.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Nabayinda', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: josepn84@gmail.com.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Braithwaite', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: rachel.brathwaite@wustl.edu.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Witte', 'Affiliation': 'Columbia University School of Social Work1255 Amsterdam Avenue, New York, NY 10027, USA. Electronic address: ssw12@columbia.edu.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: fms1@wustl.edu.'}]",Psychiatry research,['10.1016/j.psychres.2021.113817']
299,33636453,Impact of subsequent immune checkpoint inhibitor treatment on overall survival with avelumab vs docetaxel in platinum-treated advanced NSCLC: Post hoc analyses from the phase 3 JAVELIN Lung 200 trial.,"OBJECTIVES


The JAVELIN Lung 200 phase 3 trial did not meet its primary endpoint of improving overall survival (OS) with avelumab vs docetaxel in patients with platinum-treated PD-L1+ NSCLC. We report post hoc analyses assessing the effects of subsequent immune checkpoint inhibitor (ICI) treatment on OS.
MATERIAL AND METHODS


Patients with stage IIIB/IV NSCLC progressed following platinum-doublet therapy were randomized to receive avelumab or docetaxel. OS was analyzed in the PD-L1+ population (≥1% of tumor cells) and full analysis set (PD-L1+ or PD-L1-). Effects of subsequent ICI (after permanent discontinuation of study treatment) on OS were analyzed using a preplanned naive sensitivity analysis and post hoc inverse probability of censoring weighting (IPCW) analysis. Subgroups with or without subsequent ICI treatment were analyzed using descriptive statistics.
RESULTS


In the avelumab and docetaxel arms, a subsequent ICI was received by 16/396 (4.0 %) and 104/396 (26.3 %) after a median of 10.5 months (range, 3.9-20.4) and 5.7 months (range, 0.1-24.4), respectively. Some subgroups showed trends for higher subsequent ICI treatment, including patients with non-squamous NSCLC (avelumab arm, 4.3 % vs docetaxel arm, 32.1 %) or with a baseline ECOG performance status of 0 (6.3 % vs 31.3 %); those enrolled in the early recruitment wave (11.6 % vs 54.3 %), or enrolled in the US/Western Europe (2.8 % vs 45.5 %) or Asia (11.0 % vs 35.4 %); and non-white patients (10.1 % vs 35.0 %). The hazard ratio for OS with avelumab vs docetaxel was lower in the IPCW analysis than in the naive sensitivity analysis (PD-L1+ population: 0.80 [95 % CI, 0.62-1.04] vs 0.86 [95 % CI, 0.68-1.09], respectively).
CONCLUSION


In the JAVELIN Lung 200 trial, avelumab showed clinical activity as second-line treatment for patients with advanced NSCLC. Post hoc analyses suggest that the primary OS analysis may have been confounded by subsequent ICI use in the docetaxel arm. ClinicalTrials.gov identifier: NCT02395172.",2021,"The hazard ratio for OS with avelumab vs docetaxel was lower in the IPCW analysis than in the naive sensitivity analysis (PD-L1+ population: 0.80 [95 % CI, 0.62-1.04] vs 0.86 [95 % CI, 0.68-1.09], respectively).
","['patients with platinum-treated PD-L1+ NSCLC', 'patients with advanced NSCLC', 'Patients with stage IIIB/IV NSCLC progressed following platinum-doublet therapy', 'platinum-treated advanced NSCLC']","['avelumab and docetaxel', 'avelumab vs docetaxel', 'avelumab or docetaxel', 'subsequent immune checkpoint inhibitor (ICI', 'subsequent ICI']","['overall survival (OS', 'clinical activity', 'hazard ratio for OS', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.166791,"The hazard ratio for OS with avelumab vs docetaxel was lower in the IPCW analysis than in the naive sensitivity analysis (PD-L1+ population: 0.80 [95 % CI, 0.62-1.04] vs 0.86 [95 % CI, 0.68-1.09], respectively).
","[{'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: kpark@skku.edu.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, Cerrahpaşa Medical Faculty, Istanbul University Cerrahpaşa, Istanbul, Turkey. Electronic address: ozguroglu@gmail.com.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vansteenkiste', 'Affiliation': 'Department of Respiratory Oncology, University Hospital KU Leuven, Leuven, Belgium. Electronic address: johan.vansteenkiste@uzleuven.be.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, TN, USA. Electronic address: David.Spigel@sarahcannon.com.'}, {'ForeName': 'James C-H', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, National Taiwan University Cancer Center, Taipei, Taiwan. Electronic address: chihyang@ntu.edu.tw.'}, {'ForeName': 'Marcis', 'Initials': 'M', 'LastName': 'Bajars', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany. Electronic address: marcis.bajars@emdserono.com.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ruisi', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany. Electronic address: mary.ruisi@emdserono.com.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Manitz', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany. Electronic address: juliane.manitz@emdserono.com.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Aix Marseille University, CNRS, INSERM, CRCM, Marseille, France; Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: fabrice.barlesi@gustaveroussy.fr.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2021.01.026']
300,33658655,Randomized trial of azithromycin to eradicate Ureaplasma respiratory colonization in preterm infants: 2-year outcomes.,"BACKGROUND


To assess the potential impact of azithromycin treatment in the first week following birth on 2-year outcomes in preterm infants with and without Ureaplasma respiratory colonization who participated in a double-blind, placebo-controlled randomized controlled trial.
METHODS


Respiratory morbidity was assessed at NICU discharge and at 6, 12, and 22-26 months corrected age using pulmonary questionnaires. Comprehensive neurodevelopmental assessments were completed between 22 and 26 months corrected age. The primary and secondary composite outcomes were death or severe respiratory morbidity and death or moderate-severe neurodevelopmental impairment, respectively, at 22-26 months corrected age.
RESULTS


One hundred and twenty-one randomized participants (azithromycin, N = 60; placebo, N = 61) were included in the intent-to-treat analysis. There were no significant differences in death or serious respiratory morbidity (34.8 vs 30.4%, p = 0.67) or death or moderate-severe neurodevelopmental impairment (47 vs 33%, p = 0.11) between the azithromycin and placebo groups. Among all trial participants, tracheal aspirate Ureaplasma-positive infants experienced a higher frequency of death or serious respiratory morbidity at 22-26 months corrected age (58%) than tracheal aspirate Ureaplasma-negative infants (34%) or non-intubated infants (21%) (p = 0.028).
CONCLUSIONS


We did not observe strong evidence of a difference in long-term pulmonary and neurodevelopment outcomes in preterm infants treated with azithromycin in the first week of life compared to placebo.
IMPACT


No strong evidence of a difference in long-term pulmonary and neurodevelopment outcomes was identified at 22-26 months corrected age in infants treated with azithromycin in the first week of life compared to placebo. The RCT is the first study of 2-year pulmonary and neurodevelopmental outcomes of azithromycin treatment in ELGANs. Provides evidence that ELGANs with lower respiratory tract Ureaplasma have the most frequent serious respiratory morbidity in the first 2 years of life, suggesting that a Phase III trial of azithromycin to prevent BPD targeting this population is warranted.",2021,No strong evidence of a difference in long-term pulmonary and neurodevelopment outcomes was identified at 22-26 months corrected age in infants treated with azithromycin in the first week of life compared to placebo.,"['preterm infants with and without Ureaplasma respiratory colonization who participated in a double-blind', 'preterm infants treated with', 'One hundred and twenty-one randomized participants', 'preterm infants']","['azithromycin', 'placebo', 'azithromycin, N\u2009=\u200960; placebo']","['long-term pulmonary and neurodevelopment outcomes', 'death or moderate-severe neurodevelopmental impairment', 'death or serious respiratory morbidity', 'death or severe respiratory morbidity and death or moderate-severe neurodevelopmental impairment', 'frequency of death or serious respiratory morbidity', 'Comprehensive neurodevelopmental assessments']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0041944', 'cui_str': 'Ureaplasma'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",121.0,0.273234,No strong evidence of a difference in long-term pulmonary and neurodevelopment outcomes was identified at 22-26 months corrected age in infants treated with azithromycin in the first week of life compared to placebo.,"[{'ForeName': 'Rose M', 'Initials': 'RM', 'LastName': 'Viscardi', 'Affiliation': 'Department of Pediatrics, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA. rviscard@som.umaryland.edu.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Terrin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dulkerian', 'Affiliation': 'Department of Pediatrics, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ken B', 'Initials': 'KB', 'LastName': 'Waites', 'Affiliation': 'Departments of Pathology and Pediatrics, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'Marilee', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ajoke', 'Initials': 'A', 'LastName': 'Ajayi-Akintade', 'Affiliation': 'Mount Washington Pediatric Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Departments of Pathology and Pediatrics, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'Department of Pediatrics, University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Donohue', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Tuttle', 'Affiliation': 'Department of Pediatrics, Christiana Care Health System, Newark, DE, USA.'}, {'ForeName': 'Jörn-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Pediatric research,['10.1038/s41390-021-01437-2']
301,33639516,"The effects of reiki on heart rate, blood pressure, body temperature, and stress levels: A pilot randomized, double-blinded, and placebo-controlled study.","Reiki is a biofield energy therapy that focuses on optimizing the body's natural healing abilities by balancing the life force energy or qi/chi. Reiki has been shown to reduce stress, pain levels, help with depression/anxiety, increase relaxation, improve fatigue, and quality of life. In this pilot randomized, double-blinded, and placebo-controlled study, the effects of Reiki on heart rate, diastolic and systolic blood pressure, body temperature, and stress levels were explored in an effort to gain objective outcome measures and to understand the underlying physiological mechanisms of how Reiki may be having these therapeutic effects on subjective measures of stress, pain, relaxation, and depression/anxiety. Forty eight (n = 48) subjects were block randomized into three groups (Reiki treatment, sham treatment, and no treatment). The changes in pre- and post-treatment measurements for each outcome measure was analyzed through analysis of variance (ANOVA) post hoc multiple comparison test, which found no statistically significant difference between any of the groups. The p-value for the comparison of Reiki and sham groups for heart rate was 0.053, which is very close to being significant and so, a definitive conclusion can not be made based on this pilot study alone. A second study with a larger sample size is warranted to investigate this finding further and perhaps with additional outcome measures to look at other possible physiological mechanisms that may underlie the therapeutic effects of Reiki.",2021,"The p-value for the comparison of Reiki and sham groups for heart rate was 0.053, which is very close to being significant and so, a definitive conclusion can not be made based on this pilot study alone.",['Forty eight (n\xa0=\xa048) subjects'],['placebo'],"['heart rate', 'stress, pain levels, help with depression/anxiety, increase relaxation, improve fatigue, and quality of life', 'subjective measures of stress, pain, relaxation, and depression/anxiety', 'heart rate, diastolic and systolic blood pressure, body temperature, and stress levels', 'heart rate, blood pressure, body temperature, and stress levels']","[{'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",48.0,0.13131,"The p-value for the comparison of Reiki and sham groups for heart rate was 0.053, which is very close to being significant and so, a definitive conclusion can not be made based on this pilot study alone.","[{'ForeName': 'Namuun', 'Initials': 'N', 'LastName': 'Bat', 'Affiliation': 'Ohio Wesleyan University, Delaware, OH, USA. Electronic address: namuun.bat@bastyr.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101328']
302,33618120,Feasibility and efficacy of a physical activity intervention for managing restless legs syndrome in multiple sclerosis: Results of a pilot randomized controlled trial.,"BACKGROUND


This pilot randomized controlled trial examined the feasibility and efficacy of a physical activity behavior change intervention for improving restless legs syndrome (RLS) severity and secondary sleep outcomes among a sample of adults with multiple sclerosis (MS).
METHODS


Participants with MS(N=15) were randomly assigned into intervention(n=8) or waitlist control(n=7) conditions. The physical activity intervention was delivered over a 16-week period and outcomes were assessed at baseline and immediately following the 16-week period in both conditions.
RESULTS


There was a significant, positive effect of the intervention on overall RLS severity (p=.01;η ρ 2 =.43), severity during the night(p=.03,η ρ 2 =.35), severity during the day while resting(p=.01,η ρ 2 =.44), and severity during the day while active(p<.01,η ρ 2 =.61), and non-significant improvements in RLS severity while falling asleep (p=.33,η ρ 2 =.09). There were significant positive effects on sleep satisfaction(p<.01,η ρ 2 =.49) and non-significant improvements in self-reported global sleep quality(p=.35,η ρ 2 =.08). There was a significant intervention effect on self-reported time in bed(p=.03,η ρ 2 =.37) and total sleep time(p=.03,η ρ 2 =.36), and non-significant improvements in self-reported sleep latency (p=.08,η ρ 2 =.25), sleep efficiency(p=.27,η ρ 2 =.11), and daytime sleepiness (p=.52,η ρ 2 =.04;p=.35,η ρ 2 =.08;p=.51,η ρ 2 =.04). There was no significant effect of the intervention on device-measured sleep quality.
CONCLUSIONS


We provide preliminary evidence for the feasibility and efficacy of a physical activity intervention for reducing RLS severity and potentially improving self-reported sleep outcomes in adults with MS. CLINICALTRIALS.
GOV IDENTIFICATION NUMBER


NCT04061681.",2021,"There were significant positive effects on sleep satisfaction(p<.01,η ρ 2 =.49) and non-significant improvements in self-reported global sleep quality(p=.35,η ρ 2 =.08).","['adults with MS', 'managing restless legs syndrome in multiple sclerosis', 'Participants with MS(N=15', 'adults with multiple sclerosis (MS']","['physical activity intervention', 'physical activity behavior change intervention']","['daytime sleepiness', 'device-measured sleep quality', 'Feasibility and efficacy', 'overall RLS severity', 'RLS severity while falling asleep', 'self-reported sleep latency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]","[{'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}]",15.0,0.0800824,"There were significant positive effects on sleep satisfaction(p<.01,η ρ 2 =.49) and non-significant improvements in self-reported global sleep quality(p=.35,η ρ 2 =.08).","[{'ForeName': 'Katie L J', 'Initials': 'KLJ', 'LastName': 'Cederberg', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Stanford University, 401 Quarry Road, Stanford, CA, USA. Electronic address: kcederb@stanford.edu.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, 1720 2nd Avenue South, Birmingham, AL, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102836']
303,33667741,Intermittent pneumatic compression after varicose vein surgery.,"OBJECTIVE


Intermittent pneumatic compression (IPC) is an established treatment option to remove tissue fluid from patients with lymphedema and chronic venous disease. The effects of IPC applied directly after varicose vein surgery performed with high volumes of tumescent local anesthesia have not been investigated. The aim of the present study was to evaluate the use of postoperative IPC concerning its effects on the leg volume and patient comfort after surgery.
METHODS


We performed an investigator-initiated, single-center, open-label randomized controlled trial. A total of 186 patients indicated for saphenofemoral junction ligation and great saphenous vein or anterior accessory saphenous vein stripping or great saphenous vein redo surgery were randomly assigned 1:1 to the intervention or control group. The patients in the intervention group were treated with IPC at 40 mm Hg for 45 minutes directly after surgery. The outcome measures were the leg volume changes calculated using an optical three-dimensional scanning system (primary objective), quality of life (QoL; Freiburg Life Quality Assessment for chronic venous disease, short form), pain, and extent of ecchymosis with follow-up examinations on days 1 and 7 after surgery.
RESULTS


The patients in both groups had comparable mean leg volume reductions from baseline to day 1 (IPC group, 58.8 mL; control group, 37.4 mL; P = .967) and to day 7 (63.1 mL and 57.0 mL, respectively; P = .546). We also did not observe significant differences between the two groups in QoL and pain. The patients in the IPC group had developed larger areas of ecchymosis compared with the control group (16% vs 13.3% of leg surface, respectively; P = .046), with a tendency toward an increase in pain at 7 days after surgery compared with no IPC application.
CONCLUSIONS


The present randomized controlled trial was designed to evaluate the decongestive effects of a single postoperative session of IPC and its effect on QoL, pain, and ecchymosis in patients who had undergone varicose vein surgery under tumescent local anesthesia. Because no evidence for a benefit from IPC could be found in the present study and increased ecchymosis was found, its standard use after varicose vein surgery cannot be recommended.",2021,"RESULTS


Patients of both groups had comparable mean leg volume reductions from baseline to day 1 (58.8 ml (IPC group) and 37.4 ml (control group), p= 0,967), and to day 7 (63.1 ml and 57.0 ml respectively, p=0.546).","['patients with lymphedema and chronic venous disease', 'patients undergoing varicose vein surgery under TLA', 'One hundred and eighty-six patients indicated for saphenofemoral junction ligation and great saphenous vein (GSV) or anterior accessory saphenous vein stripping or GSV redo surgery', 'varicose vein surgery']","['IPC', 'Intermittent pneumatic compression (IPC', 'Intermittent pneumatic compression', 'tumescent local anesthesia (TLA']","['leg volume changes calculated by an optical 3D scanning system (primary objective), quality of life (Freiburg Life Quality Assessment for chronic venous disease, short form: FLQA-VS-10), pain and extent of ecchymosis with follow-up examinations on day 1 and 7 after surgery', 'QoL and pain', 'ecchymosis', 'larger areas of ecchymosis', 'mean leg volume reductions', 'QoL, pain, and ecchymosis', 'leg volume and patient comfort']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0521235', 'cui_str': 'Varicose vein operation'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0447132', 'cui_str': 'Structure of saphenofemoral junction'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0226826', 'cui_str': 'Structure of accessory saphenous vein'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}]",,0.208754,"RESULTS


Patients of both groups had comparable mean leg volume reductions from baseline to day 1 (58.8 ml (IPC group) and 37.4 ml (control group), p= 0,967), and to day 7 (63.1 ml and 57.0 ml respectively, p=0.546).","[{'ForeName': 'Korina', 'Initials': 'K', 'LastName': 'Kappa-Markovi', 'Affiliation': 'Center for Venous and Peripheral Arterial Diseases, Eifelklinik St Brigida, Simmerath, Germany. Electronic address: korinakappa-markovi@hotmail.com.'}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Jalaie', 'Affiliation': 'European Venous Centre Aachen-Maastricht, University Hospital Aachen, Aachen, Germany.'}, {'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Özhan-Hasan', 'Affiliation': 'Center for Venous and Peripheral Arterial Diseases, Eifelklinik St Brigida, Simmerath, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Deges', 'Affiliation': 'Center for Venous and Peripheral Arterial Diseases, Eifelklinik St Brigida, Simmerath, Germany.'}, {'ForeName': 'Knuth', 'Initials': 'K', 'LastName': 'Rass', 'Affiliation': 'Center for Venous and Peripheral Arterial Diseases, Eifelklinik St Brigida, Simmerath, Germany.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2021.02.011']
304,33667420,"Rituximab plus high-dose chemotherapy (MegaCHOEP) or conventional chemotherapy (CHOEP-14) in young, high-risk patients with aggressive B-cell lymphoma: 10-year follow-up of a randomised, open-label, phase 3 trial.","BACKGROUND


R-MegaCHOEP was the first phase 3 study comparing high-dose chemotherapy plus rituximab followed by autologous haematopoietic stem-cell transplantation (HSCT) with conventional chemotherapy plus rituximab in first-line therapy for patients aged 60 years or younger with high-risk aggressive B-cell lymphoma. Little is known about the long-term outcomes of these patients. We aimed to evaluate the long-term efficacy and safety of conventional chemotherapy versus high-dose chemotherapy after 10 years of follow-up in the R-MegaCHOEP trial.
METHODS


In this open-label, randomised, phase 3 trial done across 61 centres in Germany, patients aged 18-60 years with newly diagnosed, high-risk (age-adjusted International Prognostic Index [IPI] 2 or 3) aggressive B-cell lymphoma were randomly assigned (1:1, using Pocock minimisation) to eight cycles of conventional chemotherapy (cyclosphosphamide, doxorubicin, vincristine, etoposide, and prednisolone) plus rituximab (R-CHOEP-14) or four cycles of high-dose chemotherapy plus rituximab followed by autologous HSCT (R-MegaCHOEP). The trial was unmasked. Patients were stratified by age-adjusted IPI factors, presence of bulky disease (tumour mass ≥7·5 cm diameter), and treatment centre. The primary endpoint was event-free survival, analysed here 10 years after randomisation. 10-year overall survival, progression-free survival, conditional survival, relapse patterns, secondary malignancies, and molecular characteristics were also analysed. All analyses were done on the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT00129090.
FINDINGS


Between March 3, 2003, and April 7, 2009, 275 patients were randomly assigned to R-CHOEP-14 (n=136) or R-MegaCHOEP (n=139). 130 patients in the R-CHOEP-14 group and 132 patients in the R-MegaCHOEP group were included in the intention-to-treat population. After a median follow-up of 9·3 years (IQR 5·1-11·1), 10-year event-free survival was 51% (95% CI 42-61) in the R-MegaCHOEP group and 57% (47-67) in the R-CHOEP-14 group (adjusted hazard ratio [HR] 1·3 [95% CI 0·9-1·8], p=0·23). 10-year progression-free survival was 59% (50-68) in the R-MegaCHOEP group and 60% (51-70) in the R-CHOEP-14 group (adjusted HR 1·1 [0·7-1·7], p=0·64). 10-year overall survival was 66% (57-76) in the R-MegaCHOEP group and 72% (63-81) in the R-CHOEP-14 group (adjusted HR 1·3 [0·8-2·1], p=0·26). Relapse occurred in 30 (16% [95% CI 11-22]) of 190 patients who had complete remission or unconfirmed complete remission; 17 (17%) of 100 patients in the R-CHOEP-14 group and 13 (14%) of 90 patients in the R-MegaCHOEP group. Seven (23%) of 30 patients had low-grade histology at relapse and had better outcomes compared with patients who relapsed with aggressive histologies. Lymphoma affected the CNS in 18 (28%) of 64 patients with treatment failure. 22 secondary malignancies were reported in the intention-to-treat population; in 12 (9%) of 127 patients in the R-CHOEP-14 group and ten (8%) of 126 patients in the R-MegaCHOEP group.
INTERPRETATION


Event-free survival and overall survival were similar between groups after 10 years of follow-up; outcomes were not improved in the R-MegaCHOEP group by high-dose chemotherapy and autologous HSCT. Patients who relapsed with aggressive histology showed a high incidence of CNS involvement and poor prognosis. For these patients, novel therapies are greatly warranted.
FUNDING


Deutsche Krebshilfe (German Cancer Aid).",2021,"INTERPRETATION


Event-free survival and overall survival were similar between groups after 10 years of follow-up; outcomes were not improved in the R-MegaCHOEP group by high-dose chemotherapy and autologous HSCT.","['patients aged 60 years or younger with high-risk aggressive B-cell lymphoma', '64 patients with treatment failure', 'Between March 3, 2003, and April 7, 2009, 275 patients were randomly assigned to R-CHOEP-14 (n=136) or R-MegaCHOEP (n=139', 'Patients were stratified by age-adjusted IPI factors, presence of bulky disease (tumour mass ≥7·5 cm diameter), and treatment centre', '1·1', '130 patients in the R-CHOEP-14 group and 132 patients in the R-MegaCHOEP group were included in the intention-to-treat population', 'young, high-risk patients with aggressive B-cell lymphoma', '1·3', '2 or 3) aggressive B-cell lymphoma', '61 centres in Germany, patients aged 18-60 years with newly diagnosed, high-risk (age-adjusted International Prognostic Index [IPI']","['autologous haematopoietic stem-cell transplantation (HSCT) with conventional chemotherapy plus rituximab', 'conventional chemotherapy (cyclosphosphamide, doxorubicin, vincristine, etoposide, and prednisolone) plus rituximab (R-CHOEP-14) or four cycles of high-dose chemotherapy plus rituximab followed by autologous HSCT (R-MegaCHOEP', 'conventional chemotherapy versus high-dose chemotherapy', 'Rituximab plus high-dose chemotherapy (MegaCHOEP) or conventional chemotherapy (CHOEP-14']","['10-year progression-free survival', 'adjusted HR 1·3', 'CNS involvement and poor prognosis', 'survival and overall survival', '10-year event-free survival', 'low-grade histology at relapse', '10-year overall survival, progression-free survival, conditional survival, relapse patterns, secondary malignancies, and molecular characteristics', 'complete remission or unconfirmed complete remission', '10-year overall survival', 'event-free survival', 'Relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0668760', 'cui_str': 'diinosine pentaphosphate'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0686377', 'cui_str': 'Secondary malignant neoplasm of central nervous system'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",275.0,0.326548,"INTERPRETATION


Event-free survival and overall survival were similar between groups after 10 years of follow-up; outcomes were not improved in the R-MegaCHOEP group by high-dose chemotherapy and autologous HSCT.","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Frontzek', 'Affiliation': 'Department of Medicine A, Haematology, Oncology, and Pneumology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Ziepert', 'Affiliation': 'Institute for Medical Informatics, Statistics, and Epidemiology, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Nickelsen', 'Affiliation': 'Onkologie Lerchenfeld, Hamburg, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Altmann', 'Affiliation': 'Institute for Medical Informatics, Statistics, and Epidemiology, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Glass', 'Affiliation': 'Clinic for Haematology, Oncology, Tumour Immunology, and Palliative Care, Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Haenel', 'Affiliation': 'Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Truemper', 'Affiliation': 'Haematology and Medical Oncology, Georg August University, Göttingen, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Held', 'Affiliation': 'Department for Haematology and Oncology, Westpfalz-Klnikum Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bentz', 'Affiliation': 'Department of Internal Medicine III, Municipal Hospital of Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dreyling', 'Affiliation': 'Department of Medicine III, Ludwig Maximilians Universität Hospital, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Viardot', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Kroschinsky', 'Affiliation': 'Department of Medicine I, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Metzner', 'Affiliation': 'Department of Internal Medicine, Oncology, and Haematology, University Hospital Klinikum Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Staiger', 'Affiliation': 'Dr Margarete Fischer-Bosch Institute of Clinical Pharmacology, University of Tübingen, Stuttgart, Germany; Department of Clinical Pathology, Robert Bosch Hospital, Stuttgart, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Horn', 'Affiliation': 'Dr Margarete Fischer-Bosch Institute of Clinical Pharmacology, University of Tübingen, Stuttgart, Germany; Department of Clinical Pathology, Robert Bosch Hospital, Stuttgart, Germany.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Ott', 'Affiliation': 'Dr Margarete Fischer-Bosch Institute of Clinical Pharmacology, University of Tübingen, Stuttgart, Germany; Department of Clinical Pathology, Robert Bosch Hospital, Stuttgart, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenwald', 'Affiliation': 'Institute of Pathology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Loeffler', 'Affiliation': 'Institute for Medical Informatics, Statistics, and Epidemiology, University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Lenz', 'Affiliation': 'Department of Medicine A, Haematology, Oncology, and Pneumology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Department of Medicine A, Haematology, Oncology, and Pneumology, University Hospital Münster, Münster, Germany. Electronic address: norbert.schmitz@ukmuenster.de.'}]",The Lancet. Haematology,['10.1016/S2352-3026(21)00022-3']
305,33675838,Subjective responses predict d-amphetamine choice in healthy volunteers.,"BACKGROUND


It is commonly believed that drugs, including stimulants, are used recreationally because of their ability to induce pleasurable subjective effects. However, recreational drug use sometimes occurs in the absence of positive subjective effects, suggesting that other factors contribute. Here, we examine the extent to which the direct subjective effects of amphetamine, a commonly misused stimulant, predict subsequent choice of the drug vs placebo.
METHODS


Healthy adults (N = 112) participated in a five-session amphetamine choice study. On the first four sessions, participants sampled either 20 mg d-amphetamine or placebo in color-coded capsules two times each. On the fifth session, they chose which color (d-amphetamine or placebo) they preferred. We examined the choice of drug vs placebo in relation to demographic characteristics, baseline mood states, personality and subjective and cardiovascular responses to acute administration of the drug.
RESULTS


Eighty-one participants chose amphetamine (Choosers) while 31 chose placebo (Non-choosers). Overall, amphetamine produced typical stimulant-like effects on subjective questionnaires, and it elevated heart rate and blood pressure vs placebo. Choosers reported greater positive mood, elation and stimulant-like effects following amphetamine compared to Non-choosers. The Choosers also exhibited a greater increase in systolic blood pressure, but not heart rate. The groups did not differ on demographic characteristics, mood states before drug administration or personality.
CONCLUSIONS


These findings support the idea that pleasurable subjective responses to amphetamine, including positive mood, elation, and stimulant-like effects influence behavioral choice of the drug.",2021,"Choosers reported greater positive mood, elation and stimulant-like effects following amphetamine compared to Non-choosers.","['Healthy adults (N\u202f=\u202f112) participated in a five-session amphetamine choice study', 'healthy volunteers']","['amphetamine or placebo', 'amphetamine', 'placebo']","['demographic characteristics, mood states before drug administration or personality', 'systolic blood pressure', 'heart rate', 'heart rate and blood pressure', 'positive mood, elation and stimulant-like effects', 'subjective questionnaires']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0233492', 'cui_str': 'Elation'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",112.0,0.202768,"Choosers reported greater positive mood, elation and stimulant-like effects following amphetamine compared to Non-choosers.","[{'ForeName': 'Conor H', 'Initials': 'CH', 'LastName': 'Murray', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637, USA.'}, {'ForeName': 'Jingfei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637, USA. Electronic address: hdew@uchicago.edu.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2021.173158']
306,33662594,Novel Application of Predictive Modeling: A Tailored Approach to Promoting HCC Surveillance in Patients With Cirrhosis.,"OBJECTIVE


There has been increased interest in interventions to promote hepatocellular carcinoma (HCC) surveillance given low utilization and high proportions of late stage detection. Accurate prediction of patients likely versus unlikely to respond to interventions could allow a cost-effective approach to outreach and facilitate targeting more intensive interventions to likely non-responders.
DESIGN


We conducted a secondary analysis of a randomized clinical trial evaluating a mailed outreach strategy to promote HCC surveillance among 1200 cirrhosis patients at a safety-net health system between December 2014 and March 2017. We developed regularized logistic regression (RLR) and gradient boosting machine (GBM) algorithm models to predict surveillance completion during each of the 3 screening rounds in a training set (n = 960). Model performance was assessed using multiple performance metrics in an independent test set (n = 240).
RESULTS


Among 1200 patients, surveillance was completed in 41-47% of patients over the three rounds. The RLR and GBM models demonstrated good discriminatory accuracy, with area under receiver operating characteristic (AUROC) curves of 0.67 and 0.66 respectively in the first surveillance round and improved to 0.77 by the third surveillance round after incorporating prior screening behavior as a feature. Additional performance characteristics including the Brier score, Hosmer-Lemeshow test and reliability diagrams were also evaluated. The most important variables for the predictive model were prior screening completion status and past primary care contact.
CONCLUSIONS


Predictive models can help stratify patients' likelihood to respond to surveillance outreach invitations, facilitating tailored strategies to maximize effectiveness and cost-effectiveness of HCC surveillance population health programs.",2021,"The RLR and GBM models demonstrated good discriminatory accuracy, with area under receiver operating characteristic (AUROC) curves of 0.67 and 0.66 respectively in the first surveillance round and improved to 0.77 by the third surveillance round after incorporating prior screening behavior as a feature.","['1200 cirrhosis patients at a safety-net health system between December 2014 and March 2017', 'Patients with Cirrhosis', '1200 patients, surveillance was completed in 41-47% of patients over the three rounds']","['Predictive Modeling', 'regularized logistic regression (RLR) and gradient boosting machine (GBM) algorithm models', 'mailed outreach strategy to promote HCC surveillance']","['Brier score, Hosmer-Lemeshow test and reliability diagrams']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}]","[{'cui': 'C0206031', 'cui_str': 'Logistic Regression'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",1200.0,0.0283754,"The RLR and GBM models demonstrated good discriminatory accuracy, with area under receiver operating characteristic (AUROC) curves of 0.67 and 0.66 respectively in the first surveillance round and improved to 0.77 by the third surveillance round after incorporating prior screening behavior as a feature.","[{'ForeName': 'Amit G', 'Initials': 'AG', 'LastName': 'Singal', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center and Parkland Health & Hospital, Dallas, Texas; Department of Population Sciences, University of Texas Southwestern Medical Center and Parkland Health & Hospital, Dallas, Texas; Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center and Parkland Health & Hospital, Dallas, Texas. Electronic address: amit.singal@utsouthwestern.edu.'}, {'ForeName': 'Yixing', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Mendoza College of Business, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Shrihari', 'Initials': 'S', 'LastName': 'Sridhar', 'Affiliation': 'Mays Business School, Texas A&M University, College Station, Texas.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Mittal', 'Affiliation': 'Jones Graduate School of Business, Rice University, Houston, Texas.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Fullington', 'Affiliation': 'Department of Population Sciences, University of Texas Southwestern Medical Center and Parkland Health & Hospital, Dallas, Texas.'}, {'ForeName': 'Muzeeb', 'Initials': 'M', 'LastName': 'Shaik', 'Affiliation': 'Mays Business School, Texas A&M University, College Station, Texas.'}, {'ForeName': 'Akbar K', 'Initials': 'AK', 'LastName': 'Waljee', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan; Michigan Integrated Center for Health Analytics and Medical Prediction (MiCHAMP), Ann Arbor, Michigan.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Tiro', 'Affiliation': 'Department of Population Sciences, University of Texas Southwestern Medical Center and Parkland Health & Hospital, Dallas, Texas; Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center and Parkland Health & Hospital, Dallas, Texas.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2021.02.038']
307,33662589,A 3-armed multicenter randomized controlled trial: Placental Transfusion in Very Preterm Infants (PT-VPI).,"Preterm infants constitute an important proportion of neonatal deaths and various complications, and very preterm infants (VPI) are more likely to develop severe complications, such as intraventricular hemorrhage (IVH), anemia, and sepsis. It has been confirmed that placental transfusion can supplement blood volume in infants and reduce preterm-associated complications, which is further conducive to the development of the nervous system and a better long-term prognosis. Based on these advantages, placental transfusion has been widely used in VPI. There are three main types of placental transfusion: delayed cord clamping (DCC), intact umbilical cord milking (I-UCM), and cut umbilical cord milking (C-UCM). However, the optimal method for PT-VPI remains controversial, and it is urgent to identify the best method of placental transfusion. We plan to fully evaluate the safety and effectiveness of these three placental transfusion methods in VPI in a 3-arm multicenter randomized controlled trial: Placental Transfusion in Very Preterm Infants (PT-VPI). Trial registration: chictr.org.cn, number ChiCTR2000030953.",2021,"There are three main types of placental transfusion: delayed cord clamping (DCC), intact umbilical cord milking (I-UCM), and cut umbilical cord milking (C-UCM).",['Very Preterm Infants (PT-VPI'],['Placental Transfusion'],"['safety and effectiveness', 'cord clamping (DCC), intact umbilical cord milking (I-UCM), and cut umbilical cord milking (C-UCM']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}]","[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}]",,0.111897,"There are three main types of placental transfusion: delayed cord clamping (DCC), intact umbilical cord milking (I-UCM), and cut umbilical cord milking (C-UCM).","[{'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Yue', 'Affiliation': ""Neonatal Department, Chengdu Women's and Children's Central Hospital, School of Medicine, School of Medicine, University of Electronic Science and Technology of China, Chengdu, PR China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Neonatal Department, Chongqing Health Center for Women and Children, Chongqing, PR China.'}, {'ForeName': 'Fangping', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Neonatal Department, Gansu Provincial Maternity and Child-Care Hospital, Lanzhou, PR China.'}, {'ForeName': 'Chunyi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Neonatal Department, Guangdong Women and Children Hospital, Guangzhou, PR China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Neonatal Department, Maternity and Child-Care Hospital of Guangxi Zhuang Autonomous Region, Nanning, PR China.'}, {'ForeName': 'Jingjie', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Neonatal Department, Guiyang Maternal and Child Health Hospital, Guizhou, PR China.'}, {'ForeName': 'Qiaoyan', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'Neonatal Department, Hunan Provincial Maternal and Child Healthcare Hospital, Changsha, PR China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Neonatal Department, Jinan Maternity and Child-Care Hospital, Jinan, PR China.'}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Neonatal Department, Liuzhou Maternity and Child Healthcare Hospital, Liuzhou, PR China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Qian', 'Affiliation': 'Neonatal Department, Nanjing Maternity and Child Health Care Hospital, Nanjing, PR China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yi', 'Affiliation': 'Neonatal Department, Affiliated Shenzhen Maternity & Child Healthcare Hospital, Southern Medical University, Shenzhen, PR China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Neonatal Department, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjin, PR China.'}, {'ForeName': 'Ruihua', 'Initials': 'R', 'LastName': 'Ba', 'Affiliation': ""Neonatal Department, Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, PR China.""}, {'ForeName': 'Liqian', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': ""Neonatal Department, Northwest Women's and Children's Hospital, Xi'an, PR China.""}, {'ForeName': 'Jiping', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""Neonatal Department, Xichang People's Hospital, Xichang, PR China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Neonatal Department, The Affiliated Hospital of Southwest Medical University, Luzhou, PR China.'}, {'ForeName': 'Jiangyi', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Neonatal Department, Chengdu Women's and Children's Central Hospital, School of Medicine, School of Medicine, University of Electronic Science and Technology of China, Chengdu, PR China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Neonatal Department, Chengdu Women's and Children's Central Hospital, School of Medicine, School of Medicine, University of Electronic Science and Technology of China, Chengdu, PR China.""}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': ""Neonatal Department, Chengdu Women's and Children's Central Hospital, School of Medicine, School of Medicine, University of Electronic Science and Technology of China, Chengdu, PR China.""}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Xi', 'Affiliation': ""Neonatal Department, Chengdu Women's and Children's Central Hospital, School of Medicine, School of Medicine, University of Electronic Science and Technology of China, Chengdu, PR China.""}, {'ForeName': 'Shuqiang', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': ""Neonatal Department, Chengdu Women's and Children's Central Hospital, School of Medicine, School of Medicine, University of Electronic Science and Technology of China, Chengdu, PR China.""}, {'ForeName': 'Xuhong', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Neonatal Department, Chengdu Women's and Children's Central Hospital, School of Medicine, School of Medicine, University of Electronic Science and Technology of China, Chengdu, PR China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Ju', 'Affiliation': ""Neonatal Department, Chengdu Women's and Children's Central Hospital, School of Medicine, School of Medicine, University of Electronic Science and Technology of China, Chengdu, PR China. Electronic address: jurong@uestc.edu.cn.""}]",Contemporary clinical trials,['10.1016/j.cct.2021.106337']
308,33667665,Investigating the impact of target lesion selection on drug effect evaluation and tumour growth rate determination using tumour growth inhibition models: Example of malignant pleural mesothelioma patients treated with cisplatin alone or in combination with pemetrexed.,"In the last update of the RECIST criteria in 2009, it was proposed that the number of target lesions to be followed over time for response-to-treatment assessment be reduced from 10 to 5 lesions maximum, with up to 2 per organ. We explored the impact of reducing the number of target lesion on the assessment of drug effect in a randomised phase III clinical trial using a tumour growth inhibition (TGI) model. Tumour size measurements from 441 (out of 456) patients were used to build two datasets for which observations were the sum of longest diameters of all measurable lesions (ALL dataset) or following the RECIST 1.1 recommendations (R1.1 dataset). TGI models incorporating a categorical covariate for treatment group or a pharmacokinetic metric (i.e. dose; simulated area under the curve) were used to describe the longitudinal tumour size kinetics. Drug exposure was not superior to treatment group at describing drug effect. ALL and R1.1 individual estimates of drug effect appeared to be strongly correlated (r 2 =0.88). Including pharmacokinetic metrics in TGI models should be conducted carefully when no pharmacokinetic samples are available. Reducing the number of target lesion did not seem to compromise the determination of drug effect using TGI models.",2021,ALL and R1.1 individual estimates of drug effect appeared to be strongly correlated (r 2 =0.88).,['malignant pleural mesothelioma patients treated with'],"['cisplatin alone or in combination with pemetrexed', 'tumour growth inhibition (TGI) model']",['number of target lesion'],"[{'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}]",456.0,0.0317837,ALL and R1.1 individual estimates of drug effect appeared to be strongly correlated (r 2 =0.88).,"[{'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Lombard', 'Affiliation': 'Centre for Applied Pharmacokinetic Research, University of Manchester, Manchester, United Kingdom; Division of Pharmacy and Optometry, University of Manchester, Manchester, United Kingdom. Electronic address: aurelie.lombard@postgrad.manchester.ac.uk.'}, {'ForeName': 'Hitesh', 'Initials': 'H', 'LastName': 'Mistry', 'Affiliation': 'Division of Pharmacy and Optometry, University of Manchester, Manchester, United Kingdom; Division of Cancer Sciences, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester M13 9PT, United Kingdom.'}, {'ForeName': 'Sonya C', 'Initials': 'SC', 'LastName': 'Chapman', 'Affiliation': 'Eli Lilly and Company, Erl Wood Manor, Windlesham, United Kingdom.'}, {'ForeName': 'Ivelina', 'Initials': 'I', 'LastName': 'Gueorguieva', 'Affiliation': 'Eli Lilly and Company, Erl Wood Manor, Windlesham, United Kingdom.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Aarons', 'Affiliation': 'Centre for Applied Pharmacokinetic Research, University of Manchester, Manchester, United Kingdom; Division of Pharmacy and Optometry, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Kayode', 'Initials': 'K', 'LastName': 'Ogungbenro', 'Affiliation': 'Centre for Applied Pharmacokinetic Research, University of Manchester, Manchester, United Kingdom; Division of Pharmacy and Optometry, University of Manchester, Manchester, United Kingdom.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2021.105781']
309,33667587,High expression of krüppel-like factor 10 or Smad4 predicts clinical benefit of adjuvant chemoradiotherapy in curatively resected pancreatic adenocarcinoma: From a randomized phase III trial.,"PURPOSE


Our previous studies have demonstrated that Krüppel-like factor 10 (Klf10) modulated tumor radiation resistance and helps to predict clinical outcomes of pancreatic adenocarcinoma (PDAC). This study aimed to evaluate whether the expression levels of Klf10, Smad4 and Runx3 can help predict the benefits of adjuvant chemoradiotherapy (CRT) in resected PDAC.
METHODS AND MATERIALS


Tissue specimens were collected from 111 patients with curatively resected PDAC who were enrolled into a randomized trial comparing adjuvant gemcitabine with or without CRT. Immunohistochemical expression of biomarkers was quantified by pathologists blinded to patient outcomes through a grading system based on the extent and intensity of staining. The predictive value of biomarkers was analyzed using SAS statistical software.
RESULTS


In total, 56 and 55 patients received adjuvant gemcitabine alone and additional CRT, respectively. The expression levels of Klf10, Smad4 and postoperative CA19-9 were significantly correlated with overall survival (OS) (p = 0.013, 0.045, and 0.047, respectively). Multivariable analysis showed that the expression level of postoperative serum CA19-9 and tumor tissue Klf10 expression level were significant predictors for OS (p = 0.038, and 0.028, respectively). Patients with high Klf10 or Smad4 (n = 55), had a significantly better local recurrence-free survival (∞ vs 19.8 months; p = 0.026) and a longer OS (33.0 vs 23.0 months; p = 0.12) if they received additional adjuvant CRT than gemcitabine only. The results were similar after adjusted by postoperative level of CA19-9.
CONCLUSION


Patients with curatively resected PDAC and a high expression of either Klf10 or Smad4 have high chances of benefiting from adjuvant CRT. Combining Klf10 and Smad4 to predict the benefits of adjuvant CRT in resected PDAC deserves further validation.",2021,"Patients with high Klf10 or Smad4 (n=55), had a significantly better local recurrence-free survival (∞ vs 19.8 months; p = 0.026) and a longer OS (33.0 vs 23.0 months; p = 0.12) if they received additional adjuvant CRT than gemcitabine only.","['curatively resected pancreatic adenocarcinoma', 'Tissue specimens were collected from 111 patients with curatively resected PDAC']","['gemcitabine', 'adjuvant chemoradiotherapy', 'adjuvant gemcitabine with or without CRT', 'adjuvant gemcitabine', 'adjuvant chemoradiotherapy (CRT']","['expression level of postoperative serum CA19-9 and tumor tissue Klf10 expression level', 'Immunohistochemical expression of biomarkers', 'overall survival (OS', 'expression levels of Klf10, Smad4 and postoperative CA19-9', 'local recurrence-free survival']","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Chemoradiotherapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006613', 'cui_str': 'Cancer antigen 19-9'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0015518', 'cui_str': 'factor X'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0385939', 'cui_str': 'SMAD4 protein, human'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",111.0,0.118104,"Patients with high Klf10 or Smad4 (n=55), had a significantly better local recurrence-free survival (∞ vs 19.8 months; p = 0.026) and a longer OS (33.0 vs 23.0 months; p = 0.12) if they received additional adjuvant CRT than gemcitabine only.","[{'ForeName': 'Shu-Ling', 'Initials': 'SL', 'LastName': 'Pen', 'Affiliation': 'Department of Pathology, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yan-Shen', 'Initials': 'YS', 'LastName': 'Shan', 'Affiliation': 'Department of Surgery, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Chin-Fu', 'Initials': 'CF', 'LastName': 'Hsiao', 'Affiliation': 'Institute of Public Health Sciences, National Health Research Institutes, Miaoli, Taiwan. Electronic address: chinfu2@nhri.edu.tw.'}, {'ForeName': 'Tsang-Wu', 'Initials': 'TW', 'LastName': 'Liu', 'Affiliation': 'National Institute of Cancer Research, National Health Research Institutes, Miaoli, Taiwan.'}, {'ForeName': 'Jen-Shi', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology-Oncology, Linkou Chang-Gung Memorial Hospital, Chang-Gung University, Tao-Yuan, Taiwan.'}, {'ForeName': 'Ching-Liang', 'Initials': 'CL', 'LastName': 'Ho', 'Affiliation': 'Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Chou', 'Affiliation': 'Department of Hematology-Oncology, Linkou Chang-Gung Memorial Hospital, Chang-Gung University, Tao-Yuan, Taiwan.'}, {'ForeName': 'Ruey-Kuen', 'Initials': 'RK', 'LastName': 'Hsieh', 'Affiliation': 'Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Li-Tzong', 'Initials': 'LT', 'LastName': 'Chen', 'Affiliation': 'National Institute of Cancer Research, National Health Research Institutes, Miaoli, Taiwan; Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': ""Ch'ang"", 'Affiliation': 'Department of Radiation Oncology, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan; National Institute of Cancer Research, National Health Research Institutes, Miaoli, Taiwan; Program for Cancer Biology and Drug Discovery, College of Medical Science and Technology, and Taipei Cancer Center, Taipei Medical University, Taipei, Taiwan. Electronic address: hjmc@nhri.org.tw.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2021.02.037']
310,33667497,Changes in food intake during the COVID-19 pandemic in New York City.,"The COVID-19 pandemic and stay-at-home orders across the nation have had substantial consequences on access to food and dietary behaviors. We investigated the dietary intake of adults in NYC, before and during the COVID-19 period. A subset of participants (n = 31) from an NIH-funded multi-level discount supermarket study were assessed. In this study, the experimental groups received a 0% (control), 15%, or 30% discount on fruits, vegetables, and noncaloric beverages for 8 months. The discount level for the participants who were selected for this study did not change from the pre-COVID to during COVID periods. Dietary intake data was collected using three unannounced 24-h dietary recalls (2 weekdays, 1 weekend) during each period. Changes in total daily kcal of food and beverages, total g of solid food, energy density of solid food (kcal/g), and g of fruit and vegetables, soda, non-caloric beverages, and snack foods were analyzed using multivariate linear regression. Energy density (ED) increased during COVID (+0.02 ± 0.5 [SD], F[4,26] = 3.0, p = 0.038). There was an interaction by gender (t = -3.2, p = 0.0035) such that ED increased for females (+0.27 ± 0.46, p = 0.037) and decreased for males (-0.22 ± 0.32, p = 0.012). The change in ED is likely due to the circumstances surrounding COVID-19, e.g. being at home, stress, and food shortages.",2021,"Energy density (ED) increased during COVID (+0.02 ± 0.5 [SD], F[4,26] = 3.0, p = 0.038).",['A subset of participants (n = 31) from an NIH-funded multi-level supermarket study were assessed'],[],"['Food Intake', 'total daily kcal of food and beverages, total g of solid food, energy density of solid food (kcal/g), and g of fruit and vegetables, soda, non-caloric beverages, and snack foods', 'Energy density (ED']","[{'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0453855', 'cui_str': 'Solid food'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0683086', 'cui_str': 'Caffeinated soft drinks'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}]",31.0,0.0524785,"Energy density (ED) increased during COVID (+0.02 ± 0.5 [SD], F[4,26] = 3.0, p = 0.038).","[{'ForeName': 'Atene S', 'Initials': 'AS', 'LastName': 'Poskute', 'Affiliation': 'Department of Psychiatry Icahn School of Medicine at Mount Sinai New York, NY, USA. Electronic address: atene.poskute@mountsinai.org.'}, {'ForeName': 'Aniema', 'Initials': 'A', 'LastName': 'Nzesi', 'Affiliation': 'Department of Psychiatry Icahn School of Medicine at Mount Sinai New York, NY, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Geliebter', 'Affiliation': 'Department of Psychiatry Icahn School of Medicine at Mount Sinai New York, NY, USA.'}]",Appetite,['10.1016/j.appet.2021.105191']
311,33358848,Editorial: The Vanishing Value of Evidence-based Treatments: Is Our Mental Health Expertise Irrelevant?,"The article in this issue of JAACAP by the CAMELS (Child/Adolescent Anxiety Multimodal Extended Long-term Study) study team, Peris et al. 1 , offers 2 very important contributions. Conveniently, the first contribution is also the stated purpose of this report: to present findings detailing the extent to which children and adolescents who previously participated (averaging 6.5 years previously) in the landmark Child and Adolescent Multimodal Study of Anxiety (CAMS) multisite randomized controlled trial (RCT) 2  did or did not receive follow-up services. This is not a good-news story. By and large, over the 6-year follow-up, only 35% of the previous RCT-treated children and youth received ""consistent"" continuing services, either through medication or cognitive-behavioral therapy (CBT), despite ongoing issues of anxiety and significant impairment.",2021,"By and large, over the 6-year follow-up, only 35% of the previous RCT-treated children and youth received ""consistent"" continuing services, either through medication or cognitive-behavioral therapy (CBT), despite ongoing issues of anxiety and significant impairment.","['children and adolescents who previously participated (averaging 6.5 years previously) in the landmark Child and Adolescent Multimodal Study of Anxiety (CAMS', 'Editorial']","['cognitive-behavioral therapy (CBT', 'JAACAP']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282412', 'cui_str': 'Editorial'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0248867,"By and large, over the 6-year follow-up, only 35% of the previous RCT-treated children and youth received ""consistent"" continuing services, either through medication or cognitive-behavioral therapy (CBT), despite ongoing issues of anxiety and significant impairment.","[{'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Jensen', 'Affiliation': 'The REACH Institute, New York, and the University of Arkansas for Medical Sciences, Little Rock. Electronic address: PeterJensen@TheReachInstitute.org.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.12.021']
312,33675989,Deep Sleep and Beeps: Sleep Quality Improvement Project in General Surgery Patients.,"BACKGROUND


Poor sleep leads to poor health outcomes. Inpatient sleep disturbance has been studied primarily in the ICU. Minimal research exists on sleep in surgical populations.
METHODS


We recruited patients undergoing elective, inpatient general surgery procedures. Participants wore Fitbit trackers while inpatient to measure total sleep time (CDC recommendation is 7 or more hours per night). At discharge, patients completed the Richards-Campbell Sleep Questionnaire (RCSQ) to measure inpatient sleep quality. The RCSQ combines 5 domains into a cumulative score (0 to 100); a higher score means better sleep quality. Patients also completed the outpatient Pittsburgh Sleep Quality Index preoperatively and postoperatively. The primary end point was percentage of patients with total sleep score ≥ 50. Secondary outcomes included mean RCSQ domain scores, Fitbit total sleep time, and percentage with Pittsburgh Sleep Quality Index Score indicating poor sleep.
RESULTS


We included 64 patients (mean ± SD age 55.0 ± 14.1 years). Mean ± SD RCSQ total sleep score was 49 ± 20.5 and 53.1% with total sleep score < 50. Mean ± SD RCSQ domain scores were Awakenings: 40.4 ± 22.8, Sleep Quality: 49.1 ± 27.9, Sleep Latency: 49.2 ± 25.3, Sleep Depth: 50.2 ± 26.5, Returning to Sleep: 55.9 ± 28.1, and Noise Disturbance: 59.1 ± 27.9. On night one, 25 devices (40%) had recorded sleep data due to enough sleep. Mean ± SD total sleep time on night 1 was 4.7 ± 2.8 hours. Mean total sleep time for nights 2, 3, and 4 remained fewer than 7 hours. Percentages for each night that achieved the CDC goal of 7 or more hours were as follows: night one 10.9%, night two 32.8%, night three 35.3%, and night four 27.6%. Per the Pittsburgh Sleep Quality Index, 88.1% of patients were poor sleepers preoperatively and 84.5% were poor sleepers at follow-up (p = 0.6).
CONCLUSIONS


Elective general surgery patients experience a severe inpatient sleep disturbance, worse than in similarly studied ICU cohorts. This disturbance is driven primarily by nighttime awakenings.",2021,"88.1% of patients were poor sleepers preoperatively per the PSQI, while 84.5% were poor sleepers at follow up (p = 0.6).
","['64 patients (Mean±SD age = 55.0±14.1', 'General Surgery Patients', 'patients undergoing elective, inpatient general surgery']",['Mean±SD'],"['mean RCSQ domain scores, Fitbit Total Sleep Time (TST), and percentage with PSQI Score indicating poor sleep', 'Sleep Latency', 'severe inpatient sleep disturbance', 'RCSQ Total Sleep Score', 'Mean TST± SD', 'Campbell Sleep Questionnaire (RCSQ) to measure inpatient sleep quality', 'percentage of patients with Total Sleep Score ≥ 50', 'outpatient Pittsburgh Sleep Quality Index (PSQI', 'total sleep time', 'Mean±SD RCSQ domain scores, Awakenings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}]",64.0,0.0183934,"88.1% of patients were poor sleepers preoperatively per the PSQI, while 84.5% were poor sleepers at follow up (p = 0.6).
","[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Allen', 'Affiliation': 'Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH. Electronic address: robert.w.allen@hitchcock.org.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Burney', 'Affiliation': 'Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Davis', 'Affiliation': 'Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Henkin', 'Affiliation': 'Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.'}, {'ForeName': 'Brooke G', 'Initials': 'BG', 'LastName': 'Judd', 'Affiliation': 'Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Sleep Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Geisel School of Medicine, Dartmouth College, Lebanon, NH.'}, {'ForeName': 'Srinivas Joga', 'Initials': 'SJ', 'LastName': 'Ivatury', 'Affiliation': 'Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Geisel School of Medicine, Dartmouth College, Lebanon, NH.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2021.02.010']
313,33662760,The elderly's physiological and perceptual responses to cooling during simulated activities of daily living in UK summer climatic conditions.,"OBJECTIVES


The elderly are the most at-risk population for heat-related illness and mortality during the periods of hot weather. However, evidence-based elderly-specific cooling strategies to prevent heat-illness are limited. The aim of this investigation was to quantify the elderly's physiological and perceptual responses to cooling through cold water ingestion (COLD) or an L-menthol mouth rinse (MENT) during simulated activities of daily living in UK summer climatic conditions.
STUDY DESIGN


Randomised, controlled repeated measures research design.
METHODS


A total of ten participants (men n = 7, women n = 3: age; 69 ± 3 yrs, height; 168 ± 10 cm, body mass; 68.88 ± 13.72 kg) completed one preliminary and three experimental trials; control (CON), COLD and MENT. Experimental trials consisted of 40 min rest followed by 30 min of cycling exercise at 6 metabolic equivalents and a 6-min walk test (6MWT), within a 35 °C, 50% relative humidity environment. Experimental interventions (every 10 min); cold water (4 °C) ingestion (total of 1.5L) or menthol (5 ml mouth swill for 5 s, menthol concentration of 0.01%).
RESULTS


Peak rectal temperature (T re ) was significantly (P < 0.05) lower in COLD compared with CON (-0.34 ± 0.16 °C) and MENT (-0.36 ± 0.20 °C). End exercise heart rate (HR) decreased in COLD compared with CON (-7 ± 9 b min -1 ) and MENT (-6 ± 7 b min -1 ). There was no difference in end exercise thermal sensation (TS) (CON; 6.1 ± 0.4, COLD; 6.0 ± 0.4, MENT; 6.4 ± 0.6) or thermal comfort (TC) (CON; 4 ± 1, COLD; 4 ± 1, MENT; 4 ± 1) between trials. The participants walked significantly further during the COLD 6MWT compared with CON (40 m ± 40 m) and MENT (40 m ± 30 m). There was reduced physiological strain in the COLD 6MWT compared with CON (T re ; -0.21 ± 0.24 °C, HR; -7 ± 8 b min -1 ) and MENT (T re ; -0.23 ± 0.24 °C, HR; -4 ± 7 b min -1 ).
CONCLUSION


The elderly have reduced physiological strain (T re  and HR) during activities of daily living and a 6MWT in hot UK climatic conditions, when they drink cold water. Furthermore, the elderly's perception (TS and TC) of the hot environment did not differ from CON at the end of exercise with COLD or MENT interventions. Menthol provided neither perceptual benefit to exercise in the heat nor functional gain. The TS data indicate that elderly may be at increased risk of heat illness, due to not feeling hot and uncomfortable enough to implement physiological strain reducing strategies such as cold-water ingestion.",2021,"RESULTS


Peak rectal temperature (T re ) was significantly (P < 0.05) lower in COLD compared with CON (-0.34 ± 0.16 °C) and MENT (-0.36 ± 0.20 ","['A total of ten participants (men n\xa0=\xa07, women n\xa0=\xa03: age; 69\xa0±\xa03\xa0yrs, height; 168\xa0±\xa010\xa0cm, body mass; 68.88\xa0±\xa013.72\xa0kg) completed one preliminary and three experimental trials', 'daily living in UK summer climatic conditions']","['40\xa0min rest followed by 30\xa0min of cycling exercise at 6 metabolic equivalents and a 6-min walk test (6MWT', 'cooling through cold water ingestion (COLD) or an L-menthol mouth rinse (MENT', 'Experimental interventions (every 10\xa0min); cold water (4\xa0°C) ingestion (total of 1.5L) or menthol', 'Menthol', 'CON', 'control (CON), COLD and MENT', 'CON (-7\xa0±']","['Peak rectal temperature (T re ', 'end exercise thermal sensation (TS', 'End exercise heart rate (HR', 'physiological strain']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0771655', 'cui_str': 'LEVOMENTHOL'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0084844', 'cui_str': 'trestolone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]",10.0,0.120661,"RESULTS


Peak rectal temperature (T re ) was significantly (P < 0.05) lower in COLD compared with CON (-0.34 ± 0.16 °C) and MENT (-0.36 ± 0.20 ","[{'ForeName': 'K A M', 'Initials': 'KAM', 'LastName': 'Waldock', 'Affiliation': 'Army Health and Performance Research, Andover, United Kingdom; Environmental Extremes Laboratory, University of Brighton, Eastbourne, United Kingdom. Electronic address: kirsty.waldock100@mod.gov.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hayes', 'Affiliation': 'Environmental Extremes Laboratory, University of Brighton, Eastbourne, United Kingdom.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Watt', 'Affiliation': 'Environmental Extremes Laboratory, University of Brighton, Eastbourne, United Kingdom.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Maxwell', 'Affiliation': 'Environmental Extremes Laboratory, University of Brighton, Eastbourne, United Kingdom.'}]",Public health,['10.1016/j.puhe.2021.01.016']
314,33668058,Effects of dietary macronutrients on serum urate: results from the OmniHeart trial.,"BACKGROUND


Dietary recommendations to prevent gout emphasize a low-purine diet. Recent evidence suggests that the Dietary Approaches to Stop Hypertension (DASH) diet reduces serum urate while also improving blood pressure and lipids.
OBJECTIVE


To compare the effects of DASH-style diets emphasizing different macronutrient proportions on serum urate reduction.
METHODS


We conducted a secondary analysis of the Optimal Macronutrient Intake Trial to Prevent Heart Disease feeding study, a 3-period, crossover design, randomized trial of adults with prehypertension or hypertension. Participants were provided with 3 DASH-style diets in random order, each for 6 wk. Each DASH-style diet emphasized different macronutrient proportions: a carbohydrate-rich (CARB) diet, a protein-rich (PROT) diet, and an unsaturated fat-rich (UNSAT) diet. In the PROT diet, approximately half of the protein came from plant sources. We compared the effects of these diets on serum urate at weeks 4 and 6 of each feeding period.
RESULTS


Of the 163 individuals included in the final analysis, the mean serum urate at baseline was 5.1 mg/dL. Only the PROT diet reduced serum urate from baseline at the end of the 6-wk feeding period (-0.16 mg/dL; 95% CI: -0.28, -0.04; P = 0.007). Neither the CARB diet (-0.03 mg/dL; 95% CI: -0.14, 0.09; P = 0.66) nor the UNSAT diet (-0.01 mg/dL; 95% CI: -0.12, 0.09; P = 0.78) reduced serum urate from baseline. The PROT diet lowered serum urate by 0.12 mg/dL (95% CI: -0.20, -0.03; P = 0.006) compared with CARB and by 0.12 mg/dL (95% CI: -0.20, -0.05; P = 0.002) compared with UNSAT.
CONCLUSIONS


A DASH-style diet emphasizing plant-based protein lowered serum urate compared with those emphasizing carbohydrates or unsaturated fat. Future trials should test the ability of a DASH-style diet emphasizing plant-based protein to lower serum urate and prevent gout flares in patients with gout. This trial was registered at clinicaltrials.gov as NCT00051350.",2021,"The PROT diet lowered serum urate by 0.12 mg/dL (95% CI: -0.20, -0.03; P = 0.006) compared with CARB and by 0.12 mg/dL (95% CI: -0.20, -0.05; P = 0.002) compared with UNSAT.
","['adults with prehypertension or hypertension', 'patients with gout']","['carbohydrate-rich (CARB) diet, a protein-rich (PROT) diet, and an unsaturated fat-rich (UNSAT) diet', 'dietary macronutrients', 'DASH-style diets']","['mean serum urate', 'blood pressure and lipids', 'serum urate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018099', 'cui_str': 'Gout'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015678', 'cui_str': 'Unsaturated fat'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",163.0,0.0537171,"The PROT diet lowered serum urate by 0.12 mg/dL (95% CI: -0.20, -0.03; P = 0.006) compared with CARB and by 0.12 mg/dL (95% CI: -0.20, -0.05; P = 0.002) compared with UNSAT.
","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Belanger', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Wee', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Shmerling', 'Affiliation': 'Division of Rheumatology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hyon K', 'Initials': 'HK', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa424']
315,33676302,The effectiveness of positive appearance and functionality reflective writing tasks on state body image and response to idealised media exposure among 35-60 year-old women.,"Functionality and appearance-based reflective writing tasks can improve body image in young women. There is limited research investigating these tasks in mature women. This study tested (a) the effectiveness of writing tasks on women's state body image and (b) whether these tasks buffered responses to idealised media. Women (N = 240, M age  = 44.58) were randomly allocated to write about the positive aspects of their body functionality, their appearance, or their stress management techniques. They were then exposed to images of cities, or thin-ideal models presented in either posed or active ways. Body appreciation, appearance satisfaction, and functionality satisfaction were measured at pre-reflection, post-reflection, and post-image exposure. Social comparison was measured at post-image. The functionality writing task produced immediate improvements across all state measures, while the positive appearance and stress reflection tasks produced improvements in functionality satisfaction. Image exposure then produced a decrease across all measures, except for body appreciation which remained stable in women who had completed the functionality reflections. No difference in social comparison was found between reflection conditions. The active images resulted in more functionality-based comparison than posed images. These findings contribute to the literature showing benefits of writing tasks which focus on appreciating one's body functionality.",2021,No difference in social comparison was found between reflection conditions.,"['young women', 'mature women', '35-60 year-old women', 'Women (N = 240, M age  = 44.58']","['positive appearance and functionality reflective writing tasks', 'writing tasks', 'Functionality and appearance-based reflective writing tasks']","['Body appreciation, appearance satisfaction, and functionality satisfaction', 'social comparison', 'functionality satisfaction']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0246504,No difference in social comparison was found between reflection conditions.,"[{'ForeName': 'Rachael M', 'Initials': 'RM', 'LastName': 'Weaver', 'Affiliation': 'School of Health and Behavioural Sciences, University of the Sunshine Coast, Maroochydore DC, Queensland, Australia.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Health and Behavioural Sciences, University of the Sunshine Coast, Maroochydore DC, Queensland, Australia. Electronic address: kmulgrew@usc.edu.au.'}]",Body image,['10.1016/j.bodyim.2021.02.008']
316,33676296,Efficacy of systemic lidocaine on postoperative quality of recovery and analgesia after video-assisted thoracic surgery: A randomized controlled trial.,"STUDY OBJECTIVE


Intraoperative systemic lidocaine has become widely accepted as an adjunct to general anesthesia, associated with opioid-sparing and enhanced recovery. We hypothesized that perioperative systemic lidocaine improves postoperative pain and enhances the quality of recovery (QoR) in patients following video-assisted thoracic surgery (VATS).
DESIGN


Prospective, single-center, double-blind, randomized placebo-controlled clinical trial.
SETTING


Single institution, tertiary university hospital.
PATIENTS


Adult patients aged 18 to 65 undergoing VATS were eligible for participation.
INTERVENTIONS


Patients enrolled in this study were randomized to receive either system lidocaine (a bolus of 1.5 mg kg -1 , followed by an infusion of 2 mg kg -1  h -1  until the end of the surgical procedure) or identical volumes and rates of 0.9% saline.
MEASUREMENTS


The primary outcome was a global QoR-15 score 24 h after surgery. Secondary outcomes included postoperative pain score, cumulative opioid consumption, emergence time, length of PACU stay, adverse events, and patient satisfaction.
MAIN RESULTS


There was no difference in the global QoR-15 scores at 24 h postoperatively between the lidocaine and saline groups (median 117, IQR 113.5-124, vs. median 116, IQR 111-120, P = 0.067), with a median difference of 3 (95% CI 0 to 6, P = 0.507). Similarly, postoperative pain scores, postoperative cumulative opioid consumption, PACU length of stay, the occurrence of PONV, and patient satisfaction were comparable between the two groups (all P > 0.05).
CONCLUSIONS


Our current findings do not support using perioperative systemic lidocaine as a potential strategy to improve postoperative pain and enhance QoR in patients undergoing VATS.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (identifier: ChiCTR1900027515).",2021,"There was no difference in the global QoR-15 scores at 24 h postoperatively between the lidocaine and saline groups (median 117, IQR 113.5-124, vs. median 116, IQR 111-120, P = 0.067), with a median difference of 3 (95% CI 0 to 6, P = 0.507).","['patients following video-assisted thoracic surgery (VATS', 'Adult patients aged 18 to 65 undergoing VATS were eligible for participation', 'Single institution, tertiary university hospital', 'after video-assisted thoracic surgery', 'patients undergoing VATS']","['system lidocaine', 'Intraoperative systemic lidocaine', 'placebo', 'perioperative systemic lidocaine', 'lidocaine', 'systemic lidocaine']","['postoperative pain', 'global QoR-15 scores', 'postoperative pain scores, postoperative cumulative opioid consumption, PACU length of stay, the occurrence of PONV, and patient satisfaction', 'global QoR-15 score 24\xa0h after surgery', 'postoperative pain score, cumulative opioid consumption, emergence time, length of PACU stay, adverse events, and patient satisfaction', 'quality of recovery (QoR', 'postoperative quality of recovery and analgesia', 'postoperative pain and enhance QoR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.792082,"There was no difference in the global QoR-15 scores at 24 h postoperatively between the lidocaine and saline groups (median 117, IQR 113.5-124, vs. median 116, IQR 111-120, P = 0.067), with a median difference of 3 (95% CI 0 to 6, P = 0.507).","[{'ForeName': 'Yusheng', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Jundan', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Yazhen', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, China. Electronic address: fjslmzk@163.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110223']
317,33676295,Prognostic and predictive impact of consensus molecular subtypes and CRCAssigner classifications in metastatic colorectal cancer: a translational analysis of the TRIBE2 study.,"INTRODUCTION


The consensus molecular subtypes (CMS) demonstrated prognostic value in metastatic colorectal cancer (mCRC). Similarly, a prognostic impact was suggested for the pre-consensus CRCAssigner (CRCA) classifier in early stages. The potential predictive role of these classifiers with regard to the choice of the first-line therapy has not been established. We investigated the prognostic and predictive impact of CMS and CRCA subtypes among mCRC patients treated in the TRIBE2 study.
METHODS


Among 679 randomized patients, 426 and 428 (63%) samples were profiled according to CMS and CRCA classifications, respectively. The prognostic and predictive impact of both CMS and CRCA subtypes was investigated with univariate and multivariate analyses for progression-free survival (PFS), PFS 2 (PFS2), and overall survival (OS).
RESULTS


Significant associations of CMS and CRCA subtypes with PFS, PFS2, and OS were demonstrated; the CMS classifier confirmed its independent prognostic value in the multivariable model (P value for PFS/PFS2/OS = 0.01/0.07/0.08). The effect of treatment intensification was independent of CMS subtypes (P value for interaction for PFS/PFS2/OS = 0.88/0.75/0.55). A significant interaction effect between CRCA subtypes and treatment arm was demonstrated in PFS (P = 0.02), PFS2 (P = 0.01), and OS (P = 0.008). The benefit of FOLFOXIRI seemed more relevant in the stem-like (PFS, hazard ratio = 0.60; P = 0.03) and mixed subtypes (hazard ratio = 0.44; P = 0.002). These findings were confirmed in a subgroup of patients of the previous TRIBE study.
CONCLUSIONS


We confirmed the independent prognostic role of CMS classification in mCRC independently of RAS/BRAF status. CRCA classification may help identifying subgroups of patients who may derive more benefit from FOLFOXIRI/bevacizumab.",2021,The effect of treatment intensification was independent of CMS subtypes (P value for interaction for PFS/PFS2/OS = 0.88/0.75/0.55).,"['mCRC patients treated in the TRIBE2 study', 'metastatic colorectal cancer (mCRC', 'Among 679 randomized patients, 426 and 428 (63', 'metastatic colorectal cancer']",['FOLFOXIRI/bevacizumab'],"['progression-free survival (PFS), PFS 2 (PFS2), and overall survival (OS', 'PFS2', 'PFS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517775', 'cui_str': '428'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",679.0,0.0761612,The effect of treatment intensification was independent of CMS subtypes (P value for interaction for PFS/PFS2/OS = 0.88/0.75/0.55).,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Borelli', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fontana', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK; Sarah Cannon Research Institute, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Giordano', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and Critical Area, University of Pisa, Pisa, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Antoniotti', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Unit of Medical Oncology 1, Department of Oncology, Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bergamo', 'Affiliation': 'Unit of Medical Oncology 1, Department of Oncology, Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy; Oncology and Hemato-Oncology Department, University of Milan, Milan, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Morano', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tamburini', 'Affiliation': 'Oncology Unit, Ospedale degli Infermi, Rimini, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Boccaccino', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Santini', 'Affiliation': 'Department of Medical Oncology, University Campus Biomedico, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Zucchelli', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Pella', 'Affiliation': 'Department of Oncology, University and General Hospital, Udine, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Oncology Unit, Foundation IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Passardi', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCSS, Meldola, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ugolini', 'Affiliation': 'Unit of Pathological Anatomy, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fontanini', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and Critical Area, University of Pisa, Pisa, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Nyamundanda', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sadanandam', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK. Electronic address: anguraj.sadanandam@icr.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy. Electronic address: chiaracremolini@gmail.com.'}]",ESMO open,['10.1016/j.esmoop.2021.100073']
318,33676197,Eculizumab in Asian patients with anti-aquaporin-IgG-positive neuromyelitis optica spectrum disorder: A subgroup analysis from the randomized phase 3 PREVENT trial and its open-label extension.,"Background Eculizumab, a terminal complement inhibitor, significantly reduced the risk of relapse compared with placebo in patients with anti-aquaporin-4 immunoglobulin G-positive (AQP4+) neuromyelitis optica spectrum disorder (NMOSD) in the PREVENT trial. We report efficacy and safety analyses in Asian patients in PREVENT and its open-label extension (OLE). Methods PREVENT was a double-blind, randomized, phase 3 trial. Patients with AQP4+ NMOSD were randomly assigned (2:1) to receive intravenous eculizumab (maintenance dose, 1200 mg/2 weeks) or placebo. Patients who completed PREVENT could receive eculizumab in an OLE. Analyses were performed in a prespecified subgroup of Asian patients. Results Of 143 patients enrolled, 52 (36.4%) were included in the Asian subgroup (eculizumab, n = 37; placebo, n = 15); 45 Asian patients received eculizumab in the OLE. Most Asian patients (86.5%) received concomitant immunosuppressive therapy. During PREVENT, one adjudicated relapse occurred in patients receiving eculizumab and six occurred in patients receiving placebo in the Asian subgroup (hazard ratio, 0.05; 95% confidence interval: 0.01-0.35; p = 0.0002). An estimated 95.2% of Asian patients remained relapse-free after 144 weeks of eculizumab treatment. Upper respiratory tract infections, headache, and nasopharyngitis were the most common adverse events with eculizumab in the Asian subgroup. Conclusion Eculizumab reduces the risk of relapse in Asian patients with AQP4+ NMOSD, with a benefit-risk profile similar to the overall PREVENT population. The benefits of eculizumab were maintained during long-term therapy. Clinical trial registration ClinicalTrials.gov identifiers: NCT01892345 (PREVENT); NCT02003144 (open-label extension).",2021,"Upper respiratory tract infections, headache, and nasopharyngitis were the most common adverse events with eculizumab in the Asian subgroup.","['patients with anti-aquaporin-4 immunoglobulin G-positive (AQP4+) neuromyelitis optica spectrum disorder (NMOSD', 'Asian patients with AQP4+ NMOSD', 'Asian patients with anti-aquaporin-IgG-positive neuromyelitis optica spectrum disorder', 'Patients with AQP4+ NMOSD', 'Asian patients in PREVENT and its open-label extension (OLE', '143 patients enrolled, 52 (36.4%) were included in the Asian subgroup (eculizumab, n\xa0=\xa037; placebo, n\xa0=\xa015); 45 Asian patients received']","['intravenous eculizumab (maintenance dose, 1200\xa0mg/2 weeks) or placebo', 'placebo', 'concomitant immunosuppressive therapy', 'eculizumab in the OLE', 'eculizumab in an OLE', 'Eculizumab', 'eculizumab']","['relapse-free', 'risk of relapse', 'Upper respiratory tract infections, headache, and nasopharyngitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0292777', 'cui_str': 'Aquaporin-4'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027873', 'cui_str': 'Neuromyelitis optica'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0599635', 'cui_str': 'Aquaporin'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}]",143.0,0.496528,"Upper respiratory tract infections, headache, and nasopharyngitis were the most common adverse events with eculizumab in the Asian subgroup.","[{'ForeName': 'Ho Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Research Institute and Hospital, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang 10408, South Korea. Electronic address: hojinkim@ncc.re.kr.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Nakashima', 'Affiliation': 'Department of Neurology, Tohoku University Graduate School of Medicine, 1-1 Seiryomachi, Aobaku, Sendai, Miyagi 980-8574, Japan; Division of Neurology, Tohoku Medical and Pharmaceutical University, 1-12-1 Fukumuro, Miyaginoku, Sendai, Miyagi 983-8512, Japan. Electronic address: nakashima@tohoku-mpu.ac.jp.'}, {'ForeName': 'Shanthi', 'Initials': 'S', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Neurology, Kuala Lumpur Hospital, Jalan Pahang, Kuala Lumpur 50560, Malaysia.'}, {'ForeName': 'Kai-Chen', 'Initials': 'KC', 'LastName': 'Wang', 'Affiliation': 'Cheng Hsin General Hospital, 45 Zhenxing Street, Beitou District, Taipei, Taiwan 112; School of Medicine, National Yang-Ming University, 155, Section 2, Linong St, Beitou District, Taipei, Taiwan 112.'}, {'ForeName': 'Shulian', 'Initials': 'S', 'LastName': 'Shang', 'Affiliation': 'Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA 02210, United States. Electronic address: shulian.shang@alexion.com.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA 02210, United States. Electronic address: Larisa.Miller@alexion.com.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Yountz', 'Affiliation': 'Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA 02210, United States. Electronic address: Marcus.Yountz@alexion.com.'}, {'ForeName': 'Dean M', 'Initials': 'DM', 'LastName': 'Wingerchuk', 'Affiliation': 'Mayo Clinic Arizona, 13400 East Shea Boulevard, Scottsdale, AZ 85259, United States. Electronic address: wingerchuk.dean@mayo.edu.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Pittock', 'Affiliation': 'Mayo Clinic, 200 First Street SW, Rochester, MN 55905, United States. Electronic address: Pittock.Sean@mayo.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levy', 'Affiliation': 'Department of Neurology,\xa0Johns Hopkins University, 1800 Orleans Street, Baltimore, MD 21287, United States. Electronic address: mlevy11@mgh.harvard.edu.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Berthele', 'Affiliation': 'Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Neuro-Kopf-Zentrum, Ismaninger Str. 22, 81675 Munich, Germany. Electronic address: achim.berthele@tum.de.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Totolyan', 'Affiliation': 'Department of Neurology, First Pavlov State Medical University of St. Petersburg, St. 6/8, Lva Tolstogo str., 197022 Petersburg, Russia. Electronic address: ntotolyan@mail.ru.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Palace', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, West Wing, John Radcliffe Hospital, University of Oxford, Headley Way, Oxford OX3 9DU, United Kingdom. Electronic address: jacqueline.palace@ndcn.ox.ac.uk.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Barnett', 'Affiliation': 'Brain and Mind Centre, University of Sydney, 94, Mallett Street, Camperdown, Sydney, NSW 2050, Australia; Royal Prince Alfred Hospital, University of Sydney, Sydney, NSW, Australia. Electronic address: michael@sydneyneurology.com.au.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Fujihara', 'Affiliation': 'Department of Neurology, Tohoku University Graduate School of Medicine, 1-1 Seiryomachi, Aobaku, Sendai, Miyagi 980-8574, Japan; Department of Multiple Sclerosis Therapeutics, Fukushima Medical University School of Medicine, 1 Hikariga-oka, Fukushima City, Fukushima 960-1295, Japan; Multiple Sclerosis and Neuromyelitis Optica Center, Southern TOHOKU Research Institute for Neuroscience (STRINS), Koriyama, 7-115, Yatsuyamada, Koriyama, Fukushima 963-8563, Japan. Electronic address: fujikazu@med.tohoku.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102849']
319,33676151,Personality traits are associated with cognitive empathy in medical students but not with its evolution and interventions to improve it.,"OBJECTIVE


Cognitive empathy might decrease during medical school. Factors associated with its evolution remain poorly understood, as well as whether such factors could moderate the effect of an intervention to preserve cognitive empathy. The aim was to explore the associations between personality traits and both cognitive empathy at baseline and its changes at follow-up. The possible effect of an intervention depended upon personality traits was also examined.
METHODS


The cohort consisted of fourth year medical students and the associations between personality traits, using the Short Big Five Inventory, and cognitive empathy changes at 3-month, using the Jefferson Scale of Empathy-Student version (JSE-S), were examined. A randomization in two groups (Balint groups versus no intervention) allowed examining whether the effect of the intervention depended upon personality traits. Linear regressions were adjusted for gender, anticipated specialty choice, parental education, living status, financial insecurity, randomization group and baseline JSE-S.
RESULTS


The cohort included 311 participants from October 2015 to December 2016 at Paris Diderot and Paris Descartes University. At follow-up, there was a JSE-S total score increase of 1.22(SD:9.10) in the intervention group, compared to a decrease of 1.64(SD:10.74) in the other group. Baseline JSE-S was positively associated with Extraversion and Conscientiousness and negatively with Neuroticism. In contrast, we found no associations between baseline personality traits and JSE-S change. There were no interactions between personality traits and randomization group.
CONCLUSION


Although personality might be linked with cognitive empathy, medical students may benefit from strategies designed for improving cognitive empathy regardless of their personality.",2021,"At follow-up, there was a JSE-S total score increase of 1.22(SD:9.10) in the intervention group, compared to a decrease of 1.64(SD:10.74) in the other group.",['311 participants from October 2015 to December 2016 at Paris Diderot and Paris Descartes University'],[],"['JSE-S total score increase of 1.22(SD:9.10', 'Jefferson Scale of Empathy-Student version (JSE-S']","[{'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",311.0,0.0203572,"At follow-up, there was a JSE-S total score increase of 1.22(SD:9.10) in the intervention group, compared to a decrease of 1.64(SD:10.74) in the other group.","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Airagnes', 'Affiliation': 'AP-HP.Centre-Université de Paris, DMU Psychiatrie et Addictologie, Paris, France; Inserm, UMS011, Population-based Epidemiological Cohorts, Villejuif, France. Electronic address: guillaume.airagnes@aphp.fr.'}, {'ForeName': 'Céline Buffel', 'Initials': 'CB', 'LastName': 'du Vaure', 'Affiliation': 'Université de Paris, Faculté de Médecine Paris Descartes, Département de Médecine Générale, Paris, France; Inserm, Epidemiology and Statistics Sorbonne Paris Cité, UMR 1153, METHODS Team, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Galam', 'Affiliation': 'Université de Paris, Faculté de Médecine Paris Diderot, Département de Médecine Générale, Paris, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Bunge', 'Affiliation': 'Université de Paris, Faculté de Médecine Paris Diderot, Département de Médecine Générale, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Hoertel', 'Affiliation': 'AP-HP.Centre-Université de Paris, DMU Psychiatrie et Addictologie, Paris, France; Inserm, U1266, UMR-S 1266, Institut de Psychiatrie et Neurosciences de Paris, Paris, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Limosin', 'Affiliation': 'AP-HP.Centre-Université de Paris, DMU Psychiatrie et Addictologie, Paris, France; Inserm, U1266, UMR-S 1266, Institut de Psychiatrie et Neurosciences de Paris, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Jaury', 'Affiliation': 'Université de Paris, Faculté de Médecine Paris Descartes, Département de Médecine Générale, Paris, France; Société Médicale Balint, Woippy, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Lemogne', 'Affiliation': 'AP-HP.Centre-Université de Paris, DMU Psychiatrie et Addictologie, Paris, France; Inserm, U1266, UMR-S 1266, Institut de Psychiatrie et Neurosciences de Paris, Paris, France.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2021.110410']
320,33677172,A randomised controlled trial of laser acupuncture improves early outcomes of osteoarthritis patients' physical functional ability after total knee replacement.,"BACKGROUND AND PURPOSE


Total knee replacement is the most effective intervention for late-stage osteoarthritis; however, a major concern is postoperative recovery of physical function. This randomised controlled trial evaluated the effects of acupuncture with low-level laser therapy (ALLLT) on early outcomes of physical function after total knee replacement.
MATERIALS AND METHODS


Eighty-two osteoarthritis patients were recruited and randomly assigned to the experimental group receiving ALLLT or the control group receiving sham ALLLT without laser beam output. Physical function was evaluated by assessing knee joint flexion and stiffness on days 1, 2, and 3 after total knee replacement.
RESULTS


Generalised estimating equations revealed a significant difference between the two groups in joint flexion. The experimental group displayed better joint flexion and less stiffness on days 2 and 3 than did the control group.
CONCLUSION


ALLLT can facilitate the recovery of physical function, as evidenced by knee joint flexion and stiffness, in patients receiving total knee replacement.",2021,"Physical function was evaluated by assessing knee joint flexion and stiffness on days 1, 2, and 3 after total knee replacement.
","['late-stage osteoarthritis', 'patients receiving total knee replacement', ""osteoarthritis patients' physical functional ability after total knee replacement"", 'Eighty-two osteoarthritis patients']","['laser acupuncture', 'acupuncture with low-level laser therapy (ALLLT', 'ALLLT or the control group receiving sham ALLLT without laser beam output']","['joint flexion', 'Physical function']","[{'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0394654', 'cui_str': 'Laser acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0458142', 'cui_str': 'Laser light'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",82.0,0.0676184,"Physical function was evaluated by assessing knee joint flexion and stiffness on days 1, 2, and 3 after total knee replacement.
","[{'ForeName': 'Chiung-Hui', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Integration of Traditional Chinese Medicine with Western Nursing, National Taipei University of Nursing and Health Sciences, Nurse, Department of Nursing, Taipei Veterans General Hospital, 201, Sec. 2, Shipai Rd., Taipei City, 11217, Taiwan. Electronic address: chhuang10@vghtpe.gov.tw.'}, {'ForeName': 'Mei-Ling', 'Initials': 'ML', 'LastName': 'Yeh', 'Affiliation': 'Department of Nursing, National Taipei University of Nursing and Health Sciences, 365, Minte Rd., Taipei City, 11219, Taiwan. Electronic address: meiling@ntunhs.edu.tw.'}, {'ForeName': 'Fang-Pey', 'Initials': 'FP', 'LastName': 'Chen', 'Affiliation': 'Center for Traditional Medicine, Taipei Veterans General Hospital and Adjunct Professor, National Taipei University of Nursing and Health Sciences, 201, Sec. 2, Shipai Rd., Taipei City, 11217, Taiwan. Electronic address: fpchen@vghtpe.gov.tw.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kuo', 'Affiliation': 'Department of Nursing, National Taipei University of Nursing and Health Sciences, Student, Taipei American School, 800, Sec. 6, Zhongshan N. Rd., Taipei City, 11152, Taiwan. Electronic address: 22matthewk@students.tas.tw.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101340']
321,33677157,The influence of high-frequency repetitive transcranial magnetic stimulation on endogenous estrogen in patients with disorders of consciousness.,"BACKGROUND


Repetitive transcranial magnetic stimulation (rTMS) has been proposed as a promising therapeutic intervention for neurological disorders. However, the precise mechanisms of rTMS in neural excitability remains poorly understood. Estradiol is known to have strong influence on cortical excitability. This study aimed to determine whether high-frequency (HF) rTMS influences endogenous estradiol in male patients with disorders of consciousness (DOC).
METHODS


A randomized controlled trial was conducted with a total of 57 male patients with DOC. Eventually, 50 patients completed the study. Twenty-five patients underwent real rTMS, and 25 patients underwent sham rTMS, which were delivered over the dorsolateral prefrontal cortex. The primary outcome measure was the change in serum estradiol from baseline to after 10 sessions of HF-rTMS. The improvement in the total score of the JFK Coma Recovery Scale-Revised (CRS-R) was also assessed.
RESULTS


Changes in estradiol levels and CRS-R scores from pre-to post-treatment were significantly different between the active rTMS and sham stimulation conditions. A significant enhancement of CRS-R scores in the patients receiving rTMS stimulation was observed compared to the sham group. Serum estradiol levels in patients following HF-rTMS were significantly higher than their baseline levels, whereas no significant changes were found in the sham group from pre-to post-stimulation. The rise in estradiol levels was greater in responders than in non-responders. The changes in estradiol levels were significantly positively correlated with the improvement in CRS-R scores.
CONCLUSION


These preliminary findings indicate that serum estradiol levels are affected by HF-rTMS and positively related to clinical responses in male patients with DOC. The elevation of estradiol levels may lay a physiological foundation for successful rTMS treatment for DOC patients by increasing cortical excitability.",2021,"RESULTS


Changes in estradiol levels and CRS-R scores from pre-to post-treatment were significantly different between the active rTMS and sham stimulation conditions.","['50 patients completed the study', 'male patients with DOC', '57 male patients with DOC', 'patients with disorders of consciousness', 'male patients with disorders of consciousness (DOC']","['Estradiol', 'real rTMS', 'Repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'high-frequency (HF) rTMS', 'sham rTMS', 'high-frequency Repetitive Transcranial Magnetic Stimulation']","['estradiol levels and CRS-R scores', 'rise in estradiol levels', 'serum estradiol levels', 'elevation of estradiol levels', 'total score of the JFK Coma Recovery Scale-Revised (CRS-R', 'estradiol levels', 'change in serum estradiol', 'CRS-R scores', 'Serum estradiol levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009792', 'cui_str': 'Consciousness Disorders'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",57.0,0.133686,"RESULTS


Changes in estradiol levels and CRS-R scores from pre-to post-treatment were significantly different between the active rTMS and sham stimulation conditions.","[{'ForeName': 'Ren Hong', 'Initials': 'RH', 'LastName': 'He', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University, P.R. China.'}, {'ForeName': 'Hui Juan', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University, P.R. China.'}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University, P.R. China.'}, {'ForeName': 'Jian Zhong', 'Initials': 'JZ', 'LastName': 'Fan', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University, P.R. China.'}, {'ForeName': 'Sheng Quan', 'Initials': 'SQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University, P.R. China.'}, {'ForeName': 'Yu Hua', 'Initials': 'YH', 'LastName': 'Zhong', 'Affiliation': 'Department of Rehabilitation Medicine, Nanfang Hospital, Southern Medical University, P.R. China. Electronic address: zhongbinyue@163.com.'}]",Brain stimulation,['10.1016/j.brs.2021.02.014']
322,33662902,Lung protective ventilation strategy to reduce postoperative pulmonary complications (PPCs) in patients undergoing robot-assisted laparoscopic radical cystectomy for bladder cancer: A randomized double blinded clinical trial.,"STUDY OBJECTIVE


To evaluate the effects of ventilation with low tidal volume and positive end-expiratory pressure (PEEP) on postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic radical cystectomy (RARC) for bladder cancer.
DESIGN


A prospective randomized double-blinded study.
SETTING


A single center trial in a comprehensive tertiary hospital from January 2017 to January 2019.
PATIENTS


A total of 258 patients undergoing RARC for bladder cancer.
INTERVENTIONS


Patients were randomly assigned to receive either lung-protective ventilation (LPV group) [tidal volume 6 ml/ kg predicated body weight (PBW) + PEEP 7 cmH 2 O] or nonprotective ventilation (control group) (tidal volume 9 ml/ kg PBW without PEEP) during anesthesia.
MEASUREMENTS


The primary outcome was the occurrence of postoperative pulmonary complications (PPCs) during the first 90 days after surgery. The secondary outcomes were extubation time, oxygenation index (OI) after extubation and at postoperative day 1 in blood gas.
MAIN RESULTS


The incidence of PPCs at postoperative day1, 2 and 3 were lower in LPV group [26.8% vs. 47.2%, odds ratio (OR) 0.41, 95% confidence interval (CI), 0.24-0.69, P = 0.0007, 21.3% vs. 43.3%, OR 0.36, 95% CI, 0.20-0.61, P = 0.0002, 14.2% vs. 27.5%, OR0.43, 95%CI, 0.23-0.82, P = 0.0087, respectively], while no differences were observed at day 7 and 28 (3.9% vs. 9.4%, P = 0.0788, 0% vs. 1.6%, P = 0.4980, respectively). No PPCs were observed at postoperative day 90 in both groups. Furthermore, immediately after extubating and at postoperative day 1, OI was significantly higher in LPV group compared with control group [390(337-467) vs. 343(303-420), P = 0.0005, 406.7(73.0) vs. 425.5(74.7), P = 0.0440, respectively]. Patients in LPV group had a significant shorter extubation time after operation compared with control group [38(33-54) vs. 35(25-46), P = 0.0012].
CONCLUSION


LPV combining low tidal volume and PEEP during anesthesia for RARC may decrease the incidence of postoperative pulmonary complications.",2021,"The incidence of PPCs at postoperative day1, 2 and 3 were lower in LPV group [26.8% vs. 47.2%, odds ratio (OR)","['patients undergoing', 'A single center trial in a comprehensive tertiary hospital from January 2017 to January 2019', 'for bladder cancer', 'A total of 258 patients undergoing RARC for bladder cancer']","['lung-protective ventilation (LPV group) [tidal volume 6\xa0ml', 'nonprotective ventilation (control group) (tidal volume 9', 'robot-assisted laparoscopic radical cystectomy (RARC', 'Lung protective ventilation strategy', 'ventilation with low tidal volume and positive end-expiratory pressure (PEEP', 'LPV', 'robot-assisted laparoscopic radical cystectomy']","['shorter extubation time', 'postoperative pulmonary complications (PPCs', 'kg predicated body weight (PBW', 'extubation time, oxygenation index (OI) after extubation and at postoperative day 1 in blood gas', 'odds ratio (OR', 'occurrence of postoperative pulmonary complications (PPCs', 'postoperative pulmonary complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4041016', 'cui_str': 'Robot assisted laparoscopic radical cystectomy'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4041016', 'cui_str': 'Robot assisted laparoscopic radical cystectomy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",258.0,0.535541,"The incidence of PPCs at postoperative day1, 2 and 3 were lower in LPV group [26.8% vs. 47.2%, odds ratio (OR)","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, Suzhou 215004, China.; Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China.'}, {'ForeName': 'Shujing', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, Suzhou 215004, China.; Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China.'}, {'ForeName': 'Zhangjie', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China.. Electronic address: 13611906592@163.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, Suzhou 215004, China.. Electronic address: hongx93044@126.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110156']
323,33678201,Oral nutritional supplement use is weakly associated with increased subjective health-related quality of life in malnourished older adults: a multicentre randomised controlled trial.,"Malnutrition is common among older adults in health-care settings and is associated with decreased quality of life (QoL). The present study aimed to investigate the effect on health-related QoL (HRQoL) among older adults after 6 months of treatment with individual dietary advice (DA) and/or oral nutritional supplements (ONS), utilising 409 patients included in a multicentre randomised controlled trial of patients ≥ 65 years old, stratified according to nutrition status (malnourished/at risk of malnutrition), admitted to hospital in Sweden 2010-2014. Patients were randomised into four arms: DA, ONS, DA + ONS or routine care (control). The intervention started at discharge from hospital, with HRQoL measured using European QoL five-dimension, three-level (EQ-5D-3L) and European QoL-visual analogue scale (EQ-VAS) at baseline and at 6-month, 1-year and 3-year follow-ups. Data were analysed using the Kruskal-Wallis test and multiple linear regression. Overall, HRQoL increased from baseline to follow-ups, although the magnitude of change in EQ-5D-3L did not differ significantly between the four arms in any of the nutrition groups. However, a significant difference was observed for change in EQ-VAS from baseline to 6-month follow-up in the malnourished group, with mean changes of 22·4 and -3·4 points for the ONS and control groups, respectively (P = 0·009). In the multiple linear regression analyses, participants in the ONS arm had 27·5, 34·4 and 38·8 points larger increases in EQ-VAS from baseline to the 6-month (P = 0·011), 1-year (P = 0·007) and 3-year (P = 0·032), respectively, follow-ups than the control group. The use of ONS improved subjectively assessed HRQoL in these malnourished older adults.",2021,"Overall, HRQoL increased from baseline to follow-ups, although the magnitude of change in EQ-5D-3L did not differ significantly between the four arms in any of the nutrition groups.","['patients ≥65 years old, stratified according to nutrition status (malnourished/at risk of malnutrition), admitted to hospital in Sweden 2010-2014', 'older adults after 6 months of treatment with', 'older adults in health-care settings', 'malnourished older adults']","['DA, ONS, DA + ONS, or routine care (control', 'health-related QoL (HRQoL', 'ONS', 'individual dietary advice (DA) and/or oral nutritional supplements (ONS']","['change in EQ-VAS', 'Overall, HRQoL', 'EQ-VAS', 'subjective health-related quality of life', 'magnitude of change in EQ-5D-3L', 'quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0449286', 'cui_str': 'Degree'}]",409.0,0.0826157,"Overall, HRQoL increased from baseline to follow-ups, although the magnitude of change in EQ-5D-3L did not differ significantly between the four arms in any of the nutrition groups.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Söderström', 'Affiliation': 'Centre for Clinical Research Västerås, Region Västmanland, Uppsala University, Västerås, Sweden.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Bergkvist', 'Affiliation': 'Centre for Clinical Research Västerås, Region Västmanland, Uppsala University, Västerås, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenblad', 'Affiliation': 'Department of Medical Sciences, Division of Clinical Diabetology and Metabolism, Uppsala University, Uppsala, Sweden.'}]",The British journal of nutrition,['10.1017/S0007114521000805']
324,33677004,"Response to ""Efficacy of sonidegib in histologic subtypes of advanced basal cell carcinoma: Results from the final analysis of the randomized phase 2 Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT) trial at 42 months"".",,2021,,['histologic subtypes of advanced basal cell carcinoma'],['sonidegib'],[],"[{'cui': 'C1301142', 'cui_str': 'WHO tumor classification'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}]","[{'cui': 'C3886731', 'cui_str': 'sonidegib'}]",[],,0.0397414,,"[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Villani', 'Affiliation': 'Dermatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy. Electronic address: ali.vil@hotmail.it.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Fabbrocini', 'Affiliation': 'Dermatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Costa', 'Affiliation': 'Dermatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Scalvenzi', 'Affiliation': 'Dermatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2021.02.074']
325,33683325,Short-Course Antimicrobial Therapy for Pediatric Community-Acquired Pneumonia: The SAFER Randomized Clinical Trial.,"Importance


Community-acquired pneumonia (CAP) is a common occurrence in childhood; consequently, evidence-based recommendations for its treatment are required.
Objective


To determine whether 5 days of high-dose amoxicillin for CAP was associated with noninferior rates of clinical cure compared with 10 days of high-dose amoxicillin.
Design, Setting, and Participants


The SAFER (Short-Course Antimicrobial Therapy for Pediatric Respiratory Infections) study was a 2-center, parallel-group, noninferiority randomized clinical trial consisting of a single-center pilot study from December 1, 2012, to March 31, 2014, and the follow-up main study from August 1, 2016, to December 31, 2019 at the emergency departments of McMaster Children's Hospital and the Children's Hospital of Eastern Ontario. Research staff, participants, and outcome assessors were blinded to treatment allocation. Eligible children were aged 6 months to 10 years and had fever within 48 hours, respiratory symptoms, chest radiography findings consistent with pneumonia as per the emergency department physician, and a primary diagnosis of pneumonia. Children were excluded if they required hospitalization, had comorbidities that would predispose them to severe disease and/or pneumonia of unusual origin, or had previous β-lactam antibiotic therapy. Data were analyzed from March 1 to July 8, 2020.
Interventions


Five days of high-dose amoxicillin therapy followed by 5 days of placebo (intervention group) vs 5 days of high-dose amoxicillin followed by a different formulation of 5 days of high-dose amoxicillin (control group).
Main Outcomes and Measures


Clinical cure at 14 to 21 days.
Results


Among the 281 participants, the median age was 2.6 (interquartile range, 1.6-4.9) years (160 boys [57.7%] of 279 with sex listed). Clinical cure was observed in 101 of 114 children (88.6%) in the intervention group and in 99 of 109 (90.8%) in the control group in per-protocol analysis (risk difference, -0.016; 97.5% confidence limit, -0.087). Clinical cure at 14 to 21 days was observed in 108 of 126 (85.7%) in the intervention group and in 106 of 126 (84.1%) in the control group in the intention-to-treat analysis (risk difference, 0.023; 97.5% confidence limit, -0.061).
Conclusions and Relevance


Short-course antibiotic therapy appeared to be comparable to standard care for the treatment of previously healthy children with CAP not requiring hospitalization. Clinical practice guidelines should consider recommending 5 days of amoxicillin for pediatric pneumonia management in accordance with antimicrobial stewardship principles.
Trial Registration


ClinicalTrials.gov Identifier: NCT02380352.",2021,"Clinical cure at 14 to 21 days was observed in 108 of 126 (85.7%) in the intervention group and in 106 of 126 (84.1%) in the control group in the intention-to-treat analysis (risk difference, 0.023; 97.5% confidence limit, -0.061).
","['281 participants, the median age was 2.6 (interquartile range, 1.6-4.9) years (160 boys [57.7%] of 279 with sex listed', 'Acquired Pneumonia', 'Pediatric Community', ""single-center pilot study from December 1, 2012, to March 31, 2014, and the follow-up main study from August 1, 2016, to December 31, 2019 at the emergency departments of McMaster Children's Hospital and the Children's Hospital of Eastern Ontario"", 'Eligible children were aged 6 months to 10 years and had fever within 48 hours, respiratory symptoms, chest radiography findings consistent with pneumonia as per the emergency department physician, and a primary diagnosis of pneumonia', 'previously healthy children with CAP not requiring hospitalization', 'Children were excluded if they required hospitalization, had comorbidities that would predispose them to severe disease and/or pneumonia of unusual origin, or had previous β-lactam antibiotic therapy']","['placebo', 'SAFER (Short-Course Antimicrobial Therapy', 'amoxicillin']",['Clinical cure'],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0586803', 'cui_str': 'Emergency department physician'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0022914', 'cui_str': 'Lactam'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.376992,"Clinical cure at 14 to 21 days was observed in 108 of 126 (85.7%) in the intervention group and in 106 of 126 (84.1%) in the control group in the intention-to-treat analysis (risk difference, 0.023; 97.5% confidence limit, -0.061).
","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Pernica', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Harman', 'Affiliation': 'Pediatric Emergency Research Canada, Calgary, Alberta, Canada.'}, {'ForeName': 'April J', 'Initials': 'AJ', 'LastName': 'Kam', 'Affiliation': 'Pediatric Emergency Research Canada, Calgary, Alberta, Canada.'}, {'ForeName': 'Redjana', 'Initials': 'R', 'LastName': 'Carciumaru', 'Affiliation': 'Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Thuva', 'Initials': 'T', 'LastName': 'Vanniyasingam', 'Affiliation': ""Biostiatistics Unit, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.""}, {'ForeName': 'Tyrus', 'Initials': 'T', 'LastName': 'Crawford', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.""}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Dalgleish', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Slinger', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Fulford', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Main', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Smieja', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Loeb', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.6735']
326,33683300,Efficacy of a Combination of Conservative Therapies vs an Education Comparator on Clinical Outcomes in Thumb Base Osteoarthritis: A Randomized Clinical Trial.,"Importance


A combination of conservative treatments is commonly used in clinical practice for thumb base osteoarthritis despite limited evidence for this approach.
Objective


To determine the efficacy of a 6-week combination of conservative treatments compared with an education comparator.
Design, Setting, and Participants


Randomized, parallel trial with 1:1 allocation ratio among people aged 40 years and older with symptomatic and radiographic thumb base osteoarthritis in a community setting in Australia.
Interventions


The intervention group (n = 102) received education on self-management and ergonomic principles, a base-of-thumb splint, hand exercises, and diclofenac sodium, 1%, gel. The comparator group (n = 102) received education on self-management and ergonomic principles alone. Intervention use was at participants' discretion from 6 to 12 weeks.
Main Outcomes and Measures


Hand function (Functional Index for Hand Osteoarthritis; 0-30) and pain (visual analog scale; 0-100 mm) were measured at week 6 (primary time point) and week 12. An α of .027 was used at week 6 to account for co-primary outcomes.
Results


Of the 204 participants randomized, 195 (96%) and 194 (95%) completed follow-ups at 6 and 12 weeks, respectively; the mean (SD) age of the population was 65.6 (8.1) years, and 155 (76.0%) were female. At week 6, hand function improved significantly more in the intervention group than the comparator (between-group difference, -1.7 units; 97.3% CI, -2.9 to -0.5; P = .002). This trend was sustained at 12 weeks (-2.4 units; 95% CI, -3.5 to -1.3; P < .001). Pain scores improved similarly at week 6 (between-group difference, -4.2 mm; 97.3% CI, -11.3 to 3.0; P = .19). At week 12, pain reduction was significantly greater in the intervention group (-8.6 mm; 95% CI, -15.2 to -2.0; P = .01). There were 34 nonserious adverse events, all in the intervention group-mostly skin reactions and exercise-related pain exacerbations.
Conclusions and Relevance


In this randomized clinical trial of people with thumb base osteoarthritis, combined treatments provided small to medium and potentially clinically beneficial effects on hand function but not pain.
Trial Registration


Australian New Zealand Clinical Trials Registry Identifier: ACTRN12616000353493.",2021,"There were 34 nonserious adverse events, all in the intervention group-mostly skin reactions and exercise-related pain exacerbations.
","['people aged 40 years and older with symptomatic and radiographic thumb base osteoarthritis in a community setting in Australia', 'Thumb Base Osteoarthritis', 'people with thumb base osteoarthritis', '204 participants randomized, 195 (96%) and 194 (95%) completed follow-ups at 6 and 12 weeks, respectively; the mean (SD) age of the population was 65.6 (8.1) years, and 155 (76.0%) were female']","['education on self-management and ergonomic principles, a base-of-thumb splint, hand exercises, and diclofenac sodium, 1%, gel', 'Conservative Therapies vs an Education Comparator', 'education on self-management and ergonomic principles alone']","['mostly skin reactions and exercise-related pain exacerbations', 'Pain scores', 'pain reduction', 'Measures\n\n\nHand function (Functional Index for Hand Osteoarthritis; 0-30) and pain (visual analog scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C1143779', 'cui_str': '2-amino-7-deazaadenine'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0454330', 'cui_str': 'Hand exercises'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",204.0,0.210641,"There were 34 nonserious adverse events, all in the intervention group-mostly skin reactions and exercise-related pain exacerbations.
","[{'ForeName': 'Leticia A', 'Initials': 'LA', 'LastName': 'Deveza', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Robbins', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Duong', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne School of Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'The University of Queensland School of Health and Rehabilitation Sciences, Brisbane, Australia.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Hodges', 'Affiliation': 'The University of Queensland School of Health and Rehabilitation Sciences, Brisbane, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wajon', 'Affiliation': 'Macquarie University Clinic, Macquarie Hand Therapy, Macquarie University, New South Wales, Australia.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Jongs', 'Affiliation': 'Physiotherapy Department, Royal North Shore Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Riordan', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Fu', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Win Min', 'Initials': 'WM', 'LastName': 'Oo', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': ""O'Connell"", 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jillian P', 'Initials': 'JP', 'LastName': 'Eyles', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.7101']
327,33681731,Hydroxychloroquine with or without azithromycin for treatment of early SARS-CoV-2 infection among high-risk outpatient adults: A randomized clinical trial.,"Background


Treatment options for outpatients with COVID-19 could reduce morbidity and prevent SARS-CoV-2 transmission.
Methods


In this randomized, double-blind, three-arm (1:1:1) placebo-equivalent controlled trial conducted remotely throughout the United States, adult outpatients with laboratory-confirmed SARS-CoV-2 infection were recruited. Participants were randomly assigned to receive hydroxychloroquine (HCQ) (400 mg BID x1day, followed by 200 mg BID x9days) with or without azithromycin (AZ) (500 mg, then 250 mg daily x4days) or placebo-equivalent (ascorbic acid (HCQ) and folic acid (AZ)), stratified by risk for progression to severe COVID-19 (high-risk vs. low-risk). Self-collected nasal swabs for SARS-CoV-2 PCR, FLUPro symptom surveys, EKGs and vital signs were collected daily. Primary endpoints were: (a) 14-day progression to lower respiratory tract infection (LRTI), 28-day COVID-19 related hospitalization, or death; (b) 14-day time to viral clearance; secondary endpoints included time to symptom resolution (ClinicalTrials.gov: NCT04354428). Due to the low rate of clinical outcomes, the study was terminated for operational futility.
Findings


Between 15th April and 27th July 2020, 231 participants were enrolled and 219 initiated medication a median of 5.9 days after symptom onset. Among 129 high-risk participants, incident LRTI occurred in six (4.7%) participants (two control, four HCQ/AZ) and COVID-19 related hospitalization in seven (5.4%) (four control, one HCQ, two HCQ/AZ); no LRTI and two (2%) hospitalizations occurred in the 102 low-risk participants (one HCQ, one HCQ/AZ). There were no deaths. Among 152 participants with viral shedding at enrollment, median time to clearance was 5 days (95% CI=4-6) in HCQ, 6 days (95% CI=4-8) in HCQ/AZ, and 8 days (95% CI=6-10) in control. Viral clearance was faster in HCQ (HR=1.62, 95% CI=1.01-2.60,  p  = 0.047) but not HCQ/AZ (HR=1.25,  p  = 0.39) compared to control. Among 197 participants who met the COVID-19 definition at enrollment, time to symptom resolution did not differ by group (HCQ: HR=1.02, 95% CI-0.63-1.64,  p  = 0.95, HCQ/AZ: HR=0.91, 95% CI=0.57-1.45,  p  = 0.70).
Interpretation


Neither HCQ nor HCQ/AZ shortened the clinical course of outpatients with COVID-19, and HCQ, but not HCQ/AZ, had only a modest effect on SARS-CoV-2 viral shedding. HCQ and HCQ/AZ are not effective therapies for outpatient treatment of SARV-CoV-2 infection.
Funding


The COVID-19 Early Treatment Study was funded by the Bill & Melinda Gates Foundation (INV-017062) through the COVID-19 Therapeutics Accelerator. University of Washington Institute of Translational Health Science (ITHS) grant support (UL1 TR002319), KL2 TR002317, and TL1 TR002318 from NCATS/NIH funded REDCap. The content is solely the responsibility of the authors and does not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. PAN and MJA were supported by the Mayo Clinic Windland Smith Rice Comprehensive Sudden Cardiac Death Program. Trial registration  ClinicalTrials.gov number NCT04354428.",2021,"Viral clearance was faster in HCQ (HR=1.62, 95% CI=1.01-2.60,  ","['early SARS-CoV-2 infection among high-risk outpatient adults', '197 participants who met the COVID-19 definition at enrollment', 'adult outpatients with laboratory-confirmed SARS-CoV-2 infection were recruited', '152 participants with viral shedding at enrollment', 'Findings\n\n\nBetween 15th April and 27th July 2020, 231 participants were enrolled and 219 initiated medication a median of 5.9 days after symptom onset']","['placebo-equivalent (ascorbic acid (HCQ) and folic acid (AZ', 'placebo', 'HCQ and HCQ/AZ', 'HCQ/AZ', 'Hydroxychloroquine with or without azithromycin', 'azithromycin (AZ', 'hydroxychloroquine (HCQ']","['14-day progression to lower respiratory tract infection (LRTI), 28-day COVID-19 related hospitalization, or death; (b) 14-day time to viral clearance; secondary endpoints included time to symptom resolution', 'median time to clearance', 'hospitalizations', 'incident LRTI', 'time to symptom resolution', 'Viral clearance']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439511', 'cui_str': 'times/day'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",231.0,0.474124,"Viral clearance was faster in HCQ (HR=1.62, 95% CI=1.01-2.60,  ","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Johnston', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Brown', 'Affiliation': 'Department of Biostatistics, University of Washington, United States.'}, {'ForeName': 'Jenell', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Helen C Stankiewicz', 'Initials': 'HCS', 'LastName': 'Karita', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Kissinger', 'Affiliation': 'School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dwyer', 'Affiliation': 'School of Medicine, Tulane University, New Orleans, LA, United States.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Hosek', 'Affiliation': 'John H. Stroger, Jr., Hospital of Cook County, Chicago, IL, United States.'}, {'ForeName': 'Temitope', 'Initials': 'T', 'LastName': 'Oyedele', 'Affiliation': 'John H. Stroger, Jr., Hospital of Cook County, Chicago, IL, United States.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Paasche-Orlow', 'Affiliation': 'Boston University School of Medicine, Boston, MA, United States.'}, {'ForeName': 'Kristopher', 'Initials': 'K', 'LastName': 'Paolino', 'Affiliation': 'State University of New York Upstate Medical University, Syracuse, NY, United States.'}, {'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Heller', 'Affiliation': 'Department of Global Health, University of Washington, United States.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Leingang', 'Affiliation': 'Department of Global Health, University of Washington, United States.'}, {'ForeName': 'Harald S', 'Initials': 'HS', 'LastName': 'Haugen', 'Affiliation': 'Department of Global Health, University of Washington, United States.'}, {'ForeName': 'Tracy Q', 'Initials': 'TQ', 'LastName': 'Dong', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bershteyn', 'Affiliation': 'New York University Grossman School of Medicine, NY, NY, United States.'}, {'ForeName': 'Arun R', 'Initials': 'AR', 'LastName': 'Sridhar', 'Affiliation': 'Division of Cardiology, University of Washington, United States.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Poole', 'Affiliation': 'Division of Cardiology, University of Washington, United States.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Noseworthy', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ackerman', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Morrison', 'Affiliation': 'Department of Global Health, University of Washington, United States.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Greninger', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Washington, United States.'}, {'ForeName': 'Meei-Li', 'Initials': 'ML', 'LastName': 'Huang', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Jerome', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Washington, United States.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wener', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Washington, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wald', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Schiffer', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EClinicalMedicine,['10.1016/j.eclinm.2021.100773']
328,33678038,A case study of ascertainment bias for the primary outcome in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial.,"BACKGROUND/AIM


In clinical trials, there is potential for bias from unblinded observers that may influence ascertainment of outcomes. This issue arose in the Strategies to Reduce Injuries and Develop Confidence in Elders trial, a cluster randomized trial to test a multicomponent intervention versus enhanced usual care (control) to prevent serious fall injuries, originally defined as a fall injury leading to medical attention. An unblinded nurse falls care manager administered the intervention, while the usual care arm did not involve contact with a falls care manager. Thus, there was an opportunity for falls care managers to refer participants reporting falls to seek medical attention. Since this type of observer bias could not occur in the usual care arm, there was potential for additional falls to be reported in the intervention arm, leading to dilution of the intervention effect and a reduction in study power. We describe the clinical basis for ascertainment bias, the statistical approach used to assess it, and its effect on study power.
METHODS


The prespecified interim monitoring plan included a decision algorithm for assessing ascertainment bias and adapting (revising) the primary outcome definition, if necessary. The original definition categorized serious fall injuries requiring medical attention into Type 1 (fracture other than thoracic/lumbar vertebral, joint dislocation, cut requiring closure) and Type 2 (head injury, sprain or strain, bruising or swelling, other). The revised definition, proposed by the monitoring plan, excluded Type 2 injuries that did not necessarily require an overnight hospitalization since these would be most subject to bias. These injuries were categorized into those with (Type 2b) and without (Type 2c) medical attention. The remaining Type 2a injuries required medical attention and an overnight hospitalization. We used the ratio of 2b/(2b + 2c) in intervention versus control as a measure of ascertainment bias; ratios > 1 indicated the likelihood of falls care manager bias. We determined the effect of ascertainment bias on study power for the revised (Types 1 and 2a) versus original definition (Types 1, 2a, and 2b).
RESULTS


The estimate of ascertainment bias was 1.14 (95% confidence interval: 0.98, 1.30), providing evidence of the likelihood of falls care manager bias. We estimated that this bias diluted the hazard ratio from the hypothesized 0.80 to 0.86 and reduced power to under 80% for the original primary outcome definition. In contrast, adapting the revised definition maintained study power at nearly 90%.
CONCLUSION


There was evidence of ascertainment bias in the Strategies to Reduce Injuries and Develop Confidence in Elders trial. The decision to adapt the primary outcome definition reduced the likelihood of this bias while preserving the intervention effect and study power.",2021,The estimate of ascertainment bias was 1.14,[],"['multicomponent intervention versus enhanced usual care (control', 'usual care arm did not involve contact with a falls care manager']",[],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0687694', 'cui_str': 'Case manager'}]",[],,0.0625494,The estimate of ascertainment bias was 1.14,"[{'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Esserman', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'Wake Forest University School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Erich J', 'Initials': 'EJ', 'LastName': 'Greene', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, CT, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Dziura', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': 'Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'Peduzzi', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, CT, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520980070']
329,33685920,Effect of the OPTIMAL programme on self-management of multimorbidity in primary care: a randomised controlled trial.,"BACKGROUND


Effective primary care interventions for multimorbidity are needed.
AIM


To evaluate the effectiveness of a group-based, 6-week, occupational therapy-led self-management support programme (OPTIMAL) for patients with multimorbidity.
DESIGN AND SETTING


A pragmatic parallel randomised controlled trial across eight primary care teams in Eastern Ireland with 149 patients with multimorbidity, from November 2015 to December 2018. Intervention was OPTIMAL with a usual care comparison.
METHOD


Primary outcomes were health-related quality of life (EQ-5D-3L) and frequency of activity participation (Frenchay Activities Index [FAI]). Secondary outcomes included independence in activities of daily living, occupational performance and satisfaction, anxiety and depression, self-efficacy, and healthcare utilisation. Complete case linear regression analyses were conducted. Age (<65/≥65 years) and the number of chronic conditions (<4/≥4) were explored further.
RESULTS


A total of 124 (83.2%) and 121 (81.2%) participants had complete data at immediate and 6-month post-intervention follow-up, respectively. Intervention participants had significant improvement in EQ-VAS (visual analogue scale) at immediate follow-up (adjusted mean difference [aMD] = 7.86; 95% confidence interval [CI] = 0.92 to 14.80) but no difference in index score (aMD = 0.04; 95% CI = -0.06 to 0.13) or FAI (aMD = 1.22; 95% CI = -0.84 to 3.29). At 6-month follow-up there were no differences in primary outcomes and mixed results for secondary outcomes. Pre-planned subgroup analyses suggested participants aged <65 years were more likely to benefit.
CONCLUSION


OPTIMAL was found to be ineffective in improving health-related quality of life or activity participation at 6-month follow-up. Existing multimorbidity interventions tend to focus on older adults; preplanned subgroup analyses results in the present study suggest that future research should target younger adults (<65 years) with multimorbidity.",2021,Intervention participants had significant improvement in EQ-VAS (visual analogue scale) at immediate follow-up (adjusted mean difference [aMD] = 7.86; 95% confidence interval [CI] = 0.92 to 14.80) but no difference in index score (aMD = 0.04; 95% CI = -0.06 to 0.13) or FAI (aMD = 1.22; 95% CI = -0.84 to 3.29).,"['eight primary care teams in Eastern Ireland with 149 patients with multimorbidity, from November 2015 to December 2018', 'older adults', 'younger adults (<65 years) with multimorbidity', 'multimorbidity in primary care', 'Age (<65/≥65 years) and the number of chronic conditions (<4/≥4) were explored further', 'patients with multimorbidity']",['occupational therapy-led self-management support programme'],"['health-related quality of life or activity participation', 'health-related quality of life (EQ-5D-3L) and frequency of activity participation (Frenchay Activities Index [FAI', 'index score', 'independence in activities of daily living, occupational performance and satisfaction, anxiety and depression, self-efficacy, and healthcare utilisation', 'EQ-VAS (visual analogue scale']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",149.0,0.154983,Intervention participants had significant improvement in EQ-VAS (visual analogue scale) at immediate follow-up (adjusted mean difference [aMD] = 7.86; 95% confidence interval [CI] = 0.92 to 14.80) but no difference in index score (aMD = 0.04; 95% CI = -0.06 to 0.13) or FAI (aMD = 1.22; 95% CI = -0.84 to 3.29).,"[{'ForeName': 'Lynn', 'Initials': 'L', 'LastName': ""O'Toole"", 'Affiliation': ""Discipline of Occupational Therapy, School of Medicine, Trinity College Dublin, St James's Hospital, Dublin.""}, {'ForeName': 'Deidre', 'Initials': 'D', 'LastName': 'Connolly', 'Affiliation': ""Discipline of Occupational Therapy, School of Medicine, Trinity College Dublin, St James's Hospital, Dublin.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Boland', 'Affiliation': 'Data Science Centre, Royal College of Surgeons in Ireland, Dublin.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X714185']
330,33677189,Effect of liraglutide 3.0mg treatment on weight reduction in obese antipsychotic-treated patients.,"BACKGROUND


Patients treated with antipsychotics experience significant weight gain and accompanying metabolic disorders. We investigated the efficacy of liraglutide 3.0 mg in reducing the weight of antipsychotic-treated obese patients.
METHOD


We retrospectively reviewed 16 obese patients with schizophrenia or bipolar disorder who were treated with 3.0 mg of liraglutide each. During the 16 weeks of treatment, changes in body weight and Clinical Global Impression-Severity scale (CGI-S) were analyzed. The participants were divided into responders (lost at least 5% of body weight) and non-responders for analysis.
RESULTS


Treatment with liraglutide 3.0 mg significantly decreased body weight (estimated marginal mean, 93.2 kg at baseline and 88.9 kg at 16 weeks; p < 0.001) as well as waist circumference, BMI and plasma glucose levels. Six of 16 patients (37.5%) complained of a modest degree of nausea. Six of the 12 subjects (50%) completing 16 weeks of treatment were responders. There were no significant differences in baseline characteristics between responders and non-responders. There was no worsening of CGI-S scores.
CONCLUSION


Liraglutide 3.0 mg significantly decreased body weight in obese patients treated with antipsychotics without altering the status of psychiatric diseases. A randomized controlled study is required to corroborate the results of this study.",2021,"During the 16 weeks of treatment, changes in body weight and Clinical Global Impression-Severity scale (CGI-S) were analyzed.","['16 obese patients with schizophrenia or bipolar disorder who were treated with 3.0 mg of liraglutide each', 'obese antipsychotic-treated patients', 'treated obese patients', 'Patients treated with antipsychotics experience significant weight gain and accompanying metabolic disorders', 'obese patients treated with']","['liraglutide', 'Liraglutide', 'antipsychotics']","['weight reduction', 'weight of antipsychotic', 'changes in body weight and Clinical Global Impression-Severity scale (CGI-S', 'body weight', 'nausea', 'CGI-S scores', 'waist circumference, BMI and plasma glucose levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",16.0,0.0244782,"During the 16 weeks of treatment, changes in body weight and Clinical Global Impression-Severity scale (CGI-S) were analyzed.","[{'ForeName': 'Seung Eun', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Gyeonggi-do, South Korea.'}, {'ForeName': 'Nam Young', 'Initials': 'NY', 'LastName': 'Lee', 'Affiliation': 'Department of Neuropsychiatry, Dongguk University Ilsan Hospital, Goyang, Gyeonggi-do, South Korea.'}, {'ForeName': 'Se Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyoung-Ah', 'Initials': 'KA', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Gyeonggi-do, South Korea.'}, {'ForeName': 'Yong Sik', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Nowon Eulji Hospital, Eulji University College of Medicine, Seoul, South Korea; Institute of Clinical Psychopharmacology, Dongguk University College of Medicine, Goyang, Gyeonggi-do, South Korea. Electronic address: kys@snu.ac.kr.'}]",Psychiatry research,['10.1016/j.psychres.2021.113830']
331,33677183,Evaluation of MADRS severity thresholds in patients with bipolar depression.,"BACKGROUND


The Montgomery-Åsberg Depression Rating Scale (MADRS) is commonly used to assess depression symptom changes in clinical trials; however, the score itself can be difficult to interpret without clinical context. Categories of depression severity corresponding to MADRS total score have not been established for bipolar depression, which was the objective of this study.
METHODS


Data were pooled from 3 randomized, double-blind, placebo-controlled trials of cariprazine in patients with bipolar I depression; placebo and cariprazine arms were pooled. An anchor-based approach was used to map MADRS total score to the clinician-rated, 7-category Clinical Global Impression of Severity scale (CGI-S). Spearman's correlation coefficient was used to assess associations between MADRS total and CGI-S scores. Optimal MADRS severity thresholds for each CGI-S category was determined via Youden index using receiver operating characteristic (ROC) analyses.
RESULTS


Using data from 1523 patients with bipolar depression, mean MADRS total scores were positively correlated with mean CGI-S scores at week 6 (r = 0.87; P<.0001). Using ROC curves, MADRS severity thresholds corresponding to each CGI-S category were estimated with high sensitivity and specificity: 0-6 for ""normal, not at all ill"", 7-12 for ""borderline mentally ill"", 13-18 for ""mildly ill"", 19-23 for ""moderately ill"", 24-36 for ""markedly ill"", 37-39 for ""severely ill"", and ≥40 for ""extremely ill"".
CONCLUSIONS


Utilizing data from 3 clinical trials of patients with bipolar depression, MADRS severity thresholds were identified. These empirical findings may help clinicians contextualize MADRS results from bipolar clinical research and apply to their practice.
TRIAL REGISTRATION


clinicaltrials.gov NCT01396447, NCT02670538, NCT02670551.",2021,"Using ROC curves, MADRS severity thresholds corresponding to each CGI-S category were estimated with high sensitivity and specificity: 0-6 for ""normal, not at all ill"", 7-12 for ""borderline mentally ill"", 13-18 for ""mildly ill"", 19-23 for ""moderately ill"", 24-36 for ""markedly ill"", 37-39 for ""severely ill"", and ≥40 for ""extremely ill"".
CONCLUSIONS


Utilizing data from 3 clinical trials of patients with bipolar depression, MADRS severity thresholds were identified.","['patients with bipolar I depression', 'patients with bipolar depression', '1523 patients with bipolar depression']","['cariprazine', 'placebo and cariprazine', 'placebo']","['mean CGI-S scores', 'mean MADRS total scores', 'MADRS total and CGI-S scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}]","[{'cui': 'C2936870', 'cui_str': 'cariprazine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",1523.0,0.297799,"Using ROC curves, MADRS severity thresholds corresponding to each CGI-S category were estimated with high sensitivity and specificity: 0-6 for ""normal, not at all ill"", 7-12 for ""borderline mentally ill"", 13-18 for ""mildly ill"", 19-23 for ""moderately ill"", 24-36 for ""markedly ill"", 37-39 for ""severely ill"", and ≥40 for ""extremely ill"".
CONCLUSIONS


Utilizing data from 3 clinical trials of patients with bipolar depression, MADRS severity thresholds were identified.","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA. Electronic address: thase@pennmedicine.upenn.edu.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Harrington', 'Affiliation': 'AbbVie, Irvine, CA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Calabrese', 'Affiliation': 'University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Montgomery', 'Affiliation': 'Imperial College, London, UK.'}, {'ForeName': 'Xiaomeng', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Mehul D', 'Initials': 'MD', 'LastName': 'Patel', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2021.02.043']
332,33684643,High-gamma oscillations as neurocorrelates of ADHD: A MEG crossover placebo-controlled study.,"Attention Deficit Hyperactive Disorder (ADHD) is a common neurobehavioral disorder with a significant and pervasive impact on patients' lives. Identifying neurophysiological correlates of ADHD is important for understanding its underlying mechanisms, as well as for improving clinical accuracy beyond cognitive and emotional factors. The present study focuses on finding a diagnostic stable neural correlate based on evaluating MEG resting state frequency bands. Twenty-two ADHD patients and 23 controls adults were blindly randomized to two methylphenidate/placebo evaluation days. On each evaluation day state anxiety was assessed, a 2N-back executive function task was performed, and resting state MEG brain activity was recorded at three timepoints. A frequency-based cluster analysis yielded higher high-gamma power for ADHD over posterior sensors and lower high-gamma power for ADHD over frontal-central sensors. These results were shown to be stable over three measurements, unaffected by methylphenidate treatment, and linked to cognitive accuracy and state anxiety. Furthermore, the differential high-gamma activity evidenced substantial ADHD diagnostic efficacy, comparable to the cognitive and emotional factors. These results indicate that resting state high-gamma activity is a promising, stable, valid and diagnostically-relevant neurocorrelate of ADHD. Due to the evolving understanding both in the cellular and network level of high-gamma oscillations, focusing future studies on this frequency band bears the potential for a better understanding of ADHD, thus advancing the specificity of the evaluation of the disorder and developing new tools for therapy.",2021,A frequency-based cluster analysis yielded higher high-gamma power for ADHD over posterior sensors and lower high-gamma power for ADHD over frontal-central sensors.,"['Twenty-two ADHD patients and 23 controls adults', 'ADHD']","['placebo', 'methylphenidate/placebo']","['substantial ADHD diagnostic efficacy', 'cognitive accuracy and state anxiety', 'resting state MEG brain activity']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",22.0,0.0257239,A frequency-based cluster analysis yielded higher high-gamma power for ADHD over posterior sensors and lower high-gamma power for ADHD over frontal-central sensors.,"[{'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Dor-Ziderman', 'Affiliation': 'Gonda Brain Research Center, Bar Ilan University, Ramat-Gan, Israel; Edmond J. Safra Brain Research Center, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Maor', 'Initials': 'M', 'LastName': 'Zeev-Wolf', 'Affiliation': 'Department of Education & Zlotowski Center for Neuroscience, Ben Gurion University of the Negev, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Hirsch Klein', 'Affiliation': 'Gonda Brain Research Center, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Dor', 'Initials': 'D', 'LastName': 'Bar-Oz', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Uriel', 'Initials': 'U', 'LastName': 'Nitzan', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Aviv', 'Initials': 'A', 'LastName': 'Segev', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': 'Gonda Brain Research Center, Bar Ilan University, Ramat-Gan, Israel; Department of Psychology, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Koubi', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Child and Adolescent Outpatient Clinic, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Mendelovic', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'The Emotion-Cognition Research Center, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Child and Adolescent Outpatient Clinic, Shalvata Mental Health Care Center, Hod-Hasharon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: yuvalbloch10@gmail.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.02.050']
333,33684639,The effects of core stabilization exercise program in obese people awaiting bariatric surgery: A randomized controlled study.,"OBJECTIVE


The aim of this study was the effects of the core stabilization exercise program (CSEP) and physical activity counseling on functional capacity, physical fitness, physical activity, fatigue and quality of life (QoL) in obese people awaiting bariatric surgery.
METHODS


Twenty-one patients were divided into two groups: an exercise group (n = 10) and a control group (n = 11). Both groups received physical activity counseling, but the exercise group also performed an 8-week CSEP. Functional capacity, physical fitness, physical activity, fatigue and QoL were assessed at baseline and after 8 weeks.
RESULTS


After eight weeks, results showed significant improvements in all parameters except for body composition for the exercise group, comparing to the control group (effect size = 0.40-0.87, p < 0.05).
CONCLUSIONS


Implementing an 8-week adding CSEP to physical activity counseling provided significant improvements in functional capacity, physical fitness, physical activity, fatigue and QoL compared to physical activity counseling in obese people awaiting bariatric surgery.",2021,"After eight weeks, results showed significant improvements in all parameters except for body composition for the exercise group, comparing to the control group (effect size = 0.40-0.87, p < 0.05).
","['obese people awaiting bariatric surgery', 'Twenty-one patients']","['core stabilization exercise program', 'exercise group', 'core stabilization exercise program (CSEP) and physical activity counseling', 'physical activity counseling, but the exercise group also performed an 8-week CSEP', 'physical activity counseling', 'CSEP to physical activity counseling']","['body composition', 'functional capacity, physical fitness, physical activity, fatigue and QoL', 'Functional capacity, physical fitness, physical activity, fatigue and QoL', 'functional capacity, physical fitness, physical activity, fatigue and quality of life (QoL']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",21.0,0.0204894,"After eight weeks, results showed significant improvements in all parameters except for body composition for the exercise group, comparing to the control group (effect size = 0.40-0.87, p < 0.05).
","[{'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Arman', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey. Electronic address: saimenilayarman@istanbul.edu.tr.'}, {'ForeName': 'Gulfidan', 'Initials': 'G', 'LastName': 'Tokgoz', 'Affiliation': ""Istanbul University-Cerrahpasa, Institute of Graduates Studies, Physiotherapy and Rehabilitation Master's Program, Istanbul, Turkey.""}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Seyit', 'Affiliation': 'University of Health Sciences, Faculty of Medicine, Bakirkoy Dr. Sadi Konuk Health Practice & Research Center, Department of General Surgery, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Karabulut', 'Affiliation': 'University of Health Sciences, Faculty of Medicine, Bakirkoy Dr. Sadi Konuk Health Practice & Research Center, Department of General Surgery, Istanbul, Turkey.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101342']
334,33684598,Motor cortex transcranial direct current stimulation effects on knee osteoarthritis pain in elderly subjects with dysfunctional descending pain inhibitory system: A randomized controlled trial.,"BACKGROUND


Although evidence has indicated a positive effect of transcranial direct current stimulation (tDCS) on reducing pain, few studies have focused on the elderly population with knee osteoarthritis (KOA).
OBJECTIVE


To evaluate whether tDCS reduces KOA pain in elderly individuals with a dysfunctional descending pain inhibitory system (DPIS).
METHODS


In a double-blind trial, individuals ≥ 60 years with KOA pain and a dysfunctional DPIS, we randomly assigned patients to receive 15 daily sessions of 2 mA tDCS over the primary motor cortex (anode) and contralateral supraorbital area (cathode) (M1-SO) for 20 min or sham tDCS. Change in pain perception indexed by the Brief Pain Inventory (BPI) at the end of intervention was the primary outcome. Secondary outcomes included: disability, quantitative sensory testing, pain pressure threshold and conditioned pain modulation (CPM). Subjects were followed-up for 2 months.
RESULTS


Of the 104 enrolled subjects, with mean (SD) age of 73.9 (8.01) years and 88 (84.6%) female, 102 finished the trial. In the intention-to-treat analysis, the active tDCS group had a significantly greater reduction in BPI compared to the sham group (difference, 1.59; 95% CI, 0.95 to 2.23; P < 0.001; Cohen's d, 0.58); and, also a significantly greater improvement in CPM-pressure in the knee (P = 0.01) and CPM-pain in the hand (P = 0.01). These effects were not sustained at follow-up. The intervention was well tolerated, with no severe adverse effects.
CONCLUSION


M1-SO tDCS is associated with a moderate effect size in reducing pain in elderly patients with KOA after 15 daily sessions of stimulation. This intervention has also shown to modulate the DPIS.",2021,M1-SO tDCS is associated with a moderate effect size in reducing pain in elderly patients with KOA after 15 daily sessions of stimulation.,"['104 enrolled subjects, with mean(SD) age of 73.9(8.01) years and 88(84.6%) female, 102 finished the trial', 'elderly patients with KOA', 'elderly individuals with a dysfunctional descending pain inhibitory system (DPIS', 'Elderly Subjects with Dysfunctional Descending Pain Inhibitory System', 'individuals ≥ 60 years with KOA pain and a dysfunctional DPIS', 'elderly population with knee osteoarthritis (KOA']","['tDCS', 'M1-SO tDCS', 'Motor Cortex Transcranial Direct Current Stimulation', '15 daily sessions of 2mA tDCS over the primary motor cortex (anode) and contralateral supraorbital area (cathode) (M1-SO) for 20 min or sham tDCS', 'transcranial direct current stimulation (tDCS']","['Knee Osteoarthritis Pain', 'pain perception indexed by the Brief Pain Inventory (BPI', 'CPM-pain', 'CPM-pressure', 'KOA pain', 'disability, quantitative sensory testing, pain pressure threshold and conditioned pain modulation (CPM', 'BPI']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0230002', 'cui_str': 'Supraorbital area structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",104.0,0.362551,M1-SO tDCS is associated with a moderate effect size in reducing pain in elderly patients with KOA after 15 daily sessions of stimulation.,"[{'ForeName': 'Daniela Regina Brandão', 'Initials': 'DRB', 'LastName': 'Tavares', 'Affiliation': 'Departament of Geriatrics and Gerontology, Federal University of São Paulo, São Paulo, SP, Brazil; Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: daniela74_tavares@hotmail.com.'}, {'ForeName': 'Jane Erika Frazao', 'Initials': 'JEF', 'LastName': 'Okazaki', 'Affiliation': 'Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: erikafrazao@gmail.com.'}, {'ForeName': 'Marcia Valéria de Andrade', 'Initials': 'MVA', 'LastName': 'Santana', 'Affiliation': 'Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: lella-andrade@hotmail.com.'}, {'ForeName': 'Ana Carolina Pereira Nunes', 'Initials': 'ACPN', 'LastName': 'Pinto', 'Affiliation': 'Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil; Department of Physical Therapy, University of Pittsburgh, Fullbright Program, USA. Electronic address: anacarolinapnp@hotmail.com.'}, {'ForeName': 'Karina Kuraoka', 'Initials': 'KK', 'LastName': 'Tutiya', 'Affiliation': 'Departament of Geriatrics and Gerontology, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: karina.tutiya@hotmail.com.'}, {'ForeName': 'Fernanda Martins', 'Initials': 'FM', 'LastName': 'Gazoni', 'Affiliation': 'Departament of Geriatrics and Gerontology, Federal University of São Paulo, São Paulo, SP, Brazil; Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil. Electronic address: fmgazoni@hotmail.com.'}, {'ForeName': 'Camila Bonin', 'Initials': 'CB', 'LastName': 'Pinto', 'Affiliation': 'Laboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: cboninpinto@gmail.com.'}, {'ForeName': 'Fania Cristina', 'Initials': 'FC', 'LastName': 'Santos', 'Affiliation': 'Departament of Geriatrics and Gerontology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Laboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: fregni.felipe@mgh.harvard.edu.'}, {'ForeName': 'Virginia Fernandes Moça', 'Initials': 'VFM', 'LastName': 'Trevisani', 'Affiliation': 'Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, São Paulo, SP, Brazil; Department of Rheumatology, Santo Amaro University, São Paulo, SP, Brazil. Electronic address: vmoca@uol.com.br.'}]",Brain stimulation,['10.1016/j.brs.2021.02.018']
335,32645160,Characteristics of REPRIEVE Trial Participants Identifying Across the Transgender Spectrum.,"Because persons who identify across the transgender spectrum (PATS) are a key population in human immunodeficiency virus (HIV) yet are underreported in HIV and cardiovascular research, we aimed to characterize this population within the REPRIEVE global clinical trial (n = 7770). Acceptance of gathering gender identity was high (96%). Participation by PATS was 1.7% overall, 2.4% among natal males, 0.3% among natal females, and varied across geographic regions (from 0% in sub-Saharan Africa to 2.3% in High Income Region). Thirty percent of natal male PATS identified other than transgender. Some characteristics differed by gender. Most notably, 38% of natal male PATS receiving gender-affirming treatment had waist circumference >102 cm (compared with ≤25% in other groups). Given that PATS is a key population, HIV research should routinely report trial participation and outcomes by gender in addition to natal sex, to provide the results needed to optimize medical care to PATS.",2020,"Participation by PATS was 1.7% overall, 2.4% among natal males, 0.3% among natal females, and varied across geographic regions (from 0% in sub-Saharan Africa to 2.3% in High Income Region).",['Trial Participants Identifying Across the Transgender Spectrum'],['PATS'],[],"[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}]",[],7770.0,0.0557971,"Participation by PATS was 1.7% overall, 2.4% among natal males, 0.3% among natal females, and varied across geographic regions (from 0% in sub-Saharan Africa to 2.3% in High Income Region).","[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Smeaton', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Kileel', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'Fundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas (INI/Fiocruz), Rio de Janeiro, Brazil.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Gardner', 'Affiliation': 'Denver Public Health, Denver, Colorado, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Starr', 'Affiliation': 'The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Murry', 'Affiliation': 'Houston Cross Network Community Advisory Board, Houston, Texas, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Alston-Smith', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Myron A', 'Initials': 'MA', 'LastName': 'Waclawiw', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Cooper-Arnold', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'José V', 'Initials': 'JV', 'LastName': 'Madruga', 'Affiliation': 'Centro de Referencia e Treinamento DST/AIDS, São Paulo, Brazil.'}, {'ForeName': 'Shashi', 'Initials': 'S', 'LastName': 'Sangle', 'Affiliation': 'Department of Medicine, BJ Medical College, Pune, India.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Karin L', 'Initials': 'KL', 'LastName': 'Klingman', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa213']
336,33677430,The effect of peer support approach on communication skills of nursing students in pediatric clinical setting.,"Peer support is a valuable teaching-learning approach to enhance deep learning in the clinical environment. The purpose of the present study was to investigate the effect of peer support on the communication skills of undergraduate nursing students when interacting with hospitalized children and their parents. This was a pre-and post-test quasi-experimental study with two groups. Through the cluster random sampling method, six practical groups of students who undertook a 3-week pediatric practicum were selected. Three groups were allocated to the experimental (n = 51) and control groups (n = 52). Two volunteer post-graduate students in pediatric nursing formed the peer group. First, the peers participated in three 45-min sessions using different scenarios about communication skills. They then tutored the intervention group to improve their communication skills. The communication skills with 5 children and 5 parents were observed for each undergraduate student via the checklist. The experimental group demonstrated significantly higher mean scores of the communication skills than the control groups in post-test (P < 0.001). Moreover, the mean scores of communication skills was significantly higher in post-test than pre-test in both the experimental and control groups (p < 0.001). Peer support approach promoted the communication skills of undergraduate nursing students in pediatric clinical setting.",2021,The experimental group demonstrated significantly higher mean scores of the communication skills than the control groups in post-test (P < 0.001).,"['undergraduate nursing students when interacting with hospitalized children and their parents', 'Two volunteer post-graduate students in pediatric nursing formed the peer group', 'nursing students in pediatric clinical setting', 'undergraduate nursing students in pediatric clinical setting']","['peer support approach', 'peer support']","['mean scores of communication skills', 'mean scores of the communication skills']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030753', 'cui_str': 'Nursing, Pediatric'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",5.0,0.0185718,The experimental group demonstrated significantly higher mean scores of the communication skills than the control groups in post-test (P < 0.001).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Cheraghi', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: f_cheraghi@yahoo.com.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Hooshangian', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Doosti-Irani', 'Affiliation': 'Department of Epidemiology, School of Public Health and Research Center for Health Sciences, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Khalili', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: arash5920@yahoo.com.'}]",Nurse education in practice,['10.1016/j.nepr.2021.102984']
337,33677425,Comparison of the TetraGraph and TOFscan for monitoring recovery from neuromuscular blockade in the Post Anesthesia Care Unit.,"STUDY OBJECTIVE


Comparison of the TetraGraph (TG) and TOFscan (TS) for monitoring recovery from neuromuscular blockade in the Post Anesthesia Care Unit (PACU).
DESIGN


Randomized, multicenter trial.
SETTING


PACU in three tertiary care hospitals.
PATIENTS


120 patients (40 per site) receiving neuromuscular blockade during elective surgery.
INTERVENTIONS


Patients were enrolled preoperatively and intraoperative neuromuscular blockade management was at the discretion of the anesthesiologist. Upon arrival to the PACU, patients were randomized to have either TG or TS placed on their dominant hand. The alternate device (TS or TG) was placed on the non-dominant hand. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis was measured.
MEASUREMENTS


Train-of-four ratios (TOFRs) were obtained upon arrival to the PACU (t = 0), after 5 min (t = + 5) and after +10 min (t = + 10).
MAIN RESULTS


There was there was no significant difference in the mean TOFRs obtained with the TG and TS at t = 0 (0.97 ± 0.18 vs 0.94 ± 0.13, P = 0.06, respectively) and t = + 5 (0.96 ± 0.20 vs 0.95 ± 0.12, P = 0.29, respectively). At (t = + 10), there was a statistically significant difference in mean TOFRs obtained with the TG and TS, (0.99 ± 0.14 vs 0.94 ± 0.12, P < 0.001, respectively). The bias between devices at t = 0 was estimated to be 0.03 (95% CI, -0.29 to 0.35, P = 0.26); at t = + 5 min, it was estimated to be 0.02 (95% CI, -0.36 to 0.40, P = 0.54); and at t = +10 min, it was estimated to be 0.05 (95% CI, -0.25 to 0.36, P = 0.77).
CONCLUSIONS


TS and TG provide interchangeable quantitative measurements once the TOF ratio has returned to a value of 0.90 or greater in the PACU.",2021,There was there was no significant difference in the mean TOFRs obtained with the TG and TS at t = 0,"['120 patients (40 per site) receiving neuromuscular blockade during elective surgery', 'PACU in three tertiary care hospitals']","['TetraGraph (TG) and TOFscan (TS', 'alternate device (TS or TG', 'TetraGraph and TOFscan']","['Train-of-four ratios (TOFRs', 'mean TOFRs', 'TOF ratio']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0428698', 'cui_str': 'Train of four ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",120.0,0.319183,There was there was no significant difference in the mean TOFRs obtained with the TG and TS at t = 0,"[{'ForeName': 'J Ross', 'Initials': 'JR', 'LastName': 'Renew', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Jacksonville, FL, USA. Electronic address: renew.j@mayo.edu.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Hernandez-Torres', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Logvinov', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Reka', 'Initials': 'R', 'LastName': 'Nemes', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Nagy', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Liah', 'Initials': 'L', 'LastName': 'Watt', 'Affiliation': 'Department of Anesthesiology, NorthShore University Health System, University of Chicago, Pritzker School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Murphy', 'Affiliation': 'Department of Anesthesiology, NorthShore University Health System, University of Chicago, Pritzker School of Medicine, Chicago, IL, USA.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110234']
338,33677411,A randomized pilot trial of oral prednisone taper vs placebo following iv methylprednisolone for multiple sclerosis relapses: Effects on adrenal function and clinical efficacy.,"We performed a pilot trial investigating the effect of a steroid taper on adrenal function and safety measures after acute MS relapses. Twenty-five patients were randomized to either prednisone taper (n=12) or placebo (n=13) after 3 days of intravenous methylprednisolone. No patient showed signs of adrenal insufficiency at any time by cortisol response to ACTH. This significantly increased between baseline and 6 months in both groups. Patients remained clinically and radiologically stable, but those under prednisone taper experienced more frequently mood disorders, hyperglycaemia and weight increase. If confirmed by sufficiently powered studies, these results would question the need of a steroid taper following short-term intravenous methylprednisolone.",2021,"Patients remained clinically and radiologically stable, but those under prednisone taper experienced more frequently mood disorders, hyperglycaemia and weight increase.","['multiple sclerosis relapses', 'Twenty-five patients']","['steroid taper', 'prednisone taper', 'placebo', 'oral prednisone taper vs placebo', 'methylprednisolone']","['mood disorders, hyperglycaemia and weight increase', 'signs of adrenal insufficiency', 'adrenal function and safety measures', 'adrenal function and clinical efficacy']","[{'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",25.0,0.0465453,"Patients remained clinically and radiologically stable, but those under prednisone taper experienced more frequently mood disorders, hyperglycaemia and weight increase.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Zecca', 'Affiliation': 'Multiple sclerosis Center, Department of Neurology, Neurocenter of Southern Switzerland, Ospedale regionale di Lugano, Lugano, Switzerland; Faculty of biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Disanto', 'Affiliation': 'Multiple sclerosis Center, Department of Neurology, Neurocenter of Southern Switzerland, Ospedale regionale di Lugano, Lugano, Switzerland.'}, {'ForeName': 'Gianna C', 'Initials': 'GC', 'LastName': 'Riccitelli', 'Affiliation': 'Multiple sclerosis Center, Department of Neurology, Neurocenter of Southern Switzerland, Ospedale regionale di Lugano, Lugano, Switzerland.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Candrian', 'Affiliation': 'Multiple sclerosis Center, Department of Neurology, Neurocenter of Southern Switzerland, Ospedale regionale di Lugano, Lugano, Switzerland.'}, {'ForeName': 'Maurilio', 'Initials': 'M', 'LastName': 'Deandrea', 'Affiliation': 'Endocrinology, Diabetes and Metabolism Unit, A.O. Ordine Mauriziano, Torino, Italy.'}, {'ForeName': 'Paolo Piero', 'Initials': 'PP', 'LastName': 'Limone', 'Affiliation': 'Endocrinology, Diabetes and Metabolism Unit, A.O. Ordine Mauriziano, Torino, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Sacco', 'Affiliation': 'Multiple sclerosis Center, Department of Neurology, Neurocenter of Southern Switzerland, Ospedale regionale di Lugano, Lugano, Switzerland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gobbi', 'Affiliation': 'Multiple sclerosis Center, Department of Neurology, Neurocenter of Southern Switzerland, Ospedale regionale di Lugano, Lugano, Switzerland; Faculty of biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland. Electronic address: claudio.gobbi@eoc.ch.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102867']
339,33683334,Effect of a Compassion Cultivation Training Program for Caregivers of People With Mental Illness in Denmark: A Randomized Clinical Trial.,"Importance


Caregivers of people with mental illness are at increased risk of developing depression, anxiety, and stress.
Objective


To investigate the effect of a compassion cultivation training (CCT) program on decreasing caregiver psychological distress.
Design, Setting, and Participants


This waitlist-controlled randomized clinical trial was conducted in 2 different community settings in Denmark. Caregivers were excluded if they had a diagnosed and untreated mental illness, addiction, meditation practice, or current psychotherapeutic treatment. Enrollment occurred between May 2018 and March 2019. A repeated measurement model was used to examine the impact of the intervention. The primary analysis was based on the intention-to-treat principle. Data analysis was conducted from June 4 to July 7, 2020.
Interventions


Participants were randomized 1-to-1 to an 8-week CCT course or waitlist control. Block randomization was used with 40 participants in each block.
Main Outcomes and Measures


The main outcome was reduction in psychological distress, as measured by the Depression, Anxiety, Stress Scale (DASS). Baseline, postintervention, and 3- and 6-month follow-up measurements were collected.
Results


Among 192 participants assessed for eligibility, 161 participants were included in the study (mean [SD] age, 52.6 [12.5] years; 142 [88.2%] women), with 79 participants randomized to the CCT intervention and 82 participants in the waitlist control group. At baseline, the mean (SD) DASS scores for the intervention vs control groups were 10.89 (8.66) vs 10.80 (8.38) for depression, 6.89 (6.48) vs 6.68 (5.33) for anxiety, and 14.96 (7.90) vs 15.77 (7.40) for stress. The CCT group experienced statistically significant improvement in the primary outcome in mean change from baseline vs the control group at postintervention (adjusted mean difference: depression, -4.16 [95% CI, -6.75 to -1.58]; P = .002; anxiety, -2.24 [95% CI, -3.99 to -0.48]; P = .01; stress, -4.20 [95% CI, -6.73 to -1.67]; P = .001), the 3-month follow-up (adjusted mean difference: depression, -3.78 [95% CI, -6.40 to -1.17]; P = .005; anxiety, -2.50 [95% CI, -4.27 to -0.73]; P = .006; stress, -3.76 [95% CI, -6.32 to -1.21]; P = .004), and the 6-month follow-up (adjusted mean difference: depression: -4.24 [95% CI, -6.97 to -1.52]; P = .002; anxiety, -2.12 [95% CI, -3.96 to -0.29]; P = .02; stress: -3.79 [95% CI, -6.44 to -1.13]; P = .005).
Conclusions and Relevance


These findings suggest that CCT was superior to the waitlist control in supporting caregivers' mental health. Statistically and clinically significant reductions in psychological distress were found and sustained at the 6-month follow-up. The improvements noted in this randomized clinical trial could serve to encourage implementation of future evidence-based programs for caregivers.
Trial Registration


ClinicalTrials.gov Identifier: NCT03730155.",2021,"The CCT group experienced statistically significant improvement in the primary outcome in mean change from baseline vs the control group at postintervention (adjusted mean difference: depression, -4.16 [95% CI, -6.75 to -1.58]; P = .002; anxiety, -2.24","['Importance\n\n\nCaregivers of people with mental illness', '2 different community settings in Denmark', 'Caregivers of People With Mental Illness in Denmark', '192 participants assessed for eligibility, 161 participants were included in the study (mean [SD] age, 52.6 [12.5] years; 142 [88.2%] women), with 79 participants randomized to the', '40 participants in each block', 'Caregivers were excluded if they had a diagnosed and untreated mental illness, addiction, meditation practice, or current psychotherapeutic treatment', 'and 82 participants in the waitlist control group']","['compassion cultivation training (CCT) program', 'CCT', 'Compassion Cultivation Training Program', 'CCT course or waitlist control', 'CCT intervention']","['psychological distress, as measured by the Depression, Anxiety, Stress Scale (DASS', 'mean (SD) DASS scores', 'psychological distress']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",161.0,0.28082,"The CCT group experienced statistically significant improvement in the primary outcome in mean change from baseline vs the control group at postintervention (adjusted mean difference: depression, -4.16 [95% CI, -6.75 to -1.58]; P = .002; anxiety, -2.24","[{'ForeName': 'Nanja Holland', 'Initials': 'NH', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Juul', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Karen-Johanne', 'Initials': 'KJ', 'LastName': 'Pallesen', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lone Overby', 'Initials': 'LO', 'LastName': 'Fjorback', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Aarhus, Denmark.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.1020']
340,33683313,Association of Intensive vs Standard Blood Pressure Control With Magnetic Resonance Imaging Biomarkers of Alzheimer Disease: Secondary Analysis of the SPRINT MIND Randomized Trial.,"Importance


Meta-analyses of randomized clinical trials have indicated that improved hypertension control reduces the risk for cognitive impairment and dementia. However, it is unclear to what extent pathways reflective of Alzheimer disease (AD) pathology are affected by hypertension control.
Objective


To evaluate the association of intensive blood pressure control on AD-related brain biomarkers.
Design, Setting, and Participants


This is a substudy of the Systolic Blood Pressure Intervention Trial (SPRINT MIND), a multicenter randomized clinical trial that compared the efficacy of 2 different blood pressure-lowering strategies. Potential participants (n = 1267) 50 years or older with hypertension and without a history of diabetes or stroke were approached for a brain magnetic resonance imaging (MRI) study. Of these, 205 participants were deemed ineligible and 269 did not agree to participate; 673 and 454 participants completed brain MRI at baseline and at 4-year follow-up, respectively; the final follow-up date was July 1, 2016. Analysis began September 2019 and ended November 2020.
Interventions


Participants were randomized to either a systolic blood pressure goal of less than 120 mm Hg (intensive treatment: n = 356) or less than 140 mm Hg (standard treatment: n = 317).
Main Outcomes and Measures


Changes in hippocampal volume, measures of AD regional atrophy, posterior cingulate cerebral blood flow, and mean fractional anisotropy in the cingulum bundle.
Results


Among 673 recruited patients who had baseline MRI (mean [SD] age, 67.3 [8.2] years; 271 women [40.3%]), 454 completed the follow-up MRI at a median (interquartile range) of 3.98 (3.7-4.1) years after randomization. In the intensive treatment group, mean hippocampal volume decreased from 7.45 cm3 to 7.39 cm3 (difference, -0.06 cm3; 95% CI, -0.08 to -0.04) vs a decrease from 7.48 cm3 to 7.46 cm3 (difference, -0.02 cm3; 95% CI, -0.05 to -0.003) in the standard treatment group (between-group difference in change, -0.033 cm3; 95% CI, -0.062 to -0.003; P = .03). There were no significant treatment group differences for measures of AD regional atrophy, cerebral blood flow, or mean fractional anisotropy.
Conclusions and Relevance


Intensive treatment was associated with a small but statistically significant greater decrease in hippocampal volume compared with standard treatment, consistent with the observation that intensive treatment is associated with greater decreases in total brain volume. However, intensive treatment was not associated with changes in any of the other MRI biomarkers of AD compared with standard treatment.
Trial Registration


ClinicalTrials.gov Identifier: NCT01206062.",2021,"Conclusions and Relevance


Intensive treatment was associated with a small but statistically significant greater decrease in hippocampal volume compared with standard treatment, consistent with the observation that intensive treatment is associated with greater decreases in total brain volume.","['205 participants were deemed ineligible and 269 did not agree to participate; 673 and 454 participants completed brain MRI at baseline and at 4-year follow-up, respectively; the final follow-up date was July 1, 2016', 'Potential participants (n\u2009=\u20091267) 50 years or older with hypertension and without a history of diabetes or stroke were approached for a brain magnetic resonance imaging (MRI) study', 'Alzheimer Disease', '673 recruited patients who had baseline MRI (mean [SD] age, 67.3 [8.2] years; 271 women [40.3']","['systolic blood pressure goal of less than 120 mm Hg (intensive treatment: n\u2009=\u2009356) or less than 140 mm Hg (standard treatment: n\u2009=\u2009317', 'Intensive vs Standard Blood Pressure Control']","['hippocampal volume', 'AD regional atrophy, cerebral blood flow, or mean fractional anisotropy', 'mean hippocampal volume', 'total brain volume', 'hippocampal volume, measures of AD regional atrophy, posterior cingulate cerebral blood flow, and mean fractional anisotropy in the cingulum bundle']","[{'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0228272', 'cui_str': 'Structure of cerebral cingulum'}]",673.0,0.203243,"Conclusions and Relevance


Intensive treatment was associated with a small but statistically significant greater decrease in hippocampal volume compared with standard treatment, consistent with the observation that intensive treatment is associated with greater decreases in total brain volume.","[{'ForeName': 'Ilya M', 'Initials': 'IM', 'LastName': 'Nasrallah', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Pomponio', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Sudipto', 'Initials': 'S', 'LastName': 'Dolui', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Guray', 'Initials': 'G', 'LastName': 'Erus', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Clinton B', 'Initials': 'CB', 'LastName': 'Wright', 'Affiliation': 'Intramural Stroke Branch, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland.'}, {'ForeName': 'Lenore J', 'Initials': 'LJ', 'LastName': 'Launer', 'Affiliation': 'Intramural Research Program, National Institute on Aging, Baltimore, Maryland.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Detre', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wolk', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Davatzikos', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Section of Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'R Nick', 'Initials': 'RN', 'LastName': 'Bryan', 'Affiliation': 'Department of Diagnostic Medicine, Dell Medical School, University of Texas at Austin, Austin.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2021.0178']
341,33684595,Continuous infusion versus intermittent administration of meropenem in critically ill patients (MERCY): A multicenter randomized double-blind trial. Rationale and design.,"OBJECTIVE


Meropenem is a β-lactam, carbapenem antibacterial agent with antimicrobial activity against gram-negative, gram-positive and anaerobic micro-organisms and is important in the empirical treatment of serious infections in Intensive Care Unit (ICU) patients. Multi-drug resistant gram-negative organisms, coupled with scarcity of new antibiotic classes, forced healthcare community to optimize the therapeutic potential of available antibiotics. Our aim is to investigate the effect of continuous infusion of meropenem against bolus administration, as indicated by a composite outcome of reducing death and emergence of extensive or pan drug-resistant pathogens in a population of ICU patients.
DESIGN


Double blind, double dummy, multicenter randomized controlled trial (1:1 allocation ratio).
SETTING


Tertiary and University hospitals.
INTERVENTIONS


600 ICU patients with sepsis or septic shock, needing by clinical judgment antibiotic therapy with meropenem, will be randomized to receive a continuous infusion of meropenem 3 g/24 h or an equal dose divided into three daily boluses (i.e. 1g q8h).
MEASUREMENTS


The primary endpoint will be a composite outcome of reducing death and emergence of extensive or pan drug-resistant pathogens. Secondary endpoints will be death from any cause at day 90, antibiotic-free days at day 28, ICU-free days at day 28, cumulative SOFA-free (Sequential Organ Failure Assessment) score from randomization to day 28 and the two, separate, components of the primary endpoint. We expect a primary outcome reduction from 52 to 40% in the continuous infusion group.
CONCLUSIONS


The trial will provide evidence for choosing intermittent or continuous infusion of meropenem for critically ill patients with multi-drug resistant gram-negative infections.",2021,"Secondary endpoints will be death from any cause at day 90, antibiotic-free days at day 28, ICU-free days at day 28, cumulative SOFA-free (Sequential Organ Failure Assessment) score from randomization to day 28 and the two, separate, components of the primary endpoint.","['critically ill patients with multi-drug resistant gram-negative infections', 'a population of ICU patients', 'Intensive Care Unit (ICU) patients', 'critically ill patients (MERCY', '600 ICU patients with sepsis or septic shock, needing by clinical judgment antibiotic therapy with', 'Tertiary and University hospitals']","['meropenem', 'Meropenem']","['composite outcome of reducing death and emergence of extensive or pan drug-resistant pathogens', 'death and emergence of extensive or pan drug-resistant pathogens', 'death from any cause at day 90, antibiotic-free days at day 28, ICU-free days at day 28, cumulative SOFA-free (Sequential Organ Failure Assessment) score']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0066005', 'cui_str': 'meropenem'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",600.0,0.746191,"Secondary endpoints will be death from any cause at day 90, antibiotic-free days at day 28, ICU-free days at day 28, cumulative SOFA-free (Sequential Organ Failure Assessment) score from randomization to day 28 and the two, separate, components of the primary endpoint.","[{'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Monti', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: landoni.giovanni@hsr.it.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Galbiati', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Toffoletto', 'Affiliation': 'Azienda ULSS 4 Veneto Orientale, San Donà di Piave (VE), Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Calabrò', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Colombo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ferrara', 'Affiliation': 'Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giardina', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Lembo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Marzaroli', 'Affiliation': 'Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Moizo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Mucci', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Pasculli', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Valentina Paola', 'Initials': 'VP', 'LastName': 'Plumari', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Anna Mara', 'Initials': 'AM', 'LastName': 'Scandroglio', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Tozzi', 'Affiliation': 'Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Momesso', 'Affiliation': 'Azienda ULSS 4 Veneto Orientale, San Donà di Piave (VE), Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Boffa', 'Affiliation': 'Azienda ULSS 4 Veneto Orientale, San Donà di Piave (VE), Italy.'}, {'ForeName': 'Rosetta', 'Initials': 'R', 'LastName': 'Lobreglio', 'Affiliation': ""'Città della Salute e della Scienza' Hospital - Turin - Italy.""}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Montrucchio', 'Affiliation': ""'Città della Salute e della Scienza' Hospital - Turin - Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Guarracino', 'Affiliation': 'Azienda Ospedaliero - Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Biondi-Zoccai', 'Affiliation': 'Sapienza University of Rome, Latina, Italy; Mediterranea Cardiocentro, Napoli, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': ""D'Ascenzo"", 'Affiliation': ""'Città della Salute e della Scienza' Hospital - Turin - Italy.""}, {'ForeName': 'Natascia', 'Initials': 'N', 'LastName': ""D'Andrea"", 'Affiliation': 'Università degli Studi di Udine, Udine, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Paternoster', 'Affiliation': 'Azienda Ospedaliera Regionale ""San Carlo"", Potenza, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Ananiadou', 'Affiliation': 'ASST Cremona - Presidio Ospedaliero di Cremona, Cremona, Italy.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Ballestra', 'Affiliation': 'Ente Ospedaliero Ospedali Galliera, Genova, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'De Sio', 'Affiliation': 'Pineta Grande Hospital, Castel Volturno (CE), Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Pota', 'Affiliation': 'Università degli Studi della Campania Luigi Vanvitelli, Napoli, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Cotoia', 'Affiliation': 'University Hospital O.O.R.R. Foggia, Foggia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Della Selva', 'Affiliation': 'Azienda Sanitaria Locale CN2 Alba - Bra, Alba (CN), Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruni', 'Affiliation': 'Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Iapichino', 'Affiliation': 'IRCCS Humanitas Clinical and Research Center, Rozzano (MI), Italy.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Bradić', 'Affiliation': 'University Hospital Dubrava, Zagreb, Croatia.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Corradi', 'Affiliation': 'Azienda Ospedaliero - Universitaria Pisana, Pisa, Italy; Ente Ospedaliero Ospedali Galliera, Genova, Italy; Università di Pisa, Pisa, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Gemma', 'Affiliation': 'ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico, Milan, Italy.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Nogtev', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Petrova', 'Affiliation': 'Federal Research and Clinical Center of Resuscitation and Rehabilitation, Moscow, Russia.'}, {'ForeName': 'Felice Eugenio', 'Initials': 'FE', 'LastName': 'Agrò', 'Affiliation': 'Campus Bio Medico University and Teaching Hospital, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cabrini', 'Affiliation': ""ASST dei Sette Laghi - Ospedale di Circolo e Fondazione Macchi di Varese, Varese, Italy; Università degli Studi dell'Insubria, Varese, Italy.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Forfori', 'Affiliation': 'Azienda Ospedaliero - Universitaria Pisana, Pisa, Italy; Università di Pisa, Pisa, Italy.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Likhvantsev', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia; Federal Research and Clinical Center of Resuscitation and Rehabilitation, Moscow, Russia.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Bove', 'Affiliation': 'Università degli Studi di Udine, Udine, Italy; Azienda Sanitaria Universitaria Friuli Centrale - Presidio Ospedaliero Universitario Santa Maria della Misericordia, Udine, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Finco', 'Affiliation': 'Università degli Studi di Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zangrillo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2021.106346']
342,33684596,Predicting deseasonalised serum 25 hydroxy vitamin D concentrations in the D-Health Trial: An analysis using boosted regression trees.,"BACKGROUND


The D-Health Trial aims to determine whether monthly high-dose vitamin D supplementation can reduce the mortality rate and prevent cancer. We did not have adequate statistical power for subgroup analyses, so could not justify the high cost of collecting blood samples at baseline. To enable future exploratory analyses stratified by baseline vitamin D status, we developed models to predict baseline serum 25 hydroxy vitamin D [25(OH)D] concentration.
METHODS


We used data and serum 25(OH)D concentrations from participants who gave a blood sample during the trial for compliance monitoring and were randomised to placebo. Data were partitioned into training (80%) and validation (20%) datasets. Deseasonalised serum 25(OH)D concentrations were dichotomised using cut-points of 50, 60 and 75 nmol/L. We fitted boosted regression tree models, based on 13 predictors, and evaluated model performance using the validation data.
RESULTS


The training and validation datasets had 1788 (10.5% <50 nmol/L, 23.1% <60 nmol, 48.8 <75 nmol/L) and 447 (11.9% <50 nmol/L, 25.7% <60 nmol/L, and 49.2% <75 nmol/L) samples, respectively. Ambient UV radiation and total intake of vitamin D were the strongest predictors of 'low' serum 25(OH)D concentration. The area under the receiver operating characteristic curves were 0.71, 0.70, and 0.66 for cut-points of <50, <60 and <75 nmol/L respectively.
CONCLUSIONS


We exploited compliance monitoring data to develop models to predict serum 25(OH)D concentration for D-Health participants at baseline. This approach may prove useful in other trial settings where there is an obstacle to exhaustive data collection.",2021,Ambient UV radiation and total intake of vitamin D were the strongest predictors of 'low' serum 25(OH)D concentration.,['participants who gave a blood sample during the trial for compliance monitoring'],"['vitamin D supplementation', 'placebo']","['mortality rate and prevent cancer', 'Deseasonalised serum 25(OH)D concentrations', 'Ambient UV radiation and total intake of vitamin D']","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041625', 'cui_str': 'Ultraviolet radiation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",,0.180473,Ambient UV radiation and total intake of vitamin D were the strongest predictors of 'low' serum 25(OH)D concentration.,"[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Waterhouse', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: mary.waterhouse@qimrberghofer.edu.au.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Baxter', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: Catherine.Baxter@qimrberghofer.edu.au.'}, {'ForeName': 'Briony', 'Initials': 'B', 'LastName': 'Duarte Romero', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: Briony.DuarteRomero@qimrberghofer.edu.au.'}, {'ForeName': 'Donald S A', 'Initials': 'DSA', 'LastName': 'McLeod', 'Affiliation': ""Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; Department of Endocrinology and Diabetes, Royal Brisbane and Women's Hospital, Brisbane, Australia. Electronic address: Donald.McLeod@qimrberghofer.edu.au.""}, {'ForeName': 'Dallas R', 'Initials': 'DR', 'LastName': 'English', 'Affiliation': 'Melbourne School of Population Health, University of Melbourne, Melbourne, Australia; Cancer Epidemiology and Intelligence Division, Cancer Council Victoria, Melbourne, Australia. Electronic address: d.english@unimelb.edu.au.'}, {'ForeName': 'Bruce K', 'Initials': 'BK', 'LastName': 'Armstrong', 'Affiliation': 'School of Public Health, University of Sydney, Sydney, Australia. Electronic address: bruce@brucekarmstrong.org.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Clarke', 'Affiliation': 'Metabolomics Australia, Centre for Microscopy, Characterisation and Analysis, The University of Western Australia, Perth, Australia. Electronic address: michael.clarke@uwa.edu.au.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ebeling', 'Affiliation': 'Department of Medicine, School of Clinical Sciences, Monash University, Melbourne, Australia. Electronic address: peter.ebeling@monash.edu.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Hartel', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: Gunter.Hartel@qimrberghofer.edu.au.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Kimlin', 'Affiliation': 'Queensland University of Technology (QUT), School of Biomedical Sciences, Faculty of Health, Brisbane, Australia. Electronic address: m.kimlin@qut.edu.au.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': ""O'Connell"", 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia. Electronic address: rachel.oconnell@ctc.usyd.edu.au.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Pham', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; School of Public Health, The University of Queensland, Brisbane, Australia. Electronic address: Hai.Pham@qimrberghofer.edu.au.'}, {'ForeName': 'Rachael M', 'Initials': 'RM', 'LastName': 'Rodney Harris', 'Affiliation': 'National Centre for Epidemiology and Population Health, College of Health & Medicine, The Australian National University, Canberra, Australia. Electronic address: Rachael.Rodney@anu.edu.au.'}, {'ForeName': 'Jolieke C', 'Initials': 'JC', 'LastName': 'van der Pols', 'Affiliation': 'Queensland University of Technology (QUT), School of Exercise and Nutrition Sciences, Faculty of Health, Brisbane, Australia. Electronic address: j.vanderpols@qut.edu.au.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Venn', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia. Electronic address: alison.venn@utas.edu.au.'}, {'ForeName': 'Penelope M', 'Initials': 'PM', 'LastName': 'Webb', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: Penny.Webb@qimrberghofer.edu.au.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Whiteman', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: David.Whiteman@qimrberghofer.edu.au.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Neale', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; School of Public Health, The University of Queensland, Brisbane, Australia. Electronic address: Rachel.Neale@qimrberghofer.edu.au.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106347']
343,32415792,"Low educational level of head of household, as a proxy for poverty, is associated with severe anaemia among children with sickle cell disease living in a low-resource setting: evidence from the SPRING trial.","Severe anaemia, defined as haemoglobin level < 6·0 g/dl, is an independent risk factor for death in individuals with sickle cell disease living in resource-limited settings. We conducted a cross-sectional study of 941 children with sickle cell anaemia, who had been defined as phenotype HbSS or HbSβ 0  thalassaemia, aged five to 12 years, and were screened for enrollment into a large primary stroke prevention trial in Nigeria (SPRING; NCT02560935). The main aim of the study was to determine the prevalence and risk factors for severe anaemia. We found severe anaemia to be present in 3·9% (37 of 941) of the SPRING study participants. Severe anaemia was significantly associated with the lower educational level of the head of the household (P = 0·003), as a proxy for poverty, and a greater number of children per room in the household (P = 0·004). Body mass index was not associated with severe anaemia. The etiology of severe anaemia in children living with sickle cell anaemia in Nigeria is likely to be multifactorial with an interplay between an individual's disease severity and other socio-economic factors related to poverty.",2020,"Severe anaemia was significantly associated with the lower educational level of the head of the household (P = 0·003), as a proxy for poverty, and a greater number of children per room in the household (P = 0·004).","['individuals with sickle cell disease living in resource-limited settings', 'children living with sickle cell anaemia in Nigeria', 'severe anaemia', '941 children with sickle cell anaemia, who had been defined as phenotype HbSS or HbSβ 0  thalassaemia, aged five to 12\xa0years, and were screened for enrollment into a large primary stroke prevention trial in Nigeria (SPRING; NCT02560935', 'children with sickle cell disease living in a low-resource setting']",[],"['Body mass index', 'Severe anaemia', 'severe anaemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1963096', 'cui_str': 'AE-941'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",941.0,0.151042,"Severe anaemia was significantly associated with the lower educational level of the head of the household (P = 0·003), as a proxy for poverty, and a greater number of children per room in the household (P = 0·004).","[{'ForeName': 'Halima', 'Initials': 'H', 'LastName': 'Bello-Manga', 'Affiliation': 'Department of Hematology and Blood Transfusion, Barau Dikko Teaching Hospital/Kaduna State University, Kaduna, Nigeria.'}, {'ForeName': 'Aisha A', 'Initials': 'AA', 'LastName': 'Galadanci', 'Affiliation': 'Department of Hematology and Blood Transfusion, Aminu Kano Teaching Hospital/Bayero University, Kano, Nigeria.'}, {'ForeName': 'Shehu', 'Initials': 'S', 'LastName': 'Abdullahi', 'Affiliation': 'Department of Pediatrics, Aminu Kano Teaching Hospital/Bayero University, Kano, Nigeria.'}, {'ForeName': 'Shehi', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Radiology, Aminu Kano Teaching Hospital/Bayero University, Kano, Nigeria.'}, {'ForeName': 'Binta', 'Initials': 'B', 'LastName': 'Jibir', 'Affiliation': ""Department of Pediatrics, Hasiya Bayero Children's Hospital, Kano, Nigeria.""}, {'ForeName': 'Safiya', 'Initials': 'S', 'LastName': 'Gambo', 'Affiliation': 'Department of Pediatrics, Murtala Muhammad Specialist Hospital Kano, Kano, Nigeria.'}, {'ForeName': 'Lawal', 'Initials': 'L', 'LastName': 'Haliru', 'Affiliation': 'Department of Pediatrics, Barau Dikko Teaching Hospital/Kaduna State University, Kaduna, Nigeria.'}, {'ForeName': 'Lori C', 'Initials': 'LC', 'LastName': 'Jordan', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Neurology, Vanderbilt University of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Muktar H', 'Initials': 'MH', 'LastName': 'Aliyu', 'Affiliation': 'Family Medicine/Preventive Medicine, Vanderbilt Institute for Global Health, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rodeghier', 'Affiliation': 'Rodeghier Consulting, Chicago, IL, USA.'}, {'ForeName': 'Adetola A', 'Initials': 'AA', 'LastName': 'Kassim', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Vanderbilt-Meharry Center of Excellence in Sickle Cell Disease, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'DeBaun', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology, Vanderbilt-Meharry Center of Excellence in Sickle Cell Disease, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Najibah A', 'Initials': 'NA', 'LastName': 'Galadanci', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",British journal of haematology,['10.1111/bjh.16746']
344,33704378,Safety and Efficacy of Virtual Prostatectomy With Single-Dose Radiotherapy in Patients With Intermediate-Risk Prostate Cancer: Results From the PROSINT Phase 2 Randomized Clinical Trial.,"Importance


Ultra-high single-dose radiotherapy (SDRT) represents a potential alternative to curative extreme hypofractionated stereotactic body radiotherapy (SBRT) in organ-confined prostate cancer.
Objective


To compare toxic effect profiles, prostate-specific antigen (PSA) responses, and quality-of-life end points of SDRT vs extreme hypofractionated SBRT.
Design, Setting, and Participants


The PROSINT single-institution phase 2 randomized clinical trial accrued, between September 2015 and January 2017, 30 participants with intermediate-risk prostate cancer to receive SDRT or extreme hypofractionated SBRT. Androgen deprivation therapy was not permitted. Data were analyzed from March to May 2020.
Interventions


Patients were randomized in a 1:1 ratio to receive 5 × 9 Gy SBRT (control arm) or 24 Gy SDRT (test arm).
Main Outcomes and Measures


The primary end point was toxic effects; the secondary end points were PSA response, PSA relapse-free survival, and patient-reported quality of life measured with the International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaires.
Results


A total of 30 men were randomized; median (interquartile range) age was 66.3 (61.2-69.9) and 73.6 (64.7-75.9) years for the SBRT and SDRT arms, respectively. Time to appearance and duration of acute and late toxic effects were similar in the 2 trial arms. Cumulative late actuarial urinary toxic effects did not differ for grade 1 (hazard ratio [HR], 0.41; 90% CI, 0.13-1.27) and grade 2 or greater (HR, 1.07; 90% CI, 0.21-5.57). Actuarial grade 1 late gastrointestinal (GI) toxic effects were comparable (HR, 0.37; 90% CI, 0.07-1.94) and there were no grade 2 or greater late GI toxic effects. Declines in PSA level to less than 0.5 ng/mL occurred by 36 months in both study arms. No PSA relapses occurred in favorable intermediate-risk disease, while in the unfavorable category, the actuarial 4-year PSA relapse-free survival values were 75.0% vs 64.0% (HR, 0.76; 90% CI, 0.17-3.31) for SBRT vs SDRT, respectively. The EPIC-26 median summary scores for the genitourinary and GI domains dropped transiently at 1 month and returned to pretreatment scores by 3 months in both arms. The IPSS-derived transient late urinary flare symptoms occurred at 9 to 18 months in 20% (90% CI, 3%-37%) of patients receiving SDRT.
Conclusions and Relevance


In this randomized clinical trial among patients with intermediate-risk prostate cancer, SDRT was safe and associated with low toxicity, and the tumor control and quality-of-life end points closely match the SBRT arm outcomes. Further studies are encouraged to explore indications for SDRT in the cure of prostate cancer.
Trial Registration


ClinicalTrials.gov Identifier: NCT02570919.",2021,"In this randomized clinical trial among patients with intermediate-risk prostate cancer, SDRT was safe and associated with low toxicity, and the tumor control and quality-of-life end points closely match the SBRT arm outcomes.","['Patients With Intermediate-Risk Prostate Cancer', 'Participants\n\n\nThe PROSINT single-institution phase 2 randomized clinical trial accrued, between September 2015 and January 2017, 30 participants with intermediate-risk prostate cancer to receive', 'A total of 30 men were randomized; median (interquartile range) age was 66.3 (61.2-69.9) and 73.6 (64.7-75.9) years for the SBRT and SDRT arms, respectively', 'patients with intermediate-risk prostate cancer']","['Importance\n\n\nUltra-high single-dose radiotherapy (SDRT', 'Androgen deprivation therapy', 'SDRT vs extreme hypofractionated SBRT', 'hypofractionated stereotactic body radiotherapy (SBRT', '5\u2009×\u20099 Gy SBRT (control arm) or 24 Gy SDRT', 'Virtual Prostatectomy With Single-Dose Radiotherapy', 'SDRT or extreme hypofractionated SBRT']","['EPIC-26 median summary scores for the genitourinary and GI domains', 'toxic effect profiles, prostate-specific antigen (PSA) responses, and quality-of-life', 'Cumulative late actuarial urinary toxic effects', 'PSA level', 'Safety and Efficacy', 'toxic effects', 'actuarial 4-year PSA relapse-free survival values', 'late GI toxic effects', 'Actuarial grade 1 late gastrointestinal (GI) toxic effects', 'Time to appearance and duration of acute and late toxic effects', 'PSA response, PSA relapse-free survival, and patient-reported quality of life measured with the International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaires', 'PSA relapses', 'IPSS-derived transient late urinary flare symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517833', 'cui_str': '61.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",30.0,0.371541,"In this randomized clinical trial among patients with intermediate-risk prostate cancer, SDRT was safe and associated with low toxicity, and the tumor control and quality-of-life end points closely match the SBRT arm outcomes.","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Greco', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Pares', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Pimentel', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Vasco', 'Initials': 'V', 'LastName': 'Louro', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Santiago', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Vieira', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Joep', 'Initials': 'J', 'LastName': 'Stroom', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Mateus', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Soares', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Marques', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Elda', 'Initials': 'E', 'LastName': 'Freitas', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Graça', 'Initials': 'G', 'LastName': 'Coelho', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Seixas', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lopez-Beltran', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Zvi', 'Initials': 'Z', 'LastName': 'Fuks', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}]",JAMA oncology,['10.1001/jamaoncol.2021.0039']
345,33704352,Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19.,"Importance


Control of the global COVID-19 pandemic will require the development and deployment of safe and effective vaccines.
Objective


To evaluate the immunogenicity of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in humans, including the kinetics, magnitude, and phenotype of SARS-CoV-2 spike-specific humoral and cellular immune responses.
Design, Setting, and Participants


Twenty-five participants were enrolled from July 29, 2020, to August 7, 2020, and the follow-up for this day 71 interim analysis was completed on October 3, 2020; follow-up to assess durability will continue for 2 years. This study was conducted at a single clinical site in Boston, Massachusetts, as part of a randomized, double-blind, placebo-controlled phase 1 clinical trial of Ad26.COV2.S.
Interventions


Participants were randomized to receive 1 or 2 intramuscular injections with 5 × 1010 viral particles or 1 × 1011 viral particles of Ad26.COV2.S vaccine or placebo administered on day 1 and day 57 (5 participants in each group).
Main Outcomes and Measures


Humoral immune responses included binding and neutralizing antibody responses at multiple time points following immunization. Cellular immune responses included immunospot-based and intracellular cytokine staining assays to measure T-cell responses.
Results


Twenty-five participants were randomized (median age, 42; age range, 22-52; 52% women, 44% male, 4% undifferentiated), and all completed the trial through the day 71 interim end point. Binding and neutralizing antibodies emerged rapidly by day 8 after initial immunization in 90% and 25% of vaccine recipients, respectively. By day 57, binding and neutralizing antibodies were detected in 100% of vaccine recipients after a single immunization. On day 71, the geometric mean titers of spike-specific binding antibodies were 2432 to 5729 and the geometric mean titers of neutralizing antibodies were 242 to 449 in the vaccinated groups. A variety of antibody subclasses, Fc receptor binding properties, and antiviral functions were induced. CD4+ and CD8+ T-cell responses were induced.
Conclusion and Relevance


In this phase 1 study, a single immunization with Ad26.COV2.S induced rapid binding and neutralization antibody responses as well as cellular immune responses. Two phase 3 clinical trials are currently underway to determine the efficacy of the Ad26.COV2.S vaccine.
Trial Registration


ClinicalTrials.gov Identifier: NCT04436276.",2021,"Binding and neutralizing antibodies emerged rapidly by day 8 after initial immunization in 90% and 25% of vaccine recipients, respectively.","['Participants\n\n\nTwenty-five participants were enrolled from July 29, 2020, to August 7, 2020, and the follow-up for this day 71 interim analysis was completed on October 3, 2020; follow-up', 'Twenty-five participants were randomized (median age, 42; age range, 22-52; 52% women, 44% male, 4% undifferentiated), and all completed the trial through the day 71 interim end point', 'controlled phase 1 clinical trial of Ad26.COV2.S.\nInterventions\n\n\nParticipants']","['placebo', 'intramuscular injections with 5\u2009×\u20091010 viral particles or 1\u2009×\u20091011 viral particles of Ad26.COV2.S vaccine or placebo', 'Ad26.COV2.S vaccine (Janssen/Johnson & Johnson']","['Immunogenicity', 'binding and neutralizing antibodies', 'CD4+ and CD8+ T-cell responses', 'geometric mean titers of spike-specific binding antibodies', 'geometric mean titers of neutralizing antibodies', 'Measures\n\n\nHumoral immune responses included binding and neutralizing antibody responses']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282459', 'cui_str': 'Clinical Trial, Phase 1'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0450317', 'cui_str': '1011'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",25.0,0.500399,"Binding and neutralizing antibodies emerged rapidly by day 8 after initial immunization in 90% and 25% of vaccine recipients, respectively.","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Le Gars', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Jerald', 'Initials': 'J', 'LastName': 'Sadoff', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Anne Marit', 'Initials': 'AM', 'LastName': 'de Groot', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Heerwegh', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Atyeo', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Loos', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'McMahan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Tostanoski', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jingyou', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Makda S', 'Initials': 'MS', 'LastName': 'Gebre', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Jacob-Dolan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Zhenfeng', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jinyan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Morgana', 'Initials': 'M', 'LastName': 'Souza', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Chen Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Zash', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Julg', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Ruvandhi R', 'Initials': 'RR', 'LastName': 'Nathavitharana', 'Affiliation': 'Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Roger L', 'Initials': 'RL', 'LastName': 'Shapiro', 'Affiliation': 'Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Ahmed Abdul', 'Initials': 'AA', 'LastName': 'Azim', 'Affiliation': 'Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Carolyn D', 'Initials': 'CD', 'LastName': 'Alonso', 'Affiliation': 'Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Caitlin J', 'Initials': 'CJ', 'LastName': 'Guiney', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Lauffenburger', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Struyf', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Macaya', 'Initials': 'M', 'LastName': 'Douoguih', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Van Hoof', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}]",JAMA,['10.1001/jama.2021.3645']
346,33704351,Topographical Response of Retinal Neovascularization to Aflibercept or Panretinal Photocoagulation in Proliferative Diabetic Retinopathy: Post Hoc Analysis of the CLARITY Randomized Clinical Trial.,"Importance


Eyes with proliferative diabetic retinopathy have a variable response to treatment with panretinal photocoagulation (PRP) or anti-vascular endothelial growth factor agents. The location of neovascularization (NV) is associated with outcomes (eg, patients with disc NV [NVD] have poorer visual prognosis than those with NV elsewhere [NVE]).
Objective


To investigate the distribution of NV in patients with proliferative diabetic retinopathy and the topographical response of NV to treatment with aflibercept or PRP.
Design, Setting, and Participants


This post hoc analysis of the phase 2b randomized clinical single-masked multicenter noninferiority Clinical Efficacy and Mechanistic Evaluation of Aflibercept for Proliferative Diabetic Retinopathy (CLARITY) trial was conducted from November 1, 2019, to September 1, 2020, among 120 treatment-naive patients with proliferative diabetic retinopathy to evaluate the topography of NVD and NVE in 4 quadrants of the retina on color fundus photography at baseline and at 12 and 52 weeks after treatment.
Exposures


In the CLARITY trial, patients were randomized to receive intravitreal aflibercept (2 mg/0.05 mL at baseline, 4 weeks, and 8 weeks, and as needed from 12 weeks onward) or PRP (completed in initial fractionated sessions and then on an as-needed basis when reviewed every 8 weeks).
Main Outcomes and Measures


Main outcomes were per-retinal quadrant frequencies of NV at baseline and frequencies of patterns of regression, recurrence, and new occurrence at 12-week and 52-week unmasked follow-up.
Results


The study included 120 treatment-naive patients (75 men; mean [SD] age, 54.8 [14.6] years) with proliferative diabetic retinopathy (there was a 1:1 ratio of eyes to patients). At baseline, NVD with or without NVE was observed in 42 eyes (35.0%), and NVE only was found in 78 eyes (65.0%); NVE had a predilection for the nasal quadrant (64 [53.3%]). Rates of regression with treatment were higher among eyes with NVE (89 of 102 [87.3%]) compared with eyes with NVD (23 of 43 [53.5%]) by 52 weeks, with NVD being more resistant to either treatment with higher rates of persistence than NVE (20 of 39 [51.3%] vs 29 of 100 [29.0%]). Considering NVE, the regression rate in the temporal quadrant was lowest (32 of 42 [76.2%]). Eyes treated with aflibercept showed higher rates of regression of NVE compared with those treated with PRP (50 of 52 [96.2%] vs 39 of 50 [78.0%]; difference, 18.2% [95% CI, 5.5%-30.8%]; P = .01), but no difference was found for NVD (11 of 17 [64.7%] vs 12 of 26 [46.2%]; difference, 18.6% [95% CI, -11.2% to 48.3%]; P = .23).
Conclusions and Relevance


This post hoc analysis found that NVD is less frequent but is associated with more resistance to currently available treatments than NVE. Aflibercept was superior to PRP for treating NVE, but neither treatment was particularly effective against NVD by 52 weeks. Future treatments are needed to better target NVD, which has poorer visual prognosis.
Trial Registration


isrctn.org Identifier: ISRCTN32207582.",2021,"Rates of regression with treatment were higher among eyes with NVE (89 of 102 [87.3%]) compared with eyes with NVD (23 of 43 [53.5%]) by 52 weeks, with NVD being more resistant to either treatment with higher rates of persistence than NVE (20 of 39 [51.3%] vs 29 of 100 [29.0%]).","['120 treatment-naive patients (75 men', 'patients with proliferative diabetic retinopathy and the topographical response of NV to treatment with aflibercept or PRP', 'Proliferative Diabetic Retinopathy (CLARITY) trial was conducted from November 1, 2019, to September 1, 2020, among 120 treatment-naive patients with proliferative diabetic retinopathy to evaluate the topography of NVD and NVE in 4 quadrants of the retina on color fundus photography at baseline and at 12 and 52 weeks after treatment', 'Importance\n\n\nEyes with proliferative diabetic retinopathy', 'Proliferative Diabetic Retinopathy', 'mean [SD] age, 54.8 [14.6] years) with proliferative diabetic retinopathy']","['panretinal photocoagulation (PRP) or anti-vascular endothelial growth factor agents', 'intravitreal aflibercept', 'PRP', 'Panretinal Photocoagulation', 'aflibercept', 'Aflibercept']","['rates of regression of NVE', 'location of neovascularization (NV', 'per-retinal quadrant frequencies of NV at baseline and frequencies of patterns of regression, recurrence, and new occurrence', 'NVD with or without NVE', 'NVD']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",120.0,0.0996383,"Rates of regression with treatment were higher among eyes with NVE (89 of 102 [87.3%]) compared with eyes with NVD (23 of 43 [53.5%]) by 52 weeks, with NVD being more resistant to either treatment with higher rates of persistence than NVE (20 of 39 [51.3%] vs 29 of 100 [29.0%]).","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Halim', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital National Health Service Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Nugawela', 'Affiliation': 'Institute of Ophthalmology, University College London, London, United Kingdom.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Institute of Clinical Science, Center for Experimental Medicine, Queen's University, Belfast, United Kingdom.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': ""St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom.""}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Madhusudhan', 'Affiliation': ""St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom.""}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Lenfestey', 'Affiliation': ""St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hamill', 'Affiliation': ""Institute of Clinical Science, Center for Experimental Medicine, Queen's University, Belfast, United Kingdom.""}, {'ForeName': 'Yalin', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Parry', 'Affiliation': ""St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom.""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Nicholson', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital National Health Service Foundation Trust, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Greenwood', 'Affiliation': 'Institute of Ophthalmology, University College London, London, United Kingdom.'}, {'ForeName': 'Sobha', 'Initials': 'S', 'LastName': 'Sivaprasad', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital National Health Service Foundation Trust, London, United Kingdom.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2021.0108']
347,33711412,Photobiomodulation therapy for the prevention of acute radiation dermatitis in head and neck cancer patients (DERMISHEAD trial).,"BACKGROUND AND PURPOSE


The purpose of this study was to investigate the effectiveness of photobiomodulation therapy (PBMT) for the prevention of acute radiation dermatitis (ARD) in head and neck cancer (HNC) patients.
MATERIALS AND METHODS


A randomised, placebo-controlled trial (RCT) with 46 HNC patients who underwent radiotherapy (RT) with or without concomitant chemotherapy was set up (DERMISHEAD trial). Patients were randomised to receive PBM or placebo treatments from the first day of RT (2×/week) alongside the institutional skincare. The severity of skin reactions was assessed by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE v4.03) and the Radiotherapy-Induced Skin Reaction Assessment Scale (RISRAS). Quality of life (QoL) was evaluated using the Skindex-16 questionnaire.
RESULTS


PBMT significantly reduced NCI-CTCAE grade 2-3 ARD with 49% at the end of RT.
CONCLUSION


The results of the first RCT in HNC patients showed that PBMT is an effective method to prevent the development of severe ARD. These results support the implementation of PBM in the clinical oncology - radiotherapy practice.",2021,"PBMT significantly reduced NCI-CTCAE grade 2-3 ARD with 49% at the end of RT.
","['acute radiation dermatitis in head and neck cancer patients', '46 HNC patients who underwent', 'acute radiation dermatitis (ARD) in head and neck cancer (HNC) patients']","['PBMT', 'placebo', 'photobiomodulation therapy (PBMT', 'PBM or placebo', 'Photobiomodulation therapy', 'radiotherapy (RT) with or without concomitant chemotherapy']","['severity of skin reactions', 'Radiotherapy-Induced Skin Reaction Assessment Scale (RISRAS', 'Quality of life (QoL']","[{'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065764', 'cui_str': 'MBD protocol'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0768997,"PBMT significantly reduced NCI-CTCAE grade 2-3 ARD with 49% at the end of RT.
","[{'ForeName': 'Jolien', 'Initials': 'J', 'LastName': 'Robijns', 'Affiliation': 'Hasselt University, Faculty of Medicine & Life Sciences, LCRC, Hasselt, Belgium. Electronic address: jolien.robijns@uhasselt.be.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Lodewijckx', 'Affiliation': 'Hasselt University, Faculty of Medicine & Life Sciences, LCRC, Hasselt, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Claes', 'Affiliation': 'Limburg Oncology Center, Jessa Hospital - Campus Virga Jesse, Hasselt, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Van Bever', 'Affiliation': 'Limburg Oncology Center, Jessa Hospital - Campus Virga Jesse, Hasselt, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Pannekoeke', 'Affiliation': 'Limburg Oncology Center, Jessa Hospital - Campus Virga Jesse, Hasselt, Belgium.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Censabella', 'Affiliation': 'Limburg Oncology Center, Jessa Hospital - Campus Virga Jesse, Hasselt, Belgium.'}, {'ForeName': 'Lore', 'Initials': 'L', 'LastName': 'Bussé', 'Affiliation': 'Hasselt University, Faculty of Medicine & Life Sciences, LCRC, Hasselt, Belgium.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Colson', 'Affiliation': 'Hasselt University, Faculty of Medicine & Life Sciences, LCRC, Hasselt, Belgium.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Kaminski', 'Affiliation': 'Hasselt University, Faculty of Medicine & Life Sciences, LCRC, Hasselt, Belgium.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Broux', 'Affiliation': 'Hasselt University, Faculty of Medicine & Life Sciences, LCRC, Hasselt, Belgium.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Puts', 'Affiliation': 'Hasselt University, Faculty of Medicine & Life Sciences, LCRC, Hasselt, Belgium.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Vanmechelen', 'Affiliation': 'Hasselt University, Faculty of Medicine & Life Sciences, LCRC, Hasselt, Belgium.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Timmermans', 'Affiliation': 'Department of Dermatology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Noé', 'Affiliation': 'Limburg Oncology Center, Jessa Hospital - Campus Virga Jesse, Hasselt, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bulens', 'Affiliation': 'Limburg Oncology Center, Jessa Hospital - Campus Virga Jesse, Hasselt, Belgium.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Govers', 'Affiliation': 'Limburg Oncology Center, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Maes', 'Affiliation': 'Limburg Oncology Center, Jessa Hospital - Campus Virga Jesse, Hasselt, Belgium; Limburg Oncology Center, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Mebis', 'Affiliation': 'Hasselt University, Faculty of Medicine & Life Sciences, LCRC, Hasselt, Belgium; Department of Medical Oncology, Jessa Hospital- Campus Virga Jesse, Hasselt, Belgium. Electronic address: Jeroen.mebis@jessazh.be.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2021.03.002']
348,33711390,THAP11 down-regulation may contribute to cardio-protective effects of sevoflurane anesthesia: Evidence from clinical and molecular evidence.,"This study aimed to explore the potential target of the cardio-protective effect induced by sevoflurane anesthesia based on evidence from clinical samples and in vitro model. Forty patients undergoing mitral valve replacement were randomly allocated to receive sevoflurane or propofol-based anesthesia. Atrial muscle specimens were collected from all patients, of which 5 were used to perform transcriptomics analysis. The cTn-I concentration was tested before, at the end of, and 24 h after surgery. In in vitro study, the expression level of the identified target gene, i.e., THAP11, was studied in H9C2 cells treated with sevoflurane or propofol. Then, we studied cell viability using CCK-8 staining, apoptosis by using flow cytometry, and cell death by lactic acid dehydrogenase (LDH) detection in H9C2 cells exposed to oxygen glucose deprivation/reoxygenation (OGD/R) injury. THAP11 was the most significantly down-regulated gene in the transcriptomics analysis (P < 0.001), as confirmed in validation samples (P = 0.006). THAP11 mRNA levels in atrial muscle specimens were positively associated with cTn-I levels at 24-h postoperatively (determination coefficient = 0.564; P < 0.001). Sevoflurane treatment down-regulated THAP11 in H9C2 cell models, which promoted cell viability, inhibited cell apoptosis, and death in the OGD/R injury cell model. Up-regulation of THAP11 reduced the protective effect of sevoflurane treatment against OGD/R injury. Sevoflurane anesthesia down-regulates the expression of THAP11, which contributes to a cardio-protective effect. THAP11 down-regulation promotes cell viability, and inhibits cell apoptosis and death, thereby protecting again myocardial injury; it may therefore be a novel target for perioperative cardio-protection.",2021,"THAP11 was the most significantly down-regulated gene in the transcriptomics analysis (P < 0.001), as confirmed in validation samples (P = 0.006).",['Forty patients undergoing mitral valve replacement'],"['sevoflurane', 'sevoflurane or propofol', 'Sevoflurane anesthesia', 'sevoflurane or propofol-based anesthesia', 'sevoflurane anesthesia', 'Sevoflurane', 'THAP11']","['THAP11 mRNA levels', 'THAP11', 'cell viability, inhibited cell apoptosis, and death', 'cell viability using CCK-8 staining, apoptosis by using flow cytometry, and cell death by lactic acid dehydrogenase (LDH) detection in H9C2 cells exposed to oxygen glucose deprivation/reoxygenation (OGD/R) injury']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026268', 'cui_str': 'Replacement of mitral valve'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007620', 'cui_str': 'Cell Viability'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0037167', 'cui_str': 'Sincalide'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0007587', 'cui_str': 'Cell death'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",40.0,0.110554,"THAP11 was the most significantly down-regulated gene in the transcriptomics analysis (P < 0.001), as confirmed in validation samples (P = 0.006).","[{'ForeName': 'Zhenxin', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Huifang', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Guangyou', 'Initials': 'G', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China. Electronic address: dgy1986anesthesia@126.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China. Electronic address: lh78553@163.com.'}]",Life sciences,['10.1016/j.lfs.2021.119327']
349,33707267,"Protocol of the study: the effectiveness of pleuran in the treatment of acute gastroenteritis in children-a randomised, placebo-controlled, double-blind trial (EPTAGE).","INTRODUCTION


Acute gastroenteritis is one of the most common causes of children's morbidity and mortality globally. Oral or intravenous rehydration was proven effective in reducing the mortality rates in acute gastroenteritis, although it does not affect the course of the disease. Attempts to identify new therapeutic methods effective in reducing the symptoms of diarrhoea are of interest. Pleuran's potential immunomodulatory effect in acute gastrointestinal infection relies on the stimulation of innate immunity. The effectiveness of pleuran (β-(1,3/1,6)-d-glucan) administration to treat acute infectious diarrhoea remains unknown. This study evaluates the efficacy of pleuran in reducing diarrhoea duration and the severity of acute gastroenteritis symptoms in children.
METHODS AND ANALYSIS


Our study is a randomised, double-blind, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio. A total of 120 children aged 2-10 years hospitalised or requiring a visit to the emergency department because of acute gastroenteritis will be randomly assigned to receive either pleuran oral suspension in the experimental group or matching placebo in the control group. The primary outcome measure will be the duration of diarrhoea. We will analyse the results in both intention-to-treat and per-protocol approaches.
ETHICS AND DISSEMINATION


The Bioethics Committee of The Medical University of Warsaw approved the study protocol (approval number: KB/45/2018). Written informed consent of the patients' caregivers participating in the study will be obligatory. The results of this study will be published in a medical journal, regardless of whether they confirm or deny the research hypothesis.
TRIAL REGISTRATION NUMBER


NCT03988257; Pre-results.",2021,A total of 120 children aged 2-10 years hospitalised or requiring a visit to the emergency department because of acute gastroenteritis will be randomly assigned to receive either pleuran oral suspension in the experimental group or matching placebo in the control group.,"['children', '120 children aged 2-10 years hospitalised or requiring a visit to the emergency department because of acute gastroenteritis', 'acute gastroenteritis in children', ""patients' caregivers participating in the study will be obligatory""]","['pleuran', 'Oral or intravenous rehydration', 'placebo', 'pleuran (β-(1,3/1,6)-d-glucan', 'pleuran oral suspension in the experimental group or matching placebo']","['mortality rates', 'duration of diarrhoea', 'diarrhoea duration and the severity of acute gastroenteritis symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0034997', 'cui_str': 'Rehydration therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0219900', 'cui_str': 'polyglucosan'}, {'cui': 'C0991537', 'cui_str': 'Oral suspension'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",120.0,0.649248,A total of 120 children aged 2-10 years hospitalised or requiring a visit to the emergency department because of acute gastroenteritis will be randomly assigned to receive either pleuran oral suspension in the experimental group or matching placebo in the control group.,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wzorek-Łyczko', 'Affiliation': 'The Department of Pediatrics with Clinical Assessment Unit, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Piwowarczyk', 'Affiliation': 'The Department of Pediatrics with Clinical Assessment Unit, Medical University of Warsaw, Warsaw, Poland apiwowarczyk@wum.edu.pl.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Kuchar', 'Affiliation': 'The Department of Pediatrics with Clinical Assessment Unit, Medical University of Warsaw, Warsaw, Poland.'}]",BMJ open,['10.1136/bmjopen-2020-042370']
350,33685241,Optimal design of cluster randomised trials with continuous recruitment and prospective baseline period.,"BACKGROUND


Cluster randomised trials, like individually randomised trials, may benefit from a baseline period of data collection. We consider trials in which clusters prospectively recruit or identify participants as a continuous process over a given calendar period, and ask whether and for how long investigators should collect baseline data as part of the trial, in order to maximise precision.
METHODS


We show how to calculate and plot the variance of the treatment effect estimator for different lengths of baseline period in a range of scenarios, and offer general advice.
RESULTS


In some circumstances it is optimal not to include a baseline, while in others there is an optimal duration for the baseline. All other things being equal, the circumstances where it is preferable not to include a baseline period are those with a smaller recruitment rate, smaller intracluster correlation, greater decay in the intracluster correlation over time, or wider transition period between recruitment under control and intervention conditions.
CONCLUSION


The variance of the treatment effect estimator can be calculated numerically, and plotted against the duration of baseline to inform design. It would be of interest to extend these investigations to cluster randomised trial designs with more than two randomised sequences of control and intervention condition, including stepped wedge designs.",2021,"We show how to calculate and plot the variance of the treatment effect estimator for different lengths of baseline period in a range of scenarios, and offer general advice.
",[],[],[],[],[],[],,0.336036,"We show how to calculate and plot the variance of the treatment effect estimator for different lengths of baseline period in a range of scenarios, and offer general advice.
","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hooper', 'Affiliation': 'Centre for Clinical Trials & Methodology, Institute of Population Health Sciences, Queen Mary University of London, London, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Copas', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, UK.'}]","Clinical trials (London, England)",['10.1177/1740774520976564']
351,32645163,Physical Function Impairment and Frailty in Middle-Aged People Living With Human Immunodeficiency Virus in the REPRIEVE Trial Ancillary Study PREPARE.,"BACKGROUND


People with human immunodeficiency virus (PWH) are at risk for accelerated development of physical function impairment and frailty; both associated with increased risk of falls, hospitalizations, and death. Identifying factors associated with physical function impairment and frailty can help target interventions.
METHODS


The REPRIEVE trial enrolled participants 40-75 years of age, receiving stable antiretroviral therapy with CD4+ T-cell count >100 cells/mm3, and with low to moderate cardiovascular disease risk. We conducted a cross-sectional analysis of those concurrently enrolled in the ancillary study PREPARE at enrollment.
RESULTS


Among the 266 participants, the median age was 51 years; 81% were male, and 45% were black, and 28% had hypertension. Body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) was 25 to <30 in 38% and ≥30 in 30%, 33% had a high waist circumference, 89% were physically inactive, 37% (95% confidence interval, 31%, 43%) had physical function impairment (Short Physical Performance Battery score ≤10), and 6% (4%, 9%) were frail and 42% prefrail. In the adjusted analyses, older age, black race, greater BMI, and physical inactivity were associated with physical function impairment; depression and hypertension were associated with frailty or prefrailty.
CONCLUSIONS


Physical function impairment was common among middle-aged PWH; greater BMI and physical inactivity are important modifiable factors that may prevent further decline in physical function with aging.
CLINICAL TRIALS REGISTRATION


NCT02344290.",2020,"In the adjusted analyses, older age, black race, greater BMI, and physical inactivity were associated with physical function impairment; depression and hypertension were associated with frailty or prefrailty.
","['266 participants, the median age was 51 years; 81% were male, and 45% were black, and 28% had hypertension', 'People with human immunodeficiency virus (PWH', 'trial enrolled participants 40-75 years of age, receiving stable antiretroviral therapy with CD4+ T-cell count >100 cells/mm3, and with low to moderate cardiovascular disease risk', 'Middle-Aged People Living With Human Immunodeficiency Virus']",[],"['Physical Function Impairment and Frailty', 'physical function impairment']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439243', 'cui_str': 'uL'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]",[],"[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}]",266.0,0.0899632,"In the adjusted analyses, older age, black race, greater BMI, and physical inactivity were associated with physical function impairment; depression and hypertension were associated with frailty or prefrailty.
","[{'ForeName': 'Triin', 'Initials': 'T', 'LastName': 'Umbleja', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Schrack', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Henn', 'Affiliation': 'Whitman Walker Health, Washington, DC, USA.'}, {'ForeName': 'Roberto C', 'Initials': 'RC', 'LastName': 'Arduino', 'Affiliation': 'McGovern Medical School at UTHealth, Houston, Texas, USA.'}, {'ForeName': 'Benigno', 'Initials': 'B', 'LastName': 'Rodriguez', 'Affiliation': 'Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Constance A', 'Initials': 'CA', 'LastName': 'Benson', 'Affiliation': 'University of California, San Diego, California, USA.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Erlandson', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa249']
352,32645159,Correlates and Timing of Reproductive Aging Transitions in a Global Cohort of Midlife Women With Human Immunodeficiency Virus: Insights From the REPRIEVE Trial.,"BACKGROUND


Reproductive aging may contribute to cardiometabolic comorbid conditions. We integrated data on gynecologic history with levels of an ovarian reserve marker (anti-müllerian hormone [AMH)] to interrogate reproductive aging patterns and associated factors among a subset of cisgender women with human immunodeficiency virus (WWH) enrolled in the REPRIEVE trial.
METHODS


A total of 1449 WWH were classified as premenopausal (n = 482) (menses within 12 months; AMH level ≥20 pg/mL; group 1), premenopausal with reduced ovarian reserve (n = 224) (menses within 12 months; AMH <20 pg/mL; group 2), or postmenopausal (n = 743) (no menses within12 months; AMH <20 pg/mL; group 3). Proportional odds models, adjusted for chronologic age, were used to investigate associations of cardiometabolic and demographic parameters with reproductive aging milestones (AMH <20 pg/mL or >12 months of amenorrhea). Excluding WWH with surgical menopause, age at final menstrual period was summarized for postmenopausal WWH (group 3) and estimated among all WWH (groups 1-3) using an accelerated failure-time model.
RESULTS


Cardiometabolic and demographic parameters associated with advanced reproductive age (controlling for chronologic age) included waist circumference (>88 vs ≤88 cm) (odds ratio [OR], 1.38; 95% confidence interval, 1.06-1.80; P = .02), hemoglobin (≥12 vs <12 g/dL) (2.32; 1.71-3.14; P < .01), and region of residence (sub-Saharan Africa [1.50; 1.07-2.11; P = .02] and Latin America and the Caribbean [1.59; 1.08-2.33; P = .02], as compared with World Health Organization Global Burden of Disease high-income regions). The median age (Q1, Q3) at the final menstrual period was 48 (45, 51) years when described among postmenopausal WWH, and either 49 (46, 52) or 50 (47, 53) years when estimated among all WWH, depending on censoring strategy.
CONCLUSIONS


Among WWH in the REPRIEVE trial, more advanced reproductive age is associated with metabolic dysregulation and region of residence. Additional research on age at menopause among WWH is needed.
CLINICAL TRIALS REGISTRATION


NCT0234429.",2020,"The median age (Q1, Q3) at the final menstrual period was 48 (45, 51) years when described among postmenopausal WWH, and either 49 (46, 52) or 50 (47, 53) years when estimated among all WWH, depending on censoring strategy.
","['The median age (Q1, Q3) at the final menstrual period was 48 (45, 51) years when described among postmenopausal WWH, and either 49 (46, 52) or 50 (47, 53) years when estimated among all WWH, depending on censoring strategy', 'Women With Human Immunodeficiency Virus', 'advanced reproductive age (controlling for chronologic age) included waist circumference (>88 vs ≤88 cm', 'cisgender women with human immunodeficiency virus (WWH', 'Global Cohort of Midlife', 'A total of 1449 WWH were classified as premenopausal (n = 482) (menses within 12 months; AMH level ≥20 pg/mL; group 1), premenopausal with reduced ovarian reserve (n = 224) (menses within 12 months; AMH <20 pg/mL; group 2), or postmenopausal (n = 743) (no menses within12 months; AMH <20 pg/mL; group 3']",['ovarian reserve marker (anti-müllerian hormone [AMH'],['hemoglobin'],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",1449.0,0.156135,"The median age (Q1, Q3) at the final menstrual period was 48 (45, 51) years when described among postmenopausal WWH, and either 49 (46, 52) or 50 (47, 53) years when estimated among all WWH, depending on censoring strategy.
","[{'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Smeaton', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Rivard', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Taron', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Tricia H', 'Initials': 'TH', 'LastName': 'Burdo', 'Affiliation': 'Department of Neuroscience, Temple University Lewis Katz School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sharlaa', 'Initials': 'S', 'LastName': 'Badal-Faesen', 'Affiliation': 'Clinical HIV Research Unit, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Umesh G', 'Initials': 'UG', 'LastName': 'Lalloo', 'Affiliation': 'Durban University of Technology, Enhancing Care Foundation and Busamed Gateway Private Hospital, Kwa Zulu-Natal, South Africa.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Pinto', 'Affiliation': 'Federal University of Minas Gerais School of Medicine, Belo Horizonte, Brazil.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': 'Clinical Trials Research Centre, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Valencia', 'Affiliation': 'Asociacion Civil Impacta Salud y Educación, Lima, Peru.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Klingman', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Allston-Smith', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Cooper-Arnold', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lu', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffman', 'Affiliation': 'Cardiovascular Imaging Research Center, Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Looby', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa214']
353,33710588,Effect of Complex Weight-Reducing Interventions on Rhythm Control in Obese Individuals with Atrial Fibrillation Following Catheter Ablation: A Study Protocol.,"INTRODUCTION


Obesity and atrial fibrillation (AF) pose a significant burden on healthcare systems worldwide. Reduction of body weight has been documented to reduce the risk of AF. Little is known about the effect of different weight-reducing interventions including bariatric surgery in obese individuals on the risk of arrhythmia recurrence following catheter ablation (CA) for AF, and about the pathophysiological mechanisms linking these two conditions.
METHODS


The Effect of complex weigHt-reducing interventiOns on rhythm control in oBese subjects wITh Atrial Fibrillation (HOBIT-AF) is a single-blinded, parallel-group randomised controlled trial with 18-month follow-up to assess the effect of complex weight-reducing interventions supported by the use of smart technologies and bariatric surgery on the arrhythmia burden in obese individuals following CA for AF. One hundred and sixty individuals (age 18-70 years, body mass index ≥ 30 kg/m 2 ) will be randomised in a 1:1 fashion to undergo a structured weight reduction programme and sleeve gastrectomy (when indicated and preferred by the patient) aiming to achieve greater than 10% weight reduction from baseline (intervention group) or standard post-ablation medical care (control group). Two-week continuous ECG monitoring will be used 3 and 18 months after CA to assess the arrhythmia burden. Other investigations will include transthoracic echocardiography with quantification of epicardial adipose tissue, and markers of low-grade inflammation and circulating adipokines.
PLANNED OUTCOMES


The main objective is to assess the effect of complex weight-reducing interventions on the arrhythmia burden and quality of life. Subgroup analyses to identify patient subgroups preferentially benefiting from weight loss related to a decrease in arrhythmia burden will be performed. Exploratory objectives will include investigation of potential mechanisms linking weight reduction with amelioration of arrhythmia burden such as changes in markers of low-grade inflammation, circulating adipokines, cytokines, monocytes or reduction of epicardial adipose tissue volume.
TRIAL REGISTRATION


NCT04560387.",2021,"The Effect of complex weigHt-reducing interventiOns on rhythm control in oBese subjects wITh Atrial Fibrillation (HOBIT-AF) is a single-blinded, parallel-group randomised controlled trial with 18-month follow-up to assess the effect of complex weight-reducing interventions supported by the use of smart technologies and bariatric surgery on the arrhythmia burden in obese individuals following CA for AF.","['obese individuals', 'oBese subjects wITh Atrial Fibrillation (HOBIT-AF', 'One hundred and sixty individuals (age 18-70\xa0years, body mass index\u2009≥\u200930\xa0kg/m 2 ', 'obese individuals following CA for AF', 'Obese Individuals with Atrial Fibrillation Following Catheter Ablation']","['structured weight reduction programme and sleeve gastrectomy (when indicated and preferred by the patient) aiming to achieve greater than 10% weight reduction from baseline (intervention group) or standard post-ablation medical care (control group', 'complex weight-reducing interventions', 'complex weigHt-reducing interventiOns', 'Complex Weight-Reducing Interventions', 'smart technologies and bariatric surgery', 'catheter ablation (CA']","['arrhythmia burden', 'arrhythmia burden and quality of life']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",160.0,0.0871576,"The Effect of complex weigHt-reducing interventiOns on rhythm control in oBese subjects wITh Atrial Fibrillation (HOBIT-AF) is a single-blinded, parallel-group randomised controlled trial with 18-month follow-up to assess the effect of complex weight-reducing interventions supported by the use of smart technologies and bariatric surgery on the arrhythmia burden in obese individuals following CA for AF.","[{'ForeName': 'Kristýna', 'Initials': 'K', 'LastName': 'Štolbová', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Novodvorský', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Vídeňská 1958, 140 21, Prague 4, Czech Republic.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Jakubíková', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Vídeňská 1958, 140 21, Prague 4, Czech Republic.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Dvořáková', 'Affiliation': 'Centre for Experimental Medicine, IKEM, Prague, Czech Republic.'}, {'ForeName': 'Miloš', 'Initials': 'M', 'LastName': 'Mráz', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Vídeňská 1958, 140 21, Prague 4, Czech Republic.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wichterle', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Kautzner', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzík', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Vídeňská 1958, 140 21, Prague 4, Czech Republic. halm@ikem.cz.'}]",Advances in therapy,['10.1007/s12325-021-01667-0']
354,33714860,S-1 and oxaliplatin versus tegafur-uracil and leucovorin as post-operative adjuvant chemotherapy in patients with high-risk stage III colon cancer: updated 5-year survival of the phase III ACTS-CC 02 trial.,"BACKGROUND


The ACTS-CC 02 trial demonstrated that S-1 plus oxaliplatin (SOX) was not superior to tegafur-uracil and leucovorin (UFT/LV) in terms of disease-free survival (DFS) as adjuvant chemotherapy for high-risk stage III colon cancer (any T, N2, or positive nodes around the origin of the feeding arteries). We now report the final overall survival (OS) and subgroup analysis according to the pathological stage (TNM 7th edition) for treatment efficacy.
PATIENTS AND METHODS


Patients who underwent curative resection for pathologically confirmed high-risk stage III colon cancer were randomly assigned to receive either UFT/LV (300 mg/m 2  of UFT and 75 mg/day of LV on days 1-28, every 35 days, five cycles) or SOX (100 mg/m 2  of oxaliplatin on day 1 and 80 mg/m 2 /day of S-1 on days 1-14, every 21 days, eight cycles). The primary endpoint was DFS and the patients' data were updated in February 2020.
RESULTS


A total of 478 patients in the UFT/LV group and 477 patients in the SOX group were included in the final analysis. With a median follow-up time of 74.3 months, the 5-year DFS rate was 55.2% in the UFT/LV group and 58.1% in the SOX group [stratified hazard ratio (HR) 0.92; 95% confidence interval (CI) 0.76-1.11; P = 0.3973], and the 5-year OS rates were 78.3% and 79.1%, respectively (stratified HR 0.97; 95% CI 0.76-1.24; P = 0.8175). In the subgroup analysis, the 5-year OS rates in patients with T4N2b disease were 51.0% and 64.1% in the UFT/LV and SOX groups, respectively (HR 0.72; 95% CI 0.40-1.31).
CONCLUSION


Our final analysis reconfirmed that SOX as adjuvant chemotherapy is not superior to UFT/LV in terms of DFS in patients with high-risk stage III colon cancer. The 5-year OS rate was similar in the UFT/LV and SOX groups.",2021,(stratified HR 0.97; 95% CI 0.76-1.24; P = 0.8175).,"['Patients who underwent curative resection for pathologically confirmed high-risk stage III colon cancer', '478 patients in the UFT/LV group and 477 patients in the SOX group were included in the final analysis', 'patients with high-risk stage III colon cancer']","['S-1 plus oxaliplatin (SOX', 'UFT/LV', 'SOX', 'oxaliplatin', 'UFT and 75 mg/day of LV', 'S-1 and oxaliplatin versus tegafur-uracil and leucovorin', 'tegafur-uracil and leucovorin (UFT/LV']","['5-year DFS rate', '5-year OS rates', '5-year survival', '5-year OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}, {'cui': 'C1446539', 'cui_str': 'Tegafur- and uracil-containing product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C1446539', 'cui_str': 'Tegafur- and uracil-containing product'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.442925,(stratified HR 0.97; 95% CI 0.76-1.24; P = 0.8175).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Watanabe', 'Affiliation': 'Gastroenterological Center, Yokohama City University Medical Center, Kanagawa, Japan. Electronic address: nabe-jun@comet.ocn.ne.jp.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sasaki', 'Affiliation': 'Department of Surgical Oncology, Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kusumoto', 'Affiliation': 'Department of Gastrointestinal Surgery and Clinical Research Institute Cancer Research Division, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroenterological Surgery, Hirosaki University Graduate School of Medicine, Aomori, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tomita', 'Affiliation': 'Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maeda', 'Affiliation': 'Department of Surgery, Ogaki Municipal Hospital, Gifu, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Teshima', 'Affiliation': 'Department of Gastrointestinal Surgery, Iwate Prefectural Central Hospital, Iwate, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yokota', 'Affiliation': 'Department of General Surgery, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tanaka', 'Affiliation': 'Department of Surgery, Gifu Prefectural General Medical Center, Gifu, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Surgery, Sendai Kousei Hospital, Miyagi, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Uetake', 'Affiliation': 'Department of Specialized Surgeries, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Itabashi', 'Affiliation': ""Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kotake', 'Affiliation': 'Department of Surgery, Sano City Hospital, Tochigi, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Aiba', 'Affiliation': 'Division of Clinical Oncology/Hematology, Department of Internal Medicine, The Tokyo Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Takenaka', 'Affiliation': 'Clinical Research & Pharmacoepidemiology Department, Medical Affairs Division, Taiho Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sugihara', 'Affiliation': 'Tokyo Medical and Dental University, Tokyo, Japan.'}]",ESMO open,['10.1016/j.esmoop.2021.100077']
355,33705671,High-Fidelity Simulation Improves Long-Term Knowledge of Clinical Swallow Evaluation.,"Purpose Clinical swallow evaluation (CSE) is a critical skill that speech-language pathologists who manage swallowing impairment must learn. The objective of this mixed-methods study was to determine if using a human patient simulator (HPS) to train speech-language pathology graduate students in CSE improved knowledge, preparedness, and anxiety as compared to traditional instruction alone. Method This was a controlled trial with repeated measures. Participants included graduate students from two cohorts who were enrolled in a swallowing disorders course in consecutive academic years ( n  = 50). Students in the experimental group participated in a simulation experience in which they performed a CSE on an HPS, generated a treatment plan, and communicated in real time with the HPS, the patient's wife, and a nurse. Quantitative results included quizzes that measured short- and long-term CSE knowledge, and qualitative findings included written feedback from instructors and students. Results Students who participated in simulation training had significantly higher long-term quiz accuracy than the control group, but their short-term quiz scores did not differ. Student ratings of preparedness and anxiety did not differ between the two groups. Many students reported that they appreciated practicing the use of patient-friendly language and preferred clinical simulation over traditional teaching methods. Facilitators reported that simulation increased student engagement and critical thinking skills more than traditional teaching methods. Conclusions CSE simulation provided objective and subjective advantages over traditional teaching methods. Recommendations from students and instructors for improving the CSE simulation training are reported.",2021,Student ratings of preparedness and anxiety did not differ between the two groups.,"['Participants included graduate students from two cohorts who were enrolled in a swallowing disorders course in consecutive academic years ( n  = 50', 'human patient simulator (HPS) to train speech-language pathology graduate students']","['swallow evaluation (CSE', 'High-Fidelity Simulation', 'CSE']","['higher long-term quiz accuracy', 'Student ratings of preparedness and anxiety', 'knowledge, preparedness, and anxiety', 'student engagement and critical thinking skills']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0037825', 'cui_str': 'Pathology, Speech-Language'}]","[{'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4279941', 'cui_str': 'Critical Thinking'}]",,0.0955892,Student ratings of preparedness and anxiety did not differ between the two groups.,"[{'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Bartlett', 'Affiliation': 'Northern Arizona University, Flagstaff.'}, {'ForeName': 'Savannah', 'Initials': 'S', 'LastName': 'Bruecker', 'Affiliation': 'Northern Arizona University, Flagstaff.'}, {'ForeName': 'Bobby', 'Initials': 'B', 'LastName': 'Eccleston', 'Affiliation': 'Northern Arizona University, Flagstaff.'}]",American journal of speech-language pathology,['10.1044/2020_AJSLP-20-00240']
356,33710587,"A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Masked Trial of a Topical Estradiol Ophthalmic Formulation in Postmenopausal Women with Moderate-to-Severe Dry Eye Disease.","INTRODUCTION


Dry eye disease (DED) is a multifactorial disorder of the ocular surface. The current phase II study was performed to assess the safety and dose regimen of a recently developed topical estradiol formulation for the treatment of DED.
METHODS


A total of 104 postmenopausal women suffering from moderate-to-severe DED were included. Topical 17-β-estradiol-3-phosphate eye drops were administered in three different dosage groups (group 1, 0.05% twice daily; group 2, 0.1% morning, vehicle in the evening; group 3, 0.1% twice daily) and vehicle twice daily as control group for a total period of 3 months. Clinical signs including Schirmer's test and corneal staining were assessed at baseline and at days 14, 30, 60, and 90. Symptoms of DED were measured using the symptom assessment in dry eye (SANDE) test at the same time points. Safety was assessed via frequency of adverse events.
RESULTS


Schirmer's test II wetting distance significantly increased in all four groups from baseline to day 90 without significant difference between groups (group 1, + 5.6 ± 6.7 mm/5 min; group 2, + 3.7 ± 4.2 mm/5 min; group 3, + 4.8 ± 4.5 mm/5 min; group 4, + 4.0 ± 5.3 mm/5 min). Statistical significance versus baseline was reached earlier in the treatment groups versus the control group. Corneal staining was significantly reduced after the 3-month treatment period with no significant difference between treatment groups. Staining of the inferior cornea, however, showed a significantly more pronounced decrease in the highest dose group compared to vehicle (p = 0.0463). Symptoms score as assessed with the SANDE test decreased at the end of the treatment period in all four groups. Estradiol eye drops showed a favorable safety profile.
CONCLUSION


Our results show that both estradiol eye drops and vehicle are safe and reduce signs and symptoms in postmenopausal women with moderate-to-severe DED. Although the study failed to reach the primary outcome to demonstrate a significant difference between the estradiol eye drops and vehicle in Schirmer's test, improvement occurred earlier in the active groups compared to the control group. The data of the current study will serve as a basis for a larger phase III study to establish a potential therapeutic effect of topical estradiol eye drops.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov registry NCT03821415.",2021,"RESULTS


Schirmer's test II wetting distance significantly increased in all four groups from baseline to day 90 without significant difference between groups (group 1, + 5.6 ± 6.7 ","['104 postmenopausal women suffering from moderate-to-severe DED', 'postmenopausal women with moderate-to-severe DED', 'Postmenopausal Women with Moderate-to-Severe Dry Eye Disease']","['Topical Estradiol Ophthalmic Formulation', 'Estradiol eye drops', '\u20094.8\u2009±\u20094.5\xa0mm/5\xa0min; group\xa04,\u2009+\u20094.0\u2009±\u20095.3\xa0mm/5\xa0min', 'Placebo', 'Topical 17-β-estradiol-3-phosphate eye drops']","[""Schirmer's test II wetting distance"", 'Symptoms of DED', ""Clinical signs including Schirmer's test and corneal staining"", 'Symptoms score', 'favorable safety profile', 'Corneal staining']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]","[{'cui': 'C0360515', 'cui_str': 'Estradiol-containing product in transdermal dose form'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}]","[{'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",104.0,0.081279,"RESULTS


Schirmer's test II wetting distance significantly increased in all four groups from baseline to day 90 without significant difference between groups (group 1, + 5.6 ± 6.7 ","[{'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Schmidl', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Szalai', 'Affiliation': 'Óbudai Egészségügyi Centrum (OEC), Budapest, Hungary.'}, {'ForeName': 'Orsolya G', 'Initials': 'OG', 'LastName': 'Kiss', 'Affiliation': 'Department of Ophthalmology, Érmellék Egészségcentrum, Baross utca 7, 4281, Létavértes, Hungary.'}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Schmetterer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Garhöfer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria. gerhard.garhoefer@meduniwien.ac.at.'}]",Advances in therapy,['10.1007/s12325-021-01680-3']
357,33724254,"Efficacy and safety of pentoxifylline combination therapy in major depressive disorder: a randomized, double-blind, placebo-controlled clinical trial.","In this randomized, double-blind, placebo-controlled clinical trial, we assessed the efficacy and safety of pentoxifylline combination therapy with sertraline in treatment of major depressive disorder (MDD). A total of 56 patients with MDD were assigned into two parallel groups to receive sertraline (100 mg/day) plus placebo or sertraline (100 mg/day) plus pentoxifylline (400 mg three times daily) for six weeks. Patients were evaluated with the Hamilton rating scale for depression (HAM-D) at baseline and weeks 2, 4 and 6. The sertraline plus pentoxifylline group demonstrated greater improvement in HAM-D scores from baseline to all three study time points (P = 0.013, 0.007 and 0.016 for week 2, 4 and 6, respectively). Response to treatment rate was also significantly higher in the sertraline plus pentoxifylline group compared to the sertraline plus placebo group at week 4 [57.1 vs. 21.4%, P = 0.013] and the study endpoint [96.4 vs. 57.1%, P = 0.001]. However, the remission rate, time to remission and time to treatment response did not show any significant difference between trial groups. Our findings support the efficacy and safety of pentoxifylline combination therapy in patients with MDD.",2021,"However, the remission rate, time to remission and time to treatment response did not show any significant difference between trial groups.","['patients with MDD', 'major depressive disorder (MDD', 'major depressive disorder', '56 patients with MDD']","['placebo or sertraline', 'sertraline plus placebo', 'sertraline', 'sertraline plus pentoxifylline', 'pentoxifylline', 'pentoxifylline combination therapy', 'placebo', 'pentoxifylline combination therapy with sertraline']","['HAM-D scores', 'efficacy and safety', 'remission rate, time to remission and time to treatment response', 'Response to treatment rate', 'Hamilton rating scale for depression (HAM-D', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",56.0,0.273033,"However, the remission rate, time to remission and time to treatment response did not show any significant difference between trial groups.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Farajollahi-Moghadam', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Sanjari-Moghaddam', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghazizadeh Hasemi', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sanatian', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Talaei', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center and Department of Psychiatry, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000353']
358,33724251,"Dasotraline in adults with attention deficit hyperactivity disorder: a placebo-controlled, fixed-dose trial.","In a previous study, dasotraline demonstrated efficacy at a dose of 8 mg/day in adults with attention deficit hyperactivity disorder (ADHD). The aim of the current study was to evaluate the efficacy and safety of dasotraline in doses of 4 and 6 mg/day. Adults meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria for ADHD were randomized to 8 weeks of double-blind, once-daily, fixed-dose treatment with dasotraline 4 mg/day, 6 mg/day, or placebo. The primary efficacy endpoint was changed in the ADHD Rating Scale, Version IV (ADHD RS-IV) total score. Secondary efficacy endpoints included the Clinical Global Impression, Severity (CGI-S) Scale. Least squares mean reduction at week 8 in the ADHD RS-IV HV total score was not significantly greater (vs. placebo) in the dasotraline 4 mg/day group (-15.0 vs. -13.9; n.s.; or in the dasotraline 6 mg/day group (-16.5 vs. -13.9; P = 0.074; Hochberg correction). Treatment with dasotraline 6 mg/day was significant at week 8 (uncorrected) on the ADHD RS-IV total score (P = 0.037) and the CGI-S score (P = 0.011). Treatment with the 4 mg/day dose of dasotraline was NS. Treatment with dasotraline was generally well tolerated. The results provide additional evidence that supports the potential efficacy of dasotraline, in doses of 6 mg/day, in adults with ADHD.",2021,Least squares mean reduction at week 8 in the ADHD RS-IV HV total score was not significantly greater (vs. placebo) in the dasotraline 4 mg/day group (-15.0 vs. -13.9; n.s.; or in the dasotraline 6 mg/day group (-16.5 vs. -13.9; P = 0.074; Hochberg correction).,"['adults with attention deficit hyperactivity disorder', 'Adults meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria for ADHD', 'adults with attention deficit hyperactivity disorder (ADHD', 'adults with ADHD']","['placebo', 'Dasotraline', 'dasotraline', 'dasotraline 4\u2009mg/day, 6\u2009mg/day, or placebo']","['ADHD RS-IV HV total score', 'ADHD RS-IV total score', 'tolerated', 'Clinical Global Impression, Severity (CGI-S', 'efficacy and safety', 'ADHD Rating Scale, Version IV (ADHD RS-IV) total score', 'CGI-S score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4276542', 'cui_str': '4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",,0.0552618,Least squares mean reduction at week 8 in the ADHD RS-IV HV total score was not significantly greater (vs. placebo) in the dasotraline 4 mg/day group (-15.0 vs. -13.9; n.s.; or in the dasotraline 6 mg/day group (-16.5 vs. -13.9; P = 0.074; Hochberg correction).,"[{'ForeName': 'Lenard A', 'Initials': 'LA', 'LastName': 'Adler', 'Affiliation': 'Department of Psychiatry, New York University Langone Medical Center, New York.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldman', 'Affiliation': 'Translational Medicine and Medical Affairs, Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts.'}, {'ForeName': 'Seth C', 'Initials': 'SC', 'LastName': 'Hopkins', 'Affiliation': 'Translational Medicine and Medical Affairs, Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts.'}, {'ForeName': 'Kenneth S', 'Initials': 'KS', 'LastName': 'Koblan', 'Affiliation': 'Translational Medicine and Medical Affairs, Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Kent', 'Affiliation': 'Translational Medicine and Medical Affairs, Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hsu', 'Affiliation': 'Biostatistics, Sunovion Pharmaceuticals Inc., Fort Lee, New Jersey, USA.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': 'Translational Medicine and Medical Affairs, Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000333']
359,33687130,Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma.,"AIM


Hepatic arterial infusion chemotherapy (HAIC) with cisplatin is beneficial to patients with advanced hepatocellular carcinoma (HCC) treated with sorafenib. This study aimed to examine the effect of HAIC with cisplatin before radiofrequency ablation (RFA) in patients with HCC.
METHODS


This was a multicenter, single-blinded, randomized controlled study (UMIN000007267). Early-stage HCC patients were randomly assigned (1:1) to receive HAIC with cisplatin before RFA therapy (HAIC group) or RFA monotherapy (non-HAIC group). The primary end-point was recurrence-free survival. Efficacy analysis and safety analysis followed the intention-to-treat principle.
RESULTS


Between August 2012 and July 2016, 74 patients were recruited. A total of 70 eligible patients were randomly assigned to the HAIC group (n = 35) and non-HAIC group (n = 35). Recurrence-free survival rates at 1 (3) year in the HAIC group and non-HAIC group were 82.9% (54.3%) and 74.3% (34.3%), respectively (hazard ratio [HR], 0.597; 95% confidence interval [CI], 0.320-1.091; p = 0.094]. Subgroup analysis showed that the beneficial effect of HAIC was observed in patients with a single nodule and Child-Pugh score 5. Intrahepatic distant recurrence-free survival rate in the HAIC group was significantly better than that in the non-HAIC group (HR, 0.468; 95% CI, 0.235-0.896; p = 0.022). Adverse events were observed in just two patients in the HAIC group (6%) - grade 2 cholecystitis and grade 2 hyperkalemia.
CONCLUSIONS


HAIC with cisplatin before RFA did not significantly decrease recurrence in patients with early-stage HCC. However, it might be effective in preventing intrahepatic distant recurrence.",2021,"Intrahepatic distant recurrence-free survival rate in the HAIC group was significantly better than that in the non-HAIC group (HR, 0.468; 95% CI, 0.235-0.896; p = 0.022).","['Early-stage HCC patients', 'patients with early-stage HCC', 'patients with HCC', '74 patients were recruited', 'Seventy eligible patients', 'patients with a single nodule and Child', 'patients with advanced HCC treated with', 'hepatocellular carcinoma', 'Between August 2012 and July 2016']","['HAIC with cisplatin before RFA therapy (HAIC group) or RFA monotherapy', 'HAIC with cisplatin before radiofrequency ablation (RFA', 'hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation', 'cisplatin', 'HAIC', 'sorafenib']","['recurrence', 'intrahepatic distant recurrence', 'grade 2 cholecystitis, and grade 2 hyperkalemia', 'recurrence-free survival', 'Recurrence-free survival rates', 'Adverse events', 'beneficial effect of HAIC', 'Intrahepatic distant recurrence-free survival rate']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C4304118', 'cui_str': 'Hepatic arterial infusion chemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0008325', 'cui_str': 'Cholecystitis'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4304118', 'cui_str': 'Hepatic arterial infusion chemotherapy'}]",74.0,0.157278,"Intrahepatic distant recurrence-free survival rate in the HAIC group was significantly better than that in the non-HAIC group (HR, 0.468; 95% CI, 0.235-0.896; p = 0.022).","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Oyama', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nouso', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Medical Center for Clinical and Translational Research, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Morimoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Onishi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Takaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Shouta', 'Initials': 'S', 'LastName': 'Iwadou', 'Affiliation': 'Department of Internal Medicine, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kariyama', 'Affiliation': 'Department of Gastroenterology, Okayama City Hospital, Okayama, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kuwaki', 'Affiliation': 'Department of Internal Medicine, Fukuyama City Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Yabushita', 'Affiliation': 'Department of Internal Medicine, Fukuyama City Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kosaku', 'Initials': 'K', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Internal Medicine, Fukuyama City Hospital, Hiroshima, Japan.'}, {'ForeName': 'Jyunichi', 'Initials': 'J', 'LastName': 'Toshimori', 'Affiliation': 'Department of Internal Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Kobashi', 'Affiliation': 'Department of Internal Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Moriya', 'Affiliation': 'Department of Gastroenterology, Mitoyo General Hospital, Kannonji, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Gastroenterology, Mitoyo General Hospital, Kannonji, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hepatology research : the official journal of the Japan Society of Hepatology,['10.1111/hepr.13633']
360,33688908,Stepped Collaborative Care Targeting Posttraumatic Stress Disorder Symptoms and Comorbidity for US Trauma Care Systems: A Randomized Clinical Trial.,"Importance


To date, few multisite investigations have evaluated early interventions for injured patients with posttraumatic stress disorder (PTSD) symptoms.
Objective


To simultaneously assess the effectiveness and implementation of a brief stepped collaborative care intervention targeting PTSD and comorbidity.
Design, Setting, and Participants


A stepped-wedge cluster randomized clinical trial was conducted at 25 US level I trauma centers. Participants included hospitalized survivors of physical injury who underwent a 2-step evaluation for PTSD symptoms. Patients reporting high levels of distress on the PTSD Checklist (PCL-C) were randomized (N = 635) per the stepped-wedge protocol to enhanced usual care control (n = 370) or intervention (n = 265) conditions. The study was conducted from January 4, 2016, through November 2018. Data analysis was performed from November 4, 2019, to December 8, 2020.
Interventions


The Trauma Survivors Outcomes and Support collaborative care intervention included proactive injury case management that assisted patients transitioning from hospital inpatient to outpatient and community settings. The intervention also integrated evidence-based pharmacotherapy and psychotherapeutic elements targeting PTSD symptoms and comorbidity.
Main Outcomes and Measures


The primary study outcome was PTSD symptoms assessed with the PCL-C at baseline in the surgical ward and at 3, 6, and 12 months postinjury. Secondary outcomes included depressive symptoms, alcohol use, and physical function. Subgroup analyses examined the effect of baseline risk factors for enduring PTSD and quality of protocol implementation on study outcomes. Primary statistical analyses were conducted using the intent-to-treat sample.
Results


A total of 327 men (51.5%) were included in analysis; mean (SD) age was 39.0 (14.2) years. The investigation attained follow-up of 75% to 80% of the participants at 3 to 12 months. The intervention lasted a mean (SD) of 122 (132) minutes. Mixed model regression analyses revealed statistically significant changes in PCL-C scores for intervention patients compared with control patients at 6 months (difference, -2.57; 95% CI, -5.12 to -0.03; effect size, 0.18; P < .05) but not 12 months (difference, -1.27; 95% CI, -4.26 to 1.73; effect size, 0.08; P = .35). Subgroup analyses revealed larger PTSD treatment effects for patients with 3 or more baseline risk factors for enduring PTSD and for patients, including firearm injury survivors, treated at trauma centers with good or excellent protocol implementation. Intervention effects for secondary outcomes did not attain statistical significance.
Conclusions and Relevance


A brief stepped collaborative care intervention was associated with significant 6-month but not 12-month PTSD symptom reductions. Greater baseline PTSD risk and good or excellent trauma center protocol implementation were associated with larger PTSD treatment effects. Orchestrated efforts targeting policy and funding should systematically incorporate the study findings into national trauma center requirements and verification criteria.
Trial Registration


ClinicalTrials.gov Identifier: NCT02655354.",2021,"Mixed model regression analyses revealed statistically significant changes in PCL-C scores for intervention patients compared with control patients at 6 months (difference, -2.57; 95% CI, -5.12 to -0.03; effect size, 0.18; P < .05) but not 12 months (difference, -1.27; 95% CI, -4.26 to 1.73; effect size, 0.08; P = .35).","['A total of 327 men (51.5%) were included in analysis; mean (SD) age was 39.0 (14.2) years', 'Participants included hospitalized survivors of physical injury who underwent a 2-step evaluation for PTSD symptoms', 'Patients reporting high levels of distress on the PTSD Checklist (PCL-C) were randomized (N\u2009=\u2009635) per the', 'injured patients with posttraumatic stress disorder (PTSD) symptoms', 'January 4, 2016, through November 2018']","['stepped-wedge protocol to enhanced usual care control (n\u2009=\u2009370) or intervention', 'collaborative care intervention included proactive injury case management that assisted patients transitioning from hospital inpatient to outpatient and community settings']","['Greater baseline PTSD risk and good or excellent trauma center protocol implementation', 'PTSD symptoms assessed with the PCL-C', 'depressive symptoms, alcohol use, and physical function', 'PTSD treatment effects', 'PCL-C scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1704423', 'cui_str': 'Hereditary lymphedema'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704423', 'cui_str': 'Hereditary lymphedema'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",327.0,0.164989,"Mixed model regression analyses revealed statistically significant changes in PCL-C scores for intervention patients compared with control patients at 6 months (difference, -2.57; 95% CI, -5.12 to -0.03; effect size, 0.18; P < .05) but not 12 months (difference, -1.27; 95% CI, -4.26 to 1.73; effect size, 0.08; P = .35).","[{'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Zatzick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Jurkovich', 'Affiliation': 'Department of Surgery, UC Davis School of Medicine, Sacramento, California.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington School of Public Health, Seattle.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Russo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Doyanne', 'Initials': 'D', 'LastName': 'Darnell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Parker', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Michelle K', 'Initials': 'MK', 'LastName': 'Roberts', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Rddhi', 'Initials': 'R', 'LastName': 'Moodliar', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Engstrom', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Harborview Injury Prevention and Research Center, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bulger', 'Affiliation': 'Department of Surgery, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Whiteside', 'Affiliation': 'Department of Emergency Medicine, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Nehra', 'Affiliation': 'Department of Surgery, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Palinkas', 'Affiliation': 'Department of Children, Youth and Families, C. Suzanne Dworak-Peck School of Social Work, Los Angeles, California.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Moloney', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Maier', 'Affiliation': 'Department of Surgery, University of Washington School of Medicine, Seattle.'}]",JAMA surgery,['10.1001/jamasurg.2021.0131']
361,33689694,"Physical Therapy Use, Costs, and Value for Latent Classes of Good vs Poor Outcome in Patients Who Catastrophize About Their Pain Prior to Knee Arthroplasty.","OBJECTIVE


To examine use, costs, and value of physical therapy (PT) among subgroups.
DESIGN


We conducted an observational study of data from a randomized trial of a pain coping skills intervention. Good and poor outcome subgroups were determined based on Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Pain and Physical Function scores. The use and costs of PT care as well as changes in WOMAC Pain and Physical Function scores over 4 time periods during a 1-year follow-up were reported. We compared the number of PT visits, total PT costs, and cost per 1-unit improvement in WOMAC scores for the 2 latent subgroups.
SETTING


Five academic medical centers.
PARTICIPANTS


Patients who catastrophized about their pain prior to knee arthroplasty (N=384).
INTERVENTIONS


Pain coping skills training, arthritis education, and usual care.
MAIN OUTCOME MEASURES


The WOMAC Pain Scale was the primary outcome.
RESULTS


The value of PT was lower and the cost of PT was higher for poor vs good outcome subgroups beginning 2 months after knee arthroplasty. For example, during the 2- to 6-month period, participants in the poor outcome subgroup incurred a PT cost of $5181.22 per 1-unit improvement in WOMAC Pain compared with $437.87 per 1-unit improvement in WOMAC Pain for the good outcome subgroup (P<.001). From the 6- to 12-month period, WOMAC scores worsened for the poor outcome subgroup, indicating no benefit from PT.
CONCLUSIONS


Patients in 2 latent classes demonstrated clinically important differences in value of PT. Future research should identify rehabilitation-based interventions that reduce utilization and enhance effectiveness for patients at high risk for poor outcome.",2021,"From the 6-12 month period, WOMAC scores worsened for the poor outcome subgroup, indicating no benefit from physical therapy.
","['Patients who catastrophized about their pain prior to knee arthroplasty', 'Five academic medical centers', 'Patients who Catastrophize about their Pain Prior to Knee Arthroplasty']","['pain coping skills intervention', 'Pain coping skills training, arthritis education and usual care']","['Number of PT visits, total PT costs and cost per one-unit improvement in WOMAC scores', 'WOMAC scores', 'PT cost', 'Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Pain and Physical Function scores', 'WOMAC Pain and Physical Function scores', 'WOMAC Pain Scale', 'WOMAC Pain', 'value of PT', 'cost of PT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0563150', 'cui_str': 'Catastrophization'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0329244,"From the 6-12 month period, WOMAC scores worsened for the poor outcome subgroup, indicating no benefit from physical therapy.
","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Orndahl', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond VA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Perera', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond VA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hung', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Dumenci', 'Affiliation': 'Department of Epidemiology and Biostatistics, Temple University, Philadelphia, PA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Riddle', 'Affiliation': 'Departments of Physical Therapy, Orthopaedic Surgery, and Rheumatology, Virginia Commonwealth University, Richmond, VA. Electronic address: dlriddle@vcu.edu.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2021.02.004']
362,33710288,Efficacy of Active vs Sham Intermittent Theta Burst Transcranial Magnetic Stimulation for Patients With Bipolar Depression: A Randomized Clinical Trial.,"Importance


Major depressive episodes in bipolar disorder are common and debilitating. Repetitive transcranial magnetic stimulation is well established in the treatment of major depressive disorder, and the intermittent theta burst stimulation (iTBS) protocol is replacing conventional protocols because of noninferiority and reduced delivery time. However, iTBS has not been adequately studied in bipolar disorder and, therefore, its efficacy is uncertain.
Objective


To determine whether iTBS to the left dorsolateral prefrontal cortex (LDLPFC) is safe and efficacious in the treatment of acute bipolar depression.
Design, Setting, and Participants


This study was a double-blind, 4-week, randomized clinical trial of iTBS targeting the LDLPFC. Two Canadian academic centers recruited patients between 2016 and 2020. Adults with bipolar disorder type I or type II experiencing an acute major depressive episode were eligible if they had not benefited from a first-line treatment for acute bipolar depression recommended by the Canadian Network for Mood and Anxiety Treatments and were currently treated with a mood stabilizer, an atypical antipsychotic, or their combination. Seventy-one participants were assessed for eligibility, and 37 were randomized to daily sham iTBS or active iTBS using a random number sequence, stratified according to current pharmacotherapy. Data analysis was performed from April to September 2020.
Interventions


Four weeks of daily active iTBS (120% resting motor threshold) or sham iTBS to the LDLPFC. Nonresponders were eligible for 4 weeks of open-label iTBS.
Main Outcomes and Measures


The primary outcome was the change in score on the Montgomery-Asberg Depression Rating Scale from baseline to study end. Secondary outcomes included clinical response, remission, and treatment-emergent mania or hypomania.
Results


The trial was terminated for futility after 37 participants (23 women [62%]; mean [SD] age, 43.86 [13.87] years; age range, 20-68 years) were randomized, 19 to sham iTBS and 18 to active iTBS. There were no significant differences in Montgomery-Asberg Depression Rating Scale score changes (least squares mean difference between groups, -1.36 [95% CI, -8.92 to 6.19; P = .91] in favor of sham iTBS), and rates of clinical response were low in both the double-blind phase (3 of 19 participants [15.8%] in the sham iTBS group and 3 of 18 participants [16.7%] in the active iTBS group) and open-label phase (5 of 21 participants [23.8%]). One active iTBS participant had a treatment emergent hypomania, and a second episode occurred during open-label treatment.
Conclusions and Relevance


iTBS targeting the LDLPFC is not efficacious in the treatment of acute bipolar depression in patients receiving antimanic or mood stabilizing agents. Additional research is required to understand how transcranial magnetic stimulation treatment protocols differ in efficacy between unipolar and bipolar depression.
Trial Registration


ClinicalTrials.gov Identifier: NCT02749006.",2021,"There were no significant differences in Montgomery-Asberg Depression Rating Scale score changes (least squares mean difference between groups, -1.36 [95% CI, -8.92 to 6.19; P = .91] in favor of sham iTBS), and rates of clinical response were low in both the double-blind phase (3 of 19 participants [15.8%] in the sham iTBS group and 3 of 18 participants [16.7%] in the active iTBS group) and open-label phase (5 of 21 participants [23.8%]).","['Seventy-one participants were assessed for eligibility, and 37 were randomized to', 'Two Canadian academic centers recruited patients between 2016 and 2020', 'Patients With Bipolar Depression', 'patients receiving antimanic or mood stabilizing agents', '37 participants (23 women [62%]; mean [SD] age, 43.86\u2009[13.87] years; age range, 20-68 years', 'Adults with bipolar disorder type I or type II experiencing an acute major depressive episode were eligible if they had not benefited from a first-line treatment for acute bipolar depression recommended by the Canadian Network for Mood and Anxiety Treatments and were currently treated with a mood stabilizer, an atypical antipsychotic, or their combination']","['Active vs Sham Intermittent Theta Burst Transcranial Magnetic Stimulation', 'iTBS', 'LDLPFC', 'Repetitive transcranial magnetic stimulation', 'daily sham iTBS or active iTBS']","['rates of clinical response', 'Montgomery-Asberg Depression Rating Scale score changes', 'clinical response, remission, and treatment-emergent mania or hypomania', 'change in score on the Montgomery-Asberg Depression Rating Scale']","[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0242911', 'cui_str': 'Antimanics'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038113', 'cui_str': 'Stabilizing Agents'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0558208', 'cui_str': 'Anxiety about treatment'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0241934', 'cui_str': 'Hypomania'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",71.0,0.387724,"There were no significant differences in Montgomery-Asberg Depression Rating Scale score changes (least squares mean difference between groups, -1.36 [95% CI, -8.92 to 6.19; P = .91] in favor of sham iTBS), and rates of clinical response were low in both the double-blind phase (3 of 19 participants [15.8%] in the sham iTBS group and 3 of 18 participants [16.7%] in the active iTBS group) and open-label phase (5 of 21 participants [23.8%]).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'McGirr', 'Affiliation': 'Department of Psychiatry, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Fidel', 'Initials': 'F', 'LastName': 'Vila-Rodriguez', 'Affiliation': 'Non-Invasive Neurostimulation Therapies Laboratory, Department of Psychiatry, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jaeden', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'Department of Psychiatry, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Ivan J', 'Initials': 'IJ', 'LastName': 'Torres', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Shyam Sundar', 'Initials': 'SS', 'LastName': 'Arumugham', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Keramatian', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Gayatri', 'Initials': 'G', 'LastName': 'Saraf', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Chakrabarty', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lakshmi N', 'Initials': 'LN', 'LastName': 'Yatham', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.0963']
363,33722866,Effect of free distribution of medicines on the process of care for adult patients with type 1 and type 2 diabetes and hypertension: post hoc analysis of randomised controlled trial findings.,"OBJECTIVES


The Carefully Selected and Easily Accessible at No charge Medicines randomised controlled trial showed that patients receiving free access to medicines had improved diabetes and hypertension outcomes compared with patients who had usual access to medicines. In this study, we aimed to test the impact of providing free access to medicine to people with diabetes and hypertension on process of care indicators.
DESIGN


In this post hoc analysis of randomised controlled trial findings, we identified process of care indicators for the management of diabetes and hypertension using relevant guidelines. The following process of care indicators were identified for diabetes management: encounters with healthcare professionals, blood pressure measurements, self-monitoring of blood glucose, annual eye and foot examination, annual administration of the influenza vaccine, and laboratory testing for glycated haemoglobin (HbA1c), low-density lipoprotein-cholesterol, serum creatinine and urine albumin to creatinine ratio. We identified the following process of care indicators for hypertension: encounters with healthcare professionals, blood pressure measurements, self-measuring of blood pressure, and serum tests for electrolytes, HbA1c, lipids and creatinine. Chart extractions were performed for all patients and the indicators for diabetes and hypertension were recorded. We compared the indicators for patients in each arm of the trial.
RESULTS


The study included 268 primary care patients. Free distribution of medicines may improve self-monitoring behaviours (adjusted rate ratio (aRR) 1.30; 95% CI 0.66 to 2.57) and reduce missed primary care appointments for patients with diabetes (aRR 0.80; 95% CI 0.48 to 1.33) or hypertension (aRR 0.41; 95% CI 0.18 to 0.90). Free distribution may also reduce primary care and consultant appointments and laboratory testing in patients with hypertension.
CONCLUSIONS


Improving medicine accessibility for patients with diabetes and hypertension not only improves surrogate health outcomes but also improves the patient experience and may also reduce healthcare costs by encouraging self-monitoring.
TRIAL REGISTRATION NUMBER


The randomised controlled trial mentioned is clinicaltrials.gov identifier: NCT02744963.",2021,Free distribution of medicines may improve self-monitoring behaviours (adjusted rate ratio (aRR) 1.30; 95% CI 0.66 to 2.57) and reduce missed primary care appointments for patients with diabetes (aRR 0.80; 95% CI 0.48 to 1.33) or hypertension (aRR 0.41; 95% CI 0.18 to 0.90).,"['patients with hypertension', '268 primary care patients', 'adult patients with type 1 and type 2 diabetes and hypertension', 'patients with diabetes and hypertension', 'people with diabetes and hypertension on process of care indicators']",[],"['self-monitoring behaviours', 'healthcare costs', 'blood pressure measurements, self-monitoring of blood glucose, annual eye and foot examination, annual administration of the influenza vaccine, and laboratory testing for glycated haemoglobin (HbA1c), low-density lipoprotein-cholesterol, serum creatinine and urine albumin to creatinine ratio', 'blood pressure measurements, self-measuring of blood pressure, and serum tests for electrolytes, HbA1c, lipids and creatinine', 'diabetes and hypertension outcomes', 'surrogate health outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",[],"[{'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",268.0,0.166121,Free distribution of medicines may improve self-monitoring behaviours (adjusted rate ratio (aRR) 1.30; 95% CI 0.66 to 2.57) and reduce missed primary care appointments for patients with diabetes (aRR 0.80; 95% CI 0.48 to 1.33) or hypertension (aRR 0.41; 95% CI 0.18 to 0.90).,"[{'ForeName': 'Onella', 'Initials': 'O', 'LastName': 'Charles', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Woods', 'Affiliation': ""MAP Centre for Urban Health Solutions, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Muhamad', 'Initials': 'M', 'LastName': 'Ally', 'Affiliation': ""MAP Centre for Urban Health Solutions, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'Manns', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Baiju R', 'Initials': 'BR', 'LastName': 'Shah', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.'}, {'ForeName': 'Ri', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""MAP Centre for Urban Health Solutions, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Nav', 'Initials': 'N', 'LastName': 'Persaud', 'Affiliation': ""MAP Centre for Urban Health Solutions, St Michael's Hospital, Toronto, Ontario, Canada nav.persaud@utoronto.ca.""}]",BMJ open,['10.1136/bmjopen-2020-042046']
364,33692185,The control of pain due to dentin hypersensitivity in individuals with molar-incisor hypomineralisation: a protocol for a randomised controlled clinical trial.,"INTRODUCTION


Dentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: (1) the dentin must be exposed and (2) the dentinal tubules must be open and connected to the pulp. Molar-incisor hypomineralisation (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH. The aim of the proposed randomised, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH.
METHODS AND ANALYSIS


One hundred and forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with PermaSeal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL, AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, Brazil). In Group 4, sensitive teeth will be treated with both LLL and PermaSeal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated 1 week, 1 month, 3 months and 6 months after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale, to determine the effectiveness of the proposed treatments, as well as differences among the evaluation times for each proposed treatment.
ETHICS AND DISSEMINATION


This protocol has been ethically approved by the local medical ethical committee (protocol number: 4.020.261). Results will be submitted to international peer-reviewed journals and presented at international conferences.
TRIAL REGISTRATION NUMBER


NCT04407702.",2021,"Molar-incisor hypomineralisation (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH.","['patients with teeth affected by MIH', 'individuals with molar-incisor hypomineralisation', 'One hundred and forty patients who meet the inclusion criteria will be allocated to four groups']","['low-level laser (LLL, AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, Brazil', 'control group (placebo']",['change in pain/sensitivity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C2350038', 'cui_str': 'Molar incisor hypomineralization'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1261077', 'cui_str': 'Structure of lower lobe of left lung'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0265286', 'cui_str': 'Dyggve-Melchior-Clausen syndrome'}, {'cui': 'C0445462', 'cui_str': 'Carlos'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.117438,"Molar-incisor hypomineralisation (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH.","[{'ForeName': 'Ana Paula Taboada', 'Initials': 'APT', 'LastName': 'Sobral', 'Affiliation': 'School of Dentistry, Universidade Metropolitana de Santos, Santos, SP, Brazil.'}, {'ForeName': 'Elaine Marcilio', 'Initials': 'EM', 'LastName': 'Santos', 'Affiliation': 'School of Dentistry, Universidade Metropolitana de Santos, Santos, SP, Brazil.'}, {'ForeName': 'Ana Cecilia', 'Initials': 'AC', 'LastName': 'Aranha', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Paulo Vinícius', 'Initials': 'PV', 'LastName': 'Soares', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Universidade Federal de Uberlândia, Uberlândia, MG, Brazil.'}, {'ForeName': 'Caroline Moraes', 'Initials': 'CM', 'LastName': 'Moriyama', 'Affiliation': 'School of Dentistry, Universidade Metropolitana de Santos, Santos, SP, Brazil.'}, {'ForeName': 'Marcela Leticia Leal', 'Initials': 'MLL', 'LastName': 'Gonçalves', 'Affiliation': 'School of Dentistry, Universidade Metropolitana de Santos, Santos, SP, Brazil.'}, {'ForeName': 'Rodrigo Alves', 'Initials': 'RA', 'LastName': 'Ribeiro', 'Affiliation': 'School of Dentistry, Universidade Metropolitana de Santos, Santos, SP, Brazil.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Postgraduation Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, São Paulo, SP, Brazil.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Postgraduation Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, São Paulo, SP, Brazil.'}, {'ForeName': 'Kristianne Porta Santos', 'Initials': 'KPS', 'LastName': 'Fernandes', 'Affiliation': 'Postgraduation Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, São Paulo, SP, Brazil.'}, {'ForeName': 'Raquel Agnelli', 'Initials': 'RA', 'LastName': 'Mesquita-Ferrari', 'Affiliation': 'Postgraduation Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, São Paulo, SP, Brazil.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'School of Dentistry, Universidade Metropolitana de Santos, Santos, SP, Brazil sandra.skb@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2020-044653']
365,33692183,Scheduled Prophylactic 6-Hourly IV AcetaminopheN to Prevent Postoperative Delirium in Older CaRdiac SurgicAl Patients (PANDORA): protocol for a multicentre randomised controlled trial.,"INTRODUCTION


Postoperative delirium is common among older cardiac surgery patients. Often difficult to predict and address prophylactically, delirium complicates the postoperative course by increasing morbidity and mortality as well as prolonging both hospital and intensive care unit (ICU) lengths of stay. Based on our pilot trial, we intend to study the effect of scheduled 6-hourly acetaminophen administration for 48 hours post-cardiac surgery with cardiopulmonary bypass (CPB) on the incidence of in-hospital delirium and long-term neurocognitive outcomes. Additionally, effect on duration and severity of delirium, rescue analgesic consumption, acute and chronic pain scores and lengths of hospital and ICU stay will also be explored.
METHODS AND ANALYSIS


This multicentre, randomised, placebo-controlled, quadruple-blinded trial will include 900 older (>60 years) cardiac surgical patients requiring CPB. Patients meeting the inclusion criteria and not meeting any exclusion criteria will be enrolled at seven centres across the USA with Beth Israel Deaconess Medical Center (BIDMC), Boston, as the central coordinating centre. Additional sites may be included to broaden or speed accrual. The primary outcome measure is the incidence of in-hospital delirium till day 30. Secondary outcomes include the duration and severity of in-hospital delirium, hospital and ICU lengths of stay, postoperative pain scores, postoperative rescue analgesic consumption, postoperative cognitive function and chronic sternal pain. Creation of a biorepository and the use of intraoperative-blinded electroencephalogram (EEG) and cerebral oximetry data will support exploratory endpoints to determine mechanistic predictors of postoperative delirium.
ETHICS AND DISSEMINATION


This trial is approved and centrally facilitated by the Institutional Review Board at BIDMC. An independent Data Safety and Monitoring Board is responsible for maintaining safety oversight. Protocol # 2019 P00075, V.1.4 (dated 20 October 2020).
TRIAL REGISTRATION NUMBER


NCT04093219.",2021,"Secondary outcomes include the duration and severity of in-hospital delirium, hospital and ICU lengths of stay, postoperative pain scores, postoperative rescue analgesic consumption, postoperative cognitive function and chronic sternal pain.","['older cardiac surgery patients', '900 older (>60 years) cardiac surgical patients requiring CPB', '48 hours post-cardiac surgery with', 'Patients meeting the inclusion criteria and not meeting any exclusion criteria will be enrolled at seven centres across the USA with Beth Israel Deaconess Medical Center (BIDMC), Boston, as the central coordinating centre', 'Older CaRdiac SurgicAl Patients (PANDORA']","['placebo', 'Prophylactic 6-Hourly IV AcetaminopheN', 'scheduled 6-hourly acetaminophen', 'cardiopulmonary bypass (CPB', 'intraoperative-blinded electroencephalogram (EEG) and cerebral oximetry data']","['duration and severity of in-hospital delirium, hospital and ICU lengths of stay, postoperative pain scores, postoperative rescue analgesic consumption, postoperative cognitive function and chronic sternal pain', 'Postoperative Delirium', 'duration and severity of delirium, rescue analgesic consumption, acute and chronic pain scores and lengths of hospital and ICU stay', 'incidence of in-hospital delirium till day 30']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0241243', 'cui_str': 'Sternal pain'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.691219,"Secondary outcomes include the duration and severity of in-hospital delirium, hospital and ICU lengths of stay, postoperative pain scores, postoperative rescue analgesic consumption, postoperative cognitive function and chronic sternal pain.","[{'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Khera', 'Affiliation': 'Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Pooja A', 'Initials': 'PA', 'LastName': 'Mathur', 'Affiliation': 'Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Valerie M', 'Initials': 'VM', 'LastName': 'Banner-Goodspeed', 'Affiliation': 'Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Narayanan', 'Affiliation': 'Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Mcgourty', 'Affiliation': 'Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Kelly', 'Affiliation': 'Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Palihnich', 'Affiliation': 'Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Novack', 'Affiliation': 'Soroka University Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Davis', 'Affiliation': 'Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Talmor', 'Affiliation': 'Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Marcantonio', 'Affiliation': 'Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Balachundhar', 'Initials': 'B', 'LastName': 'Subramaniam', 'Affiliation': 'Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA bsubrama@bidmc.harvard.edu.'}]",BMJ open,['10.1136/bmjopen-2020-044346']
366,33692177,Establishing and augmenting views on the acceptability of a paediatric critical care randomised controlled trial (the FEVER trial): a mixed methods study.,"OBJECTIVE


To explore parent and staff views on the acceptability of a randomised controlled trial investigating temperature thresholds for antipyretic intervention in critically ill children with fever and infection (the FEVER trial) during a multi-phase pilot study.
DESIGN


Mixed methods study with data collected at three time points: (1) before, (2) during and (3) after a pilot trial.
SETTING


English, Paediatric Intensive Care Units (PICUs).
PARTICIPANTS


(1) Pre-pilot trial focus groups with pilot site staff (n=56) and interviews with parents (n=25) whose child had been admitted to PICU in the last 3 years with a fever and suspected infection, (2) Questionnaires with parents of randomised children following pilot trial recruitment (n=48 from 47 families) and (3) post-pilot trial interviews with parents (n=19), focus groups (n=50) and a survey (n=48) with site staff. Analysis drew on Sekhon  et al 's theoretical framework of acceptability.
RESULTS


There was initial support for the trial, yet some held concerns regarding the proposed temperature thresholds and not using paracetamol for pain or discomfort. Pre-trial findings informed protocol changes and training, which influenced views on trial acceptability. Staff trained by the FEVER team found the trial more acceptable than those trained by colleagues. Parents and staff found the trial acceptable. Some concerns about pain or discomfort during weaning from ventilation remained.
CONCLUSIONS


Pre-trial findings and pilot trial experience influenced acceptability, providing insight into how challenges may be overcome. We present an adapted theoretical framework of acceptability to inform future trial feasibility studies.
TRIAL REGISTRATION NUMBERS


ISRCTN16022198 and NCT03028818.",2021,Staff trained by the FEVER team found the trial more acceptable than those trained by colleagues.,"['1) Pre-pilot trial focus groups with pilot site staff (n=56) and interviews with parents (n=25) whose child had been admitted to PICU in the last 3\u2009years with a fever and suspected infection, (2) Questionnaires with parents of randomised children following pilot trial recruitment (n=48 from 47 families) and (3) post-pilot trial interviews with parents (n=19), focus groups (n=50) and a survey (n=48) with site staff', 'critically ill children with fever and infection (the FEVER trial) during a multi-phase pilot study', 'English, Paediatric Intensive Care Units (PICUs']","['antipyretic intervention', 'paracetamol']",['pain or discomfort'],"[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}]","[{'cui': 'C0003419', 'cui_str': 'Antipyretic Agents'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.189235,Staff trained by the FEVER team found the trial more acceptable than those trained by colleagues.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Deja', 'Affiliation': 'Public Health, Policy and Systems, University of Liverpool, Liverpool, UK e.deja@liverpool.ac.uk.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Trust, London, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Institute of Population Health Sciences, Queen Mary University of London, London, UK.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Agbeko', 'Affiliation': ""Paediatric Intensive Care Unit, Great North Children's Hospital, Newcastle Upon Tyne, UK.""}, {'ForeName': 'Blaise', 'Initials': 'B', 'LastName': 'Fenn', 'Affiliation': 'Patient partner, London, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Watkins', 'Affiliation': 'Patient partner, London, UK.'}, {'ForeName': 'Padmanabhan', 'Initials': 'P', 'LastName': 'Ramnarayan', 'Affiliation': ""Children's Acute Transport Service, Great Ormond Street Hospital for Children, London, UK.""}, {'ForeName': 'Shane M', 'Initials': 'SM', 'LastName': 'Tibby', 'Affiliation': ""Paediatric Intensive Care Unit, Evelina London Children's Hospital, London, UK.""}, {'ForeName': 'Kentigern', 'Initials': 'K', 'LastName': 'Thorburn', 'Affiliation': ""Paediatric Intensive Care Unit, Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Lyvonne N', 'Initials': 'LN', 'LastName': 'Tume', 'Affiliation': 'School of Health and Society, University of Salford, Salford, UK.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Woolfall', 'Affiliation': 'Public Health, Policy and Systems, University of Liverpool, Liverpool, UK.'}]",BMJ open,['10.1136/bmjopen-2020-041952']
367,33707216,Home-based exercise in patients with refractory fatigue associated with primary biliary cholangitis: a protocol for the EXerCise Intervention in cholesTatic LivEr Disease (EXCITED) feasibility trial.,"INTRODUCTION


Fatigue is the most commonly reported symptom of the liver disease primary biliary cholangitis (PBC). It affects 40%-80% of patients, has no effective treatment and is associated with heightened mortality risk. The pathogenesis is unknown, but muscle bioenergetic abnormalities have been proposed to contribute. Directly observed exercise has been shown to attenuate symptoms in small groups; however, due to the rare nature of the disease, home-based interventions need to be evaluated for feasibility, safety and efficacy.
METHODS AND ANALYSIS


This is a phase 1/pilot, single-arm, open-label clinical trial evaluating a novel home-based exercise programme in patients with PBC with severe fatigue. Forty patients with moderate-severe fatigue (PBC40 fatigue domain score >33; other causes of fatigue excluded) will be selected using a convenience sampling method. A 12-week home-based exercise programme, consisting of individualised resistance, aerobic exercises and telephone health calls (first 6 weeks only), will be delivered. Measures of fatigue (PBC40 fatigue domain; fatigue impact scale), quality of life, sleep (Epworth Sleep Score), physical activity, anxiety and depression, aerobic exercise capacity (incremental shuttle walk test; Duke Activity Status Index) and functional capacity (short physical performance battery) will be assessed at baseline and at 6 and 12 weeks following the intervention.
ETHICS AND DISSEMINATION


The protocol is approved by the National Research Ethics Service Committee London (IRAS 253115). Recruitment commenced in April 2019 and ended in March 2020. Participant follow-up is due to finish by December 2020. Findings will be disseminated through peer-reviewed publication, conference presentation and social media.
TRIAL REGISTRATION NUMBER


NCT04265235.",2021,"Measures of fatigue (PBC40 fatigue domain; fatigue impact scale), quality of life, sleep (Epworth Sleep Score), physical activity, anxiety and depression, aerobic exercise capacity (incremental shuttle walk test; Duke Activity Status Index) and functional capacity (short physical performance battery) will be assessed at baseline and at 6 and 12 weeks following the intervention.
","['patients with PBC with severe fatigue', 'liver disease primary biliary cholangitis (PBC', 'Forty patients with moderate-severe fatigue (PBC40 fatigue domain score >33; other causes of fatigue excluded', 'patients with refractory fatigue associated with primary biliary cholangitis']","['novel home-based exercise programme', 'EXerCise Intervention', 'home-based exercise programme, consisting of individualised resistance, aerobic exercises and telephone health calls', 'Home-based exercise']","['fatigue (PBC40 fatigue domain; fatigue impact scale), quality of life, sleep (Epworth Sleep Score), physical activity, anxiety and depression, aerobic exercise capacity (incremental shuttle walk test; Duke Activity Status Index) and functional capacity (short physical performance battery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C4720913', 'cui_str': 'Duke activity status index'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}]",,0.14515,"Measures of fatigue (PBC40 fatigue domain; fatigue impact scale), quality of life, sleep (Epworth Sleep Score), physical activity, anxiety and depression, aerobic exercise capacity (incremental shuttle walk test; Duke Activity Status Index) and functional capacity (short physical performance battery) will be assessed at baseline and at 6 and 12 weeks following the intervention.
","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Freer', 'Affiliation': 'NIHR Birmingham BRC and Centre for Liver and Gastrointestinal Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Williams', 'Affiliation': 'NIHR Birmingham BRC and Centre for Liver and Gastrointestinal Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Durman', 'Affiliation': 'Department of Physiotherapy, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hayden', 'Affiliation': 'Liver Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Palak J', 'Initials': 'PJ', 'LastName': 'Trivedi', 'Affiliation': 'NIHR Birmingham BRC and Centre for Liver and Gastrointestinal Research, University of Birmingham, Birmingham, UK p.j.trivedi@bham.ac.uk.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Armstrong', 'Affiliation': 'Liver Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}]",BMJ open gastroenterology,['10.1136/bmjgast-2020-000579']
368,33704590,Correction to: Behavior-analytic intervention for women with fibromyalgia and insomnia: a single subject design.,,2021,,['women with fibromyalgia and insomnia'],['Behavior-analytic intervention'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0660005,,"[{'ForeName': 'Luziane', 'Initials': 'L', 'LastName': 'de Fátima Kirchner', 'Affiliation': 'Federal Univerisity of São Carlos-UFSCar, KM 235 Washington Luis, São Carlos and São Paulo, 13565-905, Brazil. luzianefk@gmail.com.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'de Jesus Dutra Dos Reis', 'Affiliation': 'Federal Univerisity of São Carlos-UFSCar, KM 235 Washington Luis, São Carlos and São Paulo, 13565-905, Brazil.'}]","Psicologia, reflexao e critica : revista semestral do Departamento de Psicologia da UFRGS",['10.1186/s41155-021-00173-0']
369,33724256,Effects of celecoxib augmentation of antidepressant or anxiolytic treatment on affective symptoms and inflammatory markers in patients with anxiety disorders: exploratory study.,"Prolonged stress has been associated with elevated levels of circulating proinflammatory cytokines. Cyclo-oxygenase-2 inhibitors such as celecoxib exert anti-inflammatory effects and may enhance the response to antidepressant drug treatment in patients with depressive disorders, but their effect on anxiety symptoms in patients with anxiety disorders is uncertain. Patients with a primary diagnosis of an anxiety disorder, with stabilised symptoms, underwent either 6 weeks of celecoxib augmentation of continued treatment (n = 18) or continued 'treatment as usual' (n = 9). Assessments included the Warwick-Edinburgh mental well-being Scale (WEMWEBS), Hospital Anxiety and Depression Scale (HADS), Oxford questionnaire of emotional side effects of antidepressants (OQUESA) and Clinical Global Impression of Illness Severity (CGI-S). Venous blood samples were collected for assays of inflammatory cytokines. Patients who underwent celecoxib augmentation showed significant reductions in anxiety (HADS-A -3.17) and depressive (HADS-D -2.11) symptoms and in overall illness severity (CGI-S -1.11), and improvements in mental well-being (WEMWBS 7.5) and positive changes in emotional responsiveness (OQUESA-RP -3.56; OQUESA-AC -4.22): these were not seen with 'treatment as usual'. There were no significant changes in blood levels of inflammatory cytokines in either group. Celecoxib augmentation appeared associated with beneficial effects on anxiety and depressive symptoms and mental well-being. The findings from this pilot study merit further exploration within a double-blind, randomised placebo-controlled study.",2021,"RESULTS


Patients who underwent celecoxib augmentation showed significant reductions in anxiety (HADS-A -3.17) and depressive (HADS-D -2.11) symptoms and in overall illness severity (CGI-S -1.11), and improvements in mental well-being (WEMWBS 7.5) and positive changes in emotional responsiveness (OQUESA-RP -3.56; OQUESA-AC -4.22): these were not seen with 'treatment as usual'.","[""Patients with a primary diagnosis of an anxiety disorder, with stabilised symptoms, underwent either 6 weeks of celecoxib augmentation of continued treatment (n = 18) or continued 'treatment as usual' (n = 9"", 'patients with anxiety disorders', 'patients with depressive disorders']","['antidepressant or anxiolytic treatment', 'celecoxib', 'Celecoxib', 'placebo']","['emotional responsiveness', 'anxiety and depressive symptoms and mental well-being', 'Warwick-Edinburgh mental well-being scale (WEMWEBS), hospital anxiety and depression scale (HADS), Oxford questionnaire of emotional side effects of antidepressants (OQUESA) and clinical global impression of illness severity (CGI-S', 'Venous blood samples', 'blood levels of inflammatory cytokines', 'affective symptoms and inflammatory markers', 'anxiety (HADS-A -3.17) and depressive (HADS-D -2.11) symptoms and in overall illness severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4273514', 'cui_str': 'Warwick Edinburgh Mental Well Being Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4517686', 'cui_str': '3.17'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0866936,"RESULTS


Patients who underwent celecoxib augmentation showed significant reductions in anxiety (HADS-A -3.17) and depressive (HADS-D -2.11) symptoms and in overall illness severity (CGI-S -1.11), and improvements in mental well-being (WEMWBS 7.5) and positive changes in emotional responsiveness (OQUESA-RP -3.56; OQUESA-AC -4.22): these were not seen with 'treatment as usual'.","[{'ForeName': 'Hesham Y', 'Initials': 'HY', 'LastName': 'Elnazer', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, Chichester.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Sampson', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Baldwin', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000356']
370,33722597,Bayesian hierarchical evaluation of dose-response for peanut allergy in clinical trial screening.,"Risk-based labeling based on the minimal eliciting doses (EDs) in sensitized populations is a potential replacement for precautionary allergen labeling of food allergens. We estimated the dose-response distribution for peanut allergen using data from double-blind placebo-controlled food challenges (DBPCFCs) conducted in the US at multiple sites, testing a population believed to be similar to the general U.S. food allergic population. Our final (placebo-adjusted) dataset included 548 challenges of 481 subjects. Bayesian hierarchical analysis facilitated model fitting, and accounted for variability associated with various levels of data organization. The data are best described using a complex hierarchical structure that accounts for inter-individual variability and variability across study locations or substudies. Bayesian model averaging could simultaneously consider the fit of multiple models, but the Weibull model dominated so strongly that model averaging was not needed. The ED01 and ED05 (and 95% credible intervals) are 0.052 (0.021, 0.13) and 0.49 (0.22, 0.97) mg peanut protein, respectively. Accounting for challenges with severe reactions at the LOAEL, by using the dose prior to the LOAEL as the new LOAEL, the ED01 drops to 0.029 (0.014, 0.074) mg peanut protein. Our results could aid in establishing improved food labeling guidelines in the management of food allergies.",2021,"Bayesian model averaging could simultaneously consider the fit of multiple models, but the Weibull model dominated so strongly that model averaging was not needed.",['548 challenges of 481 subjects'],['placebo-controlled food challenges (DBPCFCs'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]",[],548.0,0.0674927,"Bayesian model averaging could simultaneously consider the fit of multiple models, but the Weibull model dominated so strongly that model averaging was not needed.","[{'ForeName': 'Lynne T', 'Initials': 'LT', 'LastName': 'Haber', 'Affiliation': 'University of Cincinnati, Department of Environmental and Public Health Sciences, 160 Panzeca Way, Cincinnati, OH, 45267, USA. Electronic address: Lynne.Haber@uc.edu.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Reichard', 'Affiliation': 'University of Cincinnati, Department of Environmental and Public Health Sciences, 160 Panzeca Way, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Alice K', 'Initials': 'AK', 'LastName': 'Henning', 'Affiliation': 'The Emmes Company, LLC, 401 North Washington St., Suite 700, Rockville, MD, 20850, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'The Emmes Company, LLC, 401 North Washington St., Suite 700, Rockville, MD, 20850, USA.'}, {'ForeName': 'R Sharon', 'Initials': 'RS', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University and Division of Pulmonary, Allergy, & Critical Care Medicine, Department of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Sayantani B', 'Initials': 'SB', 'LastName': 'Sindher', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University and Division of Pulmonary, Allergy, & Critical Care Medicine, Department of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Long', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University and Division of Pulmonary, Allergy, & Critical Care Medicine, Department of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Vincent', 'Affiliation': 'University of Cincinnati, Department of Environmental and Public Health Sciences, 160 Panzeca Way, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University and Division of Pulmonary, Allergy, & Critical Care Medicine, Department of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Allen', 'Affiliation': 'Independent Consultant, 101 Corbin Hill Circle, Chapel Hill, NC, 27514, USA.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2021.112125']
371,32970962,Endotypic Mechanisms of Successful Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea.,"Rationale:  Approximately one-third of patients with obstructive sleep apnea (OSA) treated with hypoglossal nerve stimulation (HGNS) therapy are incomplete responders, despite careful patient selection based on baseline characteristics and drug-induced sleep endoscopy. Objectives:  Here we use polysomnographic endotyping to assess the pathophysiological mechanisms underlying favorable versus incomplete responses to HGNS therapy. Methods:  Baseline polysomnography data of the STAR (Stimulation Therapy for Apnea Reduction) trial were included. Raw baseline polysomnographic data from 91/126 patients were available for analysis. Traits-loop gain, arousal threshold, collapsibility, and muscle compensation-were calculated from the baseline polysomnography data according to Sands and colleagues (AJRCCM 2018, SLEEP 2018). Logistic regression assessed apnea-hypopnea index (AHI)-adjusted associations between HGNS response (>50% reduction in AHI to <10/h at 1 yr) and OSA traits. Measurements and Main Results:  Overall, HGNS treatment reduced AHI from 30.7 (24.9-39.9) to 8.5 (4.0-19.5) events/h ( P  < 0.0001; median [quartiles 1-3]);  N  = 53/91 were responders. In adjusted analysis, a favorable response to therapy was independently associated with higher arousal threshold (odds ratio [95% confidence interval]: 6.76 [2.44-23.3],  P  = 0.001), greater compensation (odds ratio: 4.22 [1.70-12.55] per SD,  P  = 0.004), and lower loop gain (in milder collapsibility, per significant interaction,  P  = 0.003). The higher arousal threshold was evident in responders before adjusted analysis. Predicted responders had an approximately fourfold lower treatment AHI versus predicted nonresponders (4.9 [2.7-8.5] vs. 20.7 [10.9-29.7],  P  < 0.0001; median [quartiles 1-3]); differences remained significant after cross-validation. Conclusions:  Favorable responses to HGNS therapy are associated with the pathophysiological traits causing OSA, particularly a higher arousal threshold. Along with established criteria, individuals with favorable traits could potentially be prioritized for precision HGNS therapy.This analysis was a secondary analysis of the STAR trial registered with clinicaltrials.gov (NCT01161420).",2021,"Predicted responders had an approximately fourfold lower treatment AHI versus predicted nonresponders (4.9 [2.7-8.5] vs. 20.7 [10.9-29.7],  P  < 0.0001; median [quartiles 1-3]); differences remained significant after cross-validation.","['Obstructive Sleep Apnea', 'patients with obstructive sleep apnea (OSA) treated with']","['HGNS therapy', 'hypoglossal nerve stimulation (HGNS) therapy', 'Successful Hypoglossal Nerve Stimulation', 'STAR (Stimulation Therapy']","['higher arousal threshold', 'Traits-loop gain, arousal threshold, collapsibility, and muscle compensation', 'apnea-hypopnea index', 'lower loop gain']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020614', 'cui_str': 'Hypoglossal nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.281439,"Predicted responders had an approximately fourfold lower treatment AHI versus predicted nonresponders (4.9 [2.7-8.5] vs. 20.7 [10.9-29.7],  P  < 0.0001; median [quartiles 1-3]); differences remained significant after cross-validation.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Op de Beeck', 'Affiliation': 'Translational Neurosciences, Faculty of Medicine and Health Sciences, and.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wellman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; and.""}, {'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Dieltjens', 'Affiliation': 'Translational Neurosciences, Faculty of Medicine and Health Sciences, and.'}, {'ForeName': 'Kingman P', 'Initials': 'KP', 'LastName': 'Strohl', 'Affiliation': 'Department of Medicine, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Willemen', 'Affiliation': 'Multidisciplinary Sleep Disorders Centre, and.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Van de Heyning', 'Affiliation': 'Translational Neurosciences, Faculty of Medicine and Health Sciences, and.'}, {'ForeName': 'Johan A', 'Initials': 'JA', 'LastName': 'Verbraecken', 'Affiliation': 'Laboratory of Experimental Medicine and Pediatrics, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Olivier M', 'Initials': 'OM', 'LastName': 'Vanderveken', 'Affiliation': 'Translational Neurosciences, Faculty of Medicine and Health Sciences, and.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; and.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202006-2176OC']
372,33727208,Office hysteroscopy before first in vitro fertilization. A randomized controlled trial.,"BACKGROUND


Implantation failure remains a mystery since decades. This procedure needs a ""top quality embryo"" and a ""normal"" uterine cavity. To assess uterine cavity before first in vitro fertilization (IVF), many diagnostic tools could be used. Hysteroscopy remains the gold standard to diagnose and treat intra-uterine anomalies. However, it is not clearly recommanded to offer an office hysteroscopy before first IVF when transvaginal ultrasound (TVUS) and hysterosalpingography (HSG) were normal.
PURPOSE


This study aimed to assess the role of office hysteroscopy before first IVF when no intra-uterine anomalies are suspected.
BASIC PROCEDURES


We conducted a randomized controlled trial including 171 women scheduled for their first IVF. Women were assigned to either Group I: office hysteroscopy before IVF or Group II: immediate IVF. We included women aged less than 40 years, having regular cycles, FSH levels less than10UI/l, antral follicular count ≥12, normal TVUS and HSG. Their body mass index (BMI) ranged from 19 to 30 kg/m 2 . We excluded patients known having severe endometriosis, polycystic ovarian syndrome (PCOS) and oocyte receivers. The primary outcome were livebirth rate and clinical pregnancy rate.
MAIN FUNDINGS


Between january 2016 and september 2017, we randomly assigned 171 women to either Group I (n = 84) or Group II (n = 87). Hysteroscopy was done in the mid-follicular phase immediately before IVF. Baseline characteristics and IVF features were comparable between groups except for the IVF protocol. Live birth rate was 23,9% in Group I versus 19,3% in Group II. (p = 0,607). Clinical Pregnancy rate was 32,4% in Group I versus 21,7% in Group II. (p = 0,326). No statistical significance was observed for neither miscarriage rate nor multiple pregnancy rate. Hysteroscopy showed 30% unsuspected intra-uterine anomalies: 11 intra-uterine adhesions, 7 polyps, 7 clinical endometritis and one fibroid print. Therapeutic hysteroscopy was done only for 6 intra-uterine adhesions and 3 polyps. Other anomalies did not require operative hysteroscopy. Visual analog score during hysteroscopy was 4,69 +/-2,892. 5 women (6%) of Group I experienced discomfort during diagnostic hysteroscopy. Only one patient had vagal syncope. No further complications were observed.
PRINCIPAL CONCLUSIONS


Office hysteroscopy before first IVF seems not improve IVF results. Minimal intra-uterine anomalies not diagnosed by transvaginal ultrasound and hysterosalpingography do not seem to reduce IVF results.",2021,No statistical significance was observed for neither miscarriage rate nor multiple pregnancy rate.,"['women aged less than 40 years, having regular cycles, FSH levels less than10UI/l, antral follicular count ≥12, normal TVUS and HSG', '171 women scheduled for their first IVF', 'Between january 2016 and september 2017', 'patients known having severe endometriosis, polycystic ovarian syndrome (PCOS) and oocyte receivers']","['office hysteroscopy before IVF or Group II: immediate IVF', 'office hysteroscopy before first IVF', 'transvaginal ultrasound (TVUS) and hysterosalpingography (HSG', 'Therapeutic hysteroscopy', 'transvaginal ultrasound and hysterosalpingography']","['discomfort during diagnostic hysteroscopy', 'miscarriage rate nor multiple pregnancy rate', 'Clinical Pregnancy rate', 'Live birth rate', 'Visual analog score', 'vagal syncope', 'livebirth rate and clinical pregnancy rate', 'Baseline characteristics and IVF features']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0404017', 'cui_str': 'Therapeutic endoscopic operations on uterus'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0419373', 'cui_str': 'Livebirth'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",171.0,0.290078,No statistical significance was observed for neither miscarriage rate nor multiple pregnancy rate.,"[{'ForeName': 'Haifa', 'Initials': 'H', 'LastName': 'Ben Abid', 'Affiliation': 'Department of Reproductive Medicine, Farhat Hached Teaching Hospital, Ibn Jazzar Avenue, Sousse Ezzouhour, 4031, Tunisia. Electronic address: haifa.benabid@hotmail.fr.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Fekih', 'Affiliation': 'Department of Reproductive Medicine, Farhat Hached Teaching Hospital, Ibn Jazzar Avenue, Sousse Ezzouhour, 4031, Tunisia. Electronic address: fekihm2002@yahoo.fr.'}, {'ForeName': 'Khadija', 'Initials': 'K', 'LastName': 'Fathallah', 'Affiliation': 'Department of Reproductive Medicine, Farhat Hached Teaching Hospital, Ibn Jazzar Avenue, Sousse Ezzouhour, 4031, Tunisia. Electronic address: khadija.fathallah@gmail.com.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Chachia', 'Affiliation': 'Department of Reproductive Medicine, Farhat Hached Teaching Hospital, Ibn Jazzar Avenue, Sousse Ezzouhour, 4031, Tunisia. Electronic address: salmachachia@gmail.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bibi', 'Affiliation': 'Department of Reproductive Medicine, Farhat Hached Teaching Hospital, Ibn Jazzar Avenue, Sousse Ezzouhour, 4031, Tunisia. Electronic address: hammadi.bibi@yahoo.fr.'}, {'ForeName': 'Hedi', 'Initials': 'H', 'LastName': 'Khairi', 'Affiliation': 'Department of Reproductive Medicine, Farhat Hached Teaching Hospital, Ibn Jazzar Avenue, Sousse Ezzouhour, 4031, Tunisia. Electronic address: hedi.khairi@rns.tn.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2021.102109']
373,33730409,The impact of bolgerization versus partial resection of the middle turbinate on frontal sinusotomy patency outcome: A randomised controlled study.,"OBJECTIVES


This study aimed to compare the effects of middle turbinate resection vs bolgerization on the incidence of middle meatus synechia and their prognostic value on the patency outcomes after frontal sinusotomy.
DESIGN


A randomised controlled study.
SETTING


Tertiary centre hospital.
MAIN OUTCOME MEASURES


Thirty-eight patients undergoing bilateral frontal sinusotomy for chronic frontal sinusitis were included. Partial middle turbinate resection was alternated with bolgerization in both nasal cavities of every patient. The Lund-Kennedy endoscopic scores (LKESs) for both sides were compared at the first, third and sixth months postoperatively. Middle meatus synechia was assessed using the visual analogue score (VAS). Sinus patency was assessed at the end of the sixth month using a 70° nasal endoscope.
RESULTS


The sinus patency outcome was significantly higher in the resected group (34\38) than the bolgerized group (26\38), (P = .047*). The VAS scores suggested that the middle turbinate bolgerization group showed a significantly higher incidence of middle meatal synechia than the partial middle turbinate resection group (4.47 ± 2.617 vs 3.29 ± 2.301; P = .040*).
CONCLUSION


Middle turbinate resection showed more favourable results than bolgerization concerning the sinus patency outcome after frontal sinusotomy. It also showed a lower incidence of middle meatus synechia postoperatively.",2021,"The VAS scores suggested that the middle turbinate bolgerization group showed a significantly higher incidence of middle meatal synechia than the partial middle turbinate resection group (4.47 ± 2.617 vs 3.29 ± 2.301; p = 0.040*).
",['Thirty-eight patients undergoing bilateral frontal sinusotomy for chronic frontal sinusitis'],"['middle turbinate resection versus bolgerization', 'Bolgerization versus Partial Resection of the Middle Turbinate']","['incidence of middle meatal synechia', 'sinus patency outcome', 'Frontal Sinusotomy Patency Outcome', 'VAS scores', 'Sinus patency', 'visual analogue score (VAS', 'Lund-Kennedy endoscopic scores (LKESs']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0189113', 'cui_str': 'Frontal sinusotomy'}, {'cui': 'C0008683', 'cui_str': 'Chronic frontal sinusitis'}]","[{'cui': 'C0225435', 'cui_str': 'Middle nasal turbinate structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0154933', 'cui_str': 'Adhesions of iris'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0189113', 'cui_str': 'Frontal sinusotomy'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",38.0,0.0722441,"The VAS scores suggested that the middle turbinate bolgerization group showed a significantly higher incidence of middle meatal synechia than the partial middle turbinate resection group (4.47 ± 2.617 vs 3.29 ± 2.301; p = 0.040*).
","[{'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Khafagy', 'Affiliation': 'Otorhinolaryngology, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ghonim', 'Affiliation': 'Otorhinolaryngology, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elgendy', 'Affiliation': 'Otorhinolaryngology, Faculty of medicine, Kafrelsheikh University, Kafrelsheikh, Egypt.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Elzayat', 'Affiliation': 'Otorhinolaryngology, Faculty of medicine, Kafrelsheikh University, Kafrelsheikh, Egypt.'}]",Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery,['10.1111/coa.13758']
374,33687463,Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial.,"Importance


Cervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results.
Objective


To determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year.
Design, Setting, and Participants


Randomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020.
Interventions


Patients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon's discretion.
Main Outcomes and Measures


The primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score.
Results


Among 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%).
Conclusions and Relevance


Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach.
Trial Registration


ClinicalTrials.gov Identifier: NCT02076113.",2021,"SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86).","['163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years', 'patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020', 'Patients', 'patients with cervical spondylotic myelopathy undergoing cervical spinal surgery']","['ventral surgery (n\u2009=\u200963) or dorsal surgery', 'Cervical Spondylotic Myelopathy', 'Ventral surgery involved anterior cervical disk removal and instrumented fusion', 'Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty', 'Ventral vs Dorsal Spinal Surgery', 'dorsal surgery (fusion or laminoplasty']","['included dysphagia', 'new neurological deficit', 'Rates of complications', '1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference\u2009=\u20095', 'dorsal surgery', 'SF-36 PCS mean improvement', 'patient-reported physical functioning', 'reoperations', '1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C1535956', 'cui_str': 'Laminaplasty'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.310609,"SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86).","[{'ForeName': 'Zoher', 'Initials': 'Z', 'LastName': 'Ghogawala', 'Affiliation': 'Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Terrin', 'Affiliation': 'Tufts Clinical and Translational Science Institute, Tufts University, and Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Dunbar', 'Affiliation': 'Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Janis L', 'Initials': 'JL', 'LastName': 'Breeze', 'Affiliation': 'Tufts Clinical and Translational Science Institute, Tufts University, and Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Freund', 'Affiliation': 'Tufts Clinical and Translational Science Institute, Tufts University, and Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kanter', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburg, Pennsylvania.'}, {'ForeName': 'Praveen V', 'Initials': 'PV', 'LastName': 'Mummaneni', 'Affiliation': 'Department of Neurological Surgery, University of California, San Francisco.'}, {'ForeName': 'Erica F', 'Initials': 'EF', 'LastName': 'Bisson', 'Affiliation': 'Department of Neurosurgery Clinical Neurosciences Center, University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'Fred G', 'Initials': 'FG', 'LastName': 'Barker', 'Affiliation': 'Massachusetts General Hospital Brain Tumor Center, Boston.'}, {'ForeName': 'J Sanford', 'Initials': 'JS', 'LastName': 'Schwartz', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Harrop', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Subu N', 'Initials': 'SN', 'LastName': 'Magge', 'Affiliation': 'Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Heary', 'Affiliation': 'Department of Neurological Surgery, Hackensack Meridian School of Medicine, Nutley, New Jersey.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Fehlings', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Albert', 'Affiliation': 'Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Arnold', 'Affiliation': 'Carle Neuroscience Institute, Carle Foundation Hospital, Urbana, Illinois.'}, {'ForeName': 'K Daniel', 'Initials': 'KD', 'LastName': 'Riew', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Steinmetz', 'Affiliation': 'Neurosurgery, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Marjorie C', 'Initials': 'MC', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Whitmore', 'Affiliation': 'Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Heller', 'Affiliation': 'Emory Orthopaedics & Spine Center, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Benzel', 'Affiliation': 'Neurosurgery, Cleveland Clinic Foundation, Cleveland, Ohio.'}]",JAMA,['10.1001/jama.2021.1233']
375,33692176,Across-subjects multiple baseline trial of exposure-based cognitive-behavioral therapy for severe irritability: a study protocol.,"INTRODUCTION


Irritability is defined as a tendency towards anger in response to frustration. Clinically, impairing irritability is a significant public health problem. There is a need for mechanism-based psychotherapies targeting severe irritability as it manifests in the context of disruptive mood dysregulation disorder (DMDD). This study protocol describes a randomised multiple baseline design testing the preliminary efficacy of a new treatment, exposure-based cognitive-behavioral therapy for severe irritability in youth, which also integrates components of parent management training. We will investigate associations of this intervention with primary clinical measures, as well as ecological momentary assessment measures.
METHODS AND ANALYSIS


Forty youth will be enrolled. Participants, aged 8-17 years, must present at least one of two core symptoms of DMDD: abnormal mood or increased reactivity to negative emotional stimuli, with severe impairment in one domain (home, school, peers) and moderate in another, or moderate impairment in at least two domains. Each participant is randomised to a 2-week, 4-week or 6-week baseline observation period, followed by 12 active treatment sessions. Clinical ratings are conducted at baseline, biweekly (clinician), weekly (parent/child) throughout treatment, post-treatment, and 3-month and 6-month follow-up (clinician). Clinician ratings on the Affective Reactivity Index and Clinical Global Impressions-Improvement scale for DMDD are our primary outcome measures. Secondary outcome measures include parent and child reports of irritability. Post hoc additional symptom measures include clinician, parent and self-ratings of depression, anxiety and overall functional impairment. Prospective, digitally based event sampling of symptoms is acquired for a week pre-treatment, mid-treatment and post-treatment. Based on our pathophysiological model of irritability implicating frustrative non-reward, aberrant threat processing and instrumental learning, we probe these three brain-based targets using functional MRI paradigms to assess target engagement.
ETHICS AND DISSEMINATION


The research project and all related materials were submitted and approved by the appropriate Institutional Review Board (IRB) of the National Institute of Mental Health (NIMH).
TRIAL REGISTRATION NUMBERS


NCT02531893 and NCT00025935.",2021,Clinician ratings on the Affective Reactivity Index and Clinical Global Impressions-Improvement scale for DMDD are our primary outcome measures.,"['severe irritability', 'Participants, aged 8-17 years, must present at least one of two core symptoms of DMDD: abnormal mood or increased reactivity to negative emotional stimuli, with severe impairment in one domain (home, school, peers) and moderate in another, or moderate impairment in at least two domains', 'Forty youth will be enrolled', 'severe irritability in youth, which also integrates components of parent management training']","['exposure-based cognitive-behavioral therapy', 'new treatment, exposure-based cognitive-behavioral therapy']","['clinician, parent and self-ratings of depression, anxiety and overall functional impairment', 'Affective Reactivity Index and Clinical Global Impressions-Improvement scale for DMDD', 'parent and child reports of irritability']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4065471', 'cui_str': 'Disruptive mood dysregulation disorder'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4065471', 'cui_str': 'Disruptive mood dysregulation disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}]",40.0,0.0744449,Clinician ratings on the Affective Reactivity Index and Clinical Global Impressions-Improvement scale for DMDD are our primary outcome measures.,"[{'ForeName': 'Reut', 'Initials': 'R', 'LastName': 'Naim', 'Affiliation': 'Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA naimr2@nih.gov.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kircanski', 'Affiliation': 'Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gold', 'Affiliation': 'Pediatric Anxiety Research Center, Bradley Hospital, Riverside, Rhode Island, USA.'}, {'ForeName': 'Ramaris E', 'Initials': 'RE', 'LastName': 'German', 'Affiliation': 'Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Mollie', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Perlstein', 'Affiliation': 'Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Clayton', 'Affiliation': 'Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Revzina', 'Affiliation': 'Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Brotman', 'Affiliation': 'Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}]",BMJ open,['10.1136/bmjopen-2020-039169']
376,33721611,"Safety and efficacy of first-line dacomitinib in Asian patients with EGFR mutation-positive non-small cell lung cancer: Results from a randomized, open-label, phase 3 trial (ARCHER 1050).","OBJECTIVES


To compare efficacy and safety of dacomitinib versus gefitinib as first-line therapy for EGFR mutation-positive advanced NSCLC in Asian patients enrolled in the ongoing ARCHER 1050 trial.
MATERIALS AND METHODS


In this ongoing, randomized, open-label, phase 3 trial (NCT01774721), eligible patients with newly diagnosed advanced EGFR mutation-positive NSCLC were randomized (1:1) to receive oral dacomitinib 45 mg/day or oral gefitinib 250 mg/day. Randomization, by a central computer system, was stratified by race and EGFR mutation type (exon 19 deletion mutation/exon 21 L858R substitution mutation). The primary endpoint was PFS by blinded independent review.
RESULTS


Of 346 Asian patients, 170 were randomized to dacomitinib and 176 to gefitinib. The hazard ratio (HR) for PFS with dacomitinib versus gefitinib was 0.509 (95 % confidence interval [CI]: 0.391-0.662; 1-sided p < 0.0001; median 16.5 months [95 % CI: 12.9-18.4] vs. 9.3 months [95 % CI: 9.2-11.0]). HR for OS with dacomitinib versus gefitinib was 0.759 (95 % CI: 0.578-0.996; median 37.7 months [95 % CI: 30.2-44.7] vs. 29.1 months [95 % CI: 25.6-36.0]). The OS benefit was still maintained in those patients who had a stepwise dose reduction of dacomitinib (to 30 and 15 mg/day). The most common adverse events (AEs) were diarrhea (154 [90.6 %] patients), paronychia (110 [64.7 %]), dermatitis acneiform (96 [56.5 %]), and stomatitis (87 [51.2 %]) with dacomitinib, and diarrhea (100 [56.8 %]), alanine aminotransferase increased (81 [46.0 %]), and aspartate aminotransferase increased (75 [42.6 %]) with gefitinib. Treatment-related serious AEs were reported in 16 (9.4 %) and 8 (4.5 %) patients treated with dacomitinib and gefitinib, respectively.
CONCLUSION


First-line dacomitinib was associated with significant prolongation of PFS and improved OS compared with gefitinib in Asian patients with EGFR mutation-positive advanced NSCLC. The AE profiles of dacomitinib and gefitinib in Asian patients were consistent with the overall ARCHER 1050 population.",2021,The hazard ratio (HR) for PFS with dacomitinib versus gefitinib was 0.509,"['346 Asian patients, 170 were randomized to dacomitinib and 176 to gefitinib', 'Asian patients', 'EGFR mutation-positive advanced NSCLC in Asian patients enrolled in the ongoing ARCHER 1050 trial', 'eligible patients with newly diagnosed advanced EGFR mutation-positive NSCLC', 'Asian patients with EGFR mutation-positive non-small cell lung cancer', 'Asian patients with EGFR mutation-positive advanced NSCLC']","['oral dacomitinib 45 mg/day or oral gefitinib', 'first-line dacomitinib', 'gefitinib', 'dacomitinib versus gefitinib']","['prolongation of PFS and improved OS', 'dermatitis acneiform', 'OS benefit', 'hazard ratio (HR', 'Safety and efficacy', 'paronychia', 'diarrhea', 'alanine aminotransferase', 'aspartate aminotransferase']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C2987430', 'cui_str': 'dacomitinib'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4731604', 'cui_str': 'dacomitinib 45 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C2987430', 'cui_str': 'dacomitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0234894', 'cui_str': 'Dermatitis acneiform'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}]",346.0,0.26581,The hazard ratio (HR) for PFS with dacomitinib versus gefitinib was 0.509,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Provincial Cancer Hospital, Changchun, China.'}, {'ForeName': 'Tony S', 'Initials': 'TS', 'LastName': 'Mok', 'Affiliation': 'State Key Laboratory of Translational Oncology, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'First Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Sichuan Cancer Hospital, Chengdu, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Lung Cancer, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Chengping', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory Medicine, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Thoracic Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Kindai University Hospital, Osaka, Japan.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Linke', 'Affiliation': 'SFJ Pharmaceuticals Inc., Pleasanton, CA, USA.'}, {'ForeName': 'Chew Hooi', 'Initials': 'CH', 'LastName': 'Wong', 'Affiliation': 'Pfizer Pte. Ltd., Singapore.'}, {'ForeName': 'Yiyun', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Pfizer Oncology, La Jolla, CA, USA.'}, {'ForeName': 'Fanfan', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Pfizer Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Wilner', 'Affiliation': 'Pfizer Inc., San Diego, CA, USA.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. Electronic address: syylwu@live.cn.""}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2021.02.025']
377,33689903,Fatigue failure of anterior teeth without ferrule restored with individualized fiber-reinforced post-core foundations.,"OBJECTIVES


The aim was to explore the survival of extensively damaged anterior teeth without ferrule restored with different fiber-reinforced composite (FRC) post-core foundations and composite crowns.
MATERIALS AND METHODS


Sixty extracted upper central incisors were decoronated and randomly divided into four groups (n = 15). After endodontic treatment, the specimens were restored with different individualized fiber-reinforced post-core foundations as follows: control group (CTRL): multiple unidirectional FRC-post + dual-cure composite-core, PFC: multiple unidirectional FRC-post + packable short fiber-reinforced composite (SFRC), BPFC: Bioblock technique with only packable SFRC, BFFC: Bioblock technique with only flowable SFRC. After core build-up, the teeth were finalized with adhesively luted CAD/CAM composite crowns. Cyclic isometric loading (5 Hz) was applied at 100 N for 5000 cycles, and then 200 N and 300 N for 15,000 cycles each in a fluid chamber. The specimens were loaded until fracture occurred or when a total of 35,000 cycles were reached. Kaplan-Meyer survival analysis was conducted, followed by pairwise log-rank post hoc comparisons (Mantel-Cox).
RESULTS


The survival rates of the control (8279 cycles) and PFC (6161 cycles) were significantly higher compared to BPFC (3223 cycles) and BFFC (2271 cycles) (p < 0.05). Regarding fracture pattern, nearly all specimens fractured in a restorable manner.
CONCLUSIONS


For restoring extensively damaged anterior teeth, multiple unidirectional FRC posts are recommended.
CLINICAL RELEVANCE


Although different FRC post/core systems are available for the restoration of damaged root canal treated anterior teeth, multiple unidirectional FRC posts tend to be a good option when the ferrule is missing.",2021,The survival rates of the control (8279 cycles) and PFC (6161 cycles) were significantly higher compared to BPFC (3223 cycles) and BFFC (2271 cycles) (p < 0.05).,['Sixty extracted upper central incisors'],"['control group (CTRL): multiple unidirectional FRC-post\xa0+\xa0dual-cure composite-core, PFC: multiple unidirectional FRC-post\xa0+\xa0packable short fiber-reinforced composite (SFRC), BPFC: Bioblock technique with only packable SFRC, BFFC: Bioblock technique with only flowable SFRC', 'Cyclic isometric loading (5\xa0Hz', 'individualized fiber-reinforced post-core foundations']","['survival rates', 'survival', 'Fatigue failure']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",60.0,0.051732,The survival rates of the control (8279 cycles) and PFC (6161 cycles) were significantly higher compared to BPFC (3223 cycles) and BFFC (2271 cycles) (p < 0.05).,"[{'ForeName': 'Márk', 'Initials': 'M', 'LastName': 'Fráter', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary. Electronic address: meddentist.fm@gmail.com.'}, {'ForeName': 'Tekla', 'Initials': 'T', 'LastName': 'Sáry', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Braunitzer', 'Affiliation': 'DicomLAB Dental Ltd., Szeged, Hungary.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Balázs Szabó', 'Affiliation': 'Department of Food Engineering, Faculty of Engineering, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Lippo', 'Initials': 'L', 'LastName': 'Lassila', 'Affiliation': 'Department of Biomaterials Science and Turku Clinical Biomaterials Center -TCBC Institute of Dentistry, University of Turku, Turku, Finland.'}, {'ForeName': 'Pekka K', 'Initials': 'PK', 'LastName': 'Vallittu', 'Affiliation': 'Department of Biomaterials Science and Turku Clinical Biomaterials Center -TCBC Institute of Dentistry, University of Turku, Turku, Finland; City of Turku Welfare Division, Oral Health Care, Turku, Finland.'}, {'ForeName': 'Sufyan', 'Initials': 'S', 'LastName': 'Garoushi', 'Affiliation': 'Department of Biomaterials Science and Turku Clinical Biomaterials Center -TCBC Institute of Dentistry, University of Turku, Turku, Finland.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2021.104440']
378,33739618,Immature reticulocytes are sensitive and specific to low-dose erythropoietin treatment at sea level and altitude.,"We investigated whether immature reticulocyte fraction (IRF) and immature reticulocytes to red blood cells ratio (IR/RBC) are sensitive biomarkers for low-dose recombinant human erythropoietin (rhEpo) treatment at sea level (SL) and moderate altitude (AL) and whether multi (FACS) or single (Sysmex-XN) fluorescence flow cytometry is superior for IRF and IR/RBC determination. Thirty-nine participants completed two interventions, each containing a 4-week baseline, a 4-week SL or AL (2,230 m) exposure, and a 4-week follow-up. During exposure, rhEpo (20 IU kg -1  ) or placebo (PLA) was injected at SL (SL rhEpo  , n = 25, SL PLA  n = 9) and AL (AL rhEpo  , n = 12, AL PLA  n = 27) every second day for 3 weeks. Venous blood was collected weekly. Sysmex measurements revealed that IRF and IR/RBC were up to ~70% (P < 0.01) and ~190% (P < 0.001) higher in SL rhEpo  than SL PLA  during treatment and up to ~45% (P < 0.001) and ~55% (P < 0.01) lower post-treatment, respectively. Compared with AL PLA  , IRF and IR/RBC were up to ~20% (P < 0.05) and ~45% (P < 0.001) lower post-treatment in SL rhEpo  , respectively. In AL rhEpo  , IRF and IR/RBC were up to ~40% (P < 0.05) and ~110% (P < 0.001) higher during treatment and up to ~25% (P < 0.05) and ~40% (P < 0.05) lower post-treatment, respectively, compared with AL PLA  . Calculated thresholds provided ~90% sensitivity for both biomarkers at SL and 33% (IRF) and 66% (IR/RBC) at AL. Specificity was >99%. Single-fluorescence flow cytometry coefficient of variation was >twofold higher at baseline (P < 0.001) and provided larger or similar changes compared to multi-fluorescence, albeit with smaller precision. In conclusion, IRF and IR/RBC were sensitive and specific biomarkers for low-dose rhEpo misuse at SL and AL.",2021,"Compared with AL PLA  , IRF and IR/RBC was up to ~20% (P<0.05) and ~45% (P<0.001) lower post-treatment in SL rhEpo  , respectively.",[],"['placebo (PLA', 'SL (SL rhEpo  n=25, SL PLA', 'recombinant human erythropoietin (rhEpo']","['Specificity', 'Venous blood', 'IRF and IR/RBC', 'Single-fluorescence flow cytometry coefficient of variation', 'immature reticulocyte fraction (IRF) and immature reticulocytes to red blood cells ratio (IR/RBC']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C1446165', 'cui_str': 'Immature reticulocyte fraction'}, {'cui': 'C1441141', 'cui_str': 'Immature reticulocyte'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",39.0,0.0877778,"Compared with AL PLA  , IRF and IR/RBC was up to ~20% (P<0.05) and ~45% (P<0.001) lower post-treatment in SL rhEpo  , respectively.","[{'ForeName': 'Jan Sommer', 'Initials': 'JS', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Breenfeldt Andersen', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Christian', 'Initials': 'TC', 'LastName': 'Bonne', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Thomassen', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Sørensen', 'Affiliation': 'Data Science Lab, Department of Mathematical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nikolai Baastrup', 'Initials': 'NB', 'LastName': 'Nordsborg', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels Vidiendal', 'Initials': 'NV', 'LastName': 'Olsen', 'Affiliation': 'Department of Neuroscience and Pharmacology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jesús Rodríguez', 'Initials': 'JR', 'LastName': 'Huertas', 'Affiliation': 'Department of Physiology, Faculty of Sport Sciences, Institute of Nutrition and Food Technology, Biomedical Research Centre, University of Granada, Armilla, Spain.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bejder', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}]",Drug testing and analysis,['10.1002/dta.3031']
379,33737088,The impact of acute exercise on implicit cognitive reappraisal in association with left dorsolateral prefronta activation: A fNIRS study.,"Despite findings showing that acute exercise may help enhance emotion regulation, the neurophysiological mechanisms of these effects remain poorly understood. In this study, we examined whether acute exercise influences cognitive emotion regulation, and, in particular, an implicit cognitive reappraisal. Twenty sedentary young women were randomly assigned to either a control group (n = 10) or an exercise group (n = 10). Participants underwent an implicit cognitive reappraisal task twice, before and after the 30-min acute exercise or control, alongside functional near-infrared spectroscopy recordings (NIRS). The left dorsolateral prefrontal cortex (dlPFC) and left orbital frontal cortex (OFC) were activated during implicit cognitive reappraisal at baseline, but only the left dlPFC activation was linked with behavioral performance. Acute exercise enhanced the activation of these regions, reflective of the partial neural bases of implicit cognitive reappraisal, in the left dlPFC and left OFC, but did not alter the behavioral performance. Results also showed that acute exercise moderated the positive effect of left dlPFC activation on implicit cognitive reappraisal performance; specifically, this effect was stronger in the exercise group. In conclusion, the enhanced activation of the left dlPFC by acute exercise and the increased link between behavioral performance and its neural indices may point to acute exercise as a promoter of implicit cognitive reappraisal.",2021,"Results also showed that acute exercise moderated the positive effect of left dlPFC activation on implicit cognitive reappraisal performance; specifically, this effect was stronger in the exercise group.",['Twenty sedentary young women'],"['control group (n\u2009=\u200910) or an exercise group', 'acute exercise', 'implicit cognitive reappraisal task twice, before and after the 30-min acute exercise or control, alongside functional near-infrared spectroscopy recordings (NIRS']","['left dorsolateral prefrontal cortex (dlPFC) and left orbital frontal cortex (OFC', 'implicit cognitive reappraisal performance', 'behavioral performance']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",20.0,0.0318498,"Results also showed that acute exercise moderated the positive effect of left dlPFC activation on implicit cognitive reappraisal performance; specifically, this effect was stronger in the exercise group.","[{'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'College of P. E. and Sports, Beijing Normal University, China.'}, {'ForeName': 'Wenxia', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'College of P. E. and Sports, Beijing Normal University, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'College of P. E. and Sports, Beijing Normal University, China.'}, {'ForeName': 'Mengrui', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'College of P. E. and Sports, Beijing Normal University, China.'}, {'ForeName': 'Donghui', 'Initials': 'D', 'LastName': 'Tang', 'Affiliation': 'College of P. E. and Sports, Beijing Normal University, China. Electronic address: tangdh1964@126.com.'}]",Behavioural brain research,['10.1016/j.bbr.2021.113233']
380,33704389,Effect of Clear vs Standard Covered Masks on Communication With Patients During Surgical Clinic Encounters: A Randomized Clinical Trial.,"Importance


During the COVID-19 pandemic, wearing masks has become necessary, especially within health care. However, to our knowledge, the consequences of mask wearing on communication between surgeons and patients have not been studied.
Objective


To evaluate the effects of clear vs standard covered masks on communication during surgical clinic encounters.
Design


This randomized clinical trial examined communication between surgeons and their patients when surgeons wore clear vs covered masks in surgical outpatient clinics at a single academic medical center. New patients were recruited from participating surgeons' clinic schedules.
Interventions


Surgeons wore either clear masks or covered masks for each clinic visit with a new patient, based on a per-visit randomization plan.
Main Outcomes and Measures


The primary outcome measures included patient perceptions of (1) surgeon communication and (2) trust in surgeons, as well as (3) quantitative assessments and (4) qualitative assessments regarding patient impressions of the surgeon's mask. After the clinic encounter, patients completed a verbal survey including validated Clinician and Group Consumer Assessment of Healthcare Providers and Systems questions. Additional questions involved surgeon empathy, trust, and the patient's impression of the surgeon's mask. Data were analyzed by comparing patient data in the clear vs covered groups using Cochran-Mantel-Haenszel tests, and comments were analyzed for themes.
Results


Two hundred patients were enrolled from 15 surgeons' clinics spanning 7 subspecialties. When surgeons wore a clear mask, patients rated their surgeons higher for providing understandable explanations (clear, 95 of 100 [95%] vs covered, 78 of 100 [78%]; P < .001), demonstrating empathy (clear, 99 [99%] vs covered, 85 [85%]; P < .001), and building trust (clear, 94 [94%] vs covered, 72 [72%]; P < .001). Patients preferred clear masks (clear, 100 [100%] vs covered, 72 [72%]; P < .001), citing improved surgeon communication and appreciation for visualization of the face. Conversely, 8 of 15 surgeons (53%) were unlikely to choose the clear mask over their standard covered mask.
Conclusions and Relevance


This randomized clinical trial demonstrates that patients prefer to see their surgeon's face. Surgeons who wore clear masks were perceived by patients to be better communicators, have more empathy, and elicit greater trust. Because masks will remain part of the health care landscape for some time, deliberate attention to preserving communication within the surgeon-patient relationship is warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT04595695.",2021,"Patients preferred clear masks (clear, 100 [100%] vs covered, 72 [72%]; P < .001), citing improved surgeon communication and appreciation for visualization of the face.","[""patients prefer to see their surgeon's face"", ""New patients were recruited from participating surgeons' clinic schedules"", 'surgeons and their patients when surgeons wore clear vs covered masks in surgical outpatient clinics at a single academic medical center', ""Two hundred patients were enrolled from 15 surgeons' clinics spanning 7 subspecialties""]","['Clear vs Standard Covered Masks', 'clear vs standard covered masks', 'Interventions\n\n\nSurgeons wore either clear masks or covered masks']","['surgeon communication and appreciation for visualization of the face', 'building trust', ""patient perceptions of (1) surgeon communication and (2) trust in surgeons, as well as (3) quantitative assessments and (4) qualitative assessments regarding patient impressions of the surgeon's mask""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]",200.0,0.185898,"Patients preferred clear masks (clear, 100 [100%] vs covered, 72 [72%]; P < .001), citing improved surgeon communication and appreciation for visualization of the face.","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Kratzke', 'Affiliation': 'Department of Surgery, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Marcy E', 'Initials': 'ME', 'LastName': 'Rosenbaum', 'Affiliation': 'Department of Family Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Chase', 'Initials': 'C', 'LastName': 'Cox', 'Affiliation': 'Department of Surgery, University of North Carolina, Chapel Hill.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Ollila', 'Affiliation': 'Department of Surgery, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Muneera R', 'Initials': 'MR', 'LastName': 'Kapadia', 'Affiliation': 'Department of Surgery, University of North Carolina, Chapel Hill.'}]",JAMA surgery,['10.1001/jamasurg.2021.0836']
381,33710163,Ultrasound-Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty: A Randomized Controlled Study.,"BACKGROUND


Postoperative pain after abdominoplasty can delay postoperative ambulation, leading to life-threatening complications. Previous reports have shown the utility of quadratus lumborum block in providing adequate pain relief and avoiding side effects after numerous abdominal operations. The purpose of this randomized controlled trial was to demonstrate the efficacy of the quadratus lumborum block in abdominoplasty.
METHODS


Patients were randomly allocated to receive a bilateral quadratus lumborum block with either ropivacaine or normal saline. Postoperative cumulative analgesic medication consumption, pain severity at rest and on movement, and quality of recovery were evaluated and compared in both groups.
RESULTS


Twenty patients were allocated to each group. Total morphine dose received in the postanesthesia care unit was lower in the ropivacaine group than in the control group, with a mean of 3.4 mg and 6.6 mg, respectively. Cumulative tramadol consumption per patient in the first 48 hours postoperatively was significantly lower in the ropivacaine group compared with the control group (42.5 mg versus 190 mg; p = 0.0031). The Numeric Rating Scale both at rest and with effort was significantly lower in the ropivacaine group compared with the control group. The median quality of recovery for the ropivacaine group was 133 compared with 112 for the control group (p < 0.0001).
CONCLUSIONS


Quadratus lumborum block in abdominoplasty reduces postoperative pain and opioid consumption and improves the quality of recovery. Further studies are needed to compare the quadratus lumborum block to more traditional blocks.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, II.",2021,Cumulative tramadol consumption per patient in the first 48 hours postoperatively was significantly lower in the ropivacaine group compared with the control group (42.5 mg versus 190 mg; p = 0.0031).,"['Abdominoplasty', 'Patients', 'Twenty patients were allocated to each group']","['ropivacaine', 'Ultrasound-Guided Quadratus Lumborum Block', 'bilateral quadratus lumborum block with either ropivacaine or normal saline', 'Total morphine']","['quality of recovery', 'Postoperative cumulative analgesic medication consumption, pain severity at rest and on movement, and quality of recovery', 'Numeric Rating Scale', 'postoperative pain and opioid consumption', 'median quality of recovery', 'Cumulative tramadol consumption']","[{'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]",20.0,0.249317,Cumulative tramadol consumption per patient in the first 48 hours postoperatively was significantly lower in the ropivacaine group compared with the control group (42.5 mg versus 190 mg; p = 0.0031).,"[{'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Meouchy', 'Affiliation': 'From the Departments of Anesthesia and Critical Care and Plastic and Reconstructive Surgery, Faculty of Medicine, Saint-Joseph University, Hotel-Dieu de France Hospital.'}, {'ForeName': 'Cyril J', 'Initials': 'CJ', 'LastName': 'Awaida', 'Affiliation': 'From the Departments of Anesthesia and Critical Care and Plastic and Reconstructive Surgery, Faculty of Medicine, Saint-Joseph University, Hotel-Dieu de France Hospital.'}, {'ForeName': 'Hicham J', 'Initials': 'HJ', 'LastName': 'Jabbour', 'Affiliation': 'From the Departments of Anesthesia and Critical Care and Plastic and Reconstructive Surgery, Faculty of Medicine, Saint-Joseph University, Hotel-Dieu de France Hospital.'}, {'ForeName': 'Youssef A', 'Initials': 'YA', 'LastName': 'Rayess', 'Affiliation': 'From the Departments of Anesthesia and Critical Care and Plastic and Reconstructive Surgery, Faculty of Medicine, Saint-Joseph University, Hotel-Dieu de France Hospital.'}, {'ForeName': 'Samer F', 'Initials': 'SF', 'LastName': 'Jabbour', 'Affiliation': 'From the Departments of Anesthesia and Critical Care and Plastic and Reconstructive Surgery, Faculty of Medicine, Saint-Joseph University, Hotel-Dieu de France Hospital.'}, {'ForeName': 'Marwan W', 'Initials': 'MW', 'LastName': 'Nasr', 'Affiliation': 'From the Departments of Anesthesia and Critical Care and Plastic and Reconstructive Surgery, Faculty of Medicine, Saint-Joseph University, Hotel-Dieu de France Hospital.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007767']
382,33706033,Optimal interval and duration of CAM-ICU assessments for delirium detection after cardiac surgery.,"STUDY OBJECTIVE


Our goal was to determine when postoperative delirium first occurs, and to assess evaluation strategies that reliably detect delirium with lowest frequency of testing'.
DESIGN


This was a retrospective study that used a database from a five-center randomized trial.
SETTING


Postoperative cardiothoracic ICU and surgical wards.
PARTICIPANT


Adults scheduled for elective coronary artery bypass and/or valve surgery.
INTERVENTION AND MEASUREMENTS


Postoperative delirium was assessed using CAM-ICU questionnaires twice daily for 5 days or until hospital discharge. Data were analyzed using frequency tables and Kaplan-Meier time-to-event estimators, the latter being used to summarize time to first positive CAM-ICU over POD1-5 for all patients for various evaluation strategies, including all assessments, only morning assessment, and only afternoon assessments. Sensitivity for various strategies were compared using McNemar's test for paired proportions.
MAIN RESULTS


A total of 95 of 788 patients (12% [95% CI, 10% to 15%]) had at least 1 episode of delirium within the first 5 postoperative days. Among all patients with delirium, 65% were identified by the end of the first postoperative day. Delirium was detected more often in the mornings (10% of patients) than evenings (7% of patients). Compared to delirium assessments twice daily for five days, we found that twice daily assessments for 4 days detected an estimated 97% (95% CI 91%, 99%) of delirium. Measurements twice daily for three days detected 90% (82%, 95%) of delirium.
CONCLUSIONS


Postoperative delirium is common, and CAM-ICU assessments twice daily for 4 days, versus 5 days, detects nearly all delirium with 20% fewer assessments. Four days of assessment may usually be sufficient for clinical and research purposes.",2021,Delirium was detected more often in the mornings (10% of patients) than evenings (7% of patients).,"['delirium detection after cardiac surgery', 'Postoperative cardiothoracic ICU and surgical wards', 'Adults scheduled for elective coronary artery bypass and/or valve surgery']",[],"['CAM-ICU questionnaires twice daily for 5\xa0days or until hospital discharge', 'Postoperative delirium', 'Delirium']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],"[{'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",65.0,0.194356,Delirium was detected more often in the mornings (10% of patients) than evenings (7% of patients).,"[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Hamadnalla', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, OH, United States; Department of Anesthesiology, Pain Management & Perioperative Medicine, Henry Ford Health System, MI, United States.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, OH, United States.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Troianos', 'Affiliation': 'Anesthesiology Institute, Cleveland Clinic, OH, United States.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, OH, United States.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Rivas', 'Affiliation': ""Department of Outcomes Research, Cleveland Clinic, OH, United States; Department of Anesthesiology, Hospital Clinic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona Spain.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, OH, United States; Department of Quantitative Health Sciences, Cleveland Clinic, OH, United States.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, OH, United States; Department of Quantitative Health Sciences, Cleveland Clinic, OH, United States.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, OH, United States; Department of General Anesthesiology, Cleveland Clinic, OH, United States. Electronic address: turana@ccf.org.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110233']
383,32966751,Pharmacotherapy and Lung Function Decline in Patients with Chronic Obstructive Pulmonary Disease. A Systematic Review.,"Rationale:  Whether pharmacological therapy alters decline in FEV 1  in chronic obstructive pulmonary disease remains controversial. Because pharmacotherapy improves health status, exacerbation rate, and symptoms, it may be unethical to complete placebo-controlled long-term studies aimed at modifying FEV 1  decline. Objectives:  We conducted a systematic review of placebo-controlled pharmacological trials lasting ≥1 year to address the question of whether therapy alters FEV 1  decline. Methods:  A literature search for randomized trials that included repeated spirometry with at least one active and one placebo arm was conducted. Articles were excluded if study duration was <1 year, <3 spirometric measurements, or <100 subjects per arm. Study design was assessed using the Jadad score. To combine studies and find the estimated effect, we used random effects methodology to account for both within-study and between-study variation. Measurements and Main Results:  There were 33,051 patients in the analysis (active component,  n  = 21,941; placebo,  n  = 11,110 in nine studies). The active treatment arms demonstrated a 5.0 ml/yr reduction (95% confidence interval, 0.8-9.1 ml/yr;  P  < 0.001) in the rate of FEV 1  decline compared with the placebo arms. The relative FEV 1  differences between active and placebo arms were within the range of differences reported for health status and for the exacerbation rate in the same studies. Conclusions:  In chronic obstructive pulmonary disease, pharmacotherapy ameliorates rate of lung function decline. The relative benefit observed is within the range of those reported for health status and exacerbations in the same studies. Guidelines should be adjusted according to these findings.",2021,"The active treatment arms demonstrated a 5.0 ml/yr reduction (95% confidence interval, 0.8-9.1 ml/yr;  P  < 0.001) in the rate of FEV 1  decline compared with the placebo arms.","['chronic obstructive pulmonary disease', 'Articles were excluded if study duration was <1 year, <3 spirometric measurements, or <100 subjects per arm', '33,051 patients in the analysis (active component,  n \u2009=\u200921,941; placebo,  n \u2009=\u200911,110 in nine studies', 'Patients with Chronic Obstructive Pulmonary Disease']","['pharmacological therapy', 'placebo']","['lung function decline', 'exacerbation rate', 'health status, exacerbation rate, and symptoms', 'Jadad score']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",33051.0,0.589968,"The active treatment arms demonstrated a 5.0 ml/yr reduction (95% confidence interval, 0.8-9.1 ml/yr;  P  < 0.001) in the rate of FEV 1  decline compared with the placebo arms.","[{'ForeName': 'Bartolome R', 'Initials': 'BR', 'LastName': 'Celli', 'Affiliation': ""Pulmonary and Critical Care Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Anderson', 'Affiliation': 'Research & Development, GlaxoSmithKline, Stockley Park, Middlesex, United Kingdom.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Cowans', 'Affiliation': 'Statistics & Programming, Veramed Ltd., Twickenham, United Kingdom.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'Research & Development, GlaxoSmithKline, Research Triangle Park, North Carolina.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Hartley', 'Affiliation': 'Statistics & Programming, Veramed Ltd., Twickenham, United Kingdom.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Morris', 'Affiliation': 'Research & Development, GlaxoSmithKline, Research Triangle Park, North Carolina.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Quasny', 'Affiliation': 'Research & Development, GlaxoSmithKline, Research Triangle Park, North Carolina.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Yates', 'Affiliation': 'Research & Development, GlaxoSmithKline, Research Triangle Park, North Carolina.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, The University of Manchester and Manchester University National Health Service Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom; and.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'Department of Medicine, Clinical Sciences Centre, University of Liverpool, University Hospital Aintree, Liverpool, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202005-1854OC']
384,33725322,Pharmacokinetics and Pharmacodynamics of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects After Single Subcutaneous Administration.,"BACKGROUND AND OBJECTIVES


Ropeginterferon alfa-2b is a novel monopegylated recombinant interferon alfa-2b for the treatment of patients with polycythemia vera. The objectives of this study were to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of ropeginterferon alfa-2b in healthy Japanese subjects compared with Caucasian subjects.
METHODS


In this multicenter, parallel-group phase I study, a cohort consisting of six Japanese and six Caucasian subjects was designated to receive a single subcutaneous dose of ropeginterferon alfa-2b (100, 200, 300, and 450 µg). Pharmacokinetic and pharmacodynamic parameters, and immunogenicity were evaluated. Safety was assessed throughout the study.
RESULTS


Cohort 4 (450-µg dose) was not initiated because the primary objective of this study was achieved based on the three completed cohorts. A total of 36 enrolled subjects (18 Japanese and 18 Caucasian) in three cohorts were included in the safety, pharmacokinetic, and pharmacodynamic analysis sets. Ropeginterferon alfa-2b exposure in terms of the area under the serum concentration-time curve (AUC) from time zero extrapolated to infinity and the AUC from time zero to the time of the last quantifiable concentration was approximately 1.7-fold and two-fold higher in Japanese subjects than in Caucasian subjects, respectively. Across the same dose range, the maximum serum concentration was approximately 1.25-fold higher in Japanese subjects than in Caucasian subjects. The time to reach the median maximum serum concentration was similar between ethnicities (approximately 96-111 h). The terminal half-life was 48-57 h in Japanese subjects and 31-75 h in Caucasian subjects. The slope of the relationship between dose and drug exposure was greater than 1 in both ethnicities. The dose-dependent induction of beta-2 microglobulin and neopterin expression was observed in both ethnicities, and the two groups showed similar pharmacodynamic parameters. At the end of the study, 22.2% of Japanese subjects and 11.1% of Caucasian subjects developed anti-ropeginterferon alfa-2b-binding antibodies. The neutralizing capacity of these antibodies was not tested. Ropeginterferon alfa-2b up to 300 µg was safe and well tolerated, with no unexpected safety findings based on previous experiences with ropeginterferon alfa-2b and other forms of interferon.
CONCLUSIONS


Ropeginterferon alfa-2b exposure was higher in Japanese subjects than in Caucasian subjects. The increase in ropeginterferon alfa-2b exposure was greater than the dose proportion in the dose range of 100-300 µg. Ropeginterferon alfa-2b was safe and well tolerated.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT03546465, registered on 6 June, 2018.",2021,"The dose-dependent induction of beta-2 microglobulin and neopterin expression was observed in both ethnicities, and the two groups showed similar pharmacodynamic parameters.","['patients with polycythemia vera', 'cohort consisting of six Japanese and six Caucasian subjects', 'healthy Japanese subjects compared with Caucasian subjects', 'Healthy Japanese and Caucasian Subjects', 'Japanese subjects than in Caucasian subjects', '36 enrolled subjects (18 Japanese and 18 Caucasian']","['ropeginterferon alfa-2b', 'Ropeginterferon Alfa-2b', 'recombinant interferon alfa-2b', 'Ropeginterferon alfa-2b']","['ropeginterferon alfa-2b exposure', 'pharmacokinetics, pharmacodynamics, safety, and tolerability', 'serum concentration-time curve (AUC', 'beta-2 microglobulin and neopterin expression', 'Pharmacokinetic and pharmacodynamic parameters, and immunogenicity', 'time to reach the median maximum serum concentration', 'Safety', 'maximum serum concentration', 'safe and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032463', 'cui_str': 'Polycythemia vera'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0005149', 'cui_str': 'Beta 2 microglobulin'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",36.0,0.0393325,"The dose-dependent induction of beta-2 microglobulin and neopterin expression was observed in both ethnicities, and the two groups showed similar pharmacodynamic parameters.","[{'ForeName': 'Narihisa', 'Initials': 'N', 'LastName': 'Miyachi', 'Affiliation': 'PharmaEssentia Japan KK., Akasaka Center bldg. 12F, 1-3-13 Moto-akasaka, Minato-ku, Tokyo, 107-0051, Japan. narihisa_miyachi@pharmaessentia.com.'}, {'ForeName': 'Oleh', 'Initials': 'O', 'LastName': 'Zagrijtschuk', 'Affiliation': 'PharmaEssentia Corporation USA, 35 Corporate Drive, Suite 325, Burlington, MA, 01803, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'PharmaEssentia Corporation USA, 35 Corporate Drive, Suite 325, Burlington, MA, 01803, USA.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Yonezu', 'Affiliation': 'PharmaEssentia Japan KK., Akasaka Center bldg. 12F, 1-3-13 Moto-akasaka, Minato-ku, Tokyo, 107-0051, Japan.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Qin', 'Affiliation': 'PharmaEssentia Corporation, 13F, No. 3, YuanQu Sreet, NanKang District, Taipei, 115, Taiwan.'}]",Clinical drug investigation,['10.1007/s40261-021-01026-5']
385,33725530,Considerations for evaluating digital mental health tools remotely- reflections after a randomized trial of Thought Spot.,,2021,,[],[],[],[],[],[],,0.12036,,"[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lo', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, Canada; Information Management Group, Centre for Addiction and Mental Health, Toronto, Canada; UHN Digital, University Health Network, Toronto, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, Canada; Faculty of Medicine, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Howard W', 'Initials': 'HW', 'LastName': 'Wong', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada; Slaight Family Centre for Youth in Transition, Centre for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'Alexxa', 'Initials': 'A', 'LastName': 'Abi-Jaoudé', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Hollenberg', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Chaim', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada; Margaret and Wallace McCain Centre for Child, Youth & Family Mental Health, Centre for Addiction and Mental Health, Toronto, Canada; Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Cleverley', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada; Margaret and Wallace McCain Centre for Child, Youth & Family Mental Health, Centre for Addiction and Mental Health, Toronto, Canada; Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada; Margaret and Wallace McCain Centre for Child, Youth & Family Mental Health, Centre for Addiction and Mental Health, Toronto, Canada; Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Levinson', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada; Health and Wellness, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Robb', 'Affiliation': 'Health and Wellness, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Sanches', 'Affiliation': 'Krembil Centre for Neuroinformatics, Centre for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'Aristotle', 'Initials': 'A', 'LastName': 'Voineskos', 'Affiliation': 'Slaight Family Centre for Youth in Transition, Centre for Addiction and Mental Health, Toronto, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wiljer', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, Canada; UHN Digital, University Health Network, Toronto, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada. Electronic address: david.wiljer@uhn.ca.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2021.02.010']
386,33721359,Does muscular or mental fatigue have an influence on the nociceptive flexion reflex? A randomized cross-over study in healthy people.,"BACKGROUND


The nociceptive flexion reflex (NFR) is a spinally-mediated withdrawal reflex occurring in response to noxious stimuli and is used as an electrophysiological marker of spinal nociception. Although it is well-documented that the NFR is subject to powerful modulation of several personal factors, the effects of experimentally induced fatigue on the NFR have not yet been examined. Hence, this study aimed to characterize if and how fatigue affects spinal nociception in healthy adults.
METHODS


The NFR of 58 healthy people was measured prior to and following rest and two fatiguing tasks performed in randomized order. The NFR was elicited by transcutaneous electrical stimulation of the sural nerve and objectified by electromyographic recordings from the biceps femoris muscle. An isokinetic fatiguing protocol was used to induce localized muscle fatigue of the hamstrings. The modified incongruent Stroop-word task was used to provoke mental fatigue. A linear mixed model analysis was performed to assess the influence of fatigue on the NFR.
RESULTS


Low-to-moderate levels experimentally induced localized muscle and mental fatigue did not affect the NFR in healthy adults. These results suggest that descending pain inhibitory processes to dampen spinal nociception are resistant to the effects of localized muscle and mental fatigue.
CONCLUSIONS


The relative robustness of the NFR to fatigue may be beneficial in both clinical and research settings where the influence of confounders complicates interpretation. Furthermore, the findings possibly help enhance our understanding on why even demanding cognitive/physical exercise-based treatment programs form effective treatment strategies for patients with chronic pain.
SIGNIFICANCE


The present study unraveled that low-to-moderate levels experimentally induced localized muscle and mental fatigue did not affect the NFR. These results suggest that descending pain inhibitory processes to dampen spinal nociception are resistant to the effects of localized muscle and mental fatigue. This relative robustness of the NFR may be beneficial in a clinical setting in which the evaluation of spinal nociception that is unaffected by clinical symptoms of fatigue may be useful (e.g. chronic fatigue syndrome, cancer-related fatigue, etc.).",2021,"Fatigue is a widespread complaint in both healthy and diseased individuals (Engberg et al., 2017; Finsterer et al., 2014) that is often described as an overwhelming sense of tiredness, lack of energy, and feeling of exhaustion (Gruet et al., 2013).",['healthy people'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}]",[],[],,0.0569837,"Fatigue is a widespread complaint in both healthy and diseased individuals (Engberg et al., 2017; Finsterer et al., 2014) that is often described as an overwhelming sense of tiredness, lack of energy, and feeling of exhaustion (Gruet et al., 2013).","[{'ForeName': 'Evy', 'Initials': 'E', 'LastName': 'Dhondt', 'Affiliation': 'SPINE Research Unit Ghent, Department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Danneels', 'Affiliation': 'SPINE Research Unit Ghent, Department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Rijckaert', 'Affiliation': 'SPINE Research Unit Ghent, Department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Tanneke', 'Initials': 'T', 'LastName': 'Palmans', 'Affiliation': 'SPINE Research Unit Ghent, Department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Van Oosterwijck', 'Affiliation': 'SPINE Research Unit Ghent, Department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Van Oosterwijck', 'Affiliation': 'SPINE Research Unit Ghent, Department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}]","European journal of pain (London, England)",['10.1002/ejp.1763']
387,33706052,Evaluation of efficacy and safety of intraoral negative air pressure device in adults with obstructive sleep apnea in Taiwan.,"OBJECTIVE


Through this study, we aimed to evaluate the efficacy and safety of the intraoral negative air pressure device (iNAP) in patients with moderate to severe obstructive sleep apnea (OSA) in Taiwan.
DESIGN


Crossover and evaluator-blind, self-control design.
SETTING


Academic medical center.
PATIENTS


A total of 35 patients provided their consent to participate in this study; however, only 34 patients (30 men [87.5%] and four women [12.50%]) were eligible and randomized to the Clinical Cohort and Safety Cohort. The mean age of the 32 evaluable patients (PE cohort) was 47.4 ± 11.2 years, and their mean BMI was 26.5 ± 3.2 kg/m 2 .
MEASUREMENTS AND RESULTS


The clinical response rate was 75% (24/32 patients) comparing the treatment polysomnography values to the baseline values. The mean (±standard deviation) baseline apnea-hypopnea index was 32.0 ± 11.3 events/h, which decreased significantly to 8.7 ± 9.4 events/h. Mo medical device-related adverse event or serious adverse event occurred during the study period.
CONCLUSIONS


Compared with the previous oral pressure therapy device, the iNAP treated approximately three-fourths of the patients with OSA and had a superior comfort and safety profile. Thus, the iNAP device could be an alternative treatment solution for patients with moderate to severe OSA.",2021,The clinical response rate was 75% (24/32 patients) comparing the treatment polysomnography values to the baseline values.,"['A total of 35 patients provided their consent to participate in this study; however, only 34 patients (30 men [87.5%] and four women [12.50%]) were eligible and randomized to the Clinical Cohort and Safety Cohort', 'adults with obstructive sleep apnea in Taiwan', 'patients with moderate to severe obstructive sleep apnea (OSA) in Taiwan', 'The mean age of the 32 evaluable patients (PE cohort) was 47.4\xa0±\xa011.2 years, and their mean BMI was 26.5\xa0±\xa03.2\xa0kg', 'patients with moderate to severe OSA', 'Academic medical center']","['intraoral negative air pressure device (iNAP', 'intraoral negative air pressure device']","['clinical response rate', 'superior comfort and safety profile', 'efficacy and safety', 'mean (±standard deviation) baseline apnea-hypopnea index']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001876', 'cui_str': 'Air pressure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",35.0,0.042295,The clinical response rate was 75% (24/32 patients) comparing the treatment polysomnography values to the baseline values.,"[{'ForeName': 'Ching-Yuan', 'Initials': 'CY', 'LastName': 'Cheng', 'Affiliation': 'Sleep Center, Thoracic Medicine, Shin Kong Memorial Wu Ho-Su Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chia-Chi', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Sleep Center, Thoracic Medicine, Shin Kong Memorial Wu Ho-Su Hospital, Taipei, Taiwan; Department of Biomedical Sciences & Engineering, National Central University, Taoyuan, Taiwan.'}, {'ForeName': 'Men-Tzung', 'Initials': 'MT', 'LastName': 'Lo', 'Affiliation': 'Department of Biomedical Sciences & Engineering, National Central University, Taoyuan, Taiwan.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Guilleminault', 'Affiliation': 'Stanford University Sleep Medicine Division, Redwood City, CA, USA.'}, {'ForeName': 'Chia-Mo', 'Initials': 'CM', 'LastName': 'Lin', 'Affiliation': 'Sleep Center, Thoracic Medicine, Shin Kong Memorial Wu Ho-Su Hospital, Taipei, Taiwan; Graduate Institute of Biomedical and Pharmaceutical Science, Fu-Jen Catholic University, New Taipei City, Taiwan. Electronic address: aminus64@gmail.com.'}]",Sleep medicine,['10.1016/j.sleep.2021.02.013']
388,33706032,Insights from participant engagement with the tuberculosis treatment support tools intervention: Thematic analysis of interactive messages to guide refinement to better meet end user needs.,"BACKGROUND


Tuberculosis (TB) is a largely curable disease, yet it remains one of the top ten causes of death globally. In response to known challenges to completing the long course of TB treatment, our study team developed the TB treatment support tools (TB-TSTs). The mobile application (app) is comprised of the following main components: 1) tracks treatment progress, 2) provides disease tailored information, 3) interactive communication between patients and treatment supporters, and 4) is linked with a direct adherence drug metabolite test.
OBJECTIVE


The objective of this study was to analyze the interactive communication between the patients and the treatment supporter during the TB-TSTs pilot testing to identify issues and guide intervention refinement.
METHODS


We used mixed methods to analyze the interactive communication data. The study was conducted at a pulmonary disease specialized hospital in Argentina. Of the 42 study participants enrolled in the pilot study, 21 were randomly assigned to use the TB-TSTs for 6-months during their TB treatment. The treatment supporter was a registered nurse from the regional level of the National TB program. We conducted thematic and content analysis of the messages in their original language, Spanish. We assessed the themes over time and by whom initiated the messages.
RESULTS


There were 2561 individual messages sent between the participants and treatment supporter. We identified 19 main themes: 7 were participant and 12 were treatment supporter initiated. Participant themes included missed report rationale, arranging in-person meeting, intervention support, TB treatment progress, disease/treatment questions, side effects and additional support. Treatment supporter themes included missed report inquiry, arranging in-person meeting, introduction and instructions, check-in's, positive reinforcement, treatment progress inquiry, test-strip issues, intervention orientation, initial side-effect check in, follow-up on side effects and photo quality issues. Messages and themes decreased over time with most occurring within the first 2 months of treatment.
CONCLUSIONS


Although there was a decrease in the number of messages and the theme types over the 6-month study participation, treatment adherence support remained needed throughout. Potential solutions are suggested for the main issues and recommendations are being used to guide refinement.",2021,"Although there was a decrease in the number of messages and the theme types over the 6-month study participation, treatment adherence support remained needed throughout.","['pulmonary disease specialized hospital in Argentina', '42 study participants enrolled in the pilot study, 21']",['TB-TSTs'],['interactive communication'],"[{'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}]",21.0,0.0803295,"Although there was a decrease in the number of messages and the theme types over the 6-month study participation, treatment adherence support remained needed throughout.","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Milligan', 'Affiliation': 'Department of Bio-behavioral Nursing and Health Informatics, University of Washington, Seattle, WA, United States. Electronic address: millih2@uw.edu.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Iribarren', 'Affiliation': 'Department of Bio-behavioral Nursing and Health Informatics, University of Washington, Seattle, WA, United States. Electronic address: sjiribar@uw.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Chirico', 'Affiliation': 'National Tuberculosis Control Program Region Five (Programa Control de la Tuberculosis Región Sanitaria V.), Hospital Zonal Del Torax Dr Antonio Cetrangolo, Buenos Aires, Argentina.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Telles', 'Affiliation': 'National Tuberculosis Control Program Region Five (Programa Control de la Tuberculosis Región Sanitaria V.), Hospital Zonal Del Torax Dr Antonio Cetrangolo, Buenos Aires, Argentina.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schnall', 'Affiliation': 'Columbia University School of Nursing, New York, NY, United States.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2021.104421']
389,33738860,Multisensory early intervention can improve visual function in preterm infants at term equivalent age.,,2021,,['preterm infants at term equivalent age'],['Multisensory early intervention'],['visual function'],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}]","[{'cui': 'C0042789', 'cui_str': 'Visual function'}]",,0.0454151,,"[{'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Lester', 'Affiliation': ""The Women's Hospital, Parkville, Vic, Australia.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Kwong', 'Affiliation': ""The Women's Hospital, Parkville, Vic, Australia.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Spittle', 'Affiliation': ""The Women's Hospital, Parkville, Vic, Australia.""}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15812']
390,33721740,The Impact of a Harry Potter-Based Cognitive-Behavioral Therapy Skills Curriculum on Suicidality and Well-being in Middle Schoolers: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the impact of a Harry Potter-based mental health literacy curriculum, imparting cognitive behavioral therapy (CBT) skills, on suicidality and well-being in middle-schoolers.
METHODS


Students (aged 11-14; grades 7-8) who received a 3-month teacher-delivered intervention embedded in the language arts curriculum (N=200) were compared to a wait-list control group (N=230) in the largest urban school board in Canada. Suicidality defined as a composite measure of self-reported suicidal ideation and attempts [primary outcome], self-reported emotion dysregulation, interpersonal chaos, confusion about self, and impulsivity [Life Problems Inventory (LPI)] and self-reported depression and anxiety symptoms [Revised Child Anxiety and Depression Scale (RCADS)] were the outcomes of interest. Measurements occurred prior to and after curriculum delivery with independent t-tests used to compare mean change scores between groups clustered by class.
RESULTS


Thirty-seven English teachers in 46 classes across 15 schools comprised the planned study cohort. Composite suicidality scores were significantly worse in the control than intervention group at endpoint (0.05±0.54 vs. 0.17±0.47, t= -2.60, df=428, p=0.01). There were also significant improvements in LPI and RCADS scores in the intervention group compared to controls (LPI:-3.74±7.98 vs. 1.16±10.77 t=5.28, df=428, p<.001; RCADS: (-3.08±5.49 vs. -1.51±6.53 t=2.96, df=429, p=0.01). Sub-analyses revealed that these improvements were largely driven by a significant difference in scores in girls.
LIMITATIONS


Sample size constraints as study terminated prematurely during COVID pandemic.
CONCLUSIONS


This study demonstrates significant improvement in suicidality, emotional regulation, self-concept, interpersonal difficulties, depression and anxiety in youth, particularly girls following this intervention. Replication studies in larger samples are needed to confirm these results.",2021,"Composite suicidality scores were significantly worse in the control than intervention group at endpoint (0.05±0.54 vs. 0.17±0.47, t= -2.60, df=428, p=0.01).","['Students (aged 11-14; grades 7-8) who received a', 'Thirty-seven English teachers in 46 classes across 15 schools comprised the planned study cohort', 'Middle Schoolers']","['3-month teacher-delivered intervention embedded in the language arts curriculum (N=200) were compared to a wait-list control group (N=230) in the largest urban school board in Canada', 'Harry Potter-Based Cognitive-Behavioral Therapy Skills Curriculum', 'Harry Potter-based mental health literacy curriculum, imparting cognitive behavioral therapy (CBT) skills']","['Composite suicidality scores', 'LPI and RCADS scores', 'suicidal ideation and attempts [primary outcome], self-reported emotion dysregulation, interpersonal chaos, confusion about self, and impulsivity [Life Problems Inventory (LPI)] and self-reported depression and anxiety symptoms [Revised Child Anxiety and Depression Scale (RCADS', 'suicidality, emotional regulation, self-concept, interpersonal difficulties, depression and anxiety']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023010', 'cui_str': 'Language Arts'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0336168', 'cui_str': 'Potter (general)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1194380', 'cui_str': 'Chaos'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C4305166', 'cui_str': ""RCADS - Revised Children's Anxiety and Depression Scale""}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",37.0,0.0697377,"Composite suicidality scores were significantly worse in the control than intervention group at endpoint (0.05±0.54 vs. 0.17±0.47, t= -2.60, df=428, p=0.01).","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Klim-Conforti', 'Affiliation': 'Member of the College of Psychologists of Ontario, Toronto, Ontario, Canada; Institute of Medical Science, Faculty of Medicine, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Zaheer', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Levitt', 'Affiliation': 'Department of Psychiatry, University of Toronto, Psychiatrist, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Amy H', 'Initials': 'AH', 'LastName': 'Cheung', 'Affiliation': 'Department of Psychiatry, University of Toronto, Psychiatrist, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Schachar', 'Affiliation': 'The Hospital for Sick Children. Professor, Department of Psychiatry, University of Toronto, Canada.'}, {'ForeName': 'Ayal', 'Initials': 'A', 'LastName': 'Schaffer', 'Affiliation': 'Mood and Anxiety Disorders Program, Department of Psychiatry, Sunnybrook Health Sciences Centre, Professor, Department of Psychiatry, University of Toronto, Canada.'}, {'ForeName': 'Benjamin I', 'Initials': 'BI', 'LastName': 'Goldstein', 'Affiliation': 'Department of Psychiatry, University of Toronto, Psychiatrist, The Centre for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fefergrad', 'Affiliation': 'Department of Psychiatry, University of Toronto, Psychiatrist, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Niederkrotenthaler', 'Affiliation': 'Medical University of Vienna, Centre for Public Health, Department of Social and Preventive Medicine, Unit Suicide Research and Mental Health Promotion.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sinyor', 'Affiliation': 'Department of Psychiatry, University of Toronto, Psychiatrist, Sunnybrook Health Sciences Centre, Toronto, Canada. Electronic address: mark.sinyor@sunnybrook.ca.'}]",Journal of affective disorders,['10.1016/j.jad.2021.02.028']
391,33721689,Intermittent vibrational stimulation enhances mobility during stair navigation in patients with knee pain.,"BACKGROUND


Reduced quadriceps function and proprioception can cause decreased mobility during stair navigation in patients with knee pain. Patients can benefit from interventions to mitigate pain and restore quadriceps function. Activating the somatosensory system via intermittent vibrational stimulation has the potential to improve stair navigation mobility in patients with knee pain by moderating quadriceps inhibition and enhancing proprioception.
RESEARCH QUESTION


What are the effects of intermittent vibrational stimulus synchronized to stair ambulation on muscle activity, kinematics, kinetics, and pain using a randomized controlled clinical trial design.
METHODS


Thirty-eight patients with knee pain were enrolled into a blinded cross-over study, and twenty-nine patients completed all assessments and analyses. Subjects were randomly assigned sequentially to both an active Treatment A (active) and passive Treatment B (passive) worn at the knee during ambulation for 4 weeks with a 2-week washout period between treatments.
RESULTS


Knee pain during stair navigation was significantly reduced only with Treatment A (P = 0.007). During ascent, Treatment A (active) significantly increased vastus lateralis activation (P = 0.01), increased knee flexion moment (P = 0.04) and decreased trunk flexion angles (P = 0.015) between baseline and 4-week follow-up. After using passive Treatment B, there were no significant differences in pain (P = 0.19), knee flexion moment (P = 0.09), and trunk flexion angles (P = 0.23). Changes in muscle function correlated significantly with changes in knee flexion moment and trunk flexion with Treatment A (P < 0.015). Descending differed from ascending in response to Treatment A with significantly decreased knee flexion moment(P = 0.04), hip(P = 0.02) and ankle(P = 0.04) flexion angles. Treatment B significantly reduced hip flexion angles (P = 0.005) but not knee flexion moment (P = 0.85).
SIGNIFICANCE


The results of this study suggest that intermittent vibration can improve joint motion and loading during stair navigation by enhancing quadriceps function during stair ascent and improving movement control during stair descent by modifying an adaptive flexed movement pattern in the lower limb.",2021,"During ascent, Treatment A (active) significantly increased vastus lateralis activation (P = 0.01), increased knee flexion moment (P = 0.04) and decreased trunk flexion angles (P = 0.015) between baseline and 4-week follow-up.","['patients with knee pain', 'Thirty-eight patients with knee pain']","['active Treatment A (active) and passive Treatment B (passive) worn at the knee during ambulation', 'Intermittent vibrational stimulation']","['knee flexion moment', 'knee flexion moment(P', 'Knee pain during stair navigation', 'pain', 'muscle function', 'trunk flexion angles', 'hip flexion angles', 'muscle activity, kinematics, kinetics, and pain', 'vastus lateralis activation', 'knee flexion moment and trunk flexion', 'stair navigation mobility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0450361', 'cui_str': '38'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C4302601', 'cui_str': 'During ambulation'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",38.0,0.0310784,"During ascent, Treatment A (active) significantly increased vastus lateralis activation (P = 0.01), increased knee flexion moment (P = 0.04) and decreased trunk flexion angles (P = 0.015) between baseline and 4-week follow-up.","[{'ForeName': 'Arielle G', 'Initials': 'AG', 'LastName': 'Fischer', 'Affiliation': 'Department of Biomedical Engineering, Technion - Israel Institute of Technology, Haifa, Israel; Department of Mechanical Engineering, Stanford University, Stanford, CA, United States. Electronic address: ariellef@technion.ac.il.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Erhart-Hledik', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, CA, United States; Palo Alto Veterans Hospital, Palo Alto, CA, United States.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Asay', 'Affiliation': 'Department of Mechanical Engineering, Stanford University, Stanford, CA, United States; Palo Alto Veterans Hospital, Palo Alto, CA, United States.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Andriacchi', 'Affiliation': 'Department of Mechanical Engineering, Stanford University, Stanford, CA, United States.'}]",Gait & posture,['10.1016/j.gaitpost.2021.03.013']
392,33721623,Efficacy of myoinositol in treatment of gestational diabetes mellitus in Asian Indian women: A pilot randomized clinical trial.,"OBJECTIVE


To compare efficacy of myoinositol as an adjuvant to dietary modification for treatment of gestational diabetes mellitus in Asian Indian women compared to controls.
STUDY DESIGN


Setting: This pilot randomized open label trial was conducted in a single antenatal clinic in India.
SUBJECTS


One hundred women with singleton pregnancy and gestational diabetes diagnosed between 14-28 weeks' gestation were included. Overt diabetes, twin pregnancy, pre-existing renal disease, heart disease and other chronic medical disorders were exclusions.
INTERVENTION


Participants were randomized in two groups (1:1 ratio) by opaque envelope method. Individualized nutrition counseling with dietary modification and routine antenatal care was provided to all. Fifty women received myoinositol 1000 mg twice daily; 50 controls did not receive myoinositol. Fasting and postprandial glucose levels were assessed after two weeks. Women not achieving glycemic targets (fasting glucose <95 and postprandial glucose <120 mg/dL) were given pharmacologic therapy. Contributory factors in women requiring additional pharmacologic therapy, maternal and fetal outcomes were noted.
STATISTICAL ANALYSIS


Between group comparisons reported relative risk and mean difference. To assess predictive factors for need for pharmacologic therapy, univariate and multivariable logistic regression analysis were used.
RESULTS


Baseline characteristics were comparable in both groups. Except one woman in the myoinositol group, all women provided glycaemia data throughout their pregnancy. Glycemic control was achieved in 44/ 49 (89.8 %) women in myoinositol group which was significantly higher than 34/50 (68 %) in the controls ((relative risk 0.31, 95 % confidence interval 0.13 to 0.80, p = 0.008). Mean duration of myoinositol treatment was 17.6 weeks (standard deviation 5.3). Additional treatment with metformin/insulin was needed in all women failing to achieve glycaemic control. The mean (range) dose of insulin was 25.3 units in myoinositol group compared to 14.27 units in controls (p = 0.058). Secondary outcomes were similar in two groups except baby weight which was higher in controls (p = 0.018).
CONCLUSIONS


Oral supplementation with myoinositol in dose of 1 gm twice-daily, when started soon after the diagnosis of GDM, is effective in achieving glycemic control and decreasing the need for additional pharmacological therapy in Asian Indian women.",2021,"Secondary outcomes were similar in two groups except baby weight which was higher in controls (p = 0.018).
","['gestational diabetes mellitus in Asian Indian women', 'Setting', ""One hundred women with singleton pregnancy and gestational diabetes diagnosed between 14-28 weeks' gestation were included"", 'single antenatal clinic in India', 'gestational diabetes mellitus in Asian Indian women compared to controls', 'Asian Indian women', 'Fifty women received']","['myoinositol', 'Individualized nutrition counseling with dietary modification and routine antenatal care', 'metformin/insulin', 'myoinositol 1000 mg twice daily; 50 controls did not receive myoinositol']","['Mean duration of myoinositol treatment', 'Glycemic control', 'Efficacy', 'baby weight', 'glycaemia data', 'mean (range) dose of insulin', 'Fasting and postprandial glucose levels']","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C1524069', 'cui_str': 'Indian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",100.0,0.0821245,"Secondary outcomes were similar in two groups except baby weight which was higher in controls (p = 0.018).
","[{'ForeName': 'Vidushi', 'Initials': 'V', 'LastName': 'Kulshrestha', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: drvidushi.kul@gmail.com.'}, {'ForeName': 'Shrey', 'Initials': 'S', 'LastName': 'Balani', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: shreybalani@gmail.com.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Kachhawa', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: garimakachhawa2012@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vanamail', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: pvanamail@gmail.com.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumari', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: drrajeshkumari@yahoo.com.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: jbsharma2000@gmail.com.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bhatla', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: neerja.bhatla07@gmail.com.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2021.02.017']
393,33740610,Prospective evaluation of third-generation small bowel capsule endoscopy videos by independent readers demonstrates poor reproducibility of cleanliness classifications.,"OBJECTIVE


The detection of lesions during small bowel (SB) capsule endoscopy (CE) depends on the cleanliness of the intestine. Quality reporting and comparison of different preparation methods require reliable scores. Three scores known as quantitative index (QI), qualitative evaluation (QE), and overall adequacy assessment (OAA), have been proposed to assess SB cleanliness, and are sometimes used in clinical practice and in clinical trials. However, none of these scores has received any external validation. The aim of our study was to re-assess the reproducibility of these three specific scores.
METHODS


One-hundred-and-fifty-five complete third-generation SB-CE video recordings were extracted from a multicenter randomized controlled trial (PREPINTEST) which evaluated three modalities of SB preparation for CE. Three experts independently read the 155 SB-CE video recordings twice, in a random order, over 48 -h periods at 6-week intervals, using the QI, QE and OAA scores. Cohen's linearly weighted kappa coefficients were calculated to assess intra-observer and inter-observer agreements.
RESULTS


Intra-observer reproducibility was fair to moderate, with kappa coefficients between 0.37 and 0.46 for QI, 0.41 and 0.51 for QE, 0.41 and 0.50 for OAA. Inter-observer reproducibility was fair to substantial according to kappa coefficients between experts varying from 0.40 to 0.64, 0.29 to 0.65, and 0.52 to 0.71, for QI, QE and OAA, respectively.
CONCLUSIONS


QI, QE and OAA scores, currently used for evaluation of the quality of the preparation of SB-CE, are not sufficiently reproducible. Other scores or methods are therefore needed for SB-CE cleanliness assessment.",2021,"Inter-observer reproducibility was fair to substantial according to kappa coefficients between experts varying from 0.40 to 0.64, 0.29 to 0.65, and 0.52 to 0.71, for QI, QE and OAA, respectively.
",['One-hundred-and-fifty-five complete third-generation SB-CE video recordings'],['third-generation small bowel capsule endoscopy videos'],"['QE and OAA scores', 'quantitative index (QI), qualitative evaluation (QE), and overall adequacy assessment (OAA']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C4285996', 'cui_str': 'Small bowel capsule endoscopy'}, {'cui': 'C0042650', 'cui_str': 'Audiovisual Recording'}]","[{'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C4285996', 'cui_str': 'Small bowel capsule endoscopy'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0034375', 'cui_str': 'Qualitative Evaluation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0530148,"Inter-observer reproducibility was fair to substantial according to kappa coefficients between experts varying from 0.40 to 0.64, 0.29 to 0.65, and 0.52 to 0.71, for QI, QE and OAA, respectively.
","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Dray', 'Affiliation': 'Sorbonne University, Center for Digestive Endoscopy, Hôpital Saint-Antoine, APHP, 184 rue du Faubourg Saint-Antoine, 75012 Paris, France. Electronic address: xavier.dray@aphp.fr.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Houist', 'Affiliation': 'Department of Hepato-Gastroenterology, Centre Hospitalier du Sud Francilien, 40 Avenue Serge Dassault, 91100 Corbeil-Essonnes, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Le Mouel', 'Affiliation': 'Department of Hepato-Gastroenterology, Amiens University Hospital, Amiens, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Saurin', 'Affiliation': 'Department of Hepato-gastroenterology, E. Herriot Hospital, Hospices Civils de Lyon, France.'}, {'ForeName': 'Geoffroy', 'Initials': 'G', 'LastName': 'Vanbiervliet', 'Affiliation': ""Department of Hepato-Gastroenterology, L'Archet 2 Hospital, Nice University Hospital, Nice, F-06202 Cedex 3, France.""}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Leandri', 'Affiliation': 'Department of Hepato-Gastroenterology, Cochin Hospital, AP-HP, 75014, Paris, France.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rahmi', 'Affiliation': 'Department of Hepato-Gastroenterology, Georges Pompidou European Hospital, AP-HP, Paris Descartes University, France.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Duburque', 'Affiliation': 'Delegations for Clinical Research and Innovation - Department of Gastroenterology Lille Catholic Hospitals - Lille Catholic University, Lille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Kirchgesner', 'Affiliation': 'Sorbonne University and Department of Gastroenterology, Hôpital Saint-Antoine, Paris, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Leenhardt', 'Affiliation': 'Sorbonne University, Center for Digestive Endoscopy, Hôpital Saint-Antoine, APHP, 184 rue du Faubourg Saint-Antoine, 75012 Paris, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Cholet', 'Affiliation': 'Department of Hepato-Gastroenterology, Brest University Hospital, Bd Tanguy Prigent, 29200 BREST, France.'}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2020.101612']
394,33735670,"The direct comparison of inhaled versus intravenous levosimendan in children with pulmonary hypertension undergoing on-cardiopulmonary bypass cardiac surgery: A randomized, controlled, non-inferiority study.","STUDY OBJECTIVE


Pulmonary arterial hypertension is commonly seen in children with left to right intracardiac shunts and affects the outcomes of cardiac surgery. Our study aimed to compare the efficacy of inhaled levosimendan (LS) versus intravenous LS in reducing elevated pulmonary artery pressure (PAP) in children scheduled for cardiac surgery.
DESIGN


Non-inferiority, prospective, randomized, blinded, controlled study.
SETTING


Operative room and intensive care unit (ICU), institutional children's hospital of Mansoura Faculty of Medicine, Egypt.
PATIENTS


50 patients of either sex, aged 1 to 5 years undergoing surgical repair of intracardiac left to right shunt complicated by pulmonary hypertension were recruited for the study.
INTERVENTIONS


In the intravenous LS group, patients received intravenous infusion of LS a rate of 0.1 μg/kg/min and in the inhaled LS group, LS (36 μg/kg/6 h) was delivered by nebulization.
MEASUREMENTS


The primary endpoint was systolic PAP, while the secondary endpoints were the heart rate, mean arterial blood pressure, dose of norepinephrine, time to extubation and ICU length of stay.
MAIN RESULTS


Both intravenous and inhaled routes of LS similarly reduced the high systolic PAP over all time points of measurement and intravenous LS was associated with higher heart rate, lower arterial pressure and the need for a higher dose of norepinephrine than the inhaled LS.
CONCLUSION


Inhalation of LS is non-inferior to intravenous LS in reducing high PAP in children who underwent on-pump cardiac surgery and it is associated with less tachycardia and hypotension with reduced need for vasoactive drugs.",2021,Inhalation of LS is non-inferior to intravenous LS in reducing high PAP in children who underwent on-pump cardiac surgery and it is associated with less tachycardia and hypotension with reduced need for vasoactive drugs.,"['children with pulmonary hypertension undergoing on-cardiopulmonary bypass cardiac surgery', '50 patients of either sex, aged 1 to 5\xa0years undergoing surgical repair of intracardiac left to right shunt complicated by pulmonary hypertension were recruited for the study', 'children with left to right intracardiac shunts', 'children who underwent on-pump cardiac surgery', 'children scheduled for cardiac surgery', ""Operative room and intensive care unit (ICU), institutional children's hospital of Mansoura Faculty of Medicine, Egypt""]","['norepinephrine', 'intravenous LS', 'inhaled levosimendan (LS', 'LS', 'intravenous levosimendan']","['heart rate, lower arterial pressure', 'tachycardia and hypotension', 'heart rate, mean arterial blood pressure, dose of norepinephrine, time to extubation and ICU length of stay', 'systolic PAP', 'high systolic PAP', 'elevated pulmonary artery pressure (PAP']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}, {'cui': 'C0729936', 'cui_str': 'Cardiac chamber structure'}, {'cui': 'C0428870', 'cui_str': 'Left to right cardiovascular shunt'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439757', 'cui_str': 'Left to right'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.254211,Inhalation of LS is non-inferior to intravenous LS in reducing high PAP in children who underwent on-pump cardiac surgery and it is associated with less tachycardia and hypotension with reduced need for vasoactive drugs.,"[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abdelbaser', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: ibrahimbaser2010@yahoo.com.'}, {'ForeName': 'Nabil A', 'Initials': 'NA', 'LastName': 'Mageed', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Sherif I', 'Initials': 'SI', 'LastName': 'Elfayoumy', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Portsaid University, Portsaid, Egypt.'}, {'ForeName': 'Mohamed-Adel F', 'Initials': 'MF', 'LastName': 'Elgamal', 'Affiliation': 'Department of Cardiac Surgery, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Elmorsy', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Hani I', 'Initials': 'HI', 'LastName': 'Taman', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110231']
395,33743390,Binary dance rhythm or Quaternary dance rhythm which has the greatest effect on non-motor symptoms of individuals with Parkinson's disease?,"This study aimed to compare the effect of a binary and quaternary rhythm protocol on cognition, mental activity, daily life, and quality of life among individuals with Parkinson's Disease. A two-arm randomized clinical trial with 31 individuals diagnosed with Parkinson's disease, who were allocated to the binary group or quaternary group. Both groups underwent a 12-week intervention. The following variables were analyzed: personal and clinical information; MoCA; UPDRSI and II; PDQ-39. Both intervention groups improved cognition, mental activity, activities of daily living, and quality of life. In addition, there were intergroup differences in total UPDRSII, writing, and hygiene where the quaternary group was superior to the binary group. It concludes that the binary and quaternary rhythm positively influenced and presented similar effects on the complementary treatment of individuals with Parkinson's disease on the studied variables. Thus, it is believed that both interventions are possible and feasible for the health professionals involved in the area.",2021,"Both intervention groups improved cognition, mental activity, activities of daily living, and quality of life.","[""individuals with Parkinson's Disease"", ""31 individuals diagnosed with Parkinson's disease, who were allocated to the binary group or quaternary group"", ""individuals with Parkinson's disease""]",['binary and quaternary rhythm protocol'],"['cognition, mental activity, activities of daily living, and quality of life', 'cognition, mental activity, daily life, and quality of life', 'total UPDRSII, writing, and hygiene']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]",31.0,0.0644119,"Both intervention groups improved cognition, mental activity, activities of daily living, and quality of life.","[{'ForeName': 'Jéssica', 'Initials': 'J', 'LastName': 'Moratelli', 'Affiliation': ""PhD Student in Sciences of Human Movement of the Center of Sciences of the Health and of the Sport of the State University of Santa Catarina, Brazil; Brazilian Parkinson's Disease Rehabilitation Initiative - BpaRkI, Brazil.""}, {'ForeName': 'Kettlyn Hames', 'Initials': 'KH', 'LastName': 'Alexandre', 'Affiliation': ""Master's Degree Student in Sciences of Human Movement of the Center of Sciences of the Health and of the Sport of the State University of Santa Catarina, Brazil; Brazilian Parkinson's Disease Rehabilitation Initiative - BpaRkI, Brazil.""}, {'ForeName': 'Leonessa', 'Initials': 'L', 'LastName': 'Boing', 'Affiliation': 'PhD Student in Sciences of Human Movement of the Center of Sciences of the Health and of the Sport of the State University of Santa Catarina, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Swarowsky', 'Affiliation': ""Professor of the Department of Physiotherapy and Post-Graduation Program in Physiotherapy at the Health and Sports Sciences Center of the State University of Santa Catarina, Brazil; Brazilian Parkinson's Disease Rehabilitation Initiative - BpaRkI, Brazil.""}, {'ForeName': 'Clynton Lourenço', 'Initials': 'CL', 'LastName': 'Corrêa', 'Affiliation': ""Professor of the Department of Physiotherapy and Post-Graduation Program in Physical Education of the Federal University of Rio de Janeiro, Brazil; Brazilian Parkinson's Disease Rehabilitation Initiative - BpaRkI, Brazil.""}, {'ForeName': 'Adriana Coutinho de Azevedo', 'Initials': 'ACA', 'LastName': 'Guimarães', 'Affiliation': ""Professor of the Department of Physical Education and Post-Graduation Program in Human Movement Sciences at the Health and Sports Sciences Center of the State University of Santa Catarina, Brazil; Brazilian Parkinson's Disease Rehabilitation Initiative - BpaRkI, Brazil.""}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101348']
396,33743296,Corticospinal excitability enhancement with simultanous transcranial near-infrared stimulation and anodal direct current stimulation of motor cortex.,"OBJECTIVES


Non-invasive brain stimulation (NIBS) is beneficial to many neurological and psychiatric disorders by modulating neuroplasticity and cortical excitability. However, recent studies evidence that single type of NIBS such as transcranial direct current stimulation (tDCS) does not have meaningful clinical therapeutic responses due to their small effect size. Transcranial near-infrared stimulation (tNIRS) is a novel form of NIBS. Both tNIRS and tDCS implement its therapeutic effects by modulating cortical excitability but with different mechanisms. We hypothesized that simultaneous tNIRS and tDCS is superior to single stimulation, leading to a greater cortical excitability.
METHODS


Sixteen healthy subjects participated in a double-blind, sham-controlled, cross-over designed study. Motor evoked potentials (MEPs) were used to measure motor cortex excitability. The changes of MEP were calculated and compared in the sham condition, tDCS stimulation condition, tNIRS condition and the simultaneous tNIRS and anodal tDCS condition.
RESULTS


tDCS alone and tNIRS alone both elicited higher MEP after stimulation, while the MEP amplitude in the simultaneous tNIRS and tDCS condition was significantly higher than either tNIRS alone or tDCS alone. The enhancement lasted up to at least 30 minutes after stimulation, indicating simultaneous 820 nm tNIRS with 2 mA anodal tDCS have a synergistic effect on cortical plasticity.
CONCLUSIONS


Simultaneous application of tNIRS with tDCS produces a stronger cortical excitability effect.
SIGNIFICANCE


The simultaneous tNIRS and tDCS is a promising technology with exciting potential as a means of treatment, neuro-enhancement, or neuro-protection.",2021,"RESULTS


tDCS alone and tNIRS alone both elicited higher MEP after stimulation, while the MEP amplitude in the simultaneous tNIRS and tDCS condition was significantly higher than either tNIRS alone or tDCS alone.","['Sixteen healthy subjects', 'motor cortex']","['tDCS', 'Motor evoked potentials (MEPs', 'Transcranial near-infrared stimulation (tNIRS', 'invasive brain stimulation (NIBS']","['cortical excitability effect', 'MEP amplitude', 'changes of MEP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",16.0,0.0473125,"RESULTS


tDCS alone and tNIRS alone both elicited higher MEP after stimulation, while the MEP amplitude in the simultaneous tNIRS and tDCS condition was significantly higher than either tNIRS alone or tDCS alone.","[{'ForeName': 'Penghui', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Central Laboratory, Xuanwu Hospital, Capital Medical University, Beijing, China; Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Geriatric Medical Research Center, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China.'}, {'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wensi', 'Initials': 'W', 'LastName': 'Hao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jianghong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shimin', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaona', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Neurobiology, School of Basic Medical Sciences, Capital Medical University, Beijing, China. Electronic address: jingw@ccmu.edu.cn.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Central Laboratory, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Geriatric Medical Research Center, Beijing, China; Beijing Institute for Brain Disorders, Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China. Electronic address: wangrong@xwh.ccmu.edu.cn.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute for Brain Disorders, Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China. Electronic address: doctorwangyuping@163.com.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2021.01.020']
397,33706001,"A culturally tailored intervention to reduce risk of alcohol-exposed pregnancies in American Indian communities: Rationale, design, and methods.","INTRODUCTION


Prenatal exposure to alcohol can cause lifelong physical and cognitive challenges in the form of fetal alcohol syndrome and other fetal alcohol spectrum disorders (FASDs). The prevention of prenatal alcohol exposure is thus a public health priority - and one that should account for the particular needs of subpopulations, including in American Indian/Alaska Native (AI/AN) communities. Prior to conception, alcohol-exposed pregnancy prevention is accomplished by encouraging the reduction or elimination of risky alcohol use and/or promoting effective contraceptive use among risky drinkers who could become pregnant. The current study builds on promising findings about the impact of the Centers for Disease Control and Prevention CHOICES intervention with AI/AN communities by implementing a randomized control trial of Native CHOICES, a cultural adaptation of CHOICES, with AI/AN women in a rural reservation community.
METHODS


AI/AN women aged 18-44 who are at-risk for an alcohol-exposed pregnancy are being recruited. Participants are randomized in 1:1 proportion to the intervention and a services-as-usual, waitlist control condition. The Native CHOICES intervention consists of 2 motivational interviewing (MI) sessions, an elective contraception counseling session, and electronic messaging to boost the effects of MI. Data are collected at baseline and at 6 weeks, 3 months, and 6 months post-baseline. Those assigned to the control group are eligible to enroll in Native CHOICES following the completion of the 6 months post-baseline data collection. In addition to testing intervention effectiveness, the study is designed to yield a comprehensive economic evaluation, which will provide important information regarding the financial feasibility and sustainability of Native CHOICES for healthcare systems serving AI/ANs.",2021,Those assigned to the control group are eligible to enroll in Native CHOICES following the completion of the 6 months post-baseline data collection.,"['American Indian communities', 'risky drinkers who could become pregnant', 'AN women aged 18-44 who are at-risk for an alcohol-exposed pregnancy are being recruited']","['services-as-usual, waitlist control condition', 'motivational interviewing (MI) sessions, an elective contraception counseling session, and electronic messaging']",[],"[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1443484', 'cui_str': 'Contraception care education'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}]",[],,0.0257983,Those assigned to the control group are eligible to enroll in Native CHOICES following the completion of the 6 months post-baseline data collection.,"[{'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Hanson', 'Affiliation': 'Department of Applied Human Sciences, University of Minnesota Duluth, Duluth, MN, USA. Electronic address: jdhanson@d.umn.edu.'}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Oziel', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University, Seattle, WA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Sarche', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Colorado School of Public Health, Centers for American Indian and Alaska Native Health, Aurora, CO, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'MacLehose', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rosenman', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University, Seattle, WA, USA; School of Economic Sciences, Washington State University, Pullman, WA, USA.'}, {'ForeName': 'Dedra', 'Initials': 'D', 'LastName': 'Buchwald', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University, Seattle, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106351']
398,33714863,The effect of hand and foot massage on fatigue in hemodialysis patients: A randomized controlled trial.,"OBJECTIVE


The aim of this study was to examine the effect of hand massage and foot massage on fatigue in hemodialysis patients.
METHODS


This randomized, controlled and quasi-experimental study was conducted between October 19, 2018 and February 11, 2019 with patients receiving hemodialysis therapy in the dialysis unit of a public hospital in Turkey. Data were collected using a Patient Identification Form and the Visual Analogue Scale for Fatigue. The study was carried out with 82 patients in three groups: a hand massage group (n = 27), a foot massage group (n = 27) and a control group (n = 28). The patients in the control group were not administered any treatments except for standard nursing interventions in the hemodialysis unit.
RESULTS


In between-groups comparison the hand and foot massage groups' mean fatigue score decreased after the application compared to that of the control group (p < 0.05).
CONCLUSIONS


Hand and foot massage were found to reduce fatigue in patients receiving hemodialysis.",2021,"In between-groups comparison the hand and foot massage groups' mean fatigue score decreased after the application compared to that of the control group (p < 0.05).
","['82 patients in three groups: a hand massage group (n\xa0=\xa027), a', 'hemodialysis patients', 'patients receiving hemodialysis', 'October 19, 2018 and February 11, 2019 with patients receiving hemodialysis therapy in the dialysis unit of a public hospital in Turkey']","['foot massage group', 'standard nursing interventions', 'hand and foot massage', 'hand massage and foot massage']","['mean fatigue score', 'Visual Analogue Scale for Fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C1629858', 'cui_str': 'Dialysis unit'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0321237,"In between-groups comparison the hand and foot massage groups' mean fatigue score decreased after the application compared to that of the control group (p < 0.05).
","[{'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Çeçen', 'Affiliation': 'Vocational School of Health Services, Therapy and Rehabilitation Department, Hitit University, Çorum, Turkey. Electronic address: sultancecen@hitit.edu.tr.'}, {'ForeName': 'Diğdem', 'Initials': 'D', 'LastName': 'Lafcı', 'Affiliation': 'Mersin University, Faculty of Nursing Fundamentals of Nursing Department, Mersin, Turkey. Electronic address: lafci@mersin.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101344']
399,33714169,Scalp acupuncture therapy combined with exercise can improve the ability of stroke patients to participate in daily activities.,"OBJECTIVE


To observe the improvement of stroke patients' ability to participate in daily activities by using Scalp acupuncture therapy combined with exercise.
METHODS


According to random number table, patients were divided into a treatment group, which received rehabilitation training and scalp acupuncture to retain needles at different times, and a control group, which received rehabilitation training alone. The Barthel index was used to evaluate the activities of daily living before and after treatment.
RESULTS


The scores of Barthel index of all groups were higher than those before treatment, and the scalp acupuncture for 2 h combined with rehabilitation training group had the highest score. There was significant difference compared with pre-treatment and other treatment groups.
CONCLUSION


Scalp acupuncture therapy combined with exercise therapy can significantly improve the ability of stroke patients to participate in daily activities; 2 h of scalp acupuncture combined with exercise therapy had the most significant effect.",2021,"The scores of Barthel index of all groups were higher than those before treatment, and the scalp acupuncture for 2 h combined with rehabilitation training group had the highest score.",[],"['rehabilitation training and scalp acupuncture to retain needles at different times, and a control group, which received rehabilitation training alone', 'rehabilitation training', 'Scalp acupuncture therapy combined with exercise', 'Scalp acupuncture therapy combined with exercise therapy']",['scores of Barthel index'],[],"[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",,0.0184712,"The scores of Barthel index of all groups were higher than those before treatment, and the scalp acupuncture for 2 h combined with rehabilitation training group had the highest score.","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, No. 33 Beiling Street, 110032, China. Electronic address: hero9024@163.com.'}, {'ForeName': 'Bojin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Liaoning University of Traditional Chinese Medicine, No. 79 Chongshan East Road, 110847, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, No. 33 Beiling Street, 110032, China.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101343']
400,33706066,Benefits of Thai Yoga on physical mobility and lower limb muscle strength in overweight/obese older women: A randomized controlled pilot trial.,"BACKGROUND AND PURPOSE


Although Thai Yoga (TY) is reported to improve health-related fitness for the elderly, no study has yet carried out the effect of TY Program on physical mobility and lower-limb muscle strength in overweight/obese older women.
MATERIALS AND METHODS


In a randomized controlled pilot design, twenty-two sedentary women with a BMI ≥ 23 kg/m 2 , aged 62 ± 1 years were randomly assigned to either a TY group for 60 min, 3 times a week or to a ""no exercise"" control (CON) group. Sit and reach (SRT), functional reach (FRT) and 30-s chair stand (CST-30), 8-foot up and go (8UGT), 6-min walk (6MWT)) and lower-limb muscle strength were measured at the beginning, 4, and 8 weeks.
RESULTS


At week 4, a significant between groups was obtained in CST-30, 8UGT, and 6MWT. At week 8, FRT, 8UGT, 6MWT and knee flexor and extensor muscle strength were improved in the TY over the CON. Significant improvement was found in all variables within the TY, but no change was observed in the CON.
CONCLUSION


An 8-week TY program appears to provide beneficial improvements in physical mobility in overweight/obese older women.",2021,"At week 4, a significant between groups was obtained in CST-30, 8UGT, and 6MWT.","['twenty-two sedentary women with a BMI\xa0≥\xa023\xa0kg', 'overweight/obese older women', 'm 2 , aged 62\xa0±\xa01 years']","['no exercise"" control (CON', 'Thai Yoga']","['CST-30, 8UGT, and 6MWT', 'physical mobility', 'FRT, 8UGT, 6MWT and knee flexor and extensor muscle strength', 'Sit and reach (SRT), functional reach (FRT) and 30-s chair stand (CST-30), 8-foot up and go (8UGT), 6-min walk (6MWT)) and lower-limb muscle strength', 'physical mobility and lower limb muscle strength']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",22.0,0.0324693,"At week 4, a significant between groups was obtained in CST-30, 8UGT, and 6MWT.","[{'ForeName': 'Waree', 'Initials': 'W', 'LastName': 'Widjaja', 'Affiliation': 'College of Sports Science and Technology, Mahidol University, Thailand.'}, {'ForeName': 'Thanarak', 'Initials': 'T', 'LastName': 'Wongwattanapong', 'Affiliation': 'College of Sports Science and Technology, Mahidol University, Thailand.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Laskin', 'Affiliation': 'School of Physical Therapy & Rehabilitation Sciences, University of Montana, USA.'}, {'ForeName': 'Amornpan', 'Initials': 'A', 'LastName': 'Ajjimaporn', 'Affiliation': 'College of Sports Science and Technology, Mahidol University, Thailand. Electronic address: amornpan.ajj@mahidol.ac.th.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101345']
401,33735798,Behavioural modification interventions alongside pulmonary rehabilitation improve COPD patients' experiences of physical activity.,"AIMS AND OBJECTIVES


The Clinical PROactive Physical Activity in COPD (C-PPAC) instrument, combines a questionnaire assessing the domains of amount and difficulty of physical activity (PA) with activity monitor data (steps/day and vector magnitude units) to assess patients' experiences of PA. The C-PPAC instrument is responsive to pharmacological and non-pharmacological interventions and to changes in clinically relevant variables. We compared the effect of PA behavioural modification interventions alongside pulmonary rehabilitation (PR) to PR alone on the C-PPAC scores in COPD patients with low baseline PA levels.
METHODS


In this randomised controlled trial, 48 patients (means ± SD: FEV 1 : 50 ± 19%, baseline steps/day: 3450 ± 2342) were assigned 1:1 to receive PR alone, twice weekly for 8 weeks, or PA behavioural modification interventions (comprising motivational interviews, monitoring and feedback using a pedometer and goal setting) alongside PR (PR + PA). The C-PPAC instrument was used to assess PA experience, including a perspective of the amount and difficulty of PA.
RESULTS


There were clinically important improvements in favour of the PR + PA interventions compared to PR alone in: 1) the C-PPAC total score (mean [95% CI] difference: 8 [4 to 12] points, p = 0.001), the difficulty (mean [95% CI] difference: 8 [3 to 13] points, p = 0.002) and the amount (mean [95% CI] difference 8 [3 to 16] points, p = 0.005) domains and 2) the CAT score (mean [95% CI] difference: -2.1 [-3.8 to -0.3] points, p = 0.025).
CONCLUSION


PA behavioural modification interventions alongside PR improve the experiences of PA in patients with advanced COPD and low baseline PA levels. (NCT03749655).",2021,"There were clinically important improvements in favour of the PR + PA interventions compared to PR alone in: 1) the C-PPAC total score (mean [95% CI] difference: 8 [4 to 12] points, p = 0.001), the difficulty (mean [95% CI] difference: 8 [3 to 13] points, p = 0.002) and the amount (mean [95% CI] difference 8 [3 to 16] points, p = 0.005) domains and 2)","['COPD patients with low baseline PA levels', '48 patients (means\xa0±\xa0SD: FEV 1 : 50\xa0±\xa019%, baseline steps/day: 3450\xa0±\xa02342', 'patients with advanced COPD and low baseline PA levels']","['PR alone, twice weekly for 8 weeks, or PA behavioural modification interventions (comprising motivational interviews, monitoring and feedback using a pedometer and goal setting) alongside PR (PR\xa0+\xa0PA', 'Behavioural modification interventions alongside pulmonary rehabilitation', 'PA behavioural modification interventions alongside pulmonary rehabilitation (PR) to PR alone']","['C-PPAC total score', 'CAT score']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}]",48.0,0.112604,"There were clinically important improvements in favour of the PR + PA interventions compared to PR alone in: 1) the C-PPAC total score (mean [95% CI] difference: 8 [4 to 12] points, p = 0.001), the difficulty (mean [95% CI] difference: 8 [3 to 13] points, p = 0.002) and the amount (mean [95% CI] difference 8 [3 to 16] points, p = 0.005) domains and 2)","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Armstrong', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, School of Health & Life Sciences, Northumbria University, Newcastle, UK. Electronic address: matthew.armstrong@northumbria.ac.uk.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hume', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, School of Health & Life Sciences, Northumbria University, Newcastle, UK. Electronic address: emily.c.hume@northumbria.ac.uk.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McNeillie', 'Affiliation': 'The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, Tyne & Wear, NE1 4LP, UK. Electronic address: laura.mcneillie@nhs.net.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Chambers', 'Affiliation': 'The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, Tyne & Wear, NE1 4LP, UK. Electronic address: francesca.chambers2@nhs.net.'}, {'ForeName': 'Lynsey', 'Initials': 'L', 'LastName': 'Wakenshaw', 'Affiliation': 'The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, Tyne & Wear, NE1 4LP, UK. Electronic address: l.wakenshaw@nhs.net.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Burns', 'Affiliation': 'The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, Tyne & Wear, NE1 4LP, UK. Electronic address: graham.burns2@nhs.net.'}, {'ForeName': 'Karen Heslop', 'Initials': 'KH', 'LastName': 'Marshall', 'Affiliation': 'The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, Tyne & Wear, NE1 4LP, UK. Electronic address: karen.heslop3@nhs.net.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Vogiatzis', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, School of Health & Life Sciences, Northumbria University, Newcastle, UK. Electronic address: Ioannis.vogiatzis@northumbria.ac.uk.'}]",Respiratory medicine,['10.1016/j.rmed.2021.106353']
402,33735712,Safety and efficacy of Favipiravir in moderate to severe SARS-CoV-2 pneumonia.,"BACKGROUND


We examined the safety and efficacy of a treatment protocol containing Favipiravir for the treatment of SARS-CoV-2.
METHODS


We did a multicenter randomized open-labeled clinical trial on moderate to severe cases infections of SARS-CoV-2. Patients with typical ground glass appearance on chest computerized tomography scan (CT scan) and oxygen saturation (SpO 2 ) of less than 93% were enrolled. They were randomly allocated into Favipiravir (1.6 gr loading, 1.8 gr daily) and Lopinavir/Ritonavir (800/200 mg daily) treatment regimens in addition to standard care. In-hospital mortality, ICU admission, intubation, time to clinical recovery, changes in daily SpO 2  after 5 min discontinuation of supplemental oxygen, and length of hospital stay were quantified and compared in the two groups.
RESULTS


380 patients were randomly allocated into Favipiravir (193) and Lopinavir/Ritonavir (187) groups in 13 centers. The number of deaths, intubations, and ICU admissions were not significantly different (26, 27, 31 and 21, 17, 25 respectively). Mean hospital stay was also not different (7.9 days [SD = 6] in the Favipiravir and 8.1 [SD = 6.5] days in Lopinavir/Ritonavir groups) (p = 0.61). Time to clinical recovery in the Favipiravir group was similar to Lopinavir/Ritonavir group (HR = 0.94, 95% CI 0.75 - 1.17) and likewise the changes in the daily SpO 2  after discontinuation of supplemental oxygen (p = 0.46) CONCLUSION: Adding Favipiravir to the treatment protocol did not reduce the number of ICU admissions or intubations or In-hospital mortality compared to Lopinavir/Ritonavir regimen. It also did not shorten time to clinical recovery and length of hospital stay.",2021,Mean hospital stay was also not different (7.9 days [SD = 6] in the Favipiravir and 8.1 [SD = 6.5] days in Lopinavir/Ritonavir groups),"['Patients with typical ground glass appearance on chest computerized tomography scan (CT scan) and oxygen saturation (SpO 2 ) of less than 93% were enrolled', 'moderate to severe SARS-CoV-2 pneumonia', '187) groups in 13 centers', '380 patients', 'moderate to severe cases infections of SARS-CoV-2']","['Lopinavir/Ritonavir', 'Favipiravir (193) and Lopinavir/Ritonavir', 'Favipiravir']","['number of deaths, intubations, and ICU admissions', 'safety and efficacy', 'Safety and efficacy', 'number of ICU admissions or intubations or In-hospital mortality', 'Mean hospital stay', 'hospital mortality, ICU admission, intubation, time to clinical recovery, changes in daily SpO 2  after 5\xa0min discontinuation of supplemental oxygen, and length of hospital stay', 'shorten time to clinical recovery and length of hospital stay', 'Time to clinical recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}]",380.0,0.10133,Mean hospital stay was also not different (7.9 days [SD = 6] in the Favipiravir and 8.1 [SD = 6.5] days in Lopinavir/Ritonavir groups),"[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Solaymani-Dodaran', 'Affiliation': 'Minimally Invasive Surgery Research Center, Hazrat-e-Rasool Hospital, Iran University of Medical Science, Tehran, Iran; Division of Epidemiology and Public Health, University of Nottingham, Nottingham, NG7 2UH, UK; School of Public Health, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Ghanei', 'Affiliation': 'Chemical Injuries Center, Systems Biology and Poisoning Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran. Electronic address: mghaneister@gmail.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Bagheri', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Qazvini', 'Affiliation': 'Trauma Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ensieh', 'Initials': 'E', 'LastName': 'Vahedi', 'Affiliation': 'Chemical Injuries Research Center, Systems Biology and Poisoning Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed', 'Initials': 'S', 'LastName': 'Hassan Saadat', 'Affiliation': 'Behavioral sciences research center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed', 'Initials': 'S', 'LastName': 'Amin Setarehdan', 'Affiliation': 'Minimally Invasive Surgery Research Center, Hazrat-e-Rasool Hospital, Iran University of Medical Science, Tehran, Iran; School of Public Health, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Ansarifar', 'Affiliation': 'School of Public Health, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Biganeh', 'Affiliation': 'Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Mohazzab', 'Affiliation': 'School of Public Health, Iran University of Medical Science, Tehran, Iran; Reproductive Biotechnology Research Center, Avicenna Research Institute Tehran, ACECR, Tehran, Iran.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Khalili', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Hosein Ghazale', 'Affiliation': 'Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Reza Heidari', 'Affiliation': 'Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Taheri', 'Affiliation': 'Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Khoramdad', 'Affiliation': 'School of Public Health, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mahdi Asadi', 'Affiliation': 'Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Nazemieh', 'Affiliation': 'Tuberculosis and Lung Disease Research Center, Tabriz University of Medical Science, Tabriz, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Varshochi', 'Affiliation': 'Infectious and Tropical Disease Research Center, Tabriz University of Medical Science, Tabriz, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Abbasian', 'Affiliation': 'Liver and Gastrointestinal Disease Research Center, Tabriz University of Medical Science, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bakhtiari', 'Affiliation': 'School of Medicine, Dezful University of Medical Science, Dezful, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mosaed', 'Affiliation': 'Faculty of Medicine, Aja University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Seyyed-Javad', 'Initials': 'SJ', 'LastName': 'Hosseini-Shokouh', 'Affiliation': 'Infectious Disease Research Center, Faculty of Medicine, Aja University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Masoume', 'Initials': 'M', 'LastName': 'Shahrokhi', 'Affiliation': 'School of Management, Tehran University, Tehran, Iran.'}, {'ForeName': 'Zeynab', 'Initials': 'Z', 'LastName': 'Yassin', 'Affiliation': 'Antimicrobial Resistance Research Center, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ali Zohal', 'Affiliation': 'Metabolic Diseases Research Center, Qazvin University of Medical Science, Qazvin, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Qaraati', 'Affiliation': 'Metabolic Diseases Research Center, Qazvin University of Medical Science, Qazvin, Iran.'}, {'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Rastgoo', 'Affiliation': 'Metabolic Diseases Research Center, Qazvin University of Medical Science, Qazvin, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Sami', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Isfahan University of Medical Science, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Javad Eslami', 'Affiliation': 'School of Medicine, Isfahan University of Medical Science, Isfahan, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Asghari', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Qom University of Medical sciences, Qom, Iran.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Namazi', 'Affiliation': 'Department of Cardiology, School of Medicine, Qom University of Medical sciences, Qom, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Ziaie', 'Affiliation': 'Department of Clinical pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Raana', 'Initials': 'R', 'LastName': 'Jafari-Moghaddam', 'Affiliation': 'Department of Clinical pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Kalantari', 'Affiliation': 'Antimicrobial Resistance Research Center, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Memarian', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Semnan University of Medical sciences, Semnan, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Khodadadi', 'Affiliation': 'Department of Infectious disease, School of Medicine, Qom University of Medical sciences, Qom, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hossein Afshari', 'Affiliation': 'School of Medicine, Qom University of Medical sciences, Qom, Iran.'}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Momen-Heravi', 'Affiliation': 'Infectious Diseases Research Center, School of Medicine, Kashan University of Medical Science, Kashan, Iran.'}, {'ForeName': 'Niusha', 'Initials': 'N', 'LastName': 'Behzadseresht', 'Affiliation': 'School of Medicine, Kashan University of Medical Science, Kashan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Reza Mobayen', 'Affiliation': 'Department of Infectious disease, School of Medicine, Zanjan University of Medical sciences, Zanjan, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Mozafari', 'Affiliation': 'Department of Medical sciences, Qom Branch, Islamic Azad University, Qom, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Movasaghi', 'Affiliation': 'Department of Medical sciences, Qom Branch, Islamic Azad University, Qom, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Haddadzadeh Shoushtari', 'Affiliation': 'Department of Infectious disease, School of Medicine, Ahvaz Jundishapur university of medical sciences, Ahvaz, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Moazen', 'Affiliation': 'School of Medicine, Dezful University of Medical Science, Dezful, Iran.'}]",International immunopharmacology,['10.1016/j.intimp.2021.107522']
403,33735635,Effect of rose oil on Gastroesophageal Reflux Disease in comparison with omeprazole: A double-blind controlled trial.,"BACKGROUND AND OBJECTIVE


Gastroesophageal reflux disease (GERD) as one of the most common ailments of gastrointestinal system diminishes quality of life and impairs physical functioning and work productivity. Proton-pump inhibitors (PPIs), such as omeprazole play a more dominant role in amelioration of GERD symptoms; nonetheless, there is a growing concern about their side effects. According to traditional Persian medicine (TPM), the use of rose oil is recommended to alleviate GERD symptoms.
MATERIALS AND METHODS


Therefore, a randomized double-blind controlled trial was performed on 70 subjects who were randomly enrolled in two groups and received either rose oil softgel or omeprazole capsule combined with the placebo. Data were collected within 3 sessions of visit using the Mayo-gastroesophageal reflux questionnaire (GERQ).
RESULTS


Although, our findings showed that reflux symptoms were decreased in both groups after receiving medicine and the decrement was significant in treatment group, before and after the intervention, this decrease was not significant between two groups.
CONCLUSION


Given that the rose oil used in this study was produced according to the Iranian method and effective ingredients of Rosa damascena were preserved in sesame oil in production process, it seems that effectiveness of this product can be due to its tonic and enlivening properties. Consumption of rose oil soft capsule alleviates cardinal GERD symptoms similar to omeprazole. It seems that rose oil can have the same effects as PPIs in treatment of GERD but with no side effects due to its different mechanisms of action.",2021,Consumption of rose oil soft capsule alleviates cardinal GERD symptoms similar to omeprazole.,['70 subjects who were randomly enrolled in two groups and received either'],"['traditional Persian medicine (TPM', 'rose oil', 'Proton-pump inhibitors (PPIs', 'rose oil softgel or omeprazole capsule combined with the placebo', 'omeprazole']","['Mayo-gastroesophageal reflux questionnaire (GERQ', 'reflux symptoms', 'Gastroesophageal Reflux Disease']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0304113', 'cui_str': 'Rose oil'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",70.0,0.0745187,Consumption of rose oil soft capsule alleviates cardinal GERD symptoms similar to omeprazole.,"[{'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Adel Mehraban', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: sadeghadel@gmail.com.'}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Shirzad', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: shirzadmd@gmail.com.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Ahmadian-Attari', 'Affiliation': 'Evidence-based Phytotherapy and Complementary Medicine Research Center, Alborz University of Medical Sciences, Karaj, Iran; Department of Pharmacognosy, Faculty of Pharmacy, Alborz University of Medical Sciences, Karaj, Iran. Electronic address: ahmadian.attari@gmail.com.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Shakeri', 'Affiliation': 'Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: rshakeri@gmail.com.'}, {'ForeName': 'Leila Mohamad', 'Initials': 'LM', 'LastName': 'Taghizadeh Kashani', 'Affiliation': 'Department of Traditional Medicine, Medicinal Plants Research Center of Barij, Kashan, Iran. Electronic address: kashanileila138@yahoo.com.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Tabarrai', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: Dr.mtabarrai@yahoo.com.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Shirbeigi', 'Affiliation': 'School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: l.shirbeigi@yahoo.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101361']
404,33737211,"Sensory-specific satiety, the variety effect and physical context: Does change of context during a meal enhance food intake?","Food variety has been shown to increase food intake, and sensory-specific satiety (a relative decrease in pleasantness of a food as it is consumed) has been proposed as the mechanism through which variety increases consumption. The aim of this study was to investigate whether variation of eating context can add to experienced meal variety and hence increase consumption even further. A total of 128 participants were assigned to one of four conditions in which they first ate a specific food item (ad libitum) until satiated, after which they consumed a second course ad libitum of either the same or a different food in either the same context or in a different context. We hypothesized that, compared to eating the same food in the same context during the second course, introducing a different food item or changing the context for the second course increases consumption (of the second course), and changing both food and context enhances food intake to a greater degree than only changing the food or changing the context. Results indicated that food variety (introducing a different food) significantly increased consumption in the second course, but that a context switch did not enhance consumption. These results suggest that there is little reason to believe that sensory-specific satiety is context specific.",2021,"Results indicated that food variety (introducing a different food) significantly increased consumption in the second course, but that a context switch did not enhance consumption.",['128 participants'],[],[],[],[],[],128.0,0.0958439,"Results indicated that food variety (introducing a different food) significantly increased consumption in the second course, but that a context switch did not enhance consumption.","[{'ForeName': 'Anouk E M', 'Initials': 'AEM', 'LastName': 'Hendriks', 'Affiliation': 'Laboratory of Behavioural Gastronomy, Centre for Healthy Eating and Food Innovation, Maastricht University Campus Venlo, the Netherlands. Electronic address: anouk.hendriks@maastrichtuniversity.nl.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Nederkoorn', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology & Neuroscience, Maastricht University, the Netherlands.'}, {'ForeName': 'Ilse M J', 'Initials': 'IMJ', 'LastName': 'van Lier', 'Affiliation': 'Faculty of Health, Medicine and Life Sciences, Maastricht University Campus Venlo, the Netherlands.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'van Belkom', 'Affiliation': 'Chair Youth, Food, and Health, Maastricht University Campus Venlo, the Netherlands.'}, {'ForeName': 'Aalt', 'Initials': 'A', 'LastName': 'Bast', 'Affiliation': 'Department of Pharmacology & Toxicology, School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University Campus Venlo, the Netherlands.'}, {'ForeName': 'Remco C', 'Initials': 'RC', 'LastName': 'Havermans', 'Affiliation': 'Laboratory of Behavioural Gastronomy, Centre for Healthy Eating and Food Innovation, Maastricht University Campus Venlo, the Netherlands; Chair Youth, Food, and Health, Maastricht University Campus Venlo, the Netherlands.'}]",Appetite,['10.1016/j.appet.2021.105179']
405,33714847,Nelotanserin as symptomatic treatment for rapid eye movement sleep behavior disorder: a double-blind randomized study using video analysis in patients with dementia with Lewy bodies or Parkinson's disease dementia.,"STUDY OBJECTIVES


Rapid eye movement sleep behavior disorder (RBD) is frequent in dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD), and poses a risk of injury to patients and their bed partners. We assessed the efficacy of nelotanserin, a selective 5-HT (2A) inverse agonist, for symptomatic treatment of RBD using systematic video analysis.
METHODS


This was a phase 2 multicenter study in DLB or PDD with video polysomnography (vPSG)-confirmed RBD. After a single-blind placebo run-in period, patients meeting eligibility criteria entered a 4-week double-blind treatment period (1:1 ratio with nelotanserin 80 mg/placebo). Whole-night vPSG was conducted during the run-in and at the end of the treatment period. Videos of all rapid eye movement (REM) sleep periods were analysed for RBD behaviors (movements and vocalizations) using the Innsbruck classification system by two of the central reviewers, and a third reviewer adjudicated ambiguous cases.
RESULTS


34 patients (N = 26 DLB, N = 8 PDD; 85.3% men; mean age 71.3 ± 6.36 years) were included in the analyses. Two (5.9%) patients were excluded due to protocol deviation in treatment compliance. Systematic video analysis demonstrated no difference between nelotanserin and placebo in RBD behaviors. Bland-Altman plot showed high interrater reliability.
CONCLUSIONS


Despite negative results, this is the first randomized, placebo-controlled study on symptomatic RBD treatment using objective outcome measures based on systematic video analysis. This study provides a new method for outcome research in RBD and proves that movement analysis is a feasible and meaningful outcome for studies evaluating changes in RBD severity.
CLINICAL TRIAL INFORMATION


ClinicalTrials.gov. NCT Number NCT02708186. https://clinicaltrials.gov/ct2/show/NCT02708186.",2021,Systematic video analysis demonstrated no difference between nelotanserin and placebo in RBD behaviors.,"['Rapid eye movement sleep behavior disorder (RBD', 'rapid eye movement sleep behavior disorder', '34 patients (N\xa0=\xa026 DLB, N\xa0=\xa08 PDD; 85.3% men; mean age 71.3\xa0±\xa06.36 years', ""dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD"", ""patients with dementia with Lewy bodies or Parkinson's disease dementia""]","['nelotanserin 80 mg/placebo', 'placebo', 'nelotanserin, a selective 5-HT (2A) inverse agonist', 'Nelotanserin', 'video polysomnography (vPSG)-confirmed RBD', 'nelotanserin and placebo']",['RBD behaviors (movements and vocalizations'],"[{'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2744299', 'cui_str': 'nelotanserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}]","[{'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0042932', 'cui_str': 'Singing, Animal'}]",,0.244388,Systematic video analysis demonstrated no difference between nelotanserin and placebo in RBD behaviors.,"[{'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Stefani', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Santamaria', 'Affiliation': 'Neurology Service, Hospital Clinic de Barcelona, IDIBAPS, CIBERNED, Spain.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Iranzo', 'Affiliation': 'Neurology Service, Hospital Clinic de Barcelona, IDIBAPS, CIBERNED, Spain.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Hackner', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Schenck', 'Affiliation': 'Minnesota Regional Sleep Disorders Center, and Departments of Psychiatry, Hennepin County Medical Center and University of Minnesota Medical School, Minneapolis, USA. Electronic address: schen010@umn.edu.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Högl', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: birgit.ho@i-med.ac.at.'}]",Sleep medicine,['10.1016/j.sleep.2021.02.038']
406,33713924,Influence of enhanced nutrition and psychosocial stimulation in early childhood on cognitive functioning and psychological well-being in Guatemalan adults.,"RATIONALE


Early-life nutrition interventions in low and middle-income countries have demonstrated long-term benefits on cognitive skills, however, their influence on socioemotional outcomes has not been fully explored. Moreover, the mediating processes through which nutrition intervention effects operate and are maintained over time are understudied.
METHODS


We followed-up a cohort of Guatemalan adults who participated as children in a community randomized food-supplementation trial. We examined associations of exposure to nutritional supplementation from conception to age 2 years with executive function (measured using three sub-tests of the NIH Toolbox Cognition Battery) and psychological well-being (measured using two sub-scales of the NIH Toolbox Emotion Battery) at ages 40-57 years (n = 1268). We used structural equation modeling to investigate the mediating role of psychosocial stimulation (measured in childhood using parent reports and ratings of home environments), cognitive ability (measured at ages 26-42 years using standardized tests), and executive function on the association of early-life exposure to nutritional supplementation with adult psychological well-being (n = 1640).
RESULTS


We found positive but inconsistent associations of nutritional supplementation in childhood with executive function and psychological well-being in adulthood. Psychosocial stimulation, cognitive ability, and executive function did not mediate the association of early-life nutritional supplementation with adult psychological well-being. We found strong and positive associations of psychosocial stimulation in childhood with cognitive ability, executive function, and psychological well-being in adulthood. Moreover, we observed no interaction of exposure to nutritional supplementation and psychosocial stimulation in childhood with cognitive and psychological well-being outcomes in adulthood.
CONCLUSION


Our findings suggest that childhood nutrition interventions have long-lasting effects on cognitive ability and psychological well-being outcomes.",2021,"We found strong and positive associations of psychosocial stimulation in childhood with cognitive ability, executive function, and psychological well-being in adulthood.","['early childhood on cognitive functioning and psychological well-being in Guatemalan adults', 'low and middle-income countries', 'Guatemalan adults who participated as children in a community randomized food-supplementation trial', 'conception to age 2 years with executive function (measured using three sub-tests of the NIH Toolbox Cognition Battery) and psychological well-being (measured using two sub-scales of the NIH Toolbox Emotion Battery) at ages 40-57 years (n\xa0=\xa01268']","['nutritional supplementation with adult psychological well-being (n\xa0=\xa01640', 'enhanced nutrition and psychosocial stimulation', 'nutritional supplementation']","['Psychosocial stimulation, cognitive ability, and executive function']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0850646,"We found strong and positive associations of psychosocial stimulation in childhood with cognitive ability, executive function, and psychological well-being in adulthood.","[{'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Ramírez-Luzuriaga', 'Affiliation': 'Nutrition and Health Science Program, Laney Graduate School, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'DiGirolamo', 'Affiliation': 'Georgia Health Policy Center, Georgia State University, 55 Park Place NE, Eighth Floor, Park Pl NE, Atlanta, GA, 30303, USA.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Martorell', 'Affiliation': 'Nutrition and Health Science Program, Laney Graduate School, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA; Hubert Department of Global Health, Rollins School of Public Health, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramírez-Zea', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases (CIIPEC), Institute of Nutrition of Central America and Panama (INCAP), Calzada Roosevelt 6-25 zona 11, Guatemala City, Guatemala.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Waford', 'Affiliation': 'Nutrition and Health Science Program, Laney Graduate School, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA; Hubert Department of Global Health, Rollins School of Public Health, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Nutrition and Health Science Program, Laney Graduate School, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA; Hubert Department of Global Health, Rollins School of Public Health, Emory University, 201 Dowman Drive, Atlanta, GA, 30322, USA. Electronic address: aryeh.stein@emory.edu.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2021.113810']
407,33743292,Medical high-protein nutrition therapy and loss of muscle mass in adult ICU patients: A randomized controlled trial.,"BACKGROUND & AIMS


The degradation of muscle mass and loss of functional proteins due to catabolism are associated with adverse outcomes in critically ill patients. While an adequate supply of protein within a medical nutrition concept is suggested to minimize proteolysis, the specificities on appropriate dosage and timing are still under debate. The current study aimed to evaluate the effect of two different quantities of protein as part of a standardized energetically controlled nutrition therapy for the preservation of muscle mass in the later phase of critical illness.
METHODS


A randomized controlled trial was conducted in 42 critically ill patients (age 65 ± 15; 12 females; SAPS 45 ± 11; TISS 20 ± 7; SOFA-score 7 ± 3). The subjects were randomly assigned to either the intervention (1.8 g protein/kg body weight [BW]/d) or standard (1.2 g protein/kg BW/d) group. Nutrient supply via enteral and/or parenteral nutrition was calculated based on the individual energy expenditure measured by indirect calorimetry and target protein content. Quadriceps muscle layer thickness (QMLT) was observed through sonography at inclusion, and during the follow-up period, two and four weeks after inclusion. The measurement points were fixed on two sides at the midpoint and two-thirds between the anterior superior iliac spine and top of the patella. The data were analyzed descriptively wherein chi-squared tests or unpaired two-samle t-tests checked group differences. Daily changes in muscle mass were estimated using a linear mixed model. All data are shown as the mean ± standard deviation (SD).
RESULTS


Actual protein intake reached 1.5 ± 0.5 g and 1.0 ± 0.5 g/kg BW/d in the intervention and standard group, respectively. Mean values of all measurements of QMLT at inclusion (day 13 ± 2 after ICU admission) were 13.5 ± 7.4 mm and 13.4 ± 7.1 mm in the intervention and standard group, respectively (P = 0.967). In both the groups, QMLT decreased over time (P < 0.001), while the estimated mean values of daily QMLT changes were -0.15 ± 0.08 mm (intervention) and -0.28 ± 0.08 mm (standard) without significant between-group differences (intervention effect, P = 0.368; time x intervention effect, P = 0.242). Illness scores and clinical outcomes showed no group differences.
CONCLUSION


In this single-center trial the increased amounts of protein (1.5 g vs. 1.0 g/kg BW/d) provided through medical nutrition therapy in the late phase of critical illness did not achieve a statistically significant impact on the loss of muscle mass in long-term immobilized ICU patients. Larger multi-center trials are needed to evaluate whether observed numerical differences in muscle mass could be a true finding, and will translate into improved clinical outcomes.
TRIAL REGISTRATION


German Clinical Trials Register (http://www.drks.de/), DRKS-ID: DRKS00013594.",2021,"In both the groups, QMLT decreased over time (P < 0.001), while the estimated mean values of daily QMLT changes were -0.15 ","['adult ICU patients', '42 critically ill patients (age 65\xa0±\xa015; 12 females; SAPS 45\xa0±\xa011; TISS 20\xa0±\xa07; SOFA-score 7\xa0±\xa03', 'critically ill patients']","['QMLT', 'medical nutrition therapy', 'Medical high-protein nutrition therapy']","['mean values of daily QMLT changes', 'loss of muscle mass', 'Illness scores and clinical outcomes', 'Quadriceps muscle layer thickness (QMLT']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1740186', 'cui_str': 'SKAP2 protein, human'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0225358', 'cui_str': 'Muscularis propria'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1257928', 'cui_str': 'Medical Nutrition Therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0225358', 'cui_str': 'Muscularis propria'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",42.0,0.0942149,"In both the groups, QMLT decreased over time (P < 0.001), while the estimated mean values of daily QMLT changes were -0.15 ","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Dresen', 'Affiliation': 'Department of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Nußallee 9, 53115, Bonn, Germany. Electronic address: e.dresen@uni-bonn.de.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Weißbrich', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital of Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. Electronic address: carsten.weissbrich@ukbonn.de.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Institute of Medical Biometry, Information Technology and Epidemiology, University of Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. Electronic address: fimmers@imbie.meb.uni-bonn.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Putensen', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital of Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. Electronic address: christian.putensen@ukbonn.de.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Stehle', 'Affiliation': 'Department of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Nußallee 9, 53115, Bonn, Germany. Electronic address: pstehle@uni-bonn.de.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.02.021']
408,33730652,Safety of pemetrexed plus platinum in combination with pembrolizumab for metastatic nonsquamous non-small cell lung cancer: A post hoc analysis of KEYNOTE-189.,"OBJECTIVES


This post hoc analysis assessed the safety of pemetrexed and platinum in combination with pembrolizumab, including time-to-onset and time-to-resolution of all-cause any-grade and grade ≥3 adverse events (AEs) and renal AEs.
MATERIALS AND METHODS


Patient-level data from KEYNOTE-189 were analyzed in the all-subjects-as-treated population (pembrolizumab arm, n = 405; placebo arm, n = 202), and among patients who received ≥5 cycles of pemetrexed (pemetrexed/pembrolizumab/platinum arm, n = 310; pemetrexed/placebo/platinum arm, n = 135). All-cause AEs were selected based on ≥2 % incidence from previously reported KEYNOTE-189 data and included neutropenia, febrile neutropenia, anemia, thrombocytopenia, asthenia, fatigue, dyspnea, diarrhea, nausea, vomiting, pneumonitis, and renal events. Descriptive statistics summarized all-cause AEs. Medians and interquartile ranges were used to examine time-to-onset and time-to-resolution. The data cutoff was November 8, 2017.
RESULTS


In both treatment arms, most non-hematologic (nausea, vomiting, diarrhea, and asthenia), and hematologic (febrile neutropenia, thrombocytopenia, and neutropenia) grade ≥3 AEs with ≥2 % incidence had a median time-to-onset within the first 4 cycles, and a median time-to-resolution of within 2 weeks from onset. A small number of AEs had longer median time-to-onset (pneumonitis and fatigue) and median time-to-resolution (pneumonitis, fatigue, acute kidney injury, and anemia). Among patients who received ≥5 cycles of pemetrexed, the incidence of any-grade renal toxicity in the pemetrexed/pembrolizumab/platinum arm was 2.3 % in Cycles 1-4, 4.8 % in Cycles 5-8, 2.6 % in Cycles 9-12, and 2.5 % in Cycles ≥13; and, in the pemetrexed/placebo/platinum arm, 0.7 % in Cycles 1-4, 1.5 % in Cycles 5-8, 1.3 % in Cycles 9-12, and 2.0 % in Cycles ≥13.
CONCLUSION


Pemetrexed/pembrolizumab/platinum has manageable toxicity with longer duration of treatment. While the incidence of renal toxicity was slightly higher in the pembrolizumab combination as compared to pemetrexed, the incidence did not increase in later treatment cycles. These results support the safe use of the KEYNOTE-189 regimen in clinical practice.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02578680 (clinicaltrials.gov).",2021,"A small number of AEs had longer median time-to-onset (pneumonitis and fatigue) and median time-to-resolution (pneumonitis, fatigue, acute kidney injury, and anemia).","['Patient-level data from KEYNOTE-189 were analyzed in the all-subjects-as-treated population (pembrolizumab arm, n\u202f=\u202f405; placebo arm, n\u202f=\u202f202), and among patients who received ≥5 cycles of', 'metastatic nonsquamous non-small cell lung cancer']","['pemetrexed/placebo/platinum', 'Pemetrexed/pembrolizumab/platinum', 'pemetrexed (pemetrexed/pembrolizumab/platinum arm, n\u202f=\u202f310; pemetrexed/placebo/platinum', 'pemetrexed/pembrolizumab/platinum', 'pemetrexed plus platinum', 'pembrolizumab', 'pemetrexed and platinum']","['hematologic (nausea, vomiting, diarrhea, and asthenia), and hematologic (febrile neutropenia, thrombocytopenia, and neutropenia) grade ≥3 AEs', 'renal toxicity', 'median time-to-onset (pneumonitis and fatigue) and median time-to-resolution (pneumonitis, fatigue, acute kidney injury, and anemia', 'time-to-onset and time-to-resolution of all-cause any-grade and grade ≥3 adverse events (AEs) and renal AEs', 'manageable toxicity', 'median time-to-onset', 'neutropenia, febrile neutropenia, anemia, thrombocytopenia, asthenia, fatigue, dyspnea, diarrhea, nausea, vomiting, pneumonitis, and renal events', 'incidence of any-grade renal toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.162078,"A small number of AEs had longer median time-to-onset (pneumonitis and fatigue) and median time-to-resolution (pneumonitis, fatigue, acute kidney injury, and anemia).","[{'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, 2825 Santa Monica Blvd, Santa Monica, CA, 90404, USA. Electronic address: egaron@mednet.ucla.edu.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Aerts', 'Affiliation': 'Erasmus University Medical Center, PO Box 2040, 3000 CA, Rotterdam, the Netherlands. Electronic address: j.aerts@erasmusmc.nl.'}, {'ForeName': 'Jong Seok', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. Electronic address: kim_jong_seok@lilly.com.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Muehlenbein', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. Electronic address: muehlenbein_catherine_e@lilly.com.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Peterson', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. Electronic address: peterson_patrick@lilly.com.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Rizzo', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. Electronic address: rizzo_maria_teresa@lilly.com.'}, {'ForeName': 'Shirish M', 'Initials': 'SM', 'LastName': 'Gadgeel', 'Affiliation': 'Henry Ford Cancer Institute/Henry Ford Health System, 2799 W Grand Blvd K13, Detroit, MI, 48202, USA. Electronic address: sgadgee1@hfhs.org.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2021.02.021']
409,33725664,Average narcotic usage in a group of TKA patients following a modern TKA protocol.,"INTRODUCTION


The optimal dosing of post-operative total knee arthroplasty (TKA) narcotics is unclear. We report on the average narcotic usage in a group of patients treated with an identical multimodal pain protocol following TKA.
MATERIALS AND METHODS


49 patients undergoing TKA participated in the survey. Patients with pre-op narcotic use, recent prior total joint arthroplasty or study refusal were excluded. All patients received a spinal anesthetic. No pre-surgery narcotics were given. All received an identical local infiltrative anesthetic combination along with a multimodal pain protocol. Patients were placed into an identical rapid rehab program. Narcotic usage during hospitalization was recorded in morphine equivalent doses (MED). Patients were given a journal to record their daily narcotic utilization.
RESULTS


Pre-operative pain scores of the excluded groups had slightly higher but clinically insignificant differences compared to the study group. In the hospital, POD1 study group daily MED averaged 28 (range 0-110). POD2 had an average of 33.6 and POD 3 daily usages averaged 28.6 (range 0-100). By the end of week two, the average daily use was 19.2 and 24% patients were off all narcotics. By the end of week four, the average daily usage was 7.5 and 63% of patients were off all narcotics. By 8 weeks, there were no patients still taking narcotics. KSS averaged 76.9 (range 51-97) at the 6 week visit, and 94.2 at the 3-month visit (range 72-100).
SUMMARY


This study documents the average needs of an average TKA patient treated with modern pain protocols. The majority of these patients were off narcotics by week four.",2021,"KSS averaged 76.9 (range 51-97) at the 6 week visit, and 94.2 at the 3-month visit (range 72-100).
","['49 patients undergoing TKA participated in the survey', 'patients treated with an identical multimodal pain protocol following TKA', 'Patients with pre-op narcotic use, recent prior total joint arthroplasty or study refusal were excluded']","['spinal anesthetic', 'post-operative total knee arthroplasty (TKA) narcotics', 'KSS', 'identical local infiltrative anesthetic combination']","['Narcotic usage during hospitalization', 'Pre-operative pain scores', 'POD2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}]","[{'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",49.0,0.0979792,"KSS averaged 76.9 (range 51-97) at the 6 week visit, and 94.2 at the 3-month visit (range 72-100).
","[{'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Costales', 'Affiliation': 'University of Maryland Medical Center, 110 South Paca Street 6(th) Floor Suite 300, Baltimore, MD 21201, United States.'}, {'ForeName': 'Patrick H', 'Initials': 'PH', 'LastName': 'Greenwell', 'Affiliation': 'University of Maryland Medical Center, 110 South Paca Street 6(th) Floor Suite 300, Baltimore, MD 21201, United States.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Chapman', 'Affiliation': 'The University of Maryland St. Joseph Medical Center, 7601 Osler Dr., Towson, MD 21204, United States.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Volkmann', 'Affiliation': 'The University of Maryland St. Joseph Medical Center, 7601 Osler Dr., Towson, MD 21204, United States.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dalury', 'Affiliation': 'The University of Maryland St. Joseph Medical Center, 7601 Osler Dr., Towson, MD 21204, United States. Electronic address: ddalury@gmail.com.'}]",The Knee,['10.1016/j.knee.2021.02.032']
410,33730636,When is lack of scientific integrity a reason for retracting a paper? A case study.,"OBJECTIVE


The journal received a request to retract a paper reporting the results of a triple-blind randomized placebo-controlled trial. The present and immmediate past editors expand on the journal's decision not to retract this paper in spite of undisputable evidence of scientific misconduct on behalf of one of the investigators.
METHODS


The editors present an ethical reflection on the request to retract this randomized clinical trial with consideration of relevant guidelines from the Committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE) applied to the unique contextual issues of this case.
RESULTS


In this case, scientific misconduct by a blinded provider of a homeopathy intervention attempted to undermine the study blind. As part of the study, the integrity of the study blind was assessed. Neither participants nor homeopaths were able to identify whether the participant was assigned to homeopathic medicine or placebo. Central to the decision not to retract the paper was the fact that the rigorous scientific design provided evidence that the outcome of the study was not affected by the misconduct. The misconduct itself was thought to be insufficient reason to retract the paper.
CONCLUSION


Retracting a paper of which the outcome is still valid was in itself considered unethical, as it takes away the opportunity to benefit from its results, rendering the whole study useless. In such cases, scientific misconduct is better handled through other professional channels.",2021,Neither participants nor homeopaths were able to identify whether the participant was assigned to homeopathic medicine or placebo.,[],"['placebo', 'homeopathic medicine or placebo']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0684199', 'cui_str': 'Homeopathic therapy'}]",[],,0.369292,Neither participants nor homeopaths were able to identify whether the participant was assigned to homeopathic medicine or placebo.,"[{'ForeName': 'Jess G', 'Initials': 'JG', 'LastName': 'Fiedorowicz', 'Affiliation': 'Department of Psychiatry, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: jess-fiedorowicz@uiowa.edu.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Levenson', 'Affiliation': 'Department of Psychiatry, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Albert F G', 'Initials': 'AFG', 'LastName': 'Leentjens', 'Affiliation': 'Department of Psychiatry, Maastricht University Medical Centre, Maastricht, the Netherlands.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2021.110412']
411,33714077,Trajectories of symptoms of anxiety and depression among people on sick leave with mood or anxiety disorders: Secondary analysis from a randomized controlled trial.,"BACKGROUND


Depression and anxiety are heterogenous disorders often combined into one entity in studies. Few studies have compared trajectories of depression and anxiety among clinically ill. We aimed to identify specific trajectories of depression, and anxiety and predictors of trajectory membership.
METHODS


Latent growth mixture modelling was carried out on data from the IPS-MA trial (n = 261), a supported employment intervention for people with mood or anxiety, to identify trajectories of depression and anxiety. Logistic regression was used to estimate predictors for trajectory membership. Associations between trajectory class and remission of comorbid depression or anxiety and return to work were also tested.
RESULTS


We identified three trajectories of depression and anxiety symptoms respectively; moderate-decreasing (60%), moderate-stable (26%), and low-stable (14%) depression and mild-decreasing (59%), moderate-decreasing (33%), and moderate-stable (8%) anxiety. The depression model showed low precision in class separation (entropy 0.66), hence, predictors of class membership were not estimated. For anxiety, lower age and higher levels of depressive symptoms were associated with a less desirable trajectory. Remission of comorbid depressive symptoms after two years differed significantly between classes (p < 0.000). Fewer had returned to work in the two moderate classes compared to the mild-decreasing anxiety class.
LIMITATIONS


Depression model not reliable. Only 80% of participants from original study included. Not able to distinguish between anxiety disorders.
CONCLUSION


Trajectories of anxiety confirm that, even after two years, a rather large proportion in the moderate-stable class had symptoms of moderate anxiety, moderate comorbid depressive symptoms, and less probability of having returned to work.
TRIAL REGISTRATION


ClinicalTrials.govNCT01721824.",2021,Remission of comorbid depressive symptoms after two years differed significantly between classes (p < 0.000).,"['people on sick leave with mood or anxiety disorders', '26%), and low-stable (14%) depression and mild-decreasing (59%), moderate-decreasing (33%), and moderate-stable (8%) anxiety', 'Latent growth mixture modelling was carried out on data from the IPS-MA trial (n\xa0=\xa0261']",['supported employment intervention'],"['Remission of comorbid depressive symptoms', 'moderate anxiety, moderate comorbid depressive symptoms', 'moderate-stable', 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0231402', 'cui_str': 'Moderate anxiety'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.0555192,Remission of comorbid depressive symptoms after two years differed significantly between classes (p < 0.000).,"[{'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Hellström', 'Affiliation': 'CORE: Copenhagen Research Center for Mental Health, Mental Health Centre Copenhagen, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark. Electronic address: lone.hellstroem@regionh.dk.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Madsen', 'Affiliation': 'CORE: Copenhagen Research Center for Mental Health, Mental Health Centre Copenhagen, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Nordentoft', 'Affiliation': 'CORE: Copenhagen Research Center for Mental Health, Mental Health Centre Copenhagen, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health Science, University of Copenhagen, Denmark.'}, {'ForeName': 'Lene Falgaard', 'Initials': 'LF', 'LastName': 'Eplov', 'Affiliation': 'CORE: Copenhagen Research Center for Mental Health, Mental Health Centre Copenhagen, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.02.040']
412,33706002,Supporting families of children with overweight and obesity to live healthy lifestyles: Design and rationale for the Fitline cluster randomized controlled pediatric practice-based trial.,"BACKGROUND


Over a third of preadolescent children with overweight or obesity. The American Academy of Pediatrics (AAP) recommends pediatric providers help families make changes in eating and activity to improve body mass index (BMI). However, implementation is challenging given limited time and referral sources, and family burden to access in-person weight management programs.
PURPOSE


To describe the design of a National Heart Blood and Lung Institute sponsored cluster randomized controlled pediatric-based trial evaluating the effectiveness of the Fitline pediatric practice-based referral program to reduce BMI and improve diet and physical activity in children with overweight or obesity. Comparison will be made between brief provider intervention plus referral to (1) eight weekly nutritionist-delivered coaching calls with workbook to help families make AAP-recommended lifestyle changes (Fitline-Coaching), vs. (2) the same workbook in eight mailings without coaching (Fitline-Workbook).
METHODS


Twenty practices are pair-matched and randomized to one of the two conditions; 494 parents and their children ages 8-12 with a BMI of ≥85th percentile are being recruited. The primary outcome is child BMI; secondary outcomes are child's diet and physical activity at baseline and 6- and 12-months post-baseline. Cost-effectiveness of the two interventions also will be examined.
CONCLUSION


This is the first randomized controlled trial to examine use of a centrally located telephonic coaching service to support families of children with overweight and obesity in making AAP-recommended lifestyle changes. If effective, the Fitline program will provide an innovative model for widespread dissemination, setting new standards for weight management care in pediatric practice.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03143660.",2021,This is the first randomized controlled trial to examine use of a centrally located telephonic coaching service to support families of children with overweight and obesity in making AAP-recommended lifestyle changes.,"['preadolescent children with overweight or obesity', 'children with overweight and obesity to live healthy lifestyles', 'children with overweight and obesity in making AAP-recommended lifestyle changes', 'Twenty practices are pair-matched and randomized to one of the two conditions; 494 parents and their children ages 8-12 with a BMI of ≥85th percentile are being recruited', 'children with overweight or obesity']","['Fitline pediatric practice-based referral program', 'centrally located telephonic coaching service']","[""child BMI; secondary outcomes are child's diet and physical activity"", 'Cost-effectiveness']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",494.0,0.0822427,This is the first randomized controlled trial to examine use of a centrally located telephonic coaching service to support families of children with overweight and obesity in making AAP-recommended lifestyle changes.,"[{'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Pbert', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States. Electronic address: lori.pbert@umassmed.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Druker', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bram', 'Affiliation': 'Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Olendzki', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Crawford', 'Affiliation': 'Graduate School of Nursing, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Frisard', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Waring', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT, United States.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Clements', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Schneider', 'Affiliation': 'Department of Psychology, Rosalind Franklin University of Medicine and Science, North Chicago, IL, United States.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Geller', 'Affiliation': 'Department of Social and Behavioral Sciences, Harvard School of Public Health, Boston, MA, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106348']
413,33691268,"Multi-study randomised controlled trial to develop, implement and evaluate bra prescription to reduce breast pain and improve quality of life.","BACKGROUND


and Purpose: Breast pain is a common condition presented at breast care clinics and bras are often recommended to reduce symptoms, although criteria and pathways for obtaining appropriate bras are limited. This multi-study, randomised controlled trial (RCT) aimed to establish criteria and performance variables to prescribe bras for breast pain patients, to implement this bra prescription, and evaluate whether, compared to standard care alone, the bra prescription improves breast pain and quality of life (QoL).
MATERIALS AND METHODS


Eighteen breast pain patients from a UK hospital were assigned to standard care or bra prescription groups and completed the study. Bra prescription patients were prescribed a bra to wear every day for eight weeks. Patient Global Impression of Change (PGIC), breast pain intensity, QoL, and adherence were assessed.
RESULTS


Between-groups there were no differences in baseline breast pain or QoL and no differences in PGIC or breast pain following the intervention. Within-groups, improvements in QoL within bra prescription patients were identified.
CONCLUSION


This study developed a framework for bra prescription for breast pain patients and the intervention demonstrated improvements in QoL.",2021,there were no differences in baseline breast pain or QoL and no differences in PGIC or breast pain following the intervention.,"['Eighteen breast pain patients from a UK hospital', 'breast pain patients']",[],"['baseline breast pain or QoL', 'PGIC or breast pain', 'QoL', 'breast pain and improve quality of life', 'breast pain and quality of life (QoL', 'Patient Global Impression of Change (PGIC), breast pain intensity, QoL, and adherence']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0024902', 'cui_str': 'Pain of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0024902', 'cui_str': 'Pain of breast'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.112657,there were no differences in baseline breast pain or QoL and no differences in PGIC or breast pain following the intervention.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sharland', 'Affiliation': 'School of Sport, Health & Exercise Science, University of Portsmouth, Spinnaker Building, Cambridge Road, Portsmouth, Hampshire, PO1 2ER, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Burbage', 'Affiliation': 'School of Sport, Health & Exercise Science, University of Portsmouth, Spinnaker Building, Cambridge Road, Portsmouth, Hampshire, PO1 2ER, UK. Electronic address: jenny.burbage@port.ac.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Noblet', 'Affiliation': 'Breast Services Department, Queen Alexandra Hospital, Southwick Hill Road, Cosham, Portsmouth, Hampshire, PO6 3LY, UK.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Breast Services Department, Queen Alexandra Hospital, Southwick Hill Road, Cosham, Portsmouth, Hampshire, PO6 3LY, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wakefield-Scurr', 'Affiliation': 'School of Sport, Health & Exercise Science, University of Portsmouth, Spinnaker Building, Cambridge Road, Portsmouth, Hampshire, PO1 2ER, UK.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101346']
414,33689989,Anteromedial versus posterolateral hip musculature strengthening with dose-controlled in women with patellofemoral pain: A randomized controlled trial.,"OBJECTIVE


To compare the effectiveness of adding anteromedial versus posterolateral hip musculature strengthening to knee strengthening in women with patellofemoral pain (PFP).
DESIGN


Randomized controlled trial.
SETTING


University physiotherapy clinic.
PARTICIPANTS


Fifty-two women with PFP were randomized to receive either anteromedial (AMHG) or posterolateral (PLHG) hip musculature strengthening.
MAIN OUTCOME MEASURES


The primary outcomes were pain intensity by the numeric pain rating scale and function by the Anterior Knee Pain Scale in six weeks. Secondary outcomes were pain and function at six months, global perceived effect at six weeks and six months, pain in step down, isometric torque of abductors, adductors and hip rotators measured with hand-held dynamometer, and dynamic knee valgus by step down in six weeks.
RESULTS


Both groups showed improvement in primary outcomes; however, no differences were found between groups in pain intensity and function in six weeks and the secondary outcomes. Group x time interaction found superior gains in abductor strength in the PLHG and increase in the strength of the adductors and internal rotators in AMHG.
CONCLUSION


There was no difference between the addition of anteromedial or posterolateral hip musculature strengthening to knee strengthening in improving pain and function in women with PFP.",2021,"Both groups showed improvement in primary outcomes; however, no differences were found between groups in pain intensity and function in six weeks and the secondary outcomes.","['Fifty-two women with PFP', 'women with patellofemoral pain (PFP', 'women with PFP', 'University physiotherapy clinic', 'women with patellofemoral pain']","['anteromedial versus posterolateral hip musculature strengthening', 'anteromedial (AMHG) or posterolateral (PLHG', 'Anteromedial versus posterolateral hip musculature strengthening with dose-controlled']","['pain intensity by the numeric pain rating scale and function by the Anterior Knee Pain Scale', 'pain and function', 'pain intensity and function', 'pain and function at six months, global perceived effect at six weeks and six months, pain in step down, isometric torque of abductors, adductors and hip rotators measured with hand-held dynamometer, and dynamic knee valgus by step down in six weeks', 'abductor strength', 'strength of the adductors and internal rotators']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}]","[{'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C0205102', 'cui_str': 'Internal'}]",52.0,0.122855,"Both groups showed improvement in primary outcomes; however, no differences were found between groups in pain intensity and function in six weeks and the secondary outcomes.","[{'ForeName': 'Gabriel Peixoto Leão', 'Initials': 'GPL', 'LastName': 'Almeida', 'Affiliation': 'Knee and Sports Research Group, Physical Therapy Department, School of Medicine, Federal University of Ceará, Fortaleza, CE, Brazil; Master Program in Physical Therapy and Functioning, Physical Therapy Department, School of Medicine, Federal University of Ceará, Fortaleza, CE, Brazil. Electronic address: gabriel_alm@ufc.br.'}, {'ForeName': 'Helena Larissa das Neves', 'Initials': 'HLDN', 'LastName': 'Rodrigues', 'Affiliation': 'Knee and Sports Research Group, Physical Therapy Department, School of Medicine, Federal University of Ceará, Fortaleza, CE, Brazil.'}, {'ForeName': 'Bruno Augusto Lima', 'Initials': 'BAL', 'LastName': 'Coelho', 'Affiliation': 'Knee and Sports Research Group, Physical Therapy Department, School of Medicine, Federal University of Ceará, Fortaleza, CE, Brazil.'}, {'ForeName': 'Carlos Augusto Silva', 'Initials': 'CAS', 'LastName': 'Rodrigues', 'Affiliation': 'Knee and Sports Research Group, Physical Therapy Department, School of Medicine, Federal University of Ceará, Fortaleza, CE, Brazil; Master Program in Physical Therapy and Functioning, Physical Therapy Department, School of Medicine, Federal University of Ceará, Fortaleza, CE, Brazil.'}, {'ForeName': 'Pedro Olavo de Paula', 'Initials': 'POP', 'LastName': 'Lima', 'Affiliation': 'Knee and Sports Research Group, Physical Therapy Department, School of Medicine, Federal University of Ceará, Fortaleza, CE, Brazil; Master Program in Physical Therapy and Functioning, Physical Therapy Department, School of Medicine, Federal University of Ceará, Fortaleza, CE, Brazil.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.02.016']
415,33691266,"A randomized, controlled proof-of-concept trial evaluating durable effects of memory flexibility training (MemFlex) on autobiographical memory distortions and on relapse of recurrent major depressive disorder over 12 months.","Low-intensity psychological interventions that target cognitive risk factors for depressive relapse may improve access to relapse prevention programs and thereby reduce subsequent risk. This study provides the first evaluation of an autobiographical memory-based intervention for relapse prevention, to establish whether memory-training programs that are efficacious for acute depression may also aid those currently in remission. We also provide the longest follow-up to-date of the effects of autobiographical memory training on autobiographical memory processes themselves. This pre-registered randomized-controlled proof-of-concept trial (N = 74) compared an autobiographical Memory Flexibility (MemFlex) intervention to Psychoeducation about cognitive-behavioral mechanisms which maintain depression. Both interventions were primarily self-guided, and delivered via paper workbooks completed over four weeks. The key cognitive outcome was ability to retrieve and alternate between specific and general autobiographical memories. Co-primary clinical outcomes were time until depressive relapse and depression-free days in the twelve-months following intervention. Results indicated a small-moderate effect size (d = 0.35) in favor of MemFlex for the cognitive outcome. A small Hazard Ratio (1.08) was observed for time until depressive relapse, along with a negligible effect size for depression-free days (d = 0.11). Although MemFlex produced long-term improvement in memory retrieval skills, there was little support for MemFlex as a relapse prevention program for depression.",2021,"Although MemFlex produced long-term improvement in memory retrieval skills, there was little support for MemFlex as a relapse prevention program for depression.",[],"['autobiographical Memory Flexibility (MemFlex) intervention', 'Low-intensity psychological interventions', 'memory flexibility training (MemFlex', 'autobiographical memory-based intervention', 'autobiographical memory training']","['time until depressive relapse and depression-free days', 'memory retrieval skills', 'ability to retrieve and alternate between specific and general autobiographical memories', 'autobiographical memory distortions and on relapse of recurrent major depressive disorder', 'time until depressive relapse']",[],"[{'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes'}]",,0.0460965,"Although MemFlex produced long-term improvement in memory retrieval skills, there was little support for MemFlex as a relapse prevention program for depression.","[{'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Hitchcock', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, UK. Electronic address: caitlin.hitchcock@mrc-cbu.cam.ac.uk.'}, {'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Smith', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Elliott', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, UK.'}, {'ForeName': 'Cliodhna', 'Initials': 'C', 'LastName': ""O'Leary"", 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Gormley', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, UK.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, UK.'}, {'ForeName': 'Shivam D', 'Initials': 'SD', 'LastName': 'Patel', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, UK.'}, {'ForeName': 'Carlos V', 'Initials': 'CV', 'LastName': 'Esteves', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, UK.'}, {'ForeName': 'Evangeline', 'Initials': 'E', 'LastName': 'Rodrigues', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hammond', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, UK; University of Exeter, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Watson', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, UK.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Werner-Seidler', 'Affiliation': 'The Black Dog Institute, UNSW, Sydney, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dalgleish', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, UK; Cambridgeshire and Peterborough NHS Foundation Trust, UK.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103835']
416,33735740,The Effects of Repetitive Transcranial Magnetic Stimulation in Patients with Chronic Schizophrenia: Insights from EEG Microstates.,"The objective of this study was to investigate the effects of 10 Hz repetitive transcranial magnetic stimulation (rTMS) in patients with schizophrenia using EEG microstates. Thirty-eight patients with chronic schizophrenia were included in a double-blind, randomized and sham-controlled trial (19 participants in the active group and 19 participants in the sham group) and received 10 Hz active or sham rTMS stimulation to the left dorsolateral prefrontal cortex (left DLPFC) 5 days per week over for 4 weeks. Four classical microstate classes (i.e., classes A, B, C and D) were identified by clustering, and the parameters (i.e., duration, occurrence and contribution) of each class were computed. Our results showed that (1) after stimulation, the positive and negative syndrome scale (PANSS) positive scores decreased significantly in the active group; (2) the duration of the microstate of class C derived from EEG data decreased significantly in the active group; and (3) the change of the duration of class D in the active group was significantly higher than that in the sham group. Our findings demonstrated that 10 Hz active rTMS stimulation was beneficial to improving the positive symptoms of patients with chronic schizophrenia, and the EEG microstate could be an effective indicator of symptom improvements.",2021,"Our findings demonstrated that 10 Hz active rTMS stimulation was beneficial to improving the positive symptoms of patients with chronic schizophrenia, and the EEG microstate could be an effective indicator of symptom improvements.","['patients with chronic schizophrenia', 'Thirty-eight patients with chronic schizophrenia', 'patients with schizophrenia using EEG microstates', 'Patients with Chronic Schizophrenia']","['10 Hz active or sham rTMS stimulation to the left dorsolateral prefrontal cortex (left DLPFC', 'Repetitive Transcranial Magnetic Stimulation', '10 Hz repetitive transcranial magnetic stimulation (rTMS']","['EEG data', 'duration of class D', 'positive and negative syndrome scale (PANSS) positive scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",38.0,0.0559854,"Our findings demonstrated that 10 Hz active rTMS stimulation was beneficial to improving the positive symptoms of patients with chronic schizophrenia, and the EEG microstate could be an effective indicator of symptom improvements.","[{'ForeName': 'Zhilin', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Biomedical Engineering, School of Material Science and Engineering, South China University of Technology, Guangzhou 510006, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China; National Engineering Research Center for Tissue Restoration and Reconstruction, South China University of Technology, Guangzhou 510006, China.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Xiong', 'Affiliation': 'Department of Biomedical Engineering, School of Material Science and Engineering, South China University of Technology, Guangzhou 510006, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China; National Engineering Research Center for Tissue Restoration and Reconstruction, South China University of Technology, Guangzhou 510006, China.'}, {'ForeName': 'Huisi', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Biomedical Engineering, School of Material Science and Engineering, South China University of Technology, Guangzhou 510006, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China; National Engineering Research Center for Tissue Restoration and Reconstruction, South China University of Technology, Guangzhou 510006, China.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Biomedical Engineering, School of Material Science and Engineering, South China University of Technology, Guangzhou 510006, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China; National Engineering Research Center for Tissue Restoration and Reconstruction, South China University of Technology, Guangzhou 510006, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou Huiai Hospital, Guangzhou 510370, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Biomedical Engineering, School of Material Science and Engineering, South China University of Technology, Guangzhou 510006, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China; National Engineering Research Center for Tissue Restoration and Reconstruction, South China University of Technology, Guangzhou 510006, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Guangdong Engineering Technology Research Center for Diagnosis and Rehabilitation of Dementia, Guangzhou 510500, China; National Engineering Research Center for Healthcare Devices, Guangzhou 510500, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Biomedical Engineering, New Jersey Institute of Technology, Newark, NJ, U.S.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou Huiai Hospital, Guangzhou 510370, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China.'}, {'ForeName': 'Fengchun', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou Huiai Hospital, Guangzhou 510370, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China. Electronic address: 13580380071@163.com.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Department of Biomedical Engineering, School of Material Science and Engineering, South China University of Technology, Guangzhou 510006, China; The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou Huiai Hospital, Guangzhou 510370, China; Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders, Guangzhou 510370, China; Guangdong Engineering Technology Research Center for Diagnosis and Rehabilitation of Dementia, Guangzhou 510500, China; National Engineering Research Center for Tissue Restoration and Reconstruction, South China University of Technology, Guangzhou 510006, China; Key Laboratory of Biomedical Engineering of Guangdong Province, South China University of Technology, Guangzhou 510006, China; National Engineering Research Center for Healthcare Devices, Guangzhou 510500, China; Department of Nuclear Medicine and Radiology, Institute of Development, Aging and Cancer, Tohoku University, Sendai, Japan 980-8575. Electronic address: kaiwu@scut.edu.cn.'}]",Psychiatry research,['10.1016/j.psychres.2021.113866']
417,33725616,Efficacy of hypnotherapy compared to cognitive behavioral therapy for mild to moderate depression - Results of a randomized controlled rater-blind clinical trial.,"BACKGROUND


Methodologically well-designed RCTs concerning the efficacy of Hypnotherapy in the treatment of Major Depression are lacking. The aim of this study was to determine whether Hypnotherapy (HT) is not inferior to Cognitive Behavioral Therapy (CBT), the gold-standard psychotherapy, in the percentage reduction of depressive symptoms, assessed in mild to moderate Major Depression (MD).
METHODS


This study reports the main results of a monocentric two-armed randomized-controlled rater-blind clinical trial. A total of 152 patients with MD were randomized to either CBT or HT receiving outpatient individual psychotherapy with 16 to 20 sessions for the duration of six months. The primary outcome was the mean percentage improvement in depressive symptoms assessed with the Montgomery-Asberg Depression Rating Scale (MADRS) before and after treatment.
RESULTS


The difference in the mean percentage symptom reduction between HT and CBT was 2.8 (95% CI=-9.85 to 15.44) in the Intention-to-treat sample and 4.0 (95% CI=-9.27 to 17.27) in the Per Protocol sample (N=134). Concerning the pre-specified non-inferiority margin of -16.4, both results confirm the non-inferiority of HT to CBT. The results for the follow-ups six and twelve months after the end of the treatment support the primary results.
LIMITATIONS


For ethical reasons the trial did not include a control group without treatment; therefore we can only indirectly conclude that both treatment conditions are effective.
CONCLUSION


This is the first study to demonstrate that HT was not inferior to CBT in MD, while employing rigorous methodological standards.",2021,The difference in the mean percentage symptom reduction between HT and CBT was 2.8 (95% CI=-9.85 to 15.44) in the Intention-to-treat sample and 4.0 (95% CI=-9.27 to 17.27) in the Per Protocol sample (N=134).,"['152 patients with MD', 'mild to moderate depression ']","['Hypnotherapy (HT', 'cognitive behavioral therapy', 'hypnotherapy', 'Hypnotherapy', 'CBT or HT']",['mean percentage improvement in depressive symptoms assessed with the Montgomery-Asberg Depression Rating Scale (MADRS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",152.0,0.245665,The difference in the mean percentage symptom reduction between HT and CBT was 2.8 (95% CI=-9.85 to 15.44) in the Intention-to-treat sample and 4.0 (95% CI=-9.27 to 17.27) in the Per Protocol sample (N=134).,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Fuhr', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Meisner', 'Affiliation': 'Institute for Clinical Epidemiology and Applied Biometry, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Broch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cyrny', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Hinkel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Jaberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Petrasch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Cornelie', 'Initials': 'C', 'LastName': 'Schweizer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Stiegler', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Zeep', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Batra', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tuebingen, Germany. Electronic address: anil.batra@med.uni-tuebingen.de.'}]",Journal of affective disorders,['10.1016/j.jad.2021.02.069']
418,33721836,Network analysis of nitrate-sensitive oral microbiome reveals interactions with cognitive function and cardiovascular health across dietary interventions.,"Many oral bacteria reduce inorganic nitrate, a natural part of a vegetable-rich diet, into nitrite that acts as a precursor to nitric oxide, a regulator of vascular tone and neurotransmission. Aging is hallmarked by reduced nitric oxide production with associated detriments to cardiovascular and cognitive function. This study applied a systems-level bacterial co-occurrence network analysis across 10-day dietary nitrate and placebo interventions to test the stability of relationships between physiological and cognitive traits and clusters of co-occurring oral bacteria in older people. Relative abundances of Proteobacteria increased, while Bacteroidetes, Firmicutes and Fusobacteria decreased after nitrate supplementation. Two distinct microbiome modules of co-occurring bacteria, that were sensitive to nitrate supplementation, showed stable relationships with cardiovascular (Rothia-Streptococcus) and cognitive (Neisseria-Haemophilus) indices of health across both dietary conditions. A microbiome module (Prevotella-Veillonella) that has been associated with pro-inflammatory metabolism was diminished after nitrate supplementation, including a decrease in relative abundance of pathogenic Clostridium difficile. These nitrate-sensitive oral microbiome modules are proposed as potential pre- and probiotic targets to ameliorate age-induced impairments in cardiovascular and cognitive health.",2021,"Relative abundances of Proteobacteria increased, while Bacteroidetes, Firmicutes and Fusobacteria decreased after nitrate supplementation.",['older people'],[],"['Relative abundances of Proteobacteria increased, while Bacteroidetes, Firmicutes and Fusobacteria']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0751985', 'cui_str': 'Proteobacteria'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1003893', 'cui_str': 'Fusobacteria'}]",,0.0824511,"Relative abundances of Proteobacteria increased, while Bacteroidetes, Firmicutes and Fusobacteria decreased after nitrate supplementation.","[{'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Vanhatalo', 'Affiliation': 'College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: a.vanhatalo@exeter.ac.uk.'}, {'ForeName': 'Joanna E', 'Initials': 'JE', 'LastName': ""L'Heureux"", 'Affiliation': 'College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Blackwell', 'Affiliation': 'College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Lee J', 'Initials': 'LJ', 'LastName': 'Wylie', 'Affiliation': 'College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fulford', 'Affiliation': 'NIHR Exeter Clinical Research Facility, University of Exeter, UK.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Winyard', 'Affiliation': 'College of Medicine and Health, University of Exeter, UK.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Williams', 'Affiliation': 'School of Dentistry, Cardiff University, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van der Giezen', 'Affiliation': 'Department of Chemistry, Bioscience and Environmental Engineering, University of Stavanger, Norway.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Jones', 'Affiliation': 'College of Life and Environmental Sciences, University of Exeter, UK.'}]",Redox biology,['10.1016/j.redox.2021.101933']
419,33721765,CT-FFR vs a model of combined plaque characteristics for identifying ischemia: Results from CT-FFR CHINA trial.,"OBJECTIVES


To evaluate the diagnostic performance of fractional flow reserve (FFR) derived from coronary computed tomography angiography (CCTA; CT-FFR) and combined plaque characteristics for ischemia in different CCTA stenosis levels.
METHODS


This clinical trial analyzed 317 patients with 30 %-90 % coronary stenosis in 366 vessels from 5 centers undergoing CCTA and invasive FFR. 366 vessels were assigned into < 50 % (nonobstructive) and ≥ 50 % (obstructive) stenosis groups. Lesion length (LL), plaque burden (PB), diameter stenosis (DS), volume ratio of plaque subcomponents < 30 HU (VR < 30HU), and high-risk features were analyzed. Logistic regression models were used to identify plaque characteristic predictors for lesion-specific ischemia in different stenosis grades. The area under receiver operating characteristics curve (AUC) of integrated plaque characteristics and CT-FFR were calculated and compared.
RESULTS


In < 50 % stenosis lesions, PB (OR: 1.296, p = 0.002), LL (OR:1.075, p = 0.020), and DS (OR:1.085, p = 0.031) were independent predictors of ischemia. In ≥ 50 % stenosis lesions, VR < 30HU (OR:1.031, p = 0.005) and DS (OR: 1.020, p =  0.044) were independent predictors for ischemia. AUC of plaque characteristic (VR < 30HU plus DS) for ischemia was 0.67 (95 % CI: 0.61-0.72) in ≥ 50 % stenosis level, which was significantly lower than CT-FFR (AUC=0.90; 95 % CI: 0.86-0.93) (p <  0.001). For lesions causing < 50 % stenosis, AUC of combined plaque model (VR < 30HU plus DS) was 0.88 (95 % CI: 0.80-0.95), equivalent to AUC of CT-FFR (AUC = 0.88; 95 % CI: 0.80-0.96; p =  0.957).
CONCLUSION


CT-FFR is a powerful functional assessment tool for both obstructive and nonobstructive diseases. However, for nonobstructive CAD confirmed by CCTA, a model of a combination of plaque characteristics could be a valuable alternative to CT-FFR.",2021,AUC of plaque characteristic (VR < 30HU plus DS) for ischemia was 0.67,"['366 vessels were assigned into < 50 % (nonobstructive) and ≥ 50 % (obstructive) stenosis groups', 'ischemia', '317 patients with 30 %-90 % coronary stenosis in 366 vessels from 5 centers undergoing CCTA and invasive FFR']","['CT-FFR', 'coronary computed tomography angiography (CCTA; CT-FFR']","['LL', 'area under receiver operating characteristics curve (AUC) of integrated plaque characteristics and CT-FFR', 'AUC of plaque characteristic (VR < 30HU plus DS', 'DS', 'diagnostic performance of fractional flow reserve (FFR', 'Lesion length (LL), plaque burden (PB), diameter stenosis (DS), volume ratio of plaque subcomponents < 30 HU (VR\u2009<\u200930HU), and high-risk features']","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",317.0,0.0777638,AUC of plaque characteristic (VR < 30HU plus DS) for ischemia was 0.67,"[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 North Lishi Road, Xicheng District, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Radiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 North Lishi Road, Xicheng District, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Catheterization Laboratories, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 North Lishi Road, Xicheng District, Beijing, 100037, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiology, Beijing Chao-Yang Hospital, Capital Medical University, No. 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Beijing Chao-Yang Hospital, Capital Medical University, No. 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, China.'}, {'ForeName': 'Wenqiang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Qilu Hospital of Shandong University, 107, Jinan Culture Road, Jinan, 250012, China.'}, {'ForeName': 'Dumin', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, 107, Jinan Culture Road, Jinan, 250012, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Teda International Cardiovascular Hospital, 61, Third Avenue, TEDA, Tianjin, 300457, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Radiology, Teda International Cardiovascular Hospital, 61, Third Avenue, TEDA, Tianjin, 300457, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 North Lishi Road, Xicheng District, Beijing, China. Electronic address: blu@vip.sina.com.'}]",European journal of radiology,['10.1016/j.ejrad.2021.109634']
420,33721696,Acute effect of inhaled iloprost on exercise dynamic hyperinflation in COPD patients: A randomized crossover study.,"BACKGROUND AND OBJECTIVE


We tested whether the prostacyclin analog inhaled iloprost modulates dead space, dynamic hyperinflation (DH), and systemic inflammation/oxidative stress during maximal exercise in subjects with chronic obstructive pulmonary disease (COPD) who were not selected based on pulmonary hypertension (PH).
METHODS


Twenty-four COPD patients with moderate-severe obstruction (age 59 ± 7 years, FEV 1  53 ± 13% predicted) participated in a randomized, double-blind, placebo-controlled crossover trial. Each subject received a single nebulized dose of 5.0 μg iloprost or placebo on non-consecutive days followed by maximal cardiopulmonary exercise tests. The primary outcome was DH quantified by end-expiratory lung volume/total lung capacity ratio (EELV/TLC) at metabolic isotime.
RESULTS


Inhaled iloprost was well-tolerated and reduced submaximal alveolar dead-space fraction but did not significantly reduce DH (0.70 ± 0.09 vs 0.69 ± 0.07 following placebo and iloprost, respectively, p = 0.38). Maximal exercise time (9.1 ± 2.3 vs 9.3 ± 2.2 min, p = 0.31) and peak oxygen uptake (17.4 ± 6.3 vs 17.9 ± 6.9 mL/kg/min, p = 0.30) were not significantly different following placebo versus iloprost.
CONCLUSIONS


A single dose of inhaled iloprost was safe and reduced alveolar dead space fraction; however, it was not efficacious in modulating DH or improving exercise capacity in COPD patients who were not selected for the presence of PH.",2021,"Inhaled iloprost was well-tolerated and reduced submaximal alveolar dead-space fraction but did not significantly reduce DH (0.70 ± 0.09 vs 0.69 ± 0.07 following placebo and iloprost, respectively, p = 0.38).","['COPD patients', 'COPD patients who were not selected for the presence of PH', 'subjects with chronic obstructive pulmonary disease (COPD) who were not selected based on pulmonary hypertension (PH', 'Twenty-four COPD patients with moderate-severe obstruction (age 59\xa0±\xa07 years, FEV 1']","['prostacyclin analog inhaled iloprost', 'maximal exercise', 'iloprost or placebo', 'placebo', 'inhaled iloprost', 'Inhaled iloprost']","['dead space, dynamic hyperinflation (DH), and systemic inflammation/oxidative stress', 'exercise dynamic hyperinflation', 'tolerated and reduced submaximal alveolar dead-space fraction', 'peak oxygen uptake', 'exercise capacity', 'DH quantified by end-expiratory lung volume/total lung capacity ratio (EELV/TLC) at metabolic isotime', 'Maximal exercise time (9.1\xa0±']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]","[{'cui': 'C0033567', 'cui_str': 'Epoprostenol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0079594', 'cui_str': 'Iloprost'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231976', 'cui_str': 'Alveolar dead space'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0040509', 'cui_str': 'Total lung capacity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}]",24.0,0.333452,"Inhaled iloprost was well-tolerated and reduced submaximal alveolar dead-space fraction but did not significantly reduce DH (0.70 ± 0.09 vs 0.69 ± 0.07 following placebo and iloprost, respectively, p = 0.38).","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Lammi', 'Affiliation': 'Louisiana State University Health Sciences Center, Section of Pulmonary/Critical Care and Allergy/Immunology, United States; Comprehensive Pulmonary Hypertension Center-University Medical Center, United States. Electronic address: mlammi@lsuhsc.edu.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Ghonim', 'Affiliation': 'Louisiana State University Health Sciences Center, Stanley S. Scott Cancer Center, United States; The Department of Microbiology and Immunology, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'Louisiana State University Health Sciences Center, Section of Pulmonary/Critical Care and Allergy/Immunology, United States; Xavier University of Louisiana School of Pharmacy, United States.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': ""D'Aquin"", 'Affiliation': 'East Jefferson General Hospital, United States.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Zamjahn', 'Affiliation': 'Louisiana State University Health Sciences Center, Cardiopulmonary Science, United States.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Pellett', 'Affiliation': 'Louisiana State University Health Sciences Center, Cardiopulmonary Science, United States.'}, {'ForeName': 'Samuel C', 'Initials': 'SC', 'LastName': 'Okpechi', 'Affiliation': 'Louisiana State University Health Sciences Center, Stanley S. Scott Cancer Center, United States; Louisiana State University Health Sciences Center, Department of Biochemistry and Molecular Biology, United States.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Romaine', 'Affiliation': 'Louisiana State University Health Sciences Center, Section of Pulmonary/Critical Care and Allergy/Immunology, United States.'}, {'ForeName': 'Kusma', 'Initials': 'K', 'LastName': 'Pyakurel', 'Affiliation': 'Louisiana State University Health Sciences Center, Stanley S. Scott Cancer Center, United States.'}, {'ForeName': 'Hahn H', 'Initials': 'HH', 'LastName': 'Luu', 'Affiliation': 'Louisiana State University Health Sciences Center, Stanley S. Scott Cancer Center, United States.'}, {'ForeName': 'Judd E', 'Initials': 'JE', 'LastName': 'Shellito', 'Affiliation': 'Louisiana State University Health Sciences Center, Section of Pulmonary/Critical Care and Allergy/Immunology, United States.'}, {'ForeName': 'A Hamid', 'Initials': 'AH', 'LastName': 'Boulares', 'Affiliation': 'Louisiana State University Health Sciences Center, Stanley S. Scott Cancer Center, United States.'}, {'ForeName': 'Bennett P', 'Initials': 'BP', 'LastName': 'deBoisblanc', 'Affiliation': 'Louisiana State University Health Sciences Center, Section of Pulmonary/Critical Care and Allergy/Immunology, United States; Comprehensive Pulmonary Hypertension Center-University Medical Center, United States.'}]",Respiratory medicine,['10.1016/j.rmed.2021.106354']
421,33721598,"Efficacy of pitolisant in patients with high burden of narcolepsy symptoms: pooled analysis of short-term, placebo-controlled studies.","STUDY OBJECTIVE


To evaluate the efficacy of pitolisant, a histamine 3 (H 3 )-receptor antagonist/inverse agonist, in adult patients with high burden of narcolepsy symptoms.
METHODS


Data were pooled from two randomized, placebo-controlled, 7- or 8-week studies of pitolisant (titrated to a potential maximum dose of 35.6 mg/day) in adults with narcolepsy. Analyses included three independent patient subgroups: Epworth Sleepiness Scale (ESS) baseline score ≥16, Maintenance of Wakefulness Test (MWT) sleep latency ≤8 min, and ≥15 cataplexy attacks per week.
RESULTS


The analysis populations included 118 patients for ESS (pitolisant, n = 60; placebo, n = 58), 105 for MWT (pitolisant, n = 59; placebo, n = 46), and 31 for cataplexy (pitolisant, n = 20; placebo, n = 11). On the ESS, least-squares mean change from baseline was significantly greater for pitolisant (-6.1) compared with placebo (-2.3; P < 0.001). Significantly more pitolisant-treated patients were classified as treatment responders: ESS score reduction ≥3, 69.0% in the pitolisant group versus 35.1% in the placebo group (P = 0.001); final ESS score ≤10, 36.2% versus 10.5%, respectively (P = 0.005). On the MWT, mean sleep latency increased from 3.5 min to 10.4 min with pitolisant and from 3.4 min to 6.8 min with placebo (P = 0.017). Least-squares mean change in the weekly rate of cataplexy was significantly greater for pitolisant (-14.5; baseline, 23.9; final, 9.4) compared with placebo (-0.1; baseline, 23.1; final, 23.0; P = 0.004). Headache was the most common adverse event with pitolisant.
CONCLUSIONS


Pitolisant, at once-daily doses up to 35.6 mg, was efficacious for reducing excessive daytime sleepiness and cataplexy in patients with severe narcolepsy symptom burden.",2021,"On the MWT, mean sleep latency increased from 3.5 min to 10.4 min with pitolisant and from 3.4 min to 6.8 min with placebo (P = 0.017).","['patients with high burden of narcolepsy symptoms', 'adults with narcolepsy', 'adult patients with high burden of narcolepsy symptoms', '118 patients for ESS (pitolisant, n\xa0=\xa060; placebo, n\xa0=\xa058), 105 for MWT (pitolisant, n\xa0=\xa059; placebo, n\xa0=\xa046), and 31 for', 'patients with severe narcolepsy symptom burden']","['placebo', 'cataplexy (pitolisant, n\xa0=\xa020; placebo', 'pitolisant', 'histamine 3 (H 3 )-receptor']","['mean sleep latency', 'Epworth Sleepiness Scale (ESS) baseline score ≥16, Maintenance of Wakefulness Test (MWT) sleep latency ≤8\xa0min, and ≥15 cataplexy attacks per week', 'Headache', 'excessive daytime sleepiness', 'rate of cataplexy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0206630', 'cui_str': 'Endometrial stromal sarcoma'}, {'cui': 'C3529928', 'cui_str': 'pitolisant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007384', 'cui_str': 'Cataplexy'}, {'cui': 'C3529928', 'cui_str': 'pitolisant'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0007384', 'cui_str': 'Cataplexy'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}]",118.0,0.511282,"On the MWT, mean sleep latency increased from 3.5 min to 10.4 min with pitolisant and from 3.4 min to 6.8 min with placebo (P = 0.017).","[{'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Davis', 'Affiliation': 'Harmony Biosciences, LLC, Plymouth Meeting, PA, USA. Electronic address: cdavis@harmonybiosciences.com.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Kallweit', 'Affiliation': 'Universität Witten/Herdecke, Witten, Germany.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Schwartz', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}, {'ForeName': 'Lois E', 'Initials': 'LE', 'LastName': 'Krahn', 'Affiliation': 'Mayo Clinic Hospital, Phoenix, AZ, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Vaughn', 'Affiliation': 'Rho, Durham, NC, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Thorpy', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}]",Sleep medicine,['10.1016/j.sleep.2021.02.037']
422,33711782,Cardiovascular safety of mometasone/indacaterol and mometasone/indacaterol/glycopyrronium once-daily fixed-dose combinations in asthma: pooled analysis of phase 3 trials.,"OBJECTIVE


To evaluate cardiovascular safety of two new inhaled fixed-dose combinations for treatment of asthma: (i) the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) mometasone furoate/indacaterol acetate (MF/IND), (ii) the ICS/LABA/long-acting muscarinic antagonist (LAMA) MF/IND/glycopyrronium bromide (GLY).
METHODS


Patient-level data were pooled from four randomized trials, including 52-week studies PALLADIUM (n = 2216) and IRIDIUM (n = 3092), 24-week study ARGON (n = 1426), and 12-week study QUARTZ (n = 802). Cardio-/cerebrovascular (CCV) event frequencies were examined in the following comparisons: (1) LABA effect: pooled-dose MF/IND vs. pooled-dose MF; (2) LAMA effect: pooled-dose MF/IND/GLY vs. pooled-dose MF/IND; (3) ICS-dose effects: (a) high-dose MF/IND vs. medium-dose MF/IND, (b) high-dose MF/IND/GLY vs. medium-dose MF/IND/GLY; (4) intra-class effects: (a) high-dose MF/IND vs. Fluticasone/Salmeterol (F/S), (b) high-dose MF/IND/GLY vs. F/S + Tiotropium (TIO). Risk estimates (percentage of patients with ≥1 CCV event) and risk differences (RDs) with 95% confidence intervals (CIs) were calculated for each comparison.
RESULTS


The frequency of CCV events was low, without notable differences between comparison groups. Risk estimates and corresponding RDs (95% CIs) were as follows: (1) pooled-dose MF/IND = 2.35%, pooled-dose MF = 2.18%, RD = 0.17% (-1.00%, 1.34%); (2) pooled-dose MF/IND/GLY = 3.65%, pooled-dose MF/IND = 3.77%, RD = -0.12% (-1.63%, 1.39%); (3a) high-dose MF/IND = 3.69%, medium-dose MF/IND = 3.35%, RD = 0.34% (-1.25%, 1.94%); (3b) high-dose MF/IND/GLY = 2.84%, medium-dose MF/IND/GLY = 2.02%, RD = 0.82% (-0.49%, 2.13%); (4a) high-dose MF/IND = 3.69%, F/S = 2.82%, RD = 0.87% (-0.66%, 2.40%); (4b) high-dose MF/IND/GLY = 1.26%, F/S + TIO = 1.05%, RD = 0.21% (-1.26%, 1.68%).
CONCLUSIONS


There was no evidence of increased cardiovascular risk attributable to the addition of IND to MF or addition of GLY to MF/IND. Similarly, no evidence of increased cardiovascular risk was observed with an increase in the ICS-dose or relative to F/S ± TIO.",2021,There was no evidence of increased cardiovascular risk attributable to the addition of IND to MF or addition of GLY to MF/IND.,"['asthma', 'Patient-level data']","['Fluticasone/Salmeterol (F/S), (b) high-dose MF/IND/GLY vs. F/S\xa0+\xa0Tiotropium (TIO', 'QUARTZ', 'inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) mometasone furoate/indacaterol acetate (MF/IND), (ii) the ICS/LABA/long-acting muscarinic antagonist (LAMA) MF/IND/glycopyrronium bromide (GLY', 'mometasone/indacaterol and mometasone/indacaterol/glycopyrronium']","['frequency of CCV events', 'cardiovascular safety', 'Cardio-/cerebrovascular (CCV) event frequencies', 'cardiovascular risk', 'Cardiovascular safety', 'Risk estimates and corresponding RDs']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0939232', 'cui_str': 'salmeterol and fluticasone'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0034387', 'cui_str': 'Quartz'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0054931', 'cui_str': 'CCV protocol'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439603', 'cui_str': 'Frequencies'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",,0.107998,There was no evidence of increased cardiovascular risk attributable to the addition of IND to MF or addition of GLY to MF/IND.,"[{'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Scosyrev', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: emil.scosyrev@novartis.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van Zyl-Smit', 'Affiliation': 'Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Huib', 'Initials': 'H', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, and Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gessner', 'Affiliation': 'Universitätsklinikum Leipzig, Germany POIS Leipzig GbR, Leipzig, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kornmann', 'Affiliation': 'IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany.'}, {'ForeName': 'Devendra', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Aubrun', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""D'Andrea"", 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Motoi', 'Initials': 'M', 'LastName': 'Hosoe', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Pethe', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Brittain', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Respiratory medicine,['10.1016/j.rmed.2021.106311']
423,33711748,Effects of aromatherapy with essential oil massage on the sleep quality of critical care nurses: A randomized controlled trial.,"The purpose of this study was to explore the effectiveness of an essential oil massage on the sleep quality of the critical care nurses. A randomized controlled trial with single blind was conducted. A total of 112 critical care nurses were recruited. Participants were randomly allocated to either the experimental or control group. Only the experimental group received four sessions consisting of a lavender essential oil massage. The results of this study revealed that the overall subjective sleep quality and objective sleep parameters did not reach a significant difference between the two groups before and after the intervention, but a progressive the subjective sleep quality score reduction was observed in the experimental group. The findings of this study might provide information to critical care nurses who are under high pressure to find the optional alternative way of managing their self-sleep health by employing safe and convenient alternatives through aromatherapy.",2021,"The results of this study revealed that the overall subjective sleep quality and objective sleep parameters did not reach a significant difference between the two groups before and after the intervention, but a progressive the subjective sleep quality score reduction was observed in the experimental group.","['critical care nurses', '112 critical care nurses']","['aromatherapy with essential oil massage', 'lavender essential oil massage', 'essential oil massage']","['sleep quality', 'subjective sleep quality score reduction', 'overall subjective sleep quality and objective sleep parameters']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",112.0,0.0307894,"The results of this study revealed that the overall subjective sleep quality and objective sleep parameters did not reach a significant difference between the two groups before and after the intervention, but a progressive the subjective sleep quality score reduction was observed in the experimental group.","[{'ForeName': 'Hsiu-Chin', 'Initials': 'HC', 'LastName': 'Hsu', 'Affiliation': 'Department of Graduate Institute of Health Care, Chang Gung University of Science and Technology, And Assistant Research Fellow, Department of Internal Medicine, Chang Gung Memorial Hospital. 261 Wen-Hau 1st Rd, Kweishan, Tao-Yuan, Taiwan, ROC. Electronic address: hchsu@mail.cgust.edu.tw.'}, {'ForeName': 'Mei-Hsiang', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'National Taipei University of Nursing and Health Sciences, No.365, Ming-te Road, Peitou District, Taipei City, Taiwan. Electronic address: mhlin5452@gmail.com.'}, {'ForeName': 'Hsiu-Fang', 'Initials': 'HF', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Chang Gung Medical Foundation, Linkou. Department of Nursing, Chang Gung University of Science & Technology, No.5, Fuxing St., Guishan Dist., Taoyuan City, 333, Taiwan.'}, {'ForeName': 'Chiu-Yen', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': 'Department of Cosmetics, Chang Gung University of Science and Technology, Taiwan.'}, {'ForeName': 'Chih-Ting', 'Initials': 'CT', 'LastName': 'Chou', 'Affiliation': 'Department of Nursing New Taipei Municipal Tucheng Hospital, Taiwan.'}, {'ForeName': 'Shu-Fen', 'Initials': 'SF', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Taiwan.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101358']
424,33706065,"Effectiveness of topical ozonated oil in severe osteoarthritis: A randomised, triple-blinded, placebo-controlled study.","BACKGROUND


Osteoarthritis is highly prevalent and a common locomotory disorder in the elderly. The treatments aim improves the quality of life. We aimed to evaluate the effectiveness of topical ozonated oil in relieving pain in patients with osteoarthritis.
DESIGN


A placebo-controlled, triple-blind, randomised controlled trial including osteoarthritis patients older than 50 years.
INTERVENTIONS


Eighty patients were randomly divided into two groups: treatment (ozonated oil) and placebo (non-ozonated oil). The oils were used twice a day for 60 days. Evaluations were performed using WOMAC (Western Ontario and McMaster Universities) and VAS (visual analogue scale) and laboratory analysis.
RESULTS


Pain relief was observed in all groups except in the placebo group where patients are diagnosed with severe osteoarthritis (degree 4) (p-value treatment and placebo group: 0.021 and 0.345, respectively).
CONCLUSIONS


For the first time, the pain relief in patients with severe osteoarthritis was demonstrated by the use of topical ozonated oil.",2021,"RESULTS


Pain relief was observed in all groups except in the placebo group where patients are diagnosed with severe osteoarthritis (degree 4)","['patients with severe osteoarthritis', 'osteoarthritis patients older than 50 years', 'patients with osteoarthritis', 'severe osteoarthritis', 'Eighty patients']","['treatment (ozonated oil) and placebo (non-ozonated oil', 'placebo', 'topical ozonated oil']","['quality of life', 'severe osteoarthritis', 'relieving pain', 'Pain relief', 'WOMAC (Western Ontario and McMaster Universities) and VAS (visual analogue scale) and laboratory analysis', 'pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",80.0,0.178692,"RESULTS


Pain relief was observed in all groups except in the placebo group where patients are diagnosed with severe osteoarthritis (degree 4)","[{'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Anzolin', 'Affiliation': 'Graduate Program in Human Aging, University of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil. Electronic address: anapaulasordianzolin@gmail.com.'}, {'ForeName': 'Diego da Silva', 'Initials': 'DDS', 'LastName': 'Collares', 'Affiliation': 'Clinical Hospital of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Tadeu Dos Santos', 'Affiliation': 'Clinical Hospital of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Pasqualotti', 'Affiliation': 'Graduate Program in Human Aging, University of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Luciana Grazziotin', 'Initials': 'LG', 'LastName': 'Rossato-Grando', 'Affiliation': 'Graduate Program in Bioexperimentation, University of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Charise Dallazem', 'Initials': 'CD', 'LastName': 'Bertol', 'Affiliation': 'Graduate Program in Human Aging, University of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil; College of Pharmacy, University of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil. Electronic address: charise@upf.br.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101351']
425,33744812,A randomized phase IIa study of quantified bone scan response in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 dichloride alone or in combination with abiraterone acetate/prednisone or enzalutamide.,"BACKGROUND


In metastatic castration-resistant prostate cancer (mCRPC), assessing treatment response and bone lesions with technetium-99m is limited by image resolution and subjectivity. We evaluated bone scan lesion area (BSLA), a quantitative imaging assessment of response in patients with mCRPC receiving radium-223 alone or in combination with androgen receptor pathway inhibitors (abiraterone/prednisone or enzalutamide).
PATIENTS AND METHODS


This randomized, non-comparative phase IIa three-arm trial (NCT02034552) evaluated technetium-99m-based BSLA response rate (RR), safety, radiologic progression-free survival (rPFS), and time to first symptomatic skeletal event (SSE) in men with mCRPC and bone metastases receiving radium-223 with/without abiraterone/prednisone or enzalutamide. The primary endpoint was week 24 BSLA RR.
RESULTS


Overall, 63 patients received treatment (abiraterone/prednisone combination, n = 22; enzalutamide combination, n = 22; radium-223 monotherapy, n = 19). Median treatment duration (first to last dose of any study treatment) was 12 months (abiraterone/prednisone combination), 10 months (enzalutamide combination), and 3 months (radium-223 monotherapy). Week 24 BSLA RR was 58% [80% confidence interval (CI) 41% to 74%; one-sided P < 0.0001; 11/19 patients] with abiraterone/prednisone combination, 50% (32% to 68%; one-sided P < 0.0001; 8/16 patients) with enzalutamide combination, and 22% (10% to 40%; one-sided P = 0.0109; 4/18 patients) with radium-223 monotherapy. Median rPFS was not evaluable for combination arms and 4 months (80% CI 4 to 12) for monotherapy. SSEs were reported in 32% of patients; median time to first SSE was not estimable. Fatigue and back pain were the most commonly reported treatment-emergent adverse events (TEAEs); more patients receiving combination therapy than monotherapy had TEAEs. Fractures were reported in 18% receiving abiraterone/prednisone, 32% receiving enzalutamide, and 11% receiving radium-223 monotherapy. Fracture rates were lower in patients taking bone health agents versus not taking bone health agents at baseline.
CONCLUSIONS


Technetium-99m imaging BSLA may offer objective, quantifiable assessment of isotope uptake changes, and potentially treatment response, in patients with mCRPC and bone metastases treated with radium-223 alone or in combination with abiraterone/prednisone or enzalutamide. In this largely treatment-naive population, BSLA RR was numerically lower with radium-223 monotherapy versus combination therapy, indicating a limited role as first-line treatment. Use of radium-223 should follow evidence-based treatment guidelines and the licensed indication.",2021,Median rPFS was not evaluable for combination arms and 4 months (80% CI 4 to 12) for monotherapy.,"['patients with mCRPC and bone metastases treated with radium-223 alone or in combination with', '63 patients received', 'patients with mCRPC receiving radium-223 alone or in combination with', 'metastatic castration-resistant prostate cancer (mCRPC', 'patients with metastatic castration-resistant prostate cancer (mCRPC) treated with', 'men with mCRPC and bone metastases receiving radium-223 with/without']","['radium-223 dichloride alone or in combination with abiraterone acetate/prednisone or enzalutamide', 'androgen receptor pathway inhibitors (abiraterone/prednisone or enzalutamide', 'enzalutamide', 'treatment (abiraterone/prednisone combination, n\xa0= 22; enzalutamide combination, n\xa0= 22; radium-223 monotherapy', 'radium-223 monotherapy', 'abiraterone/prednisone', 'abiraterone/prednisone or enzalutamide']","['SSEs', 'technetium-99m-based BSLA response rate (RR), safety, radiologic progression-free survival (rPFS), and time to first symptomatic skeletal event (SSE', 'Median treatment duration', 'Median rPFS', 'Fatigue and back pain', 'median time to first SSE', '24 BSLA RR', 'Fractures', 'Fracture rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0303282', 'cui_str': 'Radium-223'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3541342', 'cui_str': 'RADIUM CHLORIDE RA-223'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0303282', 'cui_str': 'Radium-223'}]","[{'cui': 'C0303611', 'cui_str': 'Technetium 99m'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",,0.0865232,Median rPFS was not evaluable for combination arms and 4 months (80% CI 4 to 12) for monotherapy.,"[{'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Department of Urology, Yale School of Medicine, New Haven, USA. Electronic address: daniel.petrylak@yale.edu.'}, {'ForeName': 'U N', 'Initials': 'UN', 'LastName': 'Vaishampayan', 'Affiliation': 'Division of Solid Tumor Oncology, Karmanos Cancer Institute, Detroit, USA.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Patel', 'Affiliation': 'Arizona Institute of Urology, Tucson, USA.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'University of Washington, Seattle, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Albany', 'Affiliation': 'Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, USA.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Dawson', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Mehlhaff', 'Affiliation': 'Oregon Urology Institute, Springfield, USA.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Department of Medicine, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, USA.'}, {'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Nordquist', 'Affiliation': 'Department of Medical Oncology, Genitourinary Research Network, Omaha, USA.'}, {'ForeName': 'V J', 'Initials': 'VJ', 'LastName': 'Wagner', 'Affiliation': 'Bayer Consumer Care AG, Basel, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Siegel', 'Affiliation': 'Oncology Clinical Statistics, Bayer HealthCare Pharmaceuticals Inc., Whippany, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Trandafir', 'Affiliation': 'Bayer Consumer Care AG, Basel, Switzerland.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': 'Tulane Cancer Center, Tulane University School of Medicine, New Orleans, USA.'}]",ESMO open,['10.1016/j.esmoop.2021.100082']
426,33744781,Health-related quality of life in the randomized phase III trial of brigatinib vs crizotinib in advanced ALK inhibitor-naive ALK + non-small cell lung cancer (ALTA-1L).,"OBJECTIVE


In ALTA-1 L, first-line brigatinib versus crizotinib significantly prolonged progression-free survival in advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC). We report health-related quality of life (HRQOL) outcomes from ALTA-1 L.
MATERIALS AND METHODS


HRQOL was assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and lung cancer-specific module (QLQ-LC13). HRQOL time to worsening, change from baseline, and duration of improvement were analyzed.
RESULTS


EORTC QLQ-C30 and QLQ-LC13 compliance was >90 % for both groups (n = 131 each). Brigatinib versus crizotinib significantly delayed time to worsening in the EORTC QLQ-C30 global health status (GHS)/QOL (median: 26.74 vs 8.31 months; hazard ratio [HR]: 0.70; 95 % CI: 0.49, 1.00; log-rank P = 0.0485); emotional functioning, social functioning, fatigue, nausea and vomiting, appetite loss, and constipation scales (log-rank P < 0.05); delays in time to worsening for the physical, role, and cognitive functioning scales were not statistically significant. Mean change from baseline showed greater improvement in GHS/QOL and most EORTC QLQ-C30 functional and symptom scales with brigatinib versus crizotinib. Among patients with GHS/QOL improvement, brigatinib had longer duration of improvement versus crizotinib (median: not reached vs 11.99 months); similar results were seen in the physical, role, emotional, and social functioning; fatigue; nausea and vomiting; and appetite loss scales. Median time to worsening in dyspnea (QLQ-LC13) was 23.98 versus 8.25 months (brigatinib vs crizotinib; HR: 0.64; 95 % CI: 0.39, 1.05).
CONCLUSION


Brigatinib significantly delayed time to worsening and prolonged duration of improvement in GHS/QOL versus crizotinib, supported by improvement in functional and symptom scores. These preliminary analyses suggest brigatinib is the first ALK inhibitor with better HRQOL versus another ALK inhibitor in ALK inhibitor-naive advanced ALK + NSCLC.",2021,Mean change from baseline showed greater improvement in GHS/QOL and most EORTC QLQ-C30 functional and symptom scales with brigatinib versus crizotinib.,[],['brigatinib vs crizotinib'],"['delayed time to worsening and prolonged duration of improvement in GHS/QOL', 'physical, role, emotional, and social functioning; fatigue; nausea and vomiting; and appetite loss scales', 'EORTC QLQ-C30 and QLQ-LC13 compliance', 'emotional functioning, social functioning, fatigue, nausea and vomiting, appetite loss, and constipation scales', 'HRQOL time to worsening, change from baseline, and duration of improvement', 'functional and symptom scores', 'Health-related quality of life', 'Median time to worsening in dyspnea (QLQ-LC13', 'Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and lung cancer-specific module (QLQ-LC13', 'cognitive functioning scales', 'GHS/QOL and most EORTC QLQ-C30 functional and symptom scales']",[],"[{'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}]","[{'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.177708,Mean change from baseline showed greater improvement in GHS/QOL and most EORTC QLQ-C30 functional and symptom scales with brigatinib versus crizotinib.,"[{'ForeName': 'Maria Rosario', 'Initials': 'MR', 'LastName': 'Garcia Campelo', 'Affiliation': 'Medical Oncology Service, University Hospital A Coruña (XXIAC-SERGAS), Xubias de Arriba, 84, 15006, A Coruña, Spain. Electronic address: MA.Rosario.Garcia.Campelo@sergas.es.'}, {'ForeName': 'Huamao M', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': 'Millennium Pharmaceuticals, Inc, 35 Landsdowne Street, Cambridge, MA, 02139, USA(3). Electronic address: mark.lin@takeda.com.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Millennium Pharmaceuticals, Inc, 35 Landsdowne Street, Cambridge, MA, 02139, USA(3). Electronic address: Yanyan.zhu@takeda.com.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Pérol', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian, 69008, Lyon, France. Electronic address: maurice.perol@lyon.unicancer.fr.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Jahanzeb', 'Affiliation': 'Florida Precision Oncology, a division of 21st Century Oncology, 3651 FAU Boulevard, Suite 100, Boca Raton, FL, 33431, USA. Electronic address: mj@fponcology.com.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'The Royal Marsden Hospital, 203 Fulham Road, Chelsea, London, SW3 6JJ, United Kingdom; The Institute of Cancer Research, 123 Old Brompton Road, London, SW7 3RP, United Kingdom. Electronic address: sanjay.popat@rmh.nhs.uk.'}, {'ForeName': 'Pingkuan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Millennium Pharmaceuticals, Inc, 300 Massachusetts Avenue, Cambridge, MA, 02139, USA(3). Electronic address: Pingkuan.Zhang@takeda.com.'}, {'ForeName': 'D Ross', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': 'University of Colorado Cancer Center, 1665 Aurora Court, Aurora, CO, 80045, USA. Electronic address: Ross.Camidge@CUAnschutz.edu.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2021.03.005']
427,33744715,Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial.,"BACKGROUND


Previous studies on oxaliplatin and fluoropyrimidines as adjuvant therapy in older patients with stage III colon cancer (CC) produced conflicting results.
PATIENTS AND METHODS


We assessed the impact of age on time to tumour recurrence (TTR), disease-free survival (DFS), cancer-specific survival (CSS), and overall survival (OS) in 2360 patients with stage III CC (1667 aged <70 years and 693 ≥ 70 years) randomised to receive 3 or 6 months of FOLFOX or CAPOX within the frame of the phase III, TOSCA study.
RESULTS


Older patients compared with younger ones presented more frequently an Eastern Cooperative Oncology Group performance status equal to 1 (10.5% vs 3.3%, p < 0.001), a greater number of right-sided tumours (40.9% vs 26.6%, p < 0.001), and were at higher clinical risk (37.2% vs 33.2%, p = 0.062). The treatments were almost identical in the two cohorts (p = 0.965). We found a greater proportion of dose reductions (46.7% vs 41.4%, p = 0.018), treatment interruptions (26.1% vs 19.3%, p < 0.001) and a higher proportion of recurrences (24.2% vs 20.3%, p = 0.033) in the older patients. The multivariable analysis of the TTR did not indicate a statistically significant effect of age (hazard ratio [HR]: 1.19; 95% confidence interval [CI]: 0.98-1.44; p = 0.082). The HR comparing older with younger patients was 1.34 (95% CI: 1.12-1.59; p = 0.001) for DFS, 1.58 (95% CI: 1.26-1.99; p < 0.001) for OS, and 1.28 (95% CI: 0.96-1.70; p = 0.089) for CSS.
CONCLUSIONS


Worse prognostic factors and reduced treatment compliance have a negative impact on the efficacy of oxaliplatin-based adjuvant therapy in older patients.",2021,"The HR comparing older with younger patients was 1.34 (95% CI: 1.12-1.59; p = 0.001) for DFS, 1.58","['older patients', 'colon cancer in older patients', '2360 patients with stage III CC (1667 aged <70 years and 693\xa0≥\xa070 years', 'older patients with stage III colon cancer (CC']","['Oxaliplatin plus fluoropyrimidines', 'oxaliplatin and fluoropyrimidines', 'FOLFOX or CAPOX', 'oxaliplatin-based adjuvant therapy']","['time to tumour recurrence (TTR), disease-free survival (DFS), cancer-specific survival (CSS), and overall survival (OS', 'proportion of dose reductions', 'number of right-sided tumours', 'proportion of recurrences']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4708909', 'cui_str': '1667'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205090', 'cui_str': 'Right'}]",2360.0,0.331032,"The HR comparing older with younger patients was 1.34 (95% CI: 1.12-1.59; p = 0.001) for DFS, 1.58","[{'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'Medical Oncology Unit, Ospedale San Carlo, Potenza, Italy. Electronic address: oncogerry@yahoo.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Medical Oncology Unit 1, Istituto Oncologico Veneto-IRCCS, Padova, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS INT, Milano, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ronzoni', 'Affiliation': 'Medical Oncology Unit, Ospedale San Raffaele-IRCCS, Milano, Italy.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Zampino', 'Affiliation': 'Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumours, Istituto Europeo di Oncologia-IRCCS, Milano, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Banzi', 'Affiliation': 'Medical Oncology Unit, Azienda USL-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Pasini', 'Affiliation': 'Medical Oncology Unit, Ospedale Santa Maria della Misericordia, Rovigo, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bozzarelli', 'Affiliation': 'Humanitas Clinical and Research Center, Humanitas Cancer Center-IRCCS, Rozzano, Italy.'}, {'ForeName': 'Silvio K', 'Initials': 'SK', 'LastName': 'Garattini', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliera Universitaria S. Maria della Misericordia, Udine, Italy.'}, {'ForeName': 'Daris', 'Initials': 'D', 'LastName': 'Ferrari', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliera San Paolo, Milano, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Montesarchio', 'Affiliation': 'Medical Oncology Unit, A.O.R.N. dei Colli-Ospedali Monaldi-Cotugno-CTO, Napoli, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mambrini', 'Affiliation': 'Medical Oncology Unit, Azienda USL Toscana Nord Ovest, Massa Carrara, Italy.'}, {'ForeName': 'Libero', 'Initials': 'L', 'LastName': 'Ciuffreda', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliero Universitaria San Giovanni Battista, Torino, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Pusceddu', 'Affiliation': 'Medical Oncology, University Hospital and University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Carlomagno', 'Affiliation': 'Medical Oncology, Università degli Studi di Napoli Federico II, Napoli, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bidoli', 'Affiliation': 'Medical Oncology Unit, Ospedale San Gerardo, Monza, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Amoroso', 'Affiliation': 'Medical Oncology, Azienda USL12, Viareggio, Italy.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Bochicchio', 'Affiliation': 'Medical Oncology Unit, IRCCS CROB Basilicata, Rionero in Vulture, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Frassineti', 'Affiliation': 'Medical Oncology Unit, IRST IRCCS, Meldola, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Corsi', 'Affiliation': 'Medical Oncology Unit, Ospedale San G. Calibita Fatebenefratelli, Roma, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Bilancia', 'Affiliation': 'Medical Oncology Unit, Ospedale San Carlo, Potenza, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Pastorino', 'Affiliation': ""Medical Oncology Department, Ospedale Sant'Andrea, La Spezia, Italy.""}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'De Stefano', 'Affiliation': 'Experimental Clinical Abdominal Oncology Unit, INT-IRCCS, Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Labianca', 'Affiliation': 'Cancer Center ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.01.051']
428,33743283,SLC6A4 polymorphisms modulate the efficacy of a tryptophan-enriched diet on age-related depression and social cognition.,"BACKGROUND & AIMS


In a placebo controlled study we sought to determine if a four-weeks tryptophan-enriched diet is able to improve age-related depression or social cognitive impairment, depending on polymorphisms located in the promoter region of Solute Carrier Family 6 Member 4 (SLC6A4), also known as serotonin transporter (SERT1) gene.
METHODS


91 young volunteers (age: 21 ± 2 yrs) and 127 above 50 years old (58 ± 6 yrs) healthy volunteers completed the study. Participants from the placebo and tryptophan group followed the same protocol. Before starting the study blood samples, to measure serotonin-transporter-linked polymorphic region (5-HTTLPR) and rs25531 polymorphisms, were collected. In addition, before and after completing the study urine samples (to measure 5-hydroxyindolacetic acid (5-HIAA) were taken, while psychological questionnaires (to assess depression and social cognition levels), and a one week dietary record (to calculate the tryptophan (TRP) intake) were assessed.
RESULTS


The triallelic approach of SLC6A4 showed that in S'S´ subjects there was a positive correlation between TRP intake and 5-HIAA levels. Age of participants, SLC6A4 genotype, and experimental condition were important factors contributing to the outcome of depression and social cognition.
CONCLUSIONS


5-HTTLPR and rs25531 polymorphisms play a key role in the response to the TRP- based nutritional intervention, improving only age-related depressive symptoms and empathy in S'S´ subjects who have a higher risk to show signs of depression during their lifetime.",2021,"Age of participants, SLC6A4 genotype, and experimental condition were important factors contributing to the outcome of depression and social cognition.
","['healthy volunteers', '91 young volunteers (age: 21\xa0±\xa02\xa0yrs) and 127 above 50 years old (58\xa0±\xa06\xa0yrs']","['placebo', 'tryptophan-enriched diet', 'placebo and tryptophan']","['TRP intake and 5-HIAA levels', 'tryptophan (TRP) intake']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0020361', 'cui_str': '5-hydroxyindole acetic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",91.0,0.0537935,"Age of participants, SLC6A4 genotype, and experimental condition were important factors contributing to the outcome of depression and social cognition.
","[{'ForeName': 'Lierni', 'Initials': 'L', 'LastName': 'Ugartemendia', 'Affiliation': 'Department of Physiology, Neuroimmunophysiology and Chrononutrition Research Group, Faculty of Science, University of Extremadura, Badajoz, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Bravo', 'Affiliation': 'Department of Physiology, Neuroimmunophysiology and Chrononutrition Research Group, Faculty of Science, University of Extremadura, Badajoz, Spain. Electronic address: rbravo@unex.es.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reuter', 'Affiliation': 'Biological & Personality Psychology, Laboratory of Neurogenetics, Department of Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'M Yolanda', 'Initials': 'MY', 'LastName': 'Castaño', 'Affiliation': 'Department of Physiology, Neuroimmunophysiology and Chrononutrition Research Group, Faculty of Science, University of Extremadura, Badajoz, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Plieger', 'Affiliation': 'Biological & Personality Psychology, Laboratory of Neurogenetics, Department of Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Zamoscik', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kirsch', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Physiology, Neuroimmunophysiology and Chrononutrition Research Group, Faculty of Science, University of Extremadura, Badajoz, Spain.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.02.023']
429,33743263,Less polyethylene wear in monobloc compared to modular ultra-high-molecular-weight-polyethylene inlays in hybrid total knee arthroplasty: A 5-year randomized radiostereometry study.,"BACKGROUND


A modular polyethylene (PE) inlay in total knee arthroplasty (TKA) may wear on both sides. PE particles may induce osteolysis, which can lead to implant loosening. The aim of this study was to determine if PE wear in monobloc TKA differs from that ofmodular TKA at 60-month follow-up.
PATIENTS AND METHODS


In a prospective, patient-blinded trial, 50 patients were randomized to hybrid TKA surgery with either acementless high-porosity trabecular-metal tibial component with a monobloc UHMWPE inlay (MONO-TM) or a cementless low-porosity screw-augmented titanium fiber-mesh tibial component with a modular UHMWPE inlay (MODULAR-FM). Radiostereometry was used to measure PE wear and tibial component migration.
RESULTS


At 60-monthfollow-up, mean PE wear of the medial compartment was 0.24 mm and 0.61 mm and mean PE wear of the lateral compartment was 0.31 mm and 0.82 mm for the MONO-TM and the MODULAR-FM groups, respectively (p < 0.01). The PE wear-rate was 0.05 mm (95% CI 0.03-0.08) in the MONO-TM group and 0.14 mm (95% CI 0.12-0.17) in the MODULAR-FM group (p < 0.01). Total translation at 60 months was mean 0.30 mm (95% CI 0.10-0.51) less (p < 0.01) for MONO-TM compared with MODULAR-FM tibial components. The majority of tibial components were stable (<0.2 mm MTPM) from 12 to 24-month and 24 to 60-month follow-up.
CONCLUSION


At mid-term follow-up, monobloc PE inlay wear was approximately 40% of that of the modular PE inlay wear, which suggest that back-side wear of modular PE inlays is a significant contributor of PE wear in hybrid TKA.",2021,Total translation at 60 months was mean 0.30 mm (95% CI 0.10-0.51) less (p < 0.01) for MONO-TM compared with MODULAR-FM tibial components.,"['hybrid total knee arthroplasty', 'total knee arthroplasty (TKA', '50 patients']","['modular ultra-high-molecular-weight-polyethylene inlays', 'hybrid TKA surgery with either acementless high-porosity trabecular-metal tibial component with a monobloc UHMWPE inlay (MONO-TM) or a cementless low-porosity screw-augmented titanium fiber-mesh tibial component with a modular UHMWPE inlay (MODULAR-FM']","['majority of tibial components', 'PE wear-rate', 'Total translation', 'mean PE wear of the medial compartment']","[{'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0673477', 'cui_str': 'ultra-high molecular weight polyethylene'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0080037', 'cui_str': 'Porosity'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0530789', 'cui_str': 'titanium fiber'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}]","[{'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205098', 'cui_str': 'Medial'}]",50.0,0.186274,Total translation at 60 months was mean 0.30 mm (95% CI 0.10-0.51) less (p < 0.01) for MONO-TM compared with MODULAR-FM tibial components.,"[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Torle', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark; AutoRSA Research Group, Orthopaedic Research Unit, Aarhus University Hospital, Aarhus, Denmark. Electronic address: johantorle@outlook.com.'}, {'ForeName': 'Janni Kjærgaard', 'Initials': 'JK', 'LastName': 'Thillemann', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark; AutoRSA Research Group, Orthopaedic Research Unit, Aarhus University Hospital, Aarhus, Denmark; Department of Orthopeadics, University Clinic for Hand, Hip and Knee Surgery, Hospital Unit West, Holstebro, Denmark.'}, {'ForeName': 'Emil Toft', 'Initials': 'ET', 'LastName': 'Petersen', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark; AutoRSA Research Group, Orthopaedic Research Unit, Aarhus University Hospital, Aarhus, Denmark; Department of Orthopeadics, University Clinic for Hand, Hip and Knee Surgery, Hospital Unit West, Holstebro, Denmark.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Madsen', 'Affiliation': 'Department of Orthopedics, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Søballe', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark; Department of Orthopedics, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Maiken', 'Initials': 'M', 'LastName': 'Stilling', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark; AutoRSA Research Group, Orthopaedic Research Unit, Aarhus University Hospital, Aarhus, Denmark; Department of Orthopedics, Aarhus University Hospital, Aarhus, Denmark.'}]",The Knee,['10.1016/j.knee.2021.02.033']
430,33714843,Site-specific risk factors for local recurrence after rectal cancer surgery.,"BACKGROUND


Quite few studies examined risk factors for local recurrence after rectal cancer surgery with respect to local recurrence sites.
METHODS


Local recurrence sites were categorized into axial, anterior, posterior, and lateral (pelvic sidewall), and axial, anterior, and posterior type were combined as the ""other"" type of local recurrence. Among 76 patients enrolled into our prospective randomized controlled trial to determine the indication for pelvic autonomic nerve preservation (PANP) in patients with advanced lower rectal cancer (UMIN000021353), multivariate analyses were conducted to elucidate risk factors for either lateral or the ""other"" type of local recurrence.
RESULTS


Univariate analyses showed that tumor distance from the anal verge was significantly (p = 0.017), and type of operation (sphincter preserving operation (SPO) vs. abdominoperineal resection (APR)) was marginally (p = 0.065) associated with pelvic sidewall recurrence. Multivariate analysis using these two parameters showed that tumor distance from the anal verge was significantly and independently correlated with pelvic sidewall recurrence (p = 0.017). As for the ""other"" type of local recurrence, univariate analyses showed that depth of tumor invasion (p = 0.011), radial margin status (p < 0.001), and adjuvant chemotherapy (p = 0.037) were significantly associated, and multivariate analysis using these three parameters revealed that depth of tumor invasion (p = 0.004) and radial margin status (p < 0.001) were significantly and independently correlated with the ""other"" type of local recurrence.
CONCLUSION


Risk factors for local recurrence after rectal cancer surgery were totally different with respect to the intra-pelvic recurrent sites. Site-specific probability of local recurrence can be inferred using these risk factors.
TRIAL REGISTRATION NUMBER


UMIN000021353.",2021,Multivariate analysis using these two parameters showed that tumor distance from the anal verge was significantly and independently correlated with pelvic sidewall recurrence (p = 0.017).,"['local recurrence after rectal cancer surgery', '76 patients enrolled', 'patients with advanced lower rectal cancer (UMIN000021353']",['pelvic autonomic nerve preservation (PANP'],"['radial margin status', 'tumor distance from the anal verge', 'pelvic sidewall recurrence', 'type of operation (sphincter preserving operation (SPO) vs. abdominoperineal resection (APR', 'depth of tumor invasion']","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0206250', 'cui_str': 'Autonomic nerve structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]",76.0,0.088155,Multivariate analysis using these two parameters showed that tumor distance from the anal verge was significantly and independently correlated with pelvic sidewall recurrence (p = 0.017).,"[{'ForeName': 'Tadahiko', 'Initials': 'T', 'LastName': 'Masaki', 'Affiliation': 'Department of Surgery, Kyorin University, Japan. Electronic address: masaki@ks.kyorin-u.ac.jp.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Tomokazu', 'Initials': 'T', 'LastName': 'Kishiki', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Kojima', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Tonari', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Aso', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Beniya', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Iioka', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wakamatsu', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Sunami', 'Affiliation': 'Department of Surgery, Kyorin University, Japan.'}]",Surgical oncology,['10.1016/j.suronc.2021.101540']
431,33714071,"Erratum to 'Controlled drug delivery systems in eradicating bacterial biofilm-associated infections' [Journal of Controlled Release, Volume 329 (10 January 2021) 1102-1116].",,2021,,[],[],[],[],[],[],,0.0671359,,"[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""State Key Laboratory of Medicinal Chemical Biology, Key Laboratory of Functional Polymer Materials, Ministry of Education, Institute of Polymer Chemistry, College of Chemistry, Nankai University, 94 Weijin Road, Tianjin 300071, PR China; Jiangsu Key Laboratory for Carbon-Based Functional Materials & Devices, Institute of Functional Nano & Soft Materials (FUNSOM), Collaborative Innovation Center of Suzhou Nano Science and Technology, Soochow University, 199 Ren'ai Road, Suzhou 215123, PR China.""}, {'ForeName': 'Yuanfeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Medicinal Chemical Biology, Key Laboratory of Functional Polymer Materials, Ministry of Education, Institute of Polymer Chemistry, College of Chemistry, Nankai University, 94 Weijin Road, Tianjin 300071, PR China; University of Groningen and University Medical Center Groningen, Department of Biomedical Engineering, Antonius Deusinglaan 1, 9713, AV, Groningen, the Netherlands.'}, {'ForeName': 'Linqi', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Medicinal Chemical Biology, Key Laboratory of Functional Polymer Materials, Ministry of Education, Institute of Polymer Chemistry, College of Chemistry, Nankai University, 94 Weijin Road, Tianjin 300071, PR China. Electronic address: shilinqi@nankai.edu.cn.'}]",Journal of controlled release : official journal of the Controlled Release Society,['10.1016/j.jconrel.2021.02.034']
432,33713841,"Central monitoring in a randomized, open-label, controlled phase 3 clinical trial for a treatment-shortening regimen for pulmonary tuberculosis.","INTRODUCTION


With the growing use of online study management systems and rapid availability of data, timely data review and quality assessments are necessary to ensure proper clinical trial implementation. In this report we describe central monitoring used to ensure protocol compliance and accurate data reporting, implemented during a large phase 3 clinical trial.
MATERIAL AND METHODS


The Tuberculosis Trials Consortium (TBTC) Study 31/AIDS Clinical Trials Group (ACTG) study A5349 (S31) is an international, multi-site, randomized, open-label, controlled, non-inferiority phase 3 clinical trial comparing two 4-month regimens to a standard 6 month regimen for treatment of drug-susceptible tuberculosis (TB) among adolescents and adults with a sample size of 2500 participants.
RESULTS


Central monitoring utilized primary study data in a five-tiered approach, including (1) real-time data checks & topic-specific intervention reports, (2) missing forms reports, (3) quality assurance metrics, (4) critical data reports and (5) protocol deviation identification, aimed to detect and resolve quality challenges. Over the course of the study, 240 data checks and reports were programed across the five tiers used.
DISCUSSION


This use of primary study data to identify issues rapidly allowed the study sponsor to focus quality assurance and data cleaning activities on prioritized data, related to protocol compliance and accurate reporting of study results. Our approach enabled us to become more efficient and effective as we informed sites about deviations, resolved missing or inconsistent data, provided targeted guidance, and gained a deeper understanding of challenges experienced at clinical trial sites.
TRIAL REGISTRATION


This trial was registered with ClinicalTrials.gov (Identifier: NCT02410772) on April 8, 2015.",2021,"Our approach enabled us to become more efficient and effective as we informed sites about deviations, resolved missing or inconsistent data, provided targeted guidance, and gained a deeper understanding of challenges experienced at clinical trial sites.
","['pulmonary tuberculosis', 'adolescents and adults with a sample size of 2500 participants']",[],[],"[{'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4319601', 'cui_str': '2500'}]",[],[],2500.0,0.338964,"Our approach enabled us to become more efficient and effective as we informed sites about deviations, resolved missing or inconsistent data, provided targeted guidance, and gained a deeper understanding of challenges experienced at clinical trial sites.
","[{'ForeName': 'Kia E', 'Initials': 'KE', 'LastName': 'Bryant', 'Affiliation': 'U.S. Centers for Disease Control & Prevention, Atlanta, GA, United States of America. Electronic address: kebryant@cdc.gov.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'U.S. Centers for Disease Control & Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Engle', 'Affiliation': 'Audie L. Murphy Veterans Affairs Medical Center, University of Texas Health Science Center, San Antonio, TX, United States of America.'}, {'ForeName': 'Ekaterina V', 'Initials': 'EV', 'LastName': 'Kurbatova', 'Affiliation': 'U.S. Centers for Disease Control & Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Allen-Blige', 'Affiliation': 'Peraton, Herndon, VA, United States of America.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Batra', 'Affiliation': 'Peraton, Herndon, VA, United States of America.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Brown', 'Affiliation': 'U.S. Centers for Disease Control & Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Kuo Wei', 'Initials': 'KW', 'LastName': 'Chiu', 'Affiliation': 'Peraton, Herndon, VA, United States of America.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Davis', 'Affiliation': 'Peraton, Herndon, VA, United States of America.'}, {'ForeName': 'Mascha', 'Initials': 'M', 'LastName': 'Elskamp', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fagley', 'Affiliation': 'U.S. Centers for Disease Control & Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Fedrick', 'Affiliation': 'Peraton, Herndon, VA, United States of America.'}, {'ForeName': 'Kimberley N C', 'Initials': 'KNC', 'LastName': 'Hedges', 'Affiliation': 'U.S. Centers for Disease Control & Prevention, Atlanta, GA, United States of America; Peraton, Herndon, VA, United States of America.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Narunsky', 'Affiliation': 'University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'Joanita', 'Initials': 'J', 'LastName': 'Nassali', 'Affiliation': 'Uganda-Case Western Reserve University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Phan', 'Affiliation': 'Northrop Grumman Corporation, San Diego, CA, United States of America.'}, {'ForeName': 'Ha', 'Initials': 'H', 'LastName': 'Phan', 'Affiliation': 'Vietnam National Tuberculosis Program, University of California San Francisco Research Collaboration, Hanoi, Viet Nam.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Purfield', 'Affiliation': 'U.S. Centers for Disease Control & Prevention, Atlanta, GA, United States of America; US Public Health Service Commissioned Corps, Rockville, MD, United States of America.'}, {'ForeName': 'Jessica N', 'Initials': 'JN', 'LastName': 'Ricaldi', 'Affiliation': 'U.S. Centers for Disease Control & Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Robergeau-Hunt', 'Affiliation': 'Westat, Rockville, MD, United States of America.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Whitworth', 'Affiliation': 'U.S. Centers for Disease Control & Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Sizemore', 'Affiliation': 'U.S. Centers for Disease Control & Prevention, Atlanta, GA, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2021.106355']
433,33713840,Design of CLARO (Collaboration Leading to Addiction Treatment and Recovery from other Stresses): A randomized trial of collaborative care for opioid use disorder and co-occurring depression and/or posttraumatic stress disorder.,"INTRODUCTION


Opioid use disorder (OUD) co-occurring with depression and/or posttraumatic stress disorder (PTSD) is common and, if untreated, may lead to devastating consequences. Despite the availability of evidence-based treatments for these disorders, receipt of treatment is low. Even when treatment is provided, quality is variable. Primary care is an important and underutilized setting for treating co-occurring disorders (COD) because OUD, depression and PTSD are frequently co-morbid with medical conditions and most people visit a primary care provider at least once a year. With rising rates of OUD and opioid-related fatalities, this is a critical treatment and quality gap in a vulnerable and stigmatized population.
METHODS


CLARO (Collaboration Leading to Addiction Treatment and Recovery from Other Stresses) is a multi-site, randomized pragmatic trial of collaborative care (CC) for co-occurring disorders in 13 rural and urban primary care clinics in New Mexico to improve care for patients with OUD and co-occurring depression and/or PTSD. CC, a service delivery approach that uses multi-faceted interventions, has not been tested with COD. We will enroll and randomize 900 patients to either CC adapted for COD (CC-COD) or enhanced usual care (EUC) and will collect patient data at baseline, 3-, and 6-month follow-up. Our primary outcomes are medications for OUD (MOUD) access, MOUD continuity of care, depression symptoms, and PTSD symptoms.
DISCUSSION


Although CC is effective for improving outcomes in primary care among patients with mental health conditions, it has not been tested for COD. This article describes the CLARO CC-COD intervention and clinical trial.",2021,"Although CC is effective for improving outcomes in primary care among patients with mental health conditions, it has not been tested for COD.","['13 rural and urban primary care clinics in New Mexico to improve care for patients with OUD and co-occurring depression and/or PTSD', 'patients with mental health conditions']","['collaborative care (CC', 'CLARO CC-COD intervention', 'CLARO', 'CC', 'CC adapted for COD (CC-COD) or enhanced usual care (EUC']","['medications for OUD (MOUD) access, MOUD continuity of care, depression symptoms, and PTSD symptoms']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0027972', 'cui_str': 'New Mexico'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.126415,"Although CC is effective for improving outcomes in primary care among patients with mental health conditions, it has not been tested for COD.","[{'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Meredith', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA 90407-2138, USA; VA HSR&D Center for Healthcare Innovation, Implementation & Policy, Sepulveda, CA, USA. Electronic address: lisa_meredith@rand.org.'}, {'ForeName': 'Miriam S', 'Initials': 'MS', 'LastName': 'Komaromy', 'Affiliation': 'Grayken Center for Addiction, Boston Medical Center, Boston, MA 02118, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cefalu', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA 90407-2138, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Murray-Krezan', 'Affiliation': 'University of New Mexico School of Medicine, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'University of New Mexico School of Medicine, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Karen Chan', 'Initials': 'KC', 'LastName': 'Osilla', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA 90407-2138, USA.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Dopp', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA 90407-2138, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Leamon', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA 90407-2138, USA.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tarhuni', 'Affiliation': 'University of New Mexico School of Medicine, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Hindmarch', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA 90407-2138, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Jacobsohn', 'Affiliation': 'First Choice Community Healthcare, 2001 North Centro Familiar, Albuquerque, NM 87105, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Watkins', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA 90407-2138, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2021.106354']
434,33744668,Association of skin infections with sharing of injection drug preparation equipment among people who inject drugs.,"BACKGROUND


Sharing needles and injection drug preparation equipment (IDPE) among people who inject drugs (PWID) are well-established risk factors for viral transmission. Shared needles and IDPE may serve as bacterial niduses for skin and soft tissue infections (SSTI). Given the rising rates of SSTI in PWID, we investigated the association of needle and IDPE sharing on incidence of SSTI in a cohort of PWID.
METHODS


Inpatient PWID (N = 252) were recruited to a randomized controlled trial of an intervention aimed at reducing infections. The primary outcome was self-reported incidence of SSTI one-year post-hospitalization. In this secondary analysis, we assessed two variables: 1) sharing of IDPE alone, 2) sharing needles with or without IDPE, and compared these groups separately to persons who reported no sharing of needles or IDPE via a mixed-effects negative binomial regression model to estimate the effect of baseline sharing behavior on SSTI during follow-up via incidence rate ratios (IRR).
RESULTS


Participant characteristics: 38 years [mean], 58% male, 60% White, 90% primarily injected opioids, 1.58 (± 2.35) mean SSTI in the year prior to baseline. In terms of sharing behavior, 29% didn't share needles or IDPE, 13% shared IDPE only, and 58% shared needles with or without IDPE three months prior to baseline. After adjusting for co-variables, PWID who shared IDPE alone had a 2.2 fold higher IRR of SSTI (95%CI 1.27; 3.85, p = 0.005) and PWID who shared needles with or without IDPE had a 3.31 fold higher IRR of SSTI (95%CI 2.04; 5.37, p < 0.001), compared to those who did not share any equipment. The number of SSTI at baseline was associated with an IRR of 1.20 of SSTI during follow-up (95%CI 1.09; 1.32, p < 0.001).
CONCLUSIONS


In this cohort of hospitalized PWID, we found a significant association between baseline sharing of IDPE alone and of sharing of needles with or without IDPE with one-year incidence of SSTI.",2021,"The number of SSTI at baseline was associated with an IRR of 1.20 of SSTI during follow-up (95%CI 1.09; 1.32, p < 0.001).
","['people who inject drugs (PWID', 'Inpatient PWID (N\xa0=\xa0252', 'people who inject drugs', 'Participant characteristics: 38 years [mean], 58% male, 60% White, 90% primarily injected opioids, 1.58 (± 2.35']","['Sharing needles and injection drug preparation equipment (IDPE', 'IDPE alone, 2) sharing needles with or without IDPE']","['IRR of SSTI', 'self-reported incidence of SSTI one-year post-hospitalization', 'number of SSTI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013164', 'cui_str': 'Drug Preparation'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",252.0,0.158976,"The number of SSTI at baseline was associated with an IRR of 1.20 of SSTI during follow-up (95%CI 1.09; 1.32, p < 0.001).
","[{'ForeName': 'Raagini', 'Initials': 'R', 'LastName': 'Jawa', 'Affiliation': 'Section of Infectious Diseases, Boston Medical Center, 801 Massachusetts Ave, 2nd floor, Boston 02118, MA, USA. Electronic address: raagini.jawa@bmc.org.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Stein', 'Affiliation': 'Boston University School of Public Health, Boston, MA, USA; Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Anderson', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Liebschutz', 'Affiliation': 'Division of General Internal Medicine, Center for Research on Health Care, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Kristina T', 'Initials': 'KT', 'LastName': 'Phillips', 'Affiliation': 'Center for Integrated Health Care Research, Kaiser Permanente Hawaii.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Barocas', 'Affiliation': 'Section of Infectious Diseases, Boston Medical Center, 801 Massachusetts Ave, 2nd floor, Boston 02118, MA, USA; Boston University School of Medicine, Boston, MA, USA.'}]",The International journal on drug policy,['10.1016/j.drugpo.2021.103198']
435,33744640,Whole grain intake favorably affects blood glucose and serum triacylglycerols in overweight and obese children: A randomized controlled crossover clinical trial.,"OBJECTIVES


The aim of this study was to determine the effects of whole grain consumption on the metabolic profiles of overweight or obese children.
METHODS


This was a randomized crossover clinical trial with 44 overweight or obese girls. After a 2-wk run-in period, girls were randomly assigned to either intervention or control groups. Participants in the intervention group were asked to obtain 50% of their grain servings from whole grain foods each day for 6 wk. Those in the control group were asked not to consume any of these foods. A 4-wk washout period was applied following which participants were crossed over to the alternate arm. Fasting blood samples were taken before and after each phase of study.
RESULTS


Mean (± SD) age and body mass index was 11.2 ± 1.49 y and 23.5 ± 2.5 kg/m 2 , respectively. Mean whole grain intake in intervention and control groups throughout the study was 26.5 and 3.7 g/d, respectively (P = 0.01). Whole grain consumption resulted in lower concentrations of plasma glucose (changes from baseline in intervention group: -0.10 versus 0.21 mmol/L in control group, P = 0.01), serum triacylglycerols (changes from baseline in intervention group: -0.18 versus 0.08 mmol/L in control group, P = 0.01) and higher concentrations of serum high-density lipoprotein cholesterol (changes from baseline in intervention group: 0.16 versus -0.14 mmol/L in control group, P = 0.05) after 6 wk of intervention. No effects of whole grain intake on serum concentrations of total- and low-density lipoprotein cholesterol or on blood pressure were found.
CONCLUSION


This study provided evidence supporting the beneficial effects of whole grain foods on serum concentrations of glucose, triacylglycerols and high-density lipoprotein cholesterol in overweight children.",2021,"No effects of whole grain intake on serum concentrations of total- and low-density lipoprotein cholesterol or on blood pressure were found.
","['overweight and obese children', 'overweight children', 'overweight or obese children', '44 overweight or obese girls']","['whole grain consumption', 'Whole grain intake', 'whole grain foods', 'whole grain intake']","['Mean (± SD) age and body mass index', 'higher concentrations of serum high-density lipoprotein cholesterol', 'blood glucose and serum triacylglycerols', 'serum concentrations of total- and low-density lipoprotein cholesterol or on blood pressure', 'lower concentrations of plasma glucose', 'Fasting blood samples', 'Mean whole grain intake', 'serum concentrations of glucose, triacylglycerols and high-density lipoprotein cholesterol', 'serum triacylglycerols']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",44.0,0.0377306,"No effects of whole grain intake on serum concentrations of total- and low-density lipoprotein cholesterol or on blood pressure were found.
","[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Hajihashemi', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Azadbakht', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Hashemipour', 'Affiliation': 'Pediatrics Department, Faculty of Medicine and Child Growth and Development Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Kelishadi', 'Affiliation': 'Pediatrics Department, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Parvane', 'Initials': 'P', 'LastName': 'Saneei', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: a-esmaillzadeh@tums.ac.ir.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2021.111200']
436,33743385,A therapist-guided smartphone app for major depression in young adults: A randomized clinical trial.,"BACKGROUND


Meru Health Program (MHP) is a therapist-guided, 8-week intervention for depression delivered via smartphone. The aim was to test its efficacy in patients with clinical depression in a Finnish university student health service.
METHODS


Patients (n=124, women 72.6%, mean age 25y) were stratified based on antidepressant status, and randomized into intervention group receiving MHP plus treatment as usual (TAU), and control group receiving TAU only. Depression, measured by the Patient Health Questionnaire-9 (PHQ-9) scale, was the primary outcome. After baseline (T0), follow-ups were at mid-intervention (T4), immediately post-intervention (T8); 3 months (T20), and 6 months (T32) post-intervention.
RESULTS


The intervention group and control group did not have significant differences in depression outcomes throughout end of treatment and follow-up. Among secondary outcomes, increase in resilience (d=0.32, p=0.03) and mindfulness (d=0.57, p=0.002), and reduction in perceived stress (d=-0.52, p=0.008) were greater in MHP+TAU versus TAU at T32; no differences were found in anxiety, sleep disturbances, and quality of life between groups. Post-hoc comparisons of patients on antidepressants showed significantly greater reduction in depression at T32 for MHP+TAU versus TAU (d=-0.73, p=0.01); patients not on antidepressants showed no between-group differences.
LIMITATIONS


Limitations include unknown characteristics of TAU, potential bias from patients and providers not being blinded to treatment group, and failure to specify examination of differences by antidepressant status in the protocol.
CONCLUSIONS


Most outcomes, including depression, did not significantly differ between MHP+TAU and TAU. Exploratory analysis revealed intervention effect at the end of the 6-month follow-up among patients on antidepressant medication.",2021,"Among secondary outcomes, increase in resilience (d=0.32, p=0.03) and mindfulness (d=0.57, p=0.002), and reduction in perceived stress (d=-0.52, p=0.008) were greater in MHP+TAU versus TAU at T32; no differences were found in anxiety, sleep disturbances, and quality of life between groups.","['Patients', 'n=124, women 72.6%, mean age 25y', 'patients with clinical depression in a Finnish university student health service', 'young adults']","['MHP plus treatment as usual (TAU), and control group receiving TAU only', 'therapist-guided smartphone app']","['increase in resilience', 'depression', 'depression outcomes', 'anxiety, sleep disturbances, and quality of life', 'perceived stress', 'Patient Health Questionnaire-9 (PHQ-9) scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038489', 'cui_str': 'Health Services, Student'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",124.0,0.159196,"Among secondary outcomes, increase in resilience (d=0.32, p=0.03) and mindfulness (d=0.57, p=0.002), and reduction in perceived stress (d=-0.52, p=0.008) were greater in MHP+TAU versus TAU at T32; no differences were found in anxiety, sleep disturbances, and quality of life between groups.","[{'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Raevuori', 'Affiliation': 'Department of Adolescent Psychiatry, Helsinki University Hospital, Helsinki, Finland; Clinicum, Department of Public Health, University of Helsinki, Helsinki, Finland. Electronic address: anu.raevuori@helsinki.fi.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Vahlberg', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Tellervo', 'Initials': 'T', 'LastName': 'Korhonen', 'Affiliation': 'Institute for Molecular Medicine Finland (FIMM), University of Helsinki, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Hilgert', 'Affiliation': 'Meru Health Inc. Palo Alto, The United States & Helsinki, Finland.'}, {'ForeName': 'Raija', 'Initials': 'R', 'LastName': 'Aittakumpu-Hyden', 'Affiliation': 'Finnish Student Health Service, Jyvaskyla, Finland.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Forman-Hoffman', 'Affiliation': 'Meru Health Inc. Palo Alto, The United States & Helsinki, Finland.'}]",Journal of affective disorders,['10.1016/j.jad.2021.02.007']
437,33743343,Mindfulness-based intervention to promote psychological wellbeing in people with epilepsy: A randomized controlled trial.,"BACKGROUND


We investigated the efficacy of mindfulness-based intervention (MBI) in promoting psychological wellbeing in people with epilepsy (PWE) using an assessor-blinded randomized controlled design.
METHODS


A total of 28 PWE were randomly assigned to either intervention (n = 14 cases) or control group (n = 14 controls). The intervention group received a six 2.5-hour weekly MBI, while the control group did not receive any intervention. They were assessed at three timepoints (T0: before intervention, T1: immediately after intervention, and T2: 6 weeks after intervention). Repeated measures of analyses of variance (RM-ANOVAs) were used for inter-group comparisons to determine intervention effect from baseline -to T1 and -to T2 for all outcome measures. The individual changes were calculated using the reliable change index (RCI). Key outcomes included depression (BDI-II), anxiety (BAI), epilepsy-related quality of life (QOLIE-31), satisfaction with life (SWLS), and level of mindfulness (MAAS).
RESULTS


Participants who participated in the MBI showed significant reduction in BDI-II (p = 0.001), significant increases in MAAS (p = 0.027) and QOLIE-31 (p = 0.001) at T1 when compared with the control group. However, BAI and SWLS were not significant. The trend was similar at 6-week follow-up, all outcome measures of MBI remained significant (p < 0.05) except for BAI and SWLS. Beyond the 6-week intervention, RCI analysis showed a significant improvement in levels of mindfulness (45.45% vs. 21.43%, p = 0.009), depression (45.45% vs. 0.00%, p = 0.016), quality of life (45.45% vs. 14.29%, p = 0.017) with MBI, as compared to the no-intervention phase.
CONCLUSION


Mindfulness-based intervention is effective in reducing psychological distress and improving the quality of life in PWE.",2021,"RESULTS


Participants who participated in the MBI showed significant reduction in BDI-II (p = 0.001), significant increases in MAAS (p = 0.027) and QOLIE-31 (p = 0.001) at T1 when compared with the control group.","['A total of 28 PWE', 'people with epilepsy (PWE', 'people with epilepsy']","['six 2.5-hour weekly MBI, while the control group did not receive any intervention', 'Mindfulness-based intervention', 'mindfulness-based intervention (MBI']","['depression', 'QOLIE-31', 'BDI-II', 'quality of life', 'psychological distress', 'BAI and SWLS', 'MAAS', 'levels of mindfulness', 'MBI', 'quality of life in PWE', 'depression (BDI-II), anxiety (BAI), epilepsy-related quality of life (QOLIE-31), satisfaction with life (SWLS), and level of mindfulness (MAAS']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",28.0,0.0687758,"RESULTS


Participants who participated in the MBI showed significant reduction in BDI-II (p = 0.001), significant increases in MAAS (p = 0.027) and QOLIE-31 (p = 0.001) at T1 when compared with the control group.","[{'ForeName': 'Siew-Tim', 'Initials': 'ST', 'LastName': 'Lai', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Kheng-Seang', 'Initials': 'KS', 'LastName': 'Lim', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia. Electronic address: kslimum@gmail.com.'}, {'ForeName': 'Venus', 'Initials': 'V', 'LastName': 'Tang', 'Affiliation': 'Department of Clinical Psychology, Prince of Wales Hospital, Hospital Authority, Hong Kong; Division of Neurosurgery, Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Wah-Yun', 'Initials': 'WY', 'LastName': 'Low', 'Affiliation': 'Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia; Asia-Europe Institute, University of Malaya, Kuala Lumpur, Malaysia.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.107916']
438,33743290,Nutritional risk is a predictor for long-term mortality: 5-Year follow-up of the EFFORT trial.,"BACKGROUND AND AIMS


The nutritional risk screening (NRS 2002) is a validated screening tool for malnutrition. This study aims to investigate the prognostic value of the NRS 2002 and its individual components regarding long-term mortality and adverse outcomes in a well-characterized cohort of medical inpatients.
METHODS


We performed a 5-year follow-up investigation of patients included in the investigator-initiated, prospective, randomized controlled multicenter EFFORT trial that evaluated the effects of individualized nutritional intervention vs. standard hospital food. We used multivariable cox regression analyses adjusted for randomisation arm, study centre, comorbidities and main admission diagnosis to investigate associations between NRS 2002 total scores at time of hospital admission and several long-term outcomes.
RESULTS


We had confirmed mortality data over the mean follow-up time of 3.2 years in 1874 from the initial cohort of 2028 EFFORT patients. Mortality showed a step-wise increase in patients with NRS 3 (289/565 [51.2%]) and NRS 4 (355/717 [49.6%]) to 59.5% (353/593) in patient with NRS≥5 corresponding to an adjusted Hazard Ratio (HR) of 1.28 (95%CI 1.15 to 1.42, p ≤ 0.001) for mortality after one year and 1.13 (95%CI 1.05 to 1.23, p = 0.002) for the overall time period. All individual components of NRS including disease severity, food intake, weight loss and BMI provided prognostic information regarding long-term mortality risk.
CONCLUSION


Nutritional risk mirrored by a NRS 2002 total score is a strong and independent predictor of long-term mortality and morbidity in polymorbid medical inpatients particularly in patients with high nutritional risk with an NRS ≥5 points.",2021,"Mortality showed a step-wise increase in patients with NRS 3 (289/565 [51.2%]) and NRS 4 (355/717 [49.6%]) to 59.5% (353/593) in patient with NRS≥5 corresponding to an adjusted Hazard Ratio (HR) of 1.28 (95%CI 1.15 to 1.42, p ≤ 0.001) for mortality after one year and 1.13 (95%CI 1.05 to 1.23, p = 0.002) for the overall time period.","['a well-characterized cohort of medical inpatients', 'polymorbid medical inpatients particularly in patients with high nutritional risk with an NRS ≥5 points']",['individualized nutritional intervention vs. standard hospital food'],"['disease severity, food intake, weight loss and BMI provided prognostic information regarding long-term mortality risk', 'Nutritional risk', 'mortality', 'Mortality']","[{'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}]",2028.0,0.0632958,"Mortality showed a step-wise increase in patients with NRS 3 (289/565 [51.2%]) and NRS 4 (355/717 [49.6%]) to 59.5% (353/593) in patient with NRS≥5 corresponding to an adjusted Hazard Ratio (HR) of 1.28 (95%CI 1.15 to 1.42, p ≤ 0.001) for mortality after one year and 1.13 (95%CI 1.05 to 1.23, p = 0.002) for the overall time period.","[{'ForeName': 'Andriana', 'Initials': 'A', 'LastName': 'Efthymiou', 'Affiliation': 'Division of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Hersberger', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Reber', 'Affiliation': 'Division of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Katja A', 'Initials': 'KA', 'LastName': 'Schönenberger', 'Affiliation': 'Inselspital, Bern, Switzerland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kägi-Braun', 'Affiliation': 'Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Tribolet', 'Affiliation': 'Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland. Electronic address: schuetzph@gmail.com.'}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Stanga', 'Affiliation': 'Division of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.02.032']
439,33749961,Fractional carbon dioxide laser versus trichloroacetic acid peel in the treatment of pseudo-acanthosis nigricans.,"BACKGROUND


Treatment of acanthosis nigricans (AN) is challenging, and new modalities are being explored continuously to increase the therapeutic efficacy.
AIM


To evaluate the efficacy and safety of fractional CO2 laser compared to trichloroacetic acid (TCA) peel in the treatment of pseudo-acanthosis nigricans (pseudo-AN).
METHODS


The study included 40 patients with pseudo-AN on the neck and axilla allocated into two groups each containing 20 patients. Group (A) was treated with TCA 20% peel applied on the pigmented area while group (B) received fractional CO2 laser. Both treatments were performed till complete clearance or for a maximum of four treatment sessions. Patients with excellent response were further followed up for 6 months after the end of treatment.
RESULTS


Both modalities were effective in the treatment of pseudo-AN; however, the therapeutic response was significantly higher in the fractional CO2 laser group compared to the TCA peel group (p < 0.01). Marked to excellent response (51%-100% clearance of AN lesions) was achieved in 85% of the patients in the fractional laser group versus 10% of the patients in the TCA group. Adverse effects, for example, persistent erythema, post-inflammatory hyperpigmentation, and burning sensation, were also statistically higher in the TCA group compared to the laser group (p = 0.04).
CONCLUSION


Fractional CO2 laser is a promising effective and well-tolerated treatment modality for pseudo-acanthosis nigricans.",2021,"Both modalities were effective in the treatment of pseudo-AN, however, the therapeutic response was significantly higher in the fractional CO2 laser group compared to the TCA peel group, (p < 0.01).","['pseudo-acanthosis nigricans', '40 patients with pseudo-AN on the neck and axilla allocated into two groups each containing 20 patients']","['TCA', 'fractional CO2 laser', 'fractional CO2 laser compared to trichloroacteic acid (TCA) peel', 'TCA 20% peel applied on the pigmented area while group (B) received fractional CO2 laser', 'Fractional CO2 laser', 'Fractional carbon dioxide laser versus trichloroacetic acid peel', 'TCA peel']","['Adverse effects e.g. persistent erythema, post-inflammatory hyperpigmentation, and burning sensation', 'excellent response', 'therapeutic response', 'efficacy and safety']","[{'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0000889', 'cui_str': 'Acanthosis nigricans'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",40.0,0.0225141,"Both modalities were effective in the treatment of pseudo-AN, however, the therapeutic response was significantly higher in the fractional CO2 laser group compared to the TCA peel group, (p < 0.01).","[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Eldeeb', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Reham M', 'Initials': 'RM', 'LastName': 'Wahid', 'Affiliation': 'Physiology Department, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Alakad', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14088']
440,33740751,"The SPIKES protocol does not influence the tolerance or effectiveness of intra-articular corticosteroid injection in the knees of osteoarthritis patients: A prospective, controlled, randomized single-blinded trial.","BACKGROUND


Patient user embracement involves behaviours of including and listening to the patient, appreciating their complaints, and identifying their needs, whether individual or collective. The aim of this study was to evaluate the influence of a user embracement protocol (SPIKES protocol) for patients with knee osteoarthritis (OA) immediately before intra-articular injection (IAI) relative to procedure tolerance and its effectiveness in the immediate, short and medium terms.
METHODS


This was a randomized controlled trial. Patients received IAIs with triamcinolone hexacetonide (40 mg) preceded or not by the SPIKES protocol. The outcomes measured were: visual analogue scale for pain at rest, pain on movement and joint swelling; morning stiffness; Western Ontario McMaster Universities Index Functional Questionnaire (WOMAC); pain catastrophizing scale; McGill pain questionnaire; SF-36 questionnaire on quality of life; Trace State Anxiety Inventory (IDATE); and a Timed Up and Go functional test.
RESULTS


One hundred patients were randomized in the user embracement group (n = 50) or the control group (n = 50); 89% were women and 60% white, mean age was 67.1 (±7.3) years, and mean disease time was 6.3 (±6.2) years. No statistically significant differences were found between the groups for any variables at pre-procedure time, nor did the groups differ in their tolerance to the procedure or during the 12 weeks of follow up for any evaluated variables.
CONCLUSIONS


No benefit was identified by applying a user embracement protocol to patients with knee OA prior to IAI with corticosteroid, neither to tolerance at the time of the procedure nor to its effectiveness in the immediate, short, and medium terms.",2021,"No statistically significant differences were found between the groups for any variables at pre-procedure time, nor did the groups differ in their tolerance to the procedure or during the 12 weeks of follow up for any evaluated variables.
","['knees of osteoarthritis patients', 'patients with knee osteoarthritis (OA', 'One hundred patients were randomized in the user embracement group (n\xa0=\xa050) or the control group (n\xa0=\xa050); 89% were women and 60% white, mean age was 67.1 (±7.3) years, and mean disease time was 6.3 (±6.2) years']","['user embracement protocol (SPIKES protocol', 'triamcinolone hexacetonide']","['visual analogue scale for pain at rest, pain on movement and joint swelling; morning stiffness; Western Ontario McMaster Universities Index Functional Questionnaire (WOMAC); pain catastrophizing scale; McGill pain questionnaire; SF-36 questionnaire on quality of life; Trace State Anxiety Inventory (IDATE); and a Timed Up and Go functional test']","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4319697', 'cui_str': '6.3'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0077004', 'cui_str': 'Triamcinolone hexacetonide'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0457086', 'cui_str': 'Morning stiffness - joint'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}]",100.0,0.0680985,"No statistically significant differences were found between the groups for any variables at pre-procedure time, nor did the groups differ in their tolerance to the procedure or during the 12 weeks of follow up for any evaluated variables.
","[{'ForeName': 'Sandra Regina', 'Initials': 'SR', 'LastName': 'Toffolo', 'Affiliation': 'Division of Rheumatology, Universidade Federal de São Paulo - Escola Paulista de Medicina (UNIFESP - EPM), São Paulo, Brazil.'}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Natour', 'Affiliation': 'Division of Rheumatology, Universidade Federal de São Paulo - Escola Paulista de Medicina (UNIFESP - EPM), São Paulo, Brazil.'}, {'ForeName': 'Reginaldo Carlos', 'Initials': 'RC', 'LastName': 'Boni', 'Affiliation': 'Organ Procurement Organization - Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.'}, {'ForeName': 'Jose Carlos', 'Initials': 'JC', 'LastName': 'Nunes-Tamashiro', 'Affiliation': 'Division of Rheumatology, Universidade Federal de São Paulo - Escola Paulista de Medicina (UNIFESP - EPM), São Paulo, Brazil.'}, {'ForeName': 'Rita Nely Vilar', 'Initials': 'RNV', 'LastName': 'Furtado', 'Affiliation': 'Division of Rheumatology, Universidade Federal de São Paulo - Escola Paulista de Medicina (UNIFESP - EPM), São Paulo, Brazil. Electronic address: jnatour@unifesp.br.'}]",The Knee,['10.1016/j.knee.2021.01.002']
441,33740637,"Developmental Antecedents of Adult Macaque Neurogenesis: Early-Life Adversity, 5-HTTLPR Polymorphisms, and Adolescent Hippocampal Volume.","INTRODUCTION


Attenuated adult hippocampal neurogenesis may manifest in affective symptomatology and/or resistance to antidepressant treatment. While early-life adversity and the short variant ('s') of the serotonin transporter gene's long polymorphic region (5-HTTLPR) are suggested as interacting risk factors for affective disorders, no studies have examined whether their superposed risk effectuates neurogenic changes into adulthood. Similarly, it is not established whether reduced hippocampal volume in adolescence, variously identified as a marker and antecedent of affective disorders, anticipates diminished adult neurogenesis. We investigate these potential developmental precursors of neurogenic alterations using a bonnet macaque model.
METHODS


Twenty-five male infant bonnet macaques were randomized to stressed [variable foraging demand (VFD)] or normative [low foraging demand (LFD)] rearing protocols and genotyped for 5-HTTLPR polymorphisms. Adolescent MRI brain scans (mean age 4.2y) were available for 14 subjects. Adult-born neurons were detected post-mortem (mean age 8.6y) via immunohistochemistry targeting the microtubule protein doublecortin (DCX). Models were adjusted for age and weight.
RESULTS


A putative vulnerability group (VG) of VFD-reared 's'-carriers (all 's/l') exhibited reduced neurogenesis compared to non-VG subjects. Neurogenesis levels were positively predicted by ipsilateral hippocampal volume normalized for total brain volume, but not by contralateral or raw hippocampal volume.
LIMITATIONS


No 's'-carriers were identified in LFD-reared subjects, precluding a 2×2 factorial analysis.
CONCLUSION


The 's' allele (with adverse rearing) and low adolescent hippocampal volume portend a neurogenic deficit in adult macaques, suggesting persistent alterations in hippocampal plasticity may contribute to these developmental factors' affective risk in humans.",2021,"Neurogenesis levels were positively predicted by ipsilateral hippocampal volume normalized for total brain volume, but not by contralateral or raw hippocampal volume.
",['Twenty-five male infant bonnet macaques'],['stressed [variable foraging demand (VFD)] or normative [low foraging demand (LFD)] rearing protocols and genotyped for 5-HTTLPR polymorphisms'],"['Neurogenesis levels', 'Adolescent MRI brain scans']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0024402', 'cui_str': 'Macaca radiata'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0814002', 'cui_str': 'Neurogenesis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4028269', 'cui_str': 'Nuclear magnetic resonance imaging brain'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",25.0,0.0613361,"Neurogenesis levels were positively predicted by ipsilateral hippocampal volume normalized for total brain volume, but not by contralateral or raw hippocampal volume.
","[{'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York-Downstate Medical Center, Brooklyn, NY. Electronic address: eric.schoenfeld@downstate.edu.'}, {'ForeName': 'Nishant K', 'Initials': 'NK', 'LastName': 'Gupta', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Shariful A', 'Initials': 'SA', 'LastName': 'Syed', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stony Brook, NY.'}, {'ForeName': 'Anna V', 'Initials': 'AV', 'LastName': 'Rozenboym', 'Affiliation': 'Department of Biological Sciences, Kingsborough Community College, Brooklyn, NY.'}, {'ForeName': 'Sasha L', 'Initials': 'SL', 'LastName': 'Fulton', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Andrea P', 'Initials': 'AP', 'LastName': 'Jackowski', 'Affiliation': 'UNIFESP Departamento de Psiquiatria, Universidade Federal de Sao Paulo, SP, Brazil.'}, {'ForeName': 'Tarique D', 'Initials': 'TD', 'LastName': 'Perera', 'Affiliation': 'Contemporary Care LLC, Greenwich, CT.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Coplan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York-Downstate Medical Center, Brooklyn, NY. Electronic address: jeremy.coplan@downstate.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2021.02.052']
442,33711671,Influence of BRAF and PIK3CA mutations on the efficacy of FOLFIRI plus bevacizumab or cetuximab as first-line therapy in patients with RAS wild-type metastatic colorectal carcinoma and <3 baseline circulating tumour cells: the randomised phase II VISNÚ-2 study.,"BACKGROUND


We explored the influence of BRAF and PIK3CA mutational status on the efficacy of bevacizumab or cetuximab plus 5-fluorouracil/leucovorin and irinotecan (FOLFIRI) as first-line therapy in patients with RAS wild-type metastatic colorectal cancer (mCRC).
PATIENTS AND METHODS


VISNÚ-2 was a multicentre, randomised, phase II study. Patients with RAS wild-type mCRC and <3 circulating tumour cells/7.5 ml blood were stratified by BRAF/PIK3CA status (wild-type versus mutated) and number of affected organs (1 versus >1), and allocated to bevacizumab (5 mg/kg every 2 weeks) or cetuximab (400 mg/m 2  then 250 mg/m 2  weekly) plus FOLFIRI [irinotecan 180 mg/m 2 , leucovorin 400 mg/m 2 , 5-fluorouracil 400 mg/m 2  (bolus) then 2400 mg/m 2  (46-h continuous infusion) every 2 weeks]. The primary endpoint was progression-free survival (PFS). All analyses were exploratory.
RESULTS


Two hundred and forty patients with BRAF/PIK3CA wild-type (n = 196) or BRAF- and/or PIK3CA-mutated tumours (n = 44) were enrolled. Median PFS was 12.7 and 8.8 months in patients with BRAF/PIK3CA wild-type and BRAF/PIK3CA-mutated tumours, respectively [hazard ratio (HR) = 1.22; 95% confidence interval (CI) 0.80-1.85; P = 0.3602]. In the BRAF- and/or PIK3CA-mutated cohort, median PFS was 2.8, 8.8 and 15.0 months in patients with BRAF/PI3KCA-mutated (n = 8), BRAF-mutated/PI3KCA wild-type (n = 16) and BRAF wild-type/PI3KCA-mutated (n = 20) tumours, respectively (P = 0.0002). PFS was similar with bevacizumab plus FOLFIRI versus cetuximab plus FOLFIRI in BRAF/PIK3CA wild-type (HR = 0.99; 95% CI 0.67-1.45; P = 0.9486) and BRAF/PIK3CA-mutated tumours (HR = 1.11; 95% CI 0.53-2.35; P = 0.7820). The most common grade 3/4 treatment-related adverse events were neutropenia, diarrhoea and asthenia in both treatment groups.
CONCLUSIONS


BRAF/PIK3CA status influences outcomes in patients with RAS wild-type mCRC but does not appear to assist with the selection of first-line targeted therapy.",2021,"The most common grade 3/4 treatment-related adverse events were neutropenia, diarrhoea and asthenia in both treatment groups.
","['Two hundred and forty patients with BRAF/PIK3CA wild-type (n\xa0= 196) or BRAF- and/or PIK3CA-mutated tumours (n\xa0= 44) were enrolled', 'patients with RAS wild-type metastatic colorectal cancer (mCRC', 'patients with RAS wild-type mCRC', 'patients with RAS wild-type metastatic colorectal carcinoma and <3 baseline circulating tumour cells', 'Patients with RAS wild-type mCRC and <3 circulating tumour cells/7.5 ml blood']","['FOLFIRI [irinotecan 180 mg/m 2 , leucovorin 400 mg/m 2 , 5-fluorouracil', 'FOLFIRI plus bevacizumab or cetuximab', 'bevacizumab or cetuximab plus 5-fluorouracil/leucovorin and irinotecan (FOLFIRI', 'bevacizumab', 'cetuximab']","['Median PFS', 'neutropenia, diarrhoea and asthenia', 'median PFS', 'PFS', 'progression-free survival (PFS']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C1451005', 'cui_str': 'PIK3CA protein, human'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}]",44.0,0.089367,"The most common grade 3/4 treatment-related adverse events were neutropenia, diarrhoea and asthenia in both treatment groups.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sastre', 'Affiliation': 'Medical Oncology, Hospital Clínico San Carlos, Instituto de Investigación Hospital Clínico San Carlos (IdISSC), CIBERONC, Madrid, Spain. Electronic address: jsastrev@salud.madrid.org.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'García-Alfonso', 'Affiliation': 'Medical Oncology, Hospital Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Viéitez', 'Affiliation': 'Medical Oncology, Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Cano', 'Affiliation': 'Medical Oncology, IMIBIC, Reina Sofía Hospital, University of Córdoba, CIBERONC, Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Medical Oncology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Reina-Zoilo', 'Affiliation': 'Medical Oncology, Complejo Hospitalario Virgen de la Macarena, Seville, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salud-Salvia', 'Affiliation': 'Hospital Universitario Arnau de Vilanova de Lleida, Lleida, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Quintero', 'Affiliation': 'Medical Oncology, Hospital Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Robles-Díaz', 'Affiliation': 'Medical Oncology, Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Safont', 'Affiliation': 'Medical Oncology, Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'La Casta', 'Affiliation': 'Medical Oncology, Hospital de Donostia, Guipúzcoa, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'Medical Oncology, Hospital Universitario Regional y Virgen de la Victoria, Malaga, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Polo', 'Affiliation': 'Medical Oncology, Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Asensio-Martínez', 'Affiliation': 'Medical Oncology, Hospital General Universitario de Elche, Alicante, Spain.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'García-Paredes', 'Affiliation': 'Medical Oncology, Hospital Clínico San Carlos, Instituto de Investigación Hospital Clínico San Carlos (IdISSC), CIBERONC, Madrid, Spain.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'López', 'Affiliation': 'Medical Oncology, University Clinical Hospital and Health Research Institute (IDIS), CIBERONC, Santiago de Compostela University School of Medicine, Santiago de Compostela, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Guillot', 'Affiliation': 'Medical Oncology, Hospital Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Valladares-Ayerbes', 'Affiliation': 'Medical Oncology, Complejo Hospitalario Universitario A Coruña, Instituto de Investigación Biomédica (INIBIC), A Coruña, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Aranda', 'Affiliation': 'Medical Oncology, IMIBIC, Reina Sofía Hospital, University of Córdoba, CIBERONC, Instituto de Salud Carlos III, Cordoba, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Díaz-Rubio', 'Affiliation': 'Medical Oncology, Hospital Clínico San Carlos, Instituto de Investigación Hospital Clínico San Carlos (IdISSC), CIBERONC, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ESMO open,['10.1016/j.esmoop.2021.100062']
443,33754424,Efficiency of intracavitary levobupivacaine infusion for pain management during cystoscopic procedures: A randomised study.,"AIM


This study evaluated the effect of intracavitary levobupivacaine infusion diluted with locally applied isotonic solution for pain control in cystoscopy.
METHODS


Included in this study are 100 patients who had previously undergone transurethral tumour resection for bladder tumour and were followed up by cystoscopy. The patients were randomised into five groups (n = 20). In the first, second, third, and fourth groups, 4, 6, 8, and 10 mL of levobupivacaine HCl (5.0 mg/mL) were mixed with 26, 24, 22, and 20 mL of isotonic solution, respectively. Hence, the total mixture was 30 mL for each group. The fifth group was the control group. In this group, the standard method commonly used in most clinics was utilised. That is, a gel containing Cathejell-2% lidocaine (25 mg lidocaine) was applied for local analgesia. Cystoscopic interventions were performed with a 17.5 Fr rigid cystoscope and 0°, 30°, and 70° lens. During cystoscopy and 30 min later, the pain status of patients was assessed using the Visual Analogue Scale (VAS) and patient satisfaction was questioned.
RESULTS


The mean VAS score during and after the cystoscopy procedure was significantly lower in the levobupivacaine groups compared with the lidocaine group. In addition, patient satisfaction in the levobupivacaine groups was significantly higher than in the lidocaine group. No drug-related side-effects were observed in all groups.
CONCLUSION


Thus, levobupivacaine is a more effective drug than lidocaine alone to control pain during cystoscopy. The use of levobupivacaine is recommended to prevent possible complications of general anaesthesia by eliminating the need for the aforementioned as well as its cost-saving advantage.",2021,The mean VAS score during and after the cystoscopy procedure was significantly lower in the levobupivacaine groups compared to the lidocaine group.,['100 patients who had previously undergone transurethral tumor resection for bladder tumor and were followed up by cystoscopy'],"['levobupivacaine', 'Cystoscopic interventions', 'Intracavitary Levobupivacaine Infusion For Pain Management', 'lidocaine', 'levobupivacaine HCl', 'intracavitary levobupivacaine infusion diluted with locally applied isotonic solution']","['Visual Analogue Scale (VAS), and patient satisfaction', 'patient satisfaction', 'mean VAS score']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0005695', 'cui_str': 'Neoplasm of bladder'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1298613', 'cui_str': 'Intracavitary'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0873119', 'cui_str': 'Levobupivacaine hydrochloride'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0022260', 'cui_str': 'Isotonic Solutions'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",100.0,0.00684776,The mean VAS score during and after the cystoscopy procedure was significantly lower in the levobupivacaine groups compared to the lidocaine group.,"[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Pehlivanoğlu', 'Affiliation': 'Department of Urology, University of Health Sciences, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Hasan Hüseyin', 'Initials': 'HH', 'LastName': 'Tavukçu', 'Affiliation': 'Department of Urology, University of Health Sciences, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Oktay', 'Initials': 'O', 'LastName': 'Akça', 'Affiliation': 'Department of Urology, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Yenigürbüz', 'Affiliation': 'Department of Urology, University of Health Sciences, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yusuf İlker', 'Initials': 'Yİ', 'LastName': 'Çömez', 'Affiliation': 'Department of Urology, Memorial Bahçelievler Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ömer Onur', 'Initials': 'ÖO', 'LastName': 'Çakır', 'Affiliation': ""Department of Urology, King's College Hospital NHS Foundation Trust, London, UK.""}]",International journal of clinical practice,['10.1111/ijcp.14164']
444,33753349,"Patient-centred innovation for multimorbidity care: a mixed-methods, randomised trial and qualitative study of the patients' experience.","BACKGROUND


Patient-centred interventions to help patients with multimorbidity have had mixed results.
AIM


To assess the effectiveness of a provider-created, patient-centred, multi-provider case conference with follow-up, and understand under what circumstances it worked, and did not work.
DESIGN AND SETTING


Mixed-methods design with a pragmatic randomised trial and qualitative study, involving nine urban primary care sites in Ontario, Canada.
METHOD


Patients aged 18-80 years with ≥3 chronic conditions were referred to the Telemedicine IMPACT Plus intervention; a nurse and patient planned a multi-provider case conference during which a care plan could be created. The patients were randomised into an intervention or control group. Two subgroup analyses and a fidelity assessment were conducted, with the primary outcomes at 4 months being self-management and self-efficacy. Secondary outcomes were mental and physical health status, quality of life, and health behaviours. A thematic analysis explored the patients' experiences of the intervention.
RESULTS


A total of 86 patients in the intervention group and 77 in the control group showed no differences, except that the intervention improved mental health status in the subgroup with an annual income of ≥C$50 000 (β-coefficient 11.003,  P  = 0.006). More providers and follow-up hours were associated with poorer outcomes. Five themes were identified in the qualitative study: valuing the team, patients feeling supported, receiving a follow-up plan, being offered new and helpful additions to their treatment regimen, and experiencing positive outcomes.
CONCLUSION


Overall, the intervention showed improvements only for patients who had an annual income of ≥C$50 000, implying a need to address the costs of intervention components not covered by existing health policies. Findings suggest a need to optimise team composition by revising the number and type of providers according to patient preferences and to enhance the hours of nurse follow-up to better support the patient in carrying out the case conference's recommendations.",2021,"A total of 86 patients in the intervention group and 77 in the control group showed no differences, except that the intervention improved mental health status in the subgroup with an annual income of ≥C$50 000 (β-coefficient 11.003,  P  = 0.006).","['Patients aged 18-80 years with ≥3 chronic conditions', ""patients' experience"", 'nine urban primary care sites in Ontario, Canada']","['Plus intervention', 'Telemedicine IMPACT']","['mental health status', 'mental and physical health status, quality of life, and health behaviours', 'self-management and self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",86.0,0.182561,"A total of 86 patients in the intervention group and 77 in the control group showed no differences, except that the intervention improved mental health status in the subgroup with an annual income of ≥C$50 000 (β-coefficient 11.003,  P  = 0.006).","[{'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Stewart', 'Affiliation': 'Department of Family Medicine.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fortin', 'Affiliation': 'Department of Family Medicine and Emergency Medicine, Université de Sherbrooke, Sherbrooke, Canada.'}, {'ForeName': 'Judith Belle', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'Department of Family Medicine.'}, {'ForeName': 'Bridget L', 'Initials': 'BL', 'LastName': 'Ryan', 'Affiliation': 'Department of Family Medicine.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Pariser', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Charles', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Thuy-Nga', 'Initials': 'TN', 'LastName': 'Pham', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Boeckxstaens', 'Affiliation': 'Department of Family Medicine and Primary Healthcare, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Sonja M', 'Initials': 'SM', 'LastName': 'Reichert', 'Affiliation': 'Department of Family Medicine.'}, {'ForeName': 'G Y', 'Initials': 'GY', 'LastName': 'Zou', 'Affiliation': 'Department of Epidemiology and Biostatistics, Western University, London, Canada.'}, {'ForeName': 'Onil', 'Initials': 'O', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Katz', 'Affiliation': 'Department of Community Health Sciences and Department of Family Medicine, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Piccinini-Vallis', 'Affiliation': 'Department of Family Medicine, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sampalli', 'Affiliation': 'Research and Innovation, Nova Scotia Health, Halifax, Canada.'}, {'ForeName': 'Sabrina T', 'Initials': 'ST', 'LastName': 'Wong', 'Affiliation': 'School of Nursing and Centre for Health Services and Policy Research, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Merrick', 'Initials': 'M', 'LastName': 'Zwarenstein', 'Affiliation': 'Department of Family Medicine.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp21X714293']
445,33751401,"Efficacy and Safety of the Biosimilar IBI301 Plus Standard CHOP (I-CHOP) in Comparison With Rituximab Plus CHOP (R-CHOP) in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A Randomized, Double-Blind, Parallel-Group, Phase 3 Trial.","INTRODUCTION


Patients with diffuse large B-cell lymphoma (DLBCL) have limited access to rituximab. IBI301 is a recombinant chimeric murine/human anti-CD20 monoclonal antibody and is a candidate biosimilar to rituximab. This study aimed to assess the therapeutic equivalence of IBI301 and rituximab in previously untreated patients with diffuse large B-cell lymphoma (DLBCL).
METHODS


This multicenter, randomized, double-blind, parallel-group, phase 3 trial compared IBI301 and rituximab, both plus the chemotherapy of doxorubicin, cyclophosphamide, vindesine, and prednisone (CHOP), was conducted in 68 centers across China. Eligible patients with untreated CD20 positive (CD20 + ) DLBCL randomly received IBI301 (375 mg/m 2 ) plus the standard CHOP or rituximab (375 mg/m 2 ) plus the standard CHOP for six cycles of a 21-day cycle. The primary end point was the overall remission rate (ORR). Efficacy equivalence was defined if 95% CIs for the ORR difference between the two groups were within a ± 12.0% margin.
RESULTS


Between August 22, 2016, and September 5, 2018, 419 patients were randomly allocated into the IBI301 group (N = 209) and rituximab group (N = 210). In the full analysis set, the ORR was 89.9% and 93.8% in the IBI301 and rituximab groups, respectively, and the ORR difference was -3.9% (95% CI - 9.1%-1.3%), falling within a ± 12.0% margin. The occurrences of treatment-emergent adverse events (TEAEs) (100% vs. 99.0%) and AEs of grade ≥ 3 (87.1% vs. 83.3%) were similar in the two groups (P > 0.05).
CONCLUSIONS


IBI301 had a non-inferiority efficacy and a comparable safety compared with rituximab. IBI301 plus CHOP could be suggested as a candidate treatment regimen for untreated patients with CD20 +  DLBCL.
TRIAL REGISTRATION


This trial is registered on ClinicalTrials.gov (NCT02867566).",2021,"The occurrences of treatment-emergent adverse events (TEAEs) (100% vs. 99.0%) and AEs of grade ≥ 3 (87.1% vs. 83.3%) were similar in the two groups (P > 0.05).
","['Between August 22, 2016, and September 5, 2018, 419 patients', '68 centers across China', 'untreated patients with CD20 +  DLBCL', 'Eligible patients with untreated CD20 positive (CD20 + ) DLBCL randomly received', 'Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL', 'Patients with diffuse large B-cell lymphoma (DLBCL', 'previously untreated patients with diffuse large B-cell lymphoma (DLBCL']","['IBI301 plus CHOP', 'rituximab', 'Biosimilar IBI301 Plus Standard CHOP (I-CHOP', 'IBI301 (375\xa0mg/m 2 ) plus the standard CHOP or rituximab', 'standard CHOP', 'IBI301 and rituximab, both plus the chemotherapy of doxorubicin, cyclophosphamide, vindesine, and prednisone (CHOP', 'Rituximab Plus CHOP (R-CHOP', 'IBI301 and rituximab']","['ORR', 'overall remission rate (ORR', 'Efficacy and Safety', 'Efficacy equivalence', 'ORR difference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0042682', 'cui_str': 'Vindesine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",419.0,0.482524,"The occurrences of treatment-emergent adverse events (TEAEs) (100% vs. 99.0%) and AEs of grade ≥ 3 (87.1% vs. 83.3%) were similar in the two groups (P > 0.05).
","[{'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Lymphoma and Hematology, Hunan Province Cancer Hospital, Changsha, China.'}, {'ForeName': 'Huilai', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Lymphoma, Tianjin Cancer Hospital, Tianjin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Yuerong', 'Initials': 'Y', 'LastName': 'Shuang', 'Affiliation': 'Cancer Chemotherapy Center, Jiangxi Province Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Keshu', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Hematology Department, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Lv', 'Affiliation': 'Oncology Department, Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Hematology Department, Yancheng City No. 1 People's Hospital, Yancheng, China.""}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Hematology Department, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Hematology Department, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Oncology Department, Tianjin City People's Hospital, Tianjin, China.""}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Oncology Department, The Fifth Affiliated Hospital Sun Yat-Sen University, Zhuhai, China.'}, {'ForeName': 'Haiwen', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Affiliated Cancer Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Hematology Department, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Ge', 'Affiliation': 'Hematology Department, Zhongda Hospital Southeast, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'Department of Hematology and Oncology, Chongqing Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Shuye', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Hematology Department, First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Gao', 'Affiliation': 'Hematology Department, Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': ""Shun'e"", 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Lymphoma and Breast Cancer, First Affiliated Hospital of Xinjiang Medical University, Urumchi, China.'}, {'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Department of Hematological Rheumatology, People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Oncology Department, Hainan General Hospital, Haikou, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Oncology, West China Hospital Sichuan University, Chengdu, China.'}, {'ForeName': 'Meifang', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of Hematology, Linyi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Hematology Department, Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Zonghong', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'Hematology Department, General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'Hematology Department, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Ruixiang', 'Initials': 'R', 'LastName': 'Xia', 'Affiliation': 'Hematology Department, First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Oncology Department, Second Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'Hematology Department, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'Hematology Department, Hainan General Hospital, Haikou, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Feng', 'Affiliation': 'Hematology Department, Nanfang Hospital, Guangzhou, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Cai', 'Affiliation': 'Department of Hematology, First Affiliated Hospital of Zhejiang Medical University, Hangzhou, China.'}, {'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Oncology Department, First Affiliated Hospital of Zhengzhou Medical University, Zhengzhou, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ran', 'Affiliation': 'Cancer Center, Chongqing Three-Gorge Central Hospital, Chongqing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Hematology Department, First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': 'Oncology Department, Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Hematology Department, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Hematology Department, Affiliated Zhongshan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Aibin', 'Initials': 'A', 'LastName': 'Liang', 'Affiliation': 'Hematology Department, Tongji Hospital of Tongji University, Shanghai, China.'}, {'ForeName': 'Xuelan', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Hematology Department, Zhongnan Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Qingfeng', 'Initials': 'Q', 'LastName': 'Zou', 'Affiliation': 'Department of Oncology, Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Junxun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Oncology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sang', 'Affiliation': 'Department of Hematology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Oncology Department, Shanghai East Hospital, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Hematology Department, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yongqing', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Hematology and Oncology, First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Hematology Department, First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Oncology Department, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': ""Hematology Department, Second People's Hospital of Shenzhen, Shenzhen, China.""}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Hematology Department, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Hongguo', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Hematology Department, Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Innovent Biologics, Inc, Suzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Innovent Biologics, Inc, Suzhou, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Innovent Biologics, Inc, Suzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China. zhu-jun2017@outlook.com.'}, {'ForeName': 'Lugui', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': 'State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. qiulg@ihcams.ac.cn.'}]",Advances in therapy,['10.1007/s12325-020-01603-8']
446,33752164,The effects of sprifermin on symptoms and structure in a subgroup at risk of progression in the FORWARD knee osteoarthritis trial.,"OBJECTIVE


To assess pain outcomes and cartilage thickness change in a subgroup at risk (SAR) of further progression in the FORWARD trial of knee osteoarthritis patients treated with sprifermin.
METHODS


Patients were randomised 1:1:1:1:1 to: sprifermin 100 µg every 6 months (q6mo), 100 µg q12mo, 30 µg q6mo, 30 µg q12mo, or placebo for 18 months. SAR was defined as baseline medial or lateral minimum joint-space width (mJSW) 1.5-3.5 mm and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score 40-90 units. Follow-up to 3 years was included in the analysis. Treatment benefit was explored by repeated measures, linear dose-effect trends by timepoint.
RESULTS


The SAR comprised 161 (29%) of 549 patients. Mean difference (95% CI) in WOMAC pain at year 3 for sprifermin 100 µg q6mo vs placebo SAR was -8.75 (-22.42, 4.92) for SAR vs 0.97 (-6.22, 8.16) for the intent-to-treat population. SAR placebo patients lost more cartilage over 2 years than the modified ITT (mITT) placebo arm (mean change from baseline, mm [SD]: -0.05 [0.10] vs -0.02 [0.07]). Net total femorotibial joint thickness gain with sprifermin 100 µg q6mo (adjusted mean difference from placebo [95% CI] was similar in the SAR and in the mITT group: 0.06 [0.01, 0.11] vs 0.05 [0.03, 0.07]).
CONCLUSIONS


Selection for low mJSW and moderate-to-high pain at baseline resulted in more rapid disease progression and demonstrated translation of structure modification (with maintained net benefit on total cartilage thickness) into symptomatic benefit. This subgroup may represent a target population for future trials.
CLINICAL TRIAL REGISTRATION


NCT01919164.",2021,"SAR placebo patients lost more cartilage over 2 years than the modified ITT (mITT) placebo arm (mean change from baseline, mm [SD]: -0.05 [0.10] vs -0.02 [0.07]).","['Patients', 'knee osteoarthritis patients treated with sprifermin']","['sprifermin', 'SAR placebo', 'sprifermin 100\xa0µg every 6 months (q6mo), 100\xa0µg q12mo, 30\xa0µg q6mo, 30\xa0µg q12mo, or placebo', 'modified ITT (mITT) placebo']","['Net total femorotibial joint thickness gain', 'WOMAC pain', 'SAR', 'pain outcomes and cartilage thickness change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",549.0,0.714582,"SAR placebo patients lost more cartilage over 2 years than the modified ITT (mITT) placebo arm (mean change from baseline, mm [SD]: -0.05 [0.10] vs -0.02 [0.07]).","[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Guehring', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Flavie', 'Initials': 'F', 'LastName': 'Moreau', 'Affiliation': 'EMD Serono Research and Development Institute, Inc., Billerica, MA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Daelken', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Ladel', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Guenther', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Asger Reinstrup', 'Initials': 'AR', 'LastName': 'Bihlet', 'Affiliation': 'NBCD A/S, Herlev, Denmark.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wirth', 'Affiliation': 'Chondrometrics GmbH, Ainring, Germany; Department of Imaging and Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Eckstein', 'Affiliation': 'Chondrometrics GmbH, Ainring, Germany; Department of Imaging and Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hochberg', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Chapel Allerton Hospital, Leeds, UK. Electronic address: P.Conaghan@leeds.ac.uk.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2021.03.005']
447,33752148,Effects of preoperative oral single-dose and double-dose carbohydrates on insulin resistance in patients undergoing gastrectomy:a prospective randomized controlled trial.,"BACKGROUND & AIMS


Preoperative oral carbohydrates are strongly recommended for routine use before various elective procedures. The regimen mainly includes preoperative oral single-dose carbohydrate (2-3 h before surgery) and preoperative oral double-dose carbohydrates (10 h before surgery and 2-3 h before surgery). The choice between the two options is still controversial.
METHODS


A total of 139 patients with gastric cancer who underwent radical gastrectomy were recruited from a hospital in Sichuan Province, China. The patients were randomly assigned to a single-dose group (n = 70) or a double-dose group (n = 69). Insulin resistance indicators, subjective comfort indicators, inflammatory mediators, immunological indicators, postoperative recovery indexes, and complications were compared between the two groups.
RESULTS


There were no differences in insulin resistance indicators (fasting plasma glucose, fasting insulin, and homeostasis model assessment indexes), inflammatory mediators (C-reactive protein, interleukin-6, and tumor necrosis factor-α), immunological indicators (CD3+, CD4+, CD8+, and CD4+/CD8+) between the single-dose group and double-dose group (all P > 0.05) at preoperative day 1, preoperative 3 h, and postoperative day 1. There were no differences in subjective comfort indicators (thirst, hunger, anxiety, nausea, fatigue, and weakness) between the two groups (all P > 0.05) at preoperative day 1, preoperative 3 h, preoperative 1 h, and postoperative day 1. The postoperative recovery indexes and complications (exhaust time, liquid intake time, postoperative hospital stay, complication incidence, unplanned readmission rate, and unplanned reoperation rate 30 days after operation) did not significantly differ between the two groups (all P > 0.05). The number of preoperative nighttime urinations in the double-dose group was higher than that in the single-dose group (88.3% VS 48.5%, P < 0.001), and the number of hours of preoperative sleep in the double-dose group was lower than that in the single-dose group (4.56 ± 0.68 VS 5.71 ± 0.57, P < 0.001).
CONCLUSION


Oral carbohydrates administered the night before surgery did not enhance the effects of oral carbohydrates administered 2-3 h before surgery on insulin resistance, subjective comfort, inflammation, and immunity and might affect the patients' night rest. In making a decision between oral carbohydrate regimes, evening carbohydrates could be omitted.
TRIAL REGISTRATION


ChiCTR, ChiCTR1900020608. Registered January 10, 2019, http://www.chictr.org.cn: ChiCTR1900020608.",2021,"There were no differences in subjective comfort indicators (thirst, hunger, anxiety, nausea, fatigue, and weakness) between the two groups (all P > 0.05) at preoperative day 1, preoperative 3 h, preoperative 1 h, and postoperative day 1.","['139 patients with gastric cancer who underwent radical gastrectomy were recruited from a hospital in Sichuan Province, China', 'Registered January 10, 2019, http://www.chictr.org.cn', 'patients undergoing gastrectomy']","['preoperative oral single-dose carbohydrate (2-3\xa0h before surgery) and preoperative oral double-dose carbohydrates', 'preoperative oral single-dose and double-dose carbohydrates']","['insulin resistance, subjective comfort, inflammation, and immunity', 'insulin resistance', 'number of preoperative nighttime urinations', 'Insulin resistance indicators, subjective comfort indicators, inflammatory mediators, immunological indicators, postoperative recovery indexes, and complications', 'postoperative recovery indexes and complications (exhaust time, liquid intake time, postoperative hospital stay, complication incidence, unplanned readmission rate, and unplanned reoperation rate 30 days after operation', 'insulin resistance indicators (fasting plasma glucose, fasting insulin, and homeostasis model assessment indexes), inflammatory mediators (C-reactive protein, interleukin-6, and tumor necrosis factor-α), immunological indicators (CD3+, CD4+, CD8+, and CD4+/CD8', 'subjective comfort indicators (thirst, hunger, anxiety, nausea, fatigue, and weakness', 'number of hours of preoperative sleep']","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0565313', 'cui_str': 'Radical gastrectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",139.0,0.226818,"There were no differences in subjective comfort indicators (thirst, hunger, anxiety, nausea, fatigue, and weakness) between the two groups (all P > 0.05) at preoperative day 1, preoperative 3 h, preoperative 1 h, and postoperative day 1.","[{'ForeName': 'Xinrong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'West China School of Nursing /West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Ka', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'West China School of Nursing /West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China. Electronic address: lika127@126.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital,Sichuan University, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Jiankun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital,Sichuan University, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital,Sichuan University, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'West China School of Nursing /West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Yanjie', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'West China School of Nursing /West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Xingxia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'West China School of Nursing /West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2021.03.002']
448,33752127,Itraconazole for COVID-19: preclinical studies and a proof-of-concept randomized clinical trial.,"BACKGROUND


The antifungal drug itraconazole exerts in vitro activity against SARS-CoV-2 in Vero and human Caco-2 cells. Preclinical and clinical studies are required to investigate if itraconazole is effective for the treatment and/or prevention of COVID-19.
METHODS


Due to the initial absence of preclinical models, the effect of itraconazole was explored in a clinical, proof-of-concept, open-label, single-center study, in which hospitalized COVID-19 patients were randomly assigned to standard of care with or without itraconazole. Primary outcome was the cumulative score of the clinical status until day 15 based on the 7-point ordinal scale of the World Health Organization. In parallel, itraconazole was evaluated in a newly established hamster model of acute SARS-CoV-2 infection and transmission, as soon as the model was validated.
FINDINGS


In the hamster acute infection model, itraconazole did not reduce viral load in lungs, stools or ileum, despite adequate plasma and lung drug concentrations. In the transmission model, itraconazole failed to prevent viral transmission. The clinical trial was prematurely discontinued after evaluation of the preclinical studies and because an interim analysis showed no signal for a more favorable outcome with itraconazole: mean cumulative score of the clinical status 49 vs 47, ratio of geometric means 1.01 (95% CI 0.85 to 1.19) for itraconazole vs standard of care.
INTERPRETATION


Despite in vitro activity, itraconazole was not effective in a preclinical COVID-19 hamster model. This prompted the premature termination of the proof-of-concept clinical study.
FUNDING


KU Leuven, Research Foundation - Flanders (FWO), Horizon 2020, Bill and Melinda Gates Foundation.",2021,"In the hamster acute infection model, itraconazole did not reduce viral load in lungs, stools or ileum, despite adequate plasma and lung drug concentrations.",['hospitalized COVID-19 patients'],"['Itraconazole', 'itraconazole', 'standard of care with or without itraconazole']","['cumulative score of the clinical status until day 15 based on the 7-point ordinal scale of the World Health Organization', 'viral transmission', 'viral load in lungs, stools or ileum, despite adequate plasma and lung drug concentrations']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.260187,"In the hamster acute infection model, itraconazole did not reduce viral load in lungs, stools or ileum, despite adequate plasma and lung drug concentrations.","[{'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Liesenborghs', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium; The Outbreak Research Team, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium. Electronic address: lliesenborghs@itg.be.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Spriet', 'Affiliation': 'Pharmacy Department University Hospitals Leuven and Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Jochmans', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Belmans', 'Affiliation': 'KU Leuven - University of Leuven & Universiteit Hasselt, I-BioStat, Leuven, Belgium.'}, {'ForeName': 'Iwein', 'Initials': 'I', 'LastName': 'Gyselinck', 'Affiliation': 'Department of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Laure-Anne', 'Initials': 'LA', 'LastName': 'Teuwen', 'Affiliation': 'Laboratory of Angiogenesis and Vascular Metabolism, Center for Cancer Biology, VIB, Department of Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Ter Horst', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Dreesen', 'Affiliation': 'Clinical Pharmacology and Pharmacotherapy Unit, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Geukens', 'Affiliation': 'Department of Oncology, Laboratory for Translational Breast Cancer Research, KU Leuven, Belgium.'}, {'ForeName': 'Matthias M', 'Initials': 'MM', 'LastName': 'Engelen', 'Affiliation': 'Department of Cardiovascular Sciences, UZ and KU Leuven, Belgium.'}, {'ForeName': 'Ewout', 'Initials': 'E', 'LastName': 'Landeloos', 'Affiliation': 'Department of Oncology, Laboratory for molecular Cancer biology, VIB-KU Leuven, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Geldhof', 'Affiliation': 'Laboratory of Angiogenesis and Vascular Metabolism, Center for Cancer Biology, VIB, Department of Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ceunen', 'Affiliation': 'Department of General Internal Medicine, UZ Leuven and Department of Microbiology, Immunology and Transplantation, KU Leuven, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Debaveye', 'Affiliation': 'Department of Cardiovascular Sciences, UZ and KU Leuven, Belgium.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Vandenberk', 'Affiliation': 'Department of Cardiovascular Sciences, UZ and KU Leuven, Belgium.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Van der Linden', 'Affiliation': 'Pharmacy Department University Hospitals Leuven and Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Jacobs', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Langendries', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Robbert', 'Initials': 'R', 'LastName': 'Boudewijns', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Thuc Nguyen Dan', 'Initials': 'TND', 'LastName': 'Do', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Chiu', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Weynand', 'Affiliation': 'Translational Cell and Tissue Research, Department of Imaging and Pathology, KU Leuven, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vanassche', 'Affiliation': 'Department of Cardiovascular Sciences, UZ and KU Leuven, Belgium.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Devos', 'Affiliation': 'Department of Hematology, UZ Leuven and Department of Microbiology, Immunology and Transplantation, Laboratory of Molecular Immunology (Rega Institute), KU Leuven, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Meyfroidt', 'Affiliation': 'Department and Laboratory of Intensive Care Medicine, UZ and KU Leuven, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Janssens', 'Affiliation': 'Department of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Vos', 'Affiliation': 'Department of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Vermeersch', 'Affiliation': 'Department of Cardiovascular Sciences and Clinical Department of Laboratory Medicine, KU Leuven, Belgium.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Wauters', 'Affiliation': 'Medical Intensive Care Unit, UZ Leuven and Department of Microbiology, Immunology and Transplantation, KU Leuven, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Verbeke', 'Affiliation': 'KU Leuven - University of Leuven & Universiteit Hasselt, I-BioStat, Leuven, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'De Munter', 'Affiliation': 'Department of General Internal Medicine, UZ Leuven and Department of Microbiology, Immunology and Transplantation, KU Leuven, Belgium.'}, {'ForeName': 'Suzanne J F', 'Initials': 'SJF', 'LastName': 'Kaptein', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Rocha-Pereira', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Delang', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Wijngaerden', 'Affiliation': 'Department of General Internal Medicine, UZ Leuven and Department of Microbiology, Immunology and Transplantation, KU Leuven, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Neyts', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verhamme', 'Affiliation': 'Department of Cardiovascular Sciences, UZ and KU Leuven, Belgium.'}]",EBioMedicine,['10.1016/j.ebiom.2021.103288']
449,33752119,The addition of clonidine to ropivacaine in rectus sheath nerve blocks for pediatric patients undergoing laparoscopic appendectomy: A double blinded randomized prospective study.,"STUDY OBJECTIVE


The primary goal of this study was to determine if the addition of clonidine to ropivacaine prolonged periumbilical numbness compared to ropivacaine alone in pediatric patients receiving ultrasound guided rectus sheath nerve blocks for laparoscopic appendectomy. The secondary goals were to evaluate differences in perioperative pain scores, analgesic consumption, sedation, anxiolysis, and hemodynamic effects from clonidine.
DESIGN


This was a single center, randomized, double-blinded prospective study.
SETTING


This study was conducted within the pediatric operating rooms at the Children's Hospital of Pittsburgh, a large university-based academic medical center.
PATIENTS


Fifty pediatric patients (ages 10-17 years old) without pre-existing cognitive impairment, developmental delay or chronic pain undergoing laparoscopic appendectomy during weekday hours were enrolled and randomized to control versus intervention groups.
INTERVENTION


Ultrasound guided rectus sheath nerve block injections were performed at the beginning of surgery with either ropivacaine 0.5% plus normal saline or ropivacaine 0.5% plus clonidine (2 mcg/kg, maximum of 100 mcg).
MEASUREMENTS


The duration of periumbilical numbness, Numeric Pain Rating Scale scores, University of Michigan Sedation Scale, State-Trait Anxiety Inventory for Children, analgesic consumption, heart rate, blood pressure, and mean arterial pressures, were recorded for each patient at several time points in the perioperative setting.
MAIN RESULTS


There were no significant differences in demographic characteristics between groups. The median duration of periumbilical numbness did not significantly differ between the ropivacaine only and the ropivacaine plus clonidine groups 540.0 minutes [360.0 -1015.0] (median [interquartile range (IQR)]) versus 823.5 minutes [509.5- 1080.0], p = 0.451. There were no significant differences in perioperative analgesic consumption, pain and anxiety scores, PACU sedation, or hemodynamic instability.
CONCLUSIONS


The addition of clonidine did not significantly prolong rectus sheath nerve block duration and was well tolerated in pediatric patients. Perioperative analgesia, hemodynamics, anxiety, and PACU sedation did not differ between groups.
TRIAL REGISTRATION


Clinical Trials NCT02439281.",2021,"The median duration of periumbilical numbness did not significantly differ between the ropivacaine only and the ropivacaine plus clonidine groups 540.0 minutes [360.0 -1015.0] (median [interquartile range (IQR)]) versus 823.5 minutes [509.5- 1080.0], p = 0.451.","[""pediatric operating rooms at the Children's Hospital of Pittsburgh, a large university-based academic medical center"", 'pediatric patients undergoing laparoscopic appendectomy', 'Fifty pediatric patients (ages 10-17 years old) without pre-existing cognitive impairment, developmental delay or chronic pain undergoing laparoscopic appendectomy during weekday hours', 'pediatric patients', 'pediatric patients receiving ultrasound guided rectus sheath nerve blocks for laparoscopic appendectomy']","['clonidine', 'ropivacaine', 'ropivacaine 0.5% plus normal saline or ropivacaine 0.5% plus clonidine', 'Ultrasound guided rectus sheath nerve block injections', 'ropivacaine plus clonidine']","['duration of periumbilical numbness, Numeric Pain Rating Scale scores, University of Michigan Sedation Scale, State-Trait Anxiety Inventory for Children, analgesic consumption, heart rate, blood pressure, and mean arterial pressures', 'perioperative pain scores, analgesic consumption, sedation, anxiolysis, and hemodynamic effects from clonidine', 'rectus sheath nerve block duration', 'Perioperative analgesia, hemodynamics, anxiety, and PACU sedation', 'demographic characteristics', 'median duration of periumbilical numbness', 'perioperative analgesic consumption, pain and anxiety scores, PACU sedation, or hemodynamic instability']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0457792', 'cui_str': 'Periumbilical'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1961138', 'cui_str': 'Induction of minimal sedation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}]",50.0,0.421336,"The median duration of periumbilical numbness did not significantly differ between the ropivacaine only and the ropivacaine plus clonidine groups 540.0 minutes [360.0 -1015.0] (median [interquartile range (IQR)]) versus 823.5 minutes [509.5- 1080.0], p = 0.451.","[{'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Visoiu', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Department of Anesthesiology and Perioperative Medicine, 4401 Penn Avenue, Pittsburgh, PA 15224, USA. Electronic address: visoium@upmc.edu.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Scholz', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Department of Pediatric General and Thoracic Surgery, 4401 Penn Avenue, Pittsburgh, PA 15224, USA.""}, {'ForeName': 'Marcus M', 'Initials': 'MM', 'LastName': 'Malek', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Department of Pediatric General and Thoracic Surgery, 4401 Penn Avenue, Pittsburgh, PA 15224, USA.""}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Carullo', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Department of Anesthesiology and Perioperative Medicine, 4401 Penn Avenue, Pittsburgh, PA 15224, USA.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110254']
450,33755924,"First-in-Human Randomized Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the KDM1A Inhibitor Vafidemstat.","BACKGROUND


Vafidemstat, an inhibitor of the histone lysine-specific demethylase KDM1A, corrects cognition deficits and behavior alterations in rodent models. Here, we report the results from the first-in-human trial of vafidemstat in healthy young and older adult volunteers. A total of 110 volunteers participated: 87 were treated with vafidemstat and 23 with placebo.
OBJECTIVES


The study aimed to determine the safety and tolerability of vafidemstat, to characterize its pharmacokinetic and pharmacodynamic profiles, to assess its central nervous system (CNS) exposure, and to acquire the necessary data to select the appropriate doses for long-term treatment of patients with CNS disease in phase II trials.
METHODS


This single-center, randomized, double-blind, placebo-controlled phase I trial included a single and 5-day repeated dose-escalation and open-label CNS penetration substudy. Primary outcomes were safety and tolerability; secondary outcomes included analysis of the pharmacokinetics and pharmacodynamics, including chemoprobe-based immune analysis of KDM1A target engagement (TE) in peripheral blood mononuclear cells (PBMCs) and platelet monoamine oxidase B (MAOB) inhibition. CNS and cognitive function were also evaluated.
RESULTS


No severe adverse events (AEs) were reported in the dose-escalation stage. AEs were reported at all dose levels; none were dose dependent, and no significant differences were observed between active treatment and placebo. Biochemistry, urinalysis, vital signs, electrocardiogram, and hematology did not change significantly with dose escalation, with the exception of a transient reduction of platelet counts in an extra dose level incorporated for that purpose. Vafidemstat exhibits rapid oral absorption, approximate dose-proportional exposures, and moderate systemic accumulation after 5 days of treatment. The cerebrospinal fluid-to-plasma unbound ratio demonstrated CNS penetration. Vafidemstat bound KDM1A in PBMCs in a dose-dependent manner. No MAOB inhibition was detected. Vafidemstat did not affect the CNS or cognitive function.
CONCLUSIONS


Vafidemstat displayed good safety and tolerability. This phase I trial confirmed KDM1A TE and CNS penetration and permitted characterization of platelet dynamics and selection of phase IIa doses.
TRIAL REGISTRATION


EUDRACT No. 2015-003721-33, filed 30 October 2015.",2021,"AEs were reported at all dose levels; none were dose dependent, and no significant differences were observed between active treatment and placebo.","['110 volunteers participated: 87 were treated with vafidemstat and 23 with', 'patients with CNS disease in phase II trials', 'healthy young and older adult volunteers']",['placebo'],"['severe adverse events (AEs', 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics', 'CNS or cognitive function', 'safety and tolerability', 'safety and tolerability; secondary outcomes included analysis of the pharmacokinetics and pharmacodynamics, including chemoprobe-based immune analysis of KDM1A target engagement (TE) in peripheral blood mononuclear cells (PBMCs) and platelet monoamine oxidase B (MAOB) inhibition', 'Biochemistry, urinalysis, vital signs, electrocardiogram, and hematology', 'CNS and cognitive function', 'MAOB inhibition']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007682', 'cui_str': 'Disorder of the central nervous system'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1531135', 'cui_str': 'KDM1A protein, human'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0026456', 'cui_str': 'Type B Monoamine Oxidase'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}]",110.0,0.394909,"AEs were reported at all dose levels; none were dose dependent, and no significant differences were observed between active treatment and placebo.","[{'ForeName': 'Rosa María', 'Initials': 'RM', 'LastName': 'Antonijoan', 'Affiliation': ""Centre d'Investigació del Medicament, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (IIB-Sant Pau), Barcelona, Spain.""}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Ferrero-Cafiero', 'Affiliation': ""Centre d'Investigació del Medicament, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (IIB-Sant Pau), Barcelona, Spain.""}, {'ForeName': 'Jimena', 'Initials': 'J', 'LastName': 'Coimbra', 'Affiliation': ""Centre d'Investigació del Medicament, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (IIB-Sant Pau), Barcelona, Spain.""}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Puntes', 'Affiliation': ""Centre d'Investigació del Medicament, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (IIB-Sant Pau), Barcelona, Spain.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martínez-Colomer', 'Affiliation': ""Centre d'Investigació del Medicament, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (IIB-Sant Pau), Barcelona, Spain.""}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Arévalo', 'Affiliation': 'Oryzon Genomics S.A. Carrer Sant Ferran 74, Cornellà de Llobregat, 08940, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Mascaró', 'Affiliation': 'Oryzon Genomics S.A. Carrer Sant Ferran 74, Cornellà de Llobregat, 08940, Barcelona, Spain.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Molinero', 'Affiliation': 'Oryzon Genomics S.A. Carrer Sant Ferran 74, Cornellà de Llobregat, 08940, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Buesa', 'Affiliation': 'Oryzon Genomics S.A. Carrer Sant Ferran 74, Cornellà de Llobregat, 08940, Barcelona, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Maes', 'Affiliation': 'Oryzon Genomics S.A. Carrer Sant Ferran 74, Cornellà de Llobregat, 08940, Barcelona, Spain. tmaes@oryzon.com.'}]",CNS drugs,['10.1007/s40263-021-00797-x']
451,33751297,"Immediate and early loading of hydrothermally treated, hydroxyapatite-coated dental implants: a 7-year prospective randomized clinical study.","BACKGROUND


Existing research on marginal bone stability around hydroxyapatite (HA)-coated implants often lacks adequate long-term follow-up. The purpose of this randomized prospective study was to evaluate the 7-year outcome of patients with immediate and early loaded single-tooth restorations supported by implants with plasma-sprayed, partially HA-coated surfaces. Forty-two patients in need of 50 single implants were treated in in the Postgraduate Periodontics Clinic of Louisiana State University School of Dentistry. Implants were randomly divided into 2 groups: Group A was immediately loaded, and Group B was early loaded. Continuous follow-up with periodic maintenance care and radiographic evaluations was performed. The primary outcome of interest was implant survival, characterized using the Kaplan-Meier method. Secondary study outcome consisted of peri-implant crestal bone level changes. Data on age, sex, bone quality, implant location, length and diameter, and prior augmentation of the site were collected. Multiple regression analyses were conducted to determine whether the independent variables were associated with bone loss.
RESULTS


One implant failed to maintain stability and was removed at 3 weeks. Thirty-four patients (14 males, 20 females with a total of 42 implants) completed the 7-year follow-up visit. Average age of evaluable patients was 52 in Group A and 55 in Group B. No significant difference was observed regarding sex and age distribution between the 2 groups. No significant difference was detected in the distribution of implant locations, types of bone, implant length, implant diameter, and augmentation status of the bone between the 2 groups. After 7 years of functioning for the 42 implants examined, implant survival rate was 100% for Group A and 95.5% for Group B. The results from this study of 50 implants showed that HA-coated Zimmer Tapered Screw-Vent Implants were clinically effective, with an overall cumulative 7-year survival rate of 98.0%. When comparing radiographic bone levels between 2-year and 7-year follow-ups, no significant differences in bone loss were found between Group A and Group B.
CONCLUSIONS


After 7 years in function, implants partially coated with plasma-sprayed and hydrothermally treated HA were clinically predictable when restored in occlusion immediately after or 3 weeks after implant placement.",2021,"No significant difference was detected in the distribution of implant locations, types of bone, implant length, implant diameter, and augmentation status of the bone between the 2 groups.","['Thirty-four patients (14 males, 20 females with a total of 42 implants) completed the 7-year follow-up visit', 'Forty-two patients in need of 50 single implants were treated in in the Postgraduate Periodontics Clinic of Louisiana State University School of Dentistry', 'patients with immediate and early loaded single-tooth restorations supported by implants with plasma-sprayed, partially HA-coated surfaces']",['hydroxyapatite-coated dental implants'],"['implant survival rate', 'overall cumulative 7-year survival rate', 'distribution of implant locations, types of bone, implant length, implant diameter, and augmentation status of the bone', 'implant survival, characterized using the Kaplan-Meier method', 'bone loss', 'peri-implant crestal bone level changes', 'radiographic bone levels']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0031098', 'cui_str': 'Periodontics'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C1283557', 'cui_str': 'Type of bone'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]",,0.0107704,"No significant difference was detected in the distribution of implant locations, types of bone, implant length, implant diameter, and augmentation status of the bone between the 2 groups.","[{'ForeName': 'Afarin', 'Initials': 'A', 'LastName': 'Arghami', 'Affiliation': 'Department of Periodontics, Louisiana State University Health Sciences Center School of Dentistry, 1100 Florida Avenue, New Orleans, LA, 70119, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simmons', 'Affiliation': 'Department of Periodontics, Louisiana State University Health Sciences Center School of Dentistry, 1100 Florida Avenue, New Orleans, LA, 70119, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'St Germain', 'Affiliation': 'Department of Periodontics, Louisiana State University Health Sciences Center School of Dentistry, 1100 Florida Avenue, New Orleans, LA, 70119, USA.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Maney', 'Affiliation': 'Department of Periodontics, Louisiana State University Health Sciences Center School of Dentistry, 1100 Florida Avenue, New Orleans, LA, 70119, USA. pmaney@lsuhsc.edu.'}]",International journal of implant dentistry,['10.1186/s40729-021-00299-x']
452,33757875,Increasing smear positive tuberculosis detection using a clinical score - A stepped wedge multicenter trial from Africa.,"BACKGROUND


The Bandim TBscore is a clinical score that predicts treatment outcome in Tuberculosis (TB) patients and proved useful as an indicator of which healthcare-seeking adults to refer for sputum smear microcopy. We aimed to test in a randomized trial if the TBscore could be used to enhance the detection of smear positive (SP) TB.
METHODS


We carried out a stepped wedge cluster-randomized trial at six health centers in Bissau, Guinea-Bissau, and Gondar, Ethiopia. The primary outcome was diagnostic yield for SP TB. Secondary outcomes were successful treatment and effect on overall 12 months mortality. The study was registered at the Pan African Clinical Trials Registry (PACTR201611001838365).
RESULTS


We included 3571 adults. Overall, there was no effect of the intervention on SP PTB detected (OR 1.39 (95%CI 0.75 - 2.56). Analysis stratified by country, showed that the TBscore increased case detection in Gondar (OR 4.05 (95%CI 1.67 - 9.85)) but no effect was found in Bissau (OR 0.47 (95%CI 0.22 - 1.05)) where take-up was much lower. Overall mortality decreased during the intervention (HR 0.31 (95%CI 0.13-0.72)).
CONCLUSION


Using the TBscore for triage before smear microscopy may improve case detection and decrease mortality if there is sufficient laboratory capacity to increase sputum smears.",2021,"Overall mortality decreased during the intervention (HR 0.31 (95%CI 0.13-0.72)).
","['Tuberculosis (TB) patients', '3571 adults', 'stepped wedge cluster-randomized trial at six health centers in Bissau, Guinea-Bissau, and Gondar, Ethiopia']",[],"['SP PTB', 'diagnostic yield for SP TB', 'Overall mortality', 'detection of smear positive (SP) TB', 'successful treatment and effect on overall 12 months mortality']","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0018387', 'cui_str': 'Guinea-Bissau'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}]",[],"[{'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",3571.0,0.418856,"Overall mortality decreased during the intervention (HR 0.31 (95%CI 0.13-0.72)).
","[{'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Rudolf', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Apartado 861, Bissau, Guinea-Bissau; Department of Infectious Diseases, Aarhus University Hospital, Denmark. Electronic address: frauke.rudolf@clin.au.dk.'}, {'ForeName': 'Ebba', 'Initials': 'E', 'LastName': 'Abate', 'Affiliation': 'Ethiopian Public Health Institute (EPHI), Addis Ababa, Ethiopia; Tropical & Infectious Diseases Research Centre, University of Gondar, Ethiopia.'}, {'ForeName': 'Binyam', 'Initials': 'B', 'LastName': 'Moges', 'Affiliation': 'Tropical & Infectious Diseases Research Centre, University of Gondar, Ethiopia.'}, {'ForeName': 'Antonio Mateus', 'Initials': 'AM', 'LastName': 'Mendes', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Apartado 861, Bissau, Guinea-Bissau.'}, {'ForeName': 'Mezgebu Yitayal', 'Initials': 'MY', 'LastName': 'Mengistu', 'Affiliation': 'Department of Health Systems and Policy, Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Ethiopia.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Sifna', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Apartado 861, Bissau, Guinea-Bissau.'}, {'ForeName': 'Hikma', 'Initials': 'H', 'LastName': 'Fekadu', 'Affiliation': 'Department of Internal Medicine, College of Medicine and Health Science, University of Gondar, Ethiopia.'}, {'ForeName': 'Segenet', 'Initials': 'S', 'LastName': 'Bizuneh', 'Affiliation': 'Department of Internal Medicine, College of Medicine and Health Science, University of Gondar, Ethiopia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schön', 'Affiliation': 'Department of Microbiology and Infectious Medicine, Kalmar County Hospital, Sweden; Department of Biomedical and Clinical Sciences, Division of Infectious Diseases, Linköping University, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wejse', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Apartado 861, Bissau, Guinea-Bissau; Department of Infectious Diseases, Aarhus University Hospital, Denmark; GloHAU, Center for Global Health, School of Public Health, Aarhus University, Denmark.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2021.03.041']
453,33756376,Subgroups of comorbid PTSD and AUD in U.S. military veterans predict differential responsiveness to two integrated treatments: A latent class analysis.,"Posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) frequently co-occur. Integrated treatments are effective, but not all patients respond and predicting outcome remains difficult. In this study, latent class analysis (LCA) identified symptom-based subgroups of comorbid PTSD/AUD among 119 veterans with PTSD/AUD from a randomized controlled trial of integrated exposure therapy (I-PE) versus integrated coping skills therapy (I-CS). Multilevel models compared subgroups on PTSD severity and percentage of heavy drinking days at post-treatment and 3- and 6-month follow-up. LCA revealed three subgroups best fit the data: Moderate PTSD/Low AUD Impairment (21%), High PTSD/High AUD Impairment (48%), and Low PTSD/High AUD Impairment (31%). There was a three-way interaction between time, treatment condition, and subgroup in predicting PTSD outcomes (p < .05). For the Moderate PTSD/Low AUD Impairment class, outcomes at post-treatment and 3-months were similar (ds = 0.17, 0.55), however I-PE showed greater reductions at 6-months (d = 1.36). For the High PTSD/High AUD Impairment class, I-PE demonstrated better post-treatment (d = 0.83) but comparable follow-up (ds = -0.18, 0.49) outcomes. For the Low PTSD/High AUD Impairment class, I-PE demonstrated stronger outcomes at every timepoint (ds = 0.82-1.15). Heavy drinking days declined significantly through follow-up, with an effect of subgroup, but not treatment, on timing of response. This was the first study modeling how PTSD and AUD symptoms might cluster together in a treatment sample of veterans with PTSD/AUD. Symptom-based subgroups show promise in helping understand variability in treatment response among patients with PTSD/AUD and deserve further study.",2021,"Heavy drinking days declined significantly through follow-up, with an effect of subgroup, but not treatment, on timing of response.","['patients with PTSD/AUD', 'veterans with PTSD/AUD', '119 veterans with PTSD/AUD']","['integrated exposure therapy (I-PE) versus integrated coping skills therapy (I-CS', 'LCA']",['Heavy drinking days'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4704739', 'cui_str': 'Latent Variable Modeling'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}]",,0.0284902,"Heavy drinking days declined significantly through follow-up, with an effect of subgroup, but not treatment, on timing of response.","[{'ForeName': 'Kaitlyn E', 'Initials': 'KE', 'LastName': 'Panza', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA. Electronic address: kaitlyn.panza@gmail.com.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Kline', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Norman', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Pitts', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA; National Center for Posttraumatic Stress Disorder, 163 Veterans Drive, White River Junction, VT, 05009, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.02.061']
454,33756252,Program for attention rehabilitation and strengthening (PARS) improves executive functions in children with attention deficit- hyperactivity disorder (ADHD).,"Attention is improved through cognitive rehabilitation. The purpose of the present study was the evaluation of the effect of a paper and pencil program for attention rehabilitation and strengthening (PARS) in children with ADHD. Thirty children with ADHD were randomly divided into two equal intervention and control groups. The intervention group received 12-15 sessions of intervention through PARS. Sustained, selective, and shifting attention, inhibitory control, and working memory were assessed by Persian attention registration, Stroop, color trail making, Go/No-Go, and 1- back tests. Analyses indicated that the experimental group, in comparison with the control group, showed improved selective and sustained attention and the training effects transfers to executive functions, inhibitory control and working memory. The result is discussed in the light of transferability of training effects from attention to executive functions.",2021,"Analyses indicated that the experimental group, in comparison with the control group, showed improved selective and sustained attention and the training effects transfers to executive functions, inhibitory control and working memory.","['children with attention deficit- hyperactivity disorder (ADHD', 'Thirty children with ADHD', 'children with ADHD']","['Program for attention rehabilitation and strengthening (PARS', '12-15 sessions of intervention through PARS', 'paper and pencil program for attention rehabilitation and strengthening (PARS']","['Sustained, selective, and shifting attention, inhibitory control, and working memory were assessed by Persian attention registration, Stroop, color trail making, Go/No-Go, and 1- back tests', 'executive functions', 'selective and sustained attention and the training effects transfers to executive functions, inhibitory control and working memory']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}]","[{'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",30.0,0.00192258,"Analyses indicated that the experimental group, in comparison with the control group, showed improved selective and sustained attention and the training effects transfers to executive functions, inhibitory control and working memory.","[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Nejati', 'Affiliation': 'Department of Psychology, Shahid Beheshti University, PO Box: 1983969411, Tehran, Iran. Electronic address: nejati@sbu.ac.ir.'}]",Research in developmental disabilities,['10.1016/j.ridd.2021.103937']
455,33762220,"Exposure to gamma tACS in Alzheimer's disease: A randomized, double-blind, sham-controlled, crossover, pilot study.","OBJECTIVE


To assess whether exposure to non-invasive brain stimulation with transcranial alternating current stimulation at γ frequency (γ-tACS) applied over Pz (an area overlying the medial parietal cortex and the precuneus) can improve memory and modulate cholinergic transmission in mild cognitive impairment due to Alzheimer's disease (MCI-AD).
METHODS


In this randomized, double-blind, sham controlled, crossover pilot study, participants were assigned to a single 60 min treatment with exposure to γ-tACS over Pz or sham tACS. Each subject underwent a clinical evaluation including assessment of episodic memory pre- and post-γ-tACS or sham stimulation. Indirect measures of cholinergic transmission evaluated using transcranial magnetic stimulation (TMS) pre- and post-γ-tACS or sham tACS were evaluated.
RESULTS


Twenty MCI-AD participants completed the study. No tACS-related side effects were observed, and the intervention was well tolerated in all participants. We observed a significant improvement at the Rey auditory verbal learning (RAVL) test total recall (5.7 [95% CI, 4.0 to 7.4], p < 0.001) and long delayed recall scores (1.3 [95% CI, 0.4 to 2.1], p = 0.007) after γ-tACS but not after sham tACS. Face-name associations scores improved during γ-tACS (4.3 [95% CI, 2.8 to 5.8], p < 0.001) but not after sham tACS. Short latency afferent inhibition, an indirect measure of cholinergic transmission evaluated with TMS, increased only after γ-tACS (0.31 [95% CI, 0.24 to 0.38], p < 0.001) but not after sham tACS.
CONCLUSIONS


exposure to γ-tACS over Pz showed a significant improvement of memory performances, along with restoration of intracortical connectivity measures of cholinergic neurotransmission, compared to sham tACS.",2021,"We observed a significant improvement at the Rey auditory verbal learning (RAVL) test total recall (5.7 [95% CI, 4.0 to 7.4], p<0.001) and long delayed recall scores (1.3 [95% CI, 0.4 to 2.1], p=0.007) after γ-tACS but not after sham tACS.","['Twenty MCI-AD participants completed the study', ""mild cognitive impairment due to Alzheimer's disease (MCI-AD"", ""Alzheimer's disease""]","['transcranial alternating current stimulation at γ frequency (γ-tACS) applied over Pz', 'γ-tACS over Pz or sham tACS', 'transcranial magnetic stimulation (TMS) pre- and post-γ-tACS or sham tACS', 'gamma tACS', 'episodic memory pre- and post-γ-tACS or sham stimulation']","['memory performances', 'delayed recall scores', 'side effects', 'Rey auditory verbal learning (RAVL) test total recall']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.438899,"We observed a significant improvement at the Rey auditory verbal learning (RAVL) test total recall (5.7 [95% CI, 4.0 to 7.4], p<0.001) and long delayed recall scores (1.3 [95% CI, 0.4 to 2.1], p=0.007) after γ-tACS but not after sham tACS.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Benussi', 'Affiliation': 'Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy; Neurology Unit, Department of Neurological and Vision Sciences, ASST Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cantoni', 'Affiliation': 'Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Maria Sofia', 'Initials': 'MS', 'LastName': 'Cotelli', 'Affiliation': 'Neurology Unit, Valle Camonica Hospital, Esine, Brescia, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cotelli', 'Affiliation': 'Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Brattini', 'Affiliation': 'Neurology Unit, Department of Neurological and Vision Sciences, ASST Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Research & Development, Soterix Medical, Inc., New York, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'Research & Development, Soterix Medical, Inc., New York, USA.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Santarnecchi', 'Affiliation': 'Berenson-Allen Center for Non-Invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Department of Neurology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pascual-Leone', 'Affiliation': 'Department of Neurology, Harvard Medical School, Boston, MA, USA; Hinda and Arthur Marcus Institute for Aging Research and Center for Memory Health, Hebrew SeniorLife, Boston, MA, USA; Guttmann Brain Health Institut, Institut Guttmann, Universitat Autonoma Barcelona, Spain.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Borroni', 'Affiliation': 'Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy; Neurology Unit, Department of Neurological and Vision Sciences, ASST Spedali Civili, Brescia, Italy. Electronic address: bborroni@inwind.it.'}]",Brain stimulation,['10.1016/j.brs.2021.03.007']
456,33756239,The interaction of acute physical fatigue with three traditional functional performance tests and the reactive balance test.,"OBJECTIVES


To assess the impact of acute physical fatigue on traditional and neurocognitive functional performance tests in recreational athletes.
DESIGN


randomized counterbalanced cross-over study, pre-post design SETTING: laboratory PARTICIPANTS: Twenty recreational athletes (age = 24 ± 3 years) MAIN OUTCOME MEASURES: We evaluated fatigue impairments following a 30 s all-out effort in three traditional and one neurocognitive functional performance test. The traditional functional performance tests encompassed the single leg hop for distance (SLH), countermovement jump (CMJ) and Y-balance test (YBT). The neurocognitive functional performance test encompassed the reactive balance test (RBT). A 30 s modified Wingate was used to induce acute physical fatigue.
RESULTS


Acute physical fatigue was successfully induced as indicated by a significant increase in heart rate, systolic blood pressure, blood lactate levels and rating of perceived exertion (p < 0.001). Acute physical fatigue induced significant decreases in RBT accuracy (p = 0.004) and SLH performance (p < 0.001). YBT, CMJ and RBT visuomotor reaction time remained unaffected by acute physical fatigue.
CONCLUSIONS


Acute physical fatigue impairs SLH performance and decreases accuracy in the RBT. YBT and CMJ performance remained unaffected by acute physical fatigue. Clinicians should be aware of this divergent neurocognitive functional impairments caused by one all-out effort to allow well-informed selection of functional performance tests.",2021,"RESULTS


Acute physical fatigue was successfully induced as indicated by a significant increase in heart rate, systolic blood pressure, blood lactate levels and rating of perceived exertion (p < 0.001).","[' Twenty recreational athletes (age\xa0=\xa024\xa0±\xa03 years', 'recreational athletes']",[],"['heart rate, systolic blood pressure, blood lactate levels and rating of perceived exertion', 'reactive balance test (RBT', 'SLH performance', 'RBT accuracy', 'acute physical fatigue', 'fatigue impairments', 'YBT, CMJ and RBT visuomotor reaction time', 'YBT and CMJ performance', 'single leg hop for distance (SLH), countermovement jump (CMJ) and Y-balance test (YBT']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",20.0,0.0697067,"RESULTS


Acute physical fatigue was successfully induced as indicated by a significant increase in heart rate, systolic blood pressure, blood lactate levels and rating of perceived exertion (p < 0.001).","[{'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Verschueren', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Human Physiology and Sports Physiotherapy Research Group, Vrije Universiteit Brussel, Brussels, Belgium. Electronic address: jo.verschueren@vub.be.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Tassignon', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Human Physiology and Sports Physiotherapy Research Group, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Evert', 'Initials': 'E', 'LastName': 'Verhagen', 'Affiliation': 'Amsterdam Collaboration on Health and Safety in Sports, Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Meeusen', 'Affiliation': ""Faculty of Physical Education and Physiotherapy, Human Physiology and Sports Physiotherapy Research Group, Vrije Universiteit Brussel, Brussels, Belgium; Strategic Research Program 'Exercise and the Brain in Health & Disease: the added value of Human-Centered Robotics', Vrije Universiteit Brussel, Brussels, Belgium.""}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.03.004']
457,33761517,"Optimal Dosing of Prophylactic Enoxaparin after Surgical Procedures: Results of the Double-Blind, Randomized, Controlled FIxed or Variable Enoxaparin (FIVE) Trial.","BACKGROUND


The accepted ""one-size-fits-all"" dose strategy for prophylactic enoxaparin may not optimize the medication's risks and benefits after surgical procedures. The authors hypothesized that weight-based administration might improve the pharmacokinetics of prophylactic enoxaparin when compared to fixed-dose administration.
METHODS


The FIxed or Variable Enoxaparin (FIVE) trial was a randomized, double-blind trial that compared the pharmacokinetic and clinical outcomes of patients assigned randomly to postoperative venous thromboembolism prophylaxis using enoxaparin 40 mg twice daily or enoxaparin 0.5 mg/kg twice daily. Patients were randomized after surgery and received the first enoxaparin dose at 8 hours after surgery. Primary hypotheses were (1) weight-based administration is noninferior to a fixed dose for avoiding underanticoagulation (anti-factor Xa <0.2 IU/ml) and (2) weight-based administration is superior to fixed-dose administration for avoiding overanticoagulation (anti-factor Xa >0.4 IU/ml). Secondary endpoints were 90-day venous thromboembolism and bleeding.
RESULTS


In total, 295 patients were randomized, with 151 assigned to fixed-dose and 144 to weight-based administration of enoxaparin. For avoidance of under anticoagulation, weight-based administration had a greater effectiveness (79.9 percent versus 76.6 percent); the 3.3 percent (95 percent CI, -7.5 to 12.5 percent) greater effectiveness achieved statistically significant noninferiority relative to the a priori specified -12 percent noninferiority margin (p = 0.004). For avoidance of overanticoagulation, weight-based enoxaparin administration was superior to fixed-dose administration (90.6 percent versus 82.2 percent); the 8.4 percent (95 percent CI, 0.1 to 16.6 percent) greater effectiveness showed significant safety superiority (p = 0.046). Ninety-day venous thromboembolism and major bleeding were not different between fixed-dose and weight-based cohorts (0.66 percent versus 0.69 percent, p = 0.98; 3.3 percent versus 4.2 percent, p = 0.72, respectively).
CONCLUSION


Weight-based administration showed superior pharmacokinetics for avoidance of underanticoagulation and overanticoagulation in postoperative patients receiving prophylactic enoxaparin.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, I.",2021,"Ninety-day venous thromboembolism and major bleeding were not different between fixed-dose and weight-based cohorts (0.66 percent versus 0.69 percent, p = 0.98; 3.3 percent versus 4.2 percent, p = 0.72, respectively).
","['295 patients', 'postoperative patients receiving prophylactic enoxaparin']","['enoxaparin', 'enoxaparin 40 mg twice daily or enoxaparin', 'Enoxaparin', 'Prophylactic Enoxaparin']","['90-day venous thromboembolism and bleeding', 'Ninety-day venous thromboembolism and major bleeding', 'safety superiority']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",295.0,0.536471,"Ninety-day venous thromboembolism and major bleeding were not different between fixed-dose and weight-based cohorts (0.66 percent versus 0.69 percent, p = 0.98; 3.3 percent versus 4.2 percent, p = 0.72, respectively).
","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Pannucci', 'Affiliation': 'From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.'}, {'ForeName': 'Kory I', 'Initials': 'KI', 'LastName': 'Fleming', 'Affiliation': 'From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Bertolaccini', 'Affiliation': 'From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.'}, {'ForeName': 'Jayant', 'Initials': 'J', 'LastName': 'Agarwal', 'Affiliation': 'From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.'}, {'ForeName': 'W Bradford', 'Initials': 'WB', 'LastName': 'Rockwell', 'Affiliation': 'From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.'}, {'ForeName': 'Shaun D', 'Initials': 'SD', 'LastName': 'Mendenhall', 'Affiliation': 'From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Kwok', 'Affiliation': 'From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.'}, {'ForeName': 'Isak', 'Initials': 'I', 'LastName': 'Goodwin', 'Affiliation': 'From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.'}, {'ForeName': 'Barbu', 'Initials': 'B', 'LastName': 'Gociman', 'Affiliation': 'From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Momeni', 'Affiliation': 'From the Divisions of Plastic Surgery and Health Services Research and the Department of Pharmacy Services, University of Utah; Plastic Surgery Northwest; and the Division of Plastic and Reconstructive Surgery, Stanford University.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007780']
458,33769134,Effect of continuous nursing on nursing quality and patient quality of life and satisfaction among children with pneumonia.,"OBJECTIVE


In this study, we aimed to explore the effect of continuous nursing care on children with pneumonia, including patient survival and quality of life.
METHODS


We included 90 children with pneumonia who were admitted to our hospital from May 2017 to June 20, 2017. We established two patient groups (45 children per group); the routine group received general care and the continuous group received continuous nursing care. We observed the correlation among nursing effectiveness, clinical symptom improvement, quality of life, satisfaction, and complications.
RESULTS


Our results showed that effectiveness in the continuous care group was 95.55%, significantly higher than that in the routine group (75.55%). Duration of hypothermia (1.75 ± 0.65 days), time to cough remission (4.24 ± 1.12 days), time to rale remission (4.15 ± 0.89 days), and time to remission of shortness of breath (2.65 ± 0.65 days) in the continuous group was shorter than those in the routine group. The incidence of total complications in the continuous group was 8.89%, which was significantly lower than that in the routine group (26.67%). The continuous care group showed greater improvement after intervention.
CONCLUSION


Continuous care in children with pneumonia can help to reduce illness severity, pain, heart and lung failure, and serve to avoid medical disputes.",2021,"Our results showed that effectiveness in the continuous care group was 95.55%, significantly higher than that in the routine group (75.55%).","['90 children with pneumonia who were admitted to our hospital from May 2017 to June 20, 2017', 'children with pneumonia']","['routine group received general care and the continuous group received continuous nursing care', 'continuous nursing care', 'continuous nursing']","['patient survival and quality of life', 'time to remission of shortness of breath', 'nursing effectiveness, clinical symptom improvement, quality of life, satisfaction, and complications', 'time to rale remission', 'Duration of hypothermia', 'incidence of total complications', 'illness severity, pain, heart and lung failure', 'time to cough remission', 'nursing quality and patient quality of life and satisfaction']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034642', 'cui_str': 'Respiratory crackles'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",90.0,0.0219857,"Our results showed that effectiveness in the continuous care group was 95.55%, significantly higher than that in the routine group (75.55%).","[{'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Pediatric Internal Medicine, Hebei Hengshui People's Hospital, Hebei Hengshui, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': ""Department of Rehabilitation Medicine, Hebei Hengshui People's Hospital, Hebei Hengshui, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Department of Pediatric Internal Medicine, Hebei Hengshui People's Hospital, Hebei Hengshui, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Su', 'Affiliation': ""Department of Pediatric Internal Medicine, Hebei Hengshui People's Hospital, Hebei Hengshui, China.""}]",The Journal of international medical research,['10.1177/0300060521993691']
459,33764948,"Reply: Knowledge and Skills Acquisition by Plastic Surgery Residents through Digital Simulation Training: A Prospective, Randomized, Blinded Trial.",,2021,,['Plastic Surgery Residents through Digital Simulation Training'],[],[],"[{'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]",[],[],,0.0231966,,"[{'ForeName': 'Rami S', 'Initials': 'RS', 'LastName': 'Kantar', 'Affiliation': 'Hansjörg Wyss Department of Plastic Surgery, New York University Langone Health, New York, N.Y.'}, {'ForeName': 'Roberto L', 'Initials': 'RL', 'LastName': 'Flores', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007744']
460,33764914,Reply: Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial.,,2021,,[],['DIEP Flap and Fluorescent Angiography'],[],[],"[{'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0086305', 'cui_str': 'Angiography, Fluorescence'}]",[],,0.360726,,"[{'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Varela', 'Affiliation': 'Fib/HULP IdiPaz, Plastic and Reconstructive Surgery, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Landin', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007734']
461,33769358,Ten-Year Clinical Outcomes of Acute Primary Angle Closure Randomized to Receive Early Phacoemulsification Versus Laser Peripheral Iridotomy.,"PURPOSE


To compare the 10-year clinical outcomes of eyes with acute primary angle closure (APAC) randomized to receive either early phacoemulsification or laser peripheral iridotomy (LPI).
METHODS


Sixty-two APAC patients, who underwent either early phacoemulsification (phaco group) or laser peripheral iridotomy (LPI group) in a previous randomized controlled trial, were invited for assessment 10 years after the interventions. The results of the 2 groups were compared.
RESULTS


Forty of 62 patients (64.5%; 19 in phaco group and 21 from LPI group) were examined. None of them underwent additional glaucoma procedure but 15 (71.4%) patients in the LPI group received lens extraction before this assessment. The mean follow-up duration was 10.7±0.7 years. The phaco group used less medication (0.16±0.37 vs. 0.76±1.09 bottle per eye, P=0.028), had less extensive anterior synechiae (120.0±116.12 vs. 244.3±139.8 degree, P=0.010), and greater mean Shaffer gonioscopy grading (1.79±0.84 vs. 1.40±0.87; P=0.021) than the LPI group. Five eyes had persistent intraocular pressure elevation of >21 mm Hg in 2 consecutive visits and 4 eyes had blindness (best-corrected visual acuity worse than 6/60 and/or central visual field of <20 degree) in the LPI group, compared with none in the phaco group (P=0.022 and 0.045, respectively). There was no significant difference in the mean intraocular pressure, best-corrected visual acuity, and the number of eyes with visual field progression.
CONCLUSION


At 10 years, APAC eyes that underwent early phacoemulsification required less medication, less peripheral anterior synechiae, lower incidence of intraocular pressure elevation and a lower incidence of blindness compared with APAC eyes that underwent initial LPI.",2021,"The phaco group used less medication (0.16±0.37 vs. 0.76±1.09 bottle per eye, P=0.028), had less extensive anterior synechiae (120.0±116.12 vs. 244.3±139.8 degree, P=0.010), and greater mean Shaffer gonioscopy grading (1.79±0.84 vs. 1.40±0.87; P=0.021) than the LPI group.","['eyes with acute primary angle closure (APAC', 'Sixty-two APAC patients, who underwent either']","['Early Phacoemulsification Versus Laser Peripheral Iridotomy', 'early phacoemulsification or laser peripheral iridotomy (LPI', 'early phacoemulsification (phaco group) or laser peripheral iridotomy (LPI group']","['extensive anterior synechiae', 'mean intraocular pressure, best-corrected visual acuity, and the number of eyes with visual field progression', 'peripheral anterior synechiae, lower incidence of intraocular pressure elevation', 'blindness (best-corrected visual acuity', 'persistent intraocular pressure elevation', 'mean Shaffer gonioscopy grading']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0395459', 'cui_str': 'Laser iridotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0152252', 'cui_str': 'Anterior synechiae'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0154934', 'cui_str': 'Peripheral anterior synechiae'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0018071', 'cui_str': 'Gonioscopy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",62.0,0.0894721,"The phaco group used less medication (0.16±0.37 vs. 0.76±1.09 bottle per eye, P=0.028), had less extensive anterior synechiae (120.0±116.12 vs. 244.3±139.8 degree, P=0.010), and greater mean Shaffer gonioscopy grading (1.79±0.84 vs. 1.40±0.87; P=0.021) than the LPI group.","[{'ForeName': 'Poemen P', 'Initials': 'PP', 'LastName': 'Chan', 'Affiliation': 'Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong.'}, {'ForeName': 'Fang Y', 'Initials': 'FY', 'LastName': 'Tang', 'Affiliation': 'Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong.'}, {'ForeName': 'Dexter Y', 'Initials': 'DY', 'LastName': 'Leung', 'Affiliation': 'Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Lam', 'Affiliation': 'Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong.'}, {'ForeName': 'Nafees', 'Initials': 'N', 'LastName': 'Baig', 'Affiliation': 'Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong.'}, {'ForeName': 'Clement C', 'Initials': 'CC', 'LastName': 'Tham', 'Affiliation': 'Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001799']
462,33769357,Impact of Trifocal and Trifocal Toric Intraocular Lenses on Spectral-domain OCT Retinal Measurements.,"PRECIS


Monofocal, trifocal, and trifocal toric intraocular lenses (IOLs) induce similar changes on overall retinal optical coherence tomography (OCT) measurements.
PURPOSE


The purpose of this study was to assess whether trifocal and trifocal toric IOLs affect the measurement of retinal parameters using spectral-domain OCT.
METHODS


This cross-over study included patients undergoing implantation of a trifocal IOL: AcrySof IQ PanOptix, a trifocal toric IOL: AcrySof IQ PanOptix Toric, and a monofocal IOL: AcrySof IQ. The monofocal group was considered as the control group. The refractive target was emmetropia in all cases. Mean average macular thickness, macular volume, and retinal nerve fiber layer (RNFL) thickness were measured with the Cirrus HD-OCT. All measurements were performed before and 3 months after the surgery.
RESULTS


The study analyzed 150 eyes of 150 patients (50 for each IOL group). Macular thickness and macular volume showed statistically significant differences before and after the surgery for the 3 groups (P<0.05 in all cases). RNFL thickness was found to be similar before and after the surgery in all groups (P>0.05 in all cases). Mean difference values (before and after the surgery) in the monocular, trifocal, and trifocal toric group for macular thickness, macular volume, and RNFL thickness were 4.9±7.8, 7.9±10.0, and 7.7±13.7 µm, respectively; 0.1±0.2, 0.2±0.4, and 0.2±0.3 mm3, respectively; and 0.8±5.5, 1.3±6.0, and 0.8±6.7 µm, respectively. Mean differences were found to be similar for the 3 groups.
CONCLUSION


The trifocal and the trifocal toric IOLs under study did not induce an additional impact on spectral-domain OCT retinal measurements compared with monofocal IOLs.",2021,RNFL thickness was found to be similar before and after the surgery in all groups (P>0.05 in all cases).,"['150 eyes of 150 patients (50 for each IOL group', 'patients undergoing implantation of a trifocal IOL']","['Trifocal and Trifocal Toric Intraocular Lenses', 'AcrySof IQ PanOptix, a trifocal toric IOL']","['macular thickness, macular volume, and RNFL thickness', 'Macular thickness and macular volume', 'PRECIS\n\n\nMonofocal, trifocal, and trifocal toric intraocular lenses (IOLs) induce similar changes on overall retinal optical coherence tomography (OCT) measurements', 'Mean average macular thickness, macular volume, and retinal nerve fiber layer (RNFL) thickness', 'Spectral-domain OCT Retinal Measurements', 'RNFL thickness']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}]","[{'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",150.0,0.0477234,RNFL thickness was found to be similar before and after the surgery in all groups (P>0.05 in all cases).,"[{'ForeName': 'Laureano A', 'Initials': 'LA', 'LastName': 'Rementería-Capelo', 'Affiliation': 'Clínica Rementería.'}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'García-Pérez', 'Affiliation': 'Clínica Rementería.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Contreras', 'Affiliation': 'Clínica Rementería.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Blázquez', 'Affiliation': 'Clínica Rementería.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ruiz-Alcocer', 'Affiliation': 'Optics and Optometry Department, Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001743']
463,33769299,"System Architecture for ""Support Through Mobile Messaging and Digital Health Technology for Diabetes"" (SuMMiT-D): Design and Performance in Pilot and Randomized Controlled Feasibility Studies.","BACKGROUND


Diabetes is a highly prevalent long-term condition with high morbidity and mortality rates. People with diabetes commonly worry about their diabetes medicines and do not always take them regularly as prescribed. This can lead to poor diabetes control. The Support Through Mobile Messaging and Digital Health Technology for Diabetes (SuMMiT-D) study aims to deliver brief messages as tailored interventions to support people with type 2 diabetes in better use of their diabetes medicines and to improve treatment adherence and health outcomes.
OBJECTIVE


This paper describes the overall architecture of a tailored intervention delivery system used in the pilot and randomized controlled feasibility studies of SuMMiT-D and reports its performance.
METHODS


The SuMMiT-D system includes several platforms and resources to recruit participants and deliver messages as tailored interventions. Its core component is called the clinical system and is responsible for interacting with the participants by receiving and sending SMS text messages from and to them. The personalization and tailoring of brief messages for each participant is based on a list of built-in commands that they can use.
RESULTS


For the pilot study, a total of 48 participants were recruited; they had a median age of 64 years (first quartile, third quartile [Q 1 , Q 3 : 54.5, 69]). For the feasibility study, a total of 209 participants were recruited and randomly assigned to either the control or intervention group; they had a median age of 65 years (Q 1 , Q 3 : 56, 71), with 41.1% (86/209) being female. The participants used the SuMMiT-D system for up to 6 months (26 weeks) and had a wide range of different interactions with the SuMMiT-D system while tailored interventions were being delivered. For both studies, we had low withdrawal rates: only 4.2% and 5.3% for the pilot and feasibility studies, respectively.
CONCLUSIONS


A system was developed to successfully deliver brief messages as tailored health interventions to more than 250 people with type 2 diabetes via SMS text messages. On the basis of the low withdrawal rates and positive feedback received, it can be inferred that the SuMMiT-D system is robust, user-friendly, useful, and positive for most participants. From the two studies, we found that online recruitment was more efficient than recruitment via postal mail; a regular SMS text reminder (eg, every 4 weeks) can potentially increase the participants' interactions with the system.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN13404264; http://www.isrctn.com/ISRCTN13404264.",2021,Its core component is called the clinical system and is responsible for interacting with the participants by receiving and sending SMS text messages from and to them.,"['People with diabetes commonly worry about their diabetes medicines', '250 people with type 2 diabetes via SMS text messages', '209 participants', '48 participants were recruited; they had a median age of 64 years (first quartile, third quartile ']",['SuMMiT-D'],['low withdrawal rates'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0205437', 'cui_str': 'Third'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0752189', 'cui_str': 'Health Care Technology'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",48.0,0.0994746,Its core component is called the clinical system and is responsible for interacting with the participants by receiving and sending SMS text messages from and to them.,"[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Velardo', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Riga', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Judge', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Tarassenko', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Farmer', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",JMIR formative research,['10.2196/18460']
464,33765513,Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D).,"AIM


To present the pre-specified analyses of >5-years follow-up of the Phase III ALTTO trial.
PATIENTS AND METHODS


8381 patients with stage I-III HER2 positive breast cancer randomised to chemotherapy plus 1-year of trastuzumab (T), oral lapatinib (L; no longer evaluated), trastuzumab followed by lapatinib (T→L), and lapatinib + trastuzumab (L+T). The primary endpoint was disease-free survival (DFS). A secondary analysis examined DFS treatment effects by hormone receptor status, nodal status and chemotherapy timing; time to recurrence; overall survival (OS) and safety (overall and cardiac).
RESULTS


At a median follow-up of 6.9 years, 705 DFS events for L+T versus T were observed. Hazard Ratio (HR) for DFS was 0.86 (95% CI, 0.74-1.00) for L+T versus T and 0.93 (95% CI, 0.81-1.08) for T→L versus T. The 6-year DFS were 85%, 84%, and 82% for L+T, T→L, and T, respectively. HR for OS was 0.86 (95% CI, 0.70-1.06) for L+T versus T and 0.88 (95% CI, 0.71-1.08) for T→L versus T. The 6-year OS were 93%, 92%, and 91% for L+T, T→L, and T, respectively. Subset analyses showed a numerically better HR for DFS in favour of L+T versus T for the hormone-receptor-negative [HR 0.80 (95% CI, 0.64-1.00; 6-yr DFS% = 84% versus 80%)] and the sequential chemotherapy [HR 0.83 (95% CI, 0.69-1.00; 6-yr DFS% = 83% versus79%)] subgroups.
CONCLUSION


T+L did not significantly improve DFS and OS over T alone, both with chemotherapy, and, therefore, cannot be recommended for adjuvant treatment of early-stage HER2-positive breast cancer.
TRIAL REGISTRATION


clinicaltrials.gov Identifier NCT00490139.",2021,"Subset analyses showed a numerically better HR for DFS in favour of L+T versus T for the hormone-receptor-negative [HR 0.80 (95% CI, 0.64-1.00;",['8381 patients with stage I-III HER2 positive breast cancer randomised to'],"['chemotherapy plus 1-year of\xa0trastuzumab (T), oral lapatinib (L; no longer evaluated), trastuzumab followed by lapatinib (T→L), and lapatinib\xa0+\xa0trastuzumab (L+T']","['6-year DFS', 'survival (OS) and safety (overall and cardiac', '6-year OS', 'Hazard Ratio (HR) for DFS', 'HR for OS', 'DFS and OS', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",8381.0,0.386257,"Subset analyses showed a numerically better HR for DFS in favour of L+T versus T for the hormone-receptor-negative [HR 0.80 (95% CI, 0.64-1.00;","[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Jacoby Center for Breast Health, Mayo Clinic, Jacksonville, FL, USA. Electronic address: morenoaspitia.alvaro@mayo.edu.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Holmes', 'Affiliation': 'Dundee Epidemiology and Statistics Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Department of Gynecology and Obstetrics, Sana Klinikum Offenbach GmbH, Offenbach am Main, Germany.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': ""Institute Jules Bordet and l' Université Libre de Bruxelles (U.L.B), Brussels, Belgium.""}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Boyle', 'Affiliation': 'Patricia Ritchie Centre for Cancer Care and Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hillman', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Korde', 'Affiliation': 'Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Fumagalli', 'Affiliation': 'Breast International Group, Brussels, Belgium.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Izquierdo', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'McCullough', 'Affiliation': 'Division of Anatomic Pathology, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Johns Hopkins Kimmel Cancer Center, Baltimore, MD, USA.'}, {'ForeName': 'Kathleen I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'Canadian Cancer Trials Group (CCTG), Kingston, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Guillaume', 'Affiliation': ""Institute Jules Bordet and l' Université Libre de Bruxelles (U.L.B), Brussels, Belgium.""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ewer', 'Affiliation': 'MD Anderson Cancer Center, University of Texas, Houston, TX, USA.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': ""Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Sung Hoon', 'Initials': 'SH', 'LastName': 'Sim', 'Affiliation': 'Center for Breast Cancer, National Cancer Centre, Gyeonggi-do, South Korea.'}, {'ForeName': 'Zeba', 'Initials': 'Z', 'LastName': 'Aziz', 'Affiliation': 'Allama Iqbal Medical College, Lahore, Pakistan.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Demetriou', 'Affiliation': 'University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ajay O', 'Initials': 'AO', 'LastName': 'Mehta', 'Affiliation': 'Central India Cancer Research Institute, Nagpur, Maharashtra, India.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Andersson', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Lang', 'Affiliation': 'National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Ian E', 'Initials': 'IE', 'LastName': 'Smith', 'Affiliation': 'The Royal Marsden Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Latin American Cooperative Oncology Group (LACOG), Oncoclínicas, Porto Alegre, Brazil.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'Oncology Research and Development, Astra-Zeneca, Cambridge, UK.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Harvard TH Chan School of Public Health and Frontier Science Technology Research Foundation, Boston, MA, USA.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart-Gebhart', 'Affiliation': ""Institute Jules Bordet and l' Université Libre de Bruxelles (U.L.B), Brussels, Belgium.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.01.053']
465,33765458,A Modified Pressure Dressing to Avoid Severe Bleeding After Circumcision With a Disposable Circumcision Suture Device and a Discussion on the Mechanism of Bleeding With the Disposable Circumcision Suture Device.,"INTRODUCTION


A novel type of a disposable circumcision suture device (DCSD) has been proved to be effective and safe; however, a few cases of severe bleeding took place after circumcisions.
AIM


To evaluate the effectiveness of a modified double-layer pressure dressing to avoid severe bleeding after circumcision with the DCSD, in our department in a prospective randomized controlled study, and discuss the mechanism of bleeding with DCSD.
METHODS


Patients with redundant foreskin or phimosis were included between September 2018 and November 2019 and divided into 2 groups: In group A, the conventional pressure dressing was performed; in group B, an modified double-layer pressure dressing was performed.
MAIN OUTCOME MEASURE


The main outcomes and complications (surgical time, incidence of glans ischemia, severe bleeding rate, infection rate, pain level, total cost, and overall satisfaction) were collected and analyzed.
RESULTS


A total of 624 patients were recruited for this study. There was no difference in the average age and body mass index between 2 groups. No patient suffered obvious glans ischemia. In group B, lower pain level, lower incidences of severe bleeding, and better satisfaction were recorded.
CONCLUSION


The mechanism of bleeding with the DCSD was discussed in this study, and the modified pressure dressing was proved effective, safe, and easy to perform. W Jiang, J-li Fu, W-l Guo, et al. A Modified Pressure Dressing to Avoid Severe Bleeding After Circumcision With a Disposable Circumcision Suture Device and a Discussion on the Mechanism of Bleeding With the Disposable Circumcision Suture Device. Sex Med 2020;XX:XXX-XXX.",2021,"In group B, lower pain level, lower incidences of severe bleeding, and better satisfaction were recorded.
","['Patients with redundant foreskin or phimosis were included between September 2018 and November 2019', 'A total of 624 patients were recruited for this study']","['Modified Pressure Dressing', 'modified double-layer pressure dressing was performed', 'conventional pressure dressing', 'disposable circumcision suture device (DCSD', 'modified double-layer pressure dressing']","['lower pain level, lower incidences of severe bleeding, and better satisfaction', 'complications (surgical time, incidence of glans ischemia, severe bleeding rate, infection rate, pain level, total cost, and overall satisfaction', 'average age and body mass index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0345325', 'cui_str': 'Redundant prepuce'}, {'cui': 'C0031538', 'cui_str': 'Phimosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1289828', 'cui_str': 'Pressure dressing'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",624.0,0.0507902,"In group B, lower pain level, lower incidences of severe bleeding, and better satisfaction were recorded.
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': ""Department of Urology, Dongying People's Hospital, Dongying, China. Electronic address: jwmnwk@163.com.""}, {'ForeName': 'Jia-Li', 'Initials': 'JL', 'LastName': 'Fu', 'Affiliation': ""Department of Urology, Dongying People's Hospital, Dongying, China.""}, {'ForeName': 'Wen-Liang', 'Initials': 'WL', 'LastName': 'Guo', 'Affiliation': 'Surgery Department, Health Center of Qingzhou Economic Development Zone, Qingzhou, China.'}, {'ForeName': 'Zai-Chun', 'Initials': 'ZC', 'LastName': 'Yan', 'Affiliation': ""Department of Urology, Dongying People's Hospital, Dongying, China.""}, {'ForeName': 'Ru-Qiang', 'Initials': 'RQ', 'LastName': 'Zheng', 'Affiliation': ""Department of Urology, Dongying People's Hospital, Dongying, China.""}, {'ForeName': 'Ji-Ru', 'Initials': 'JR', 'LastName': 'Lu', 'Affiliation': ""Department of Urology, Dongying People's Hospital, Dongying, China.""}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Lai', 'Affiliation': ""Department of Urology, Dongying People's Hospital, Dongying, China.""}]",Sexual medicine,['10.1016/j.esxm.2020.100288']
466,33769510,Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial.,"Importance


Patients with shorter ischemic times have a greater viable myocardium and may derive greater benefit from thrombus aspiration.
Objective


To study the association of thrombus aspiration with outcomes among patients presenting with ST-segment elevation myocardial infarction (STEMI) based on time.
Design, Setting, and Participants


The TOTAL (Thrombectomy With PCI vs PCI Alone in Patients with STEMI) trial was an international randomized clinical trial of 10 732 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset. Patients were recruited between August 5, 2010, and July 25, 2014, and were followed up for 1 year. Data analysis was performed from February 22, 2019, to January 5, 2021.
Interventions


Thrombus aspiration vs PCI alone.
Main Outcomes and Measures


Post hoc subgroup analyses were performed for total ischemic time and first medical contact (FMC)-to-device time for the primary outcomes (cardiovascular [CV] mortality, myocardial Infarction [MI], cardiogenic shock, and New York Heart Association class IV heart failure) and angiographically determined distal embolization. In addition, a multivariable analysis was performed to assess the association of total ischemic time and FMC-to-device time with CV mortality at 1 year.
Results


The study randomized 10 732 patients, and 9986 underwent primary PCI and had time data available (7737 men [77.5%]; mean [SD] age, 61.0 [12.0] years). For the randomized comparison of thrombus aspiration, there was a reduction in angiographic distal embolization with thrombus aspiration that was more pronounced in patients with short ischemic times (<2 hours: odds ratio [OR], 0.23 [95% CI, 0.09-0.62]; 2-6 hours: OR, 0.54 [95% CI, 0.39-0.73]; >6 hours: OR, 0.70 [95% CI, 0.33-1.50]; P = .12 for interaction). However, for the primary composite outcome, there was no benefit based on (1) total ischemic time (<2 hours: hazard ratio [HR], 0.77 [95% CI, 0.46-1.28]; 2-6 hours: HR, 1.03 [95% CI, 0.85-1.25]; >6 hours: HR, 0.87 [95% CI, 0.60-1.27]; P = .46 for interaction) or (2) FMC-to-device time (<60 minutes: HR, 1.14 [95% CI, 0.66-1.95]; 60-90 minutes: HR, 0.94 [95% CI, 0.67-1.32]; >90-120 minutes: HR, 1.19 [95% CI, 0.85-1.67]; >120 minutes: HR, 0.89 [95% CI, 0.70-1.14]; P = .54 for interaction). In a multivariable analysis, both total ischemic time (>2 hours: HR, 1.26 [95% CI, 1.00-1.58) and FMC-to-device time (>120 minutes: HR, 1.45 [95% CI, 1.18-1.79]) were independently associated with CV mortality.
Conclusions and Relevance


This analysis suggests that thrombus aspiration does not appear to be associated with an improvement in clinical outcomes regardless of ischemic time. In the current STEMI era, both total ischemic time and FMC-to-device times continue to be important factors associated with mortality.
Trial Registration


ClinicalTrials.gov Identifier: NCT01149044.",2021,"In a multivariable analysis, both total ischemic time (>2 hours: HR, 1.26 [95% CI, 1.00-1.58) and FMC-to-device time (>120 minutes: HR, 1.45 [95% CI, 1.18-1.79]) were independently associated with CV mortality.
","['patients presenting with ST-segment elevation myocardial infarction (STEMI) based on time', 'Patients with STEMI', 'Patients were recruited between August 5, 2010, and July 25, 2014, and were followed up for 1 year', '10\u202f732 patients, and 9986 underwent primary PCI and had time data available (7737 men [77.5%]; mean [SD] age, 61.0 [12.0] years', 'Patients With ST-Segment Elevation Myocardial Infarction', '732 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset']","['PCI vs PCI Alone', 'Interventions\n\n\nThrombus aspiration vs PCI alone']","['total ischemic time and first medical contact (FMC)-to-device time for the primary outcomes (cardiovascular [CV] mortality, myocardial Infarction [MI], cardiogenic shock, and New York Heart Association class IV heart failure) and angiographically determined distal embolization', 'CV mortality', 'angiographic distal embolization', 'total ischemic time', 'total ischemic time and FMC-to-device time with CV mortality', 'FMC-to-device time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332311', 'cui_str': 'With time'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}]",10732.0,0.318817,"In a multivariable analysis, both total ischemic time (>2 hours: HR, 1.26 [95% CI, 1.00-1.58) and FMC-to-device time (>120 minutes: HR, 1.45 [95% CI, 1.18-1.79]) were independently associated with CV mortality.
","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Moxham', 'Affiliation': 'McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Džavík', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cairns', 'Affiliation': 'Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Madhu K', 'Initials': 'MK', 'LastName': 'Natarajan', 'Affiliation': 'McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Bainey', 'Affiliation': 'Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Akl', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Tsang', 'Affiliation': 'McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Lavi', 'Affiliation': 'London Health Sciences Centre, Western University, London, Ontario, Canada.'}, {'ForeName': 'Warren J', 'Initials': 'WJ', 'LastName': 'Cantor', 'Affiliation': 'Southlake Regional Health Center, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Madan', 'Affiliation': 'Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yan Yun', 'Initials': 'YY', 'LastName': 'Liu', 'Affiliation': 'McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sanjit S', 'Initials': 'SS', 'LastName': 'Jolly', 'Affiliation': 'McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.3505']
467,33769402,Functional Training in Portuguese Firefighters: Impact of Functional Training With or Without Personal Protective Equipment.,"OBJECTIVE


To investigate the influence of specific functional training (FT) with and without personal protective equipment (PPE) and self-contained breathing apparatus (SCBA), on firefighters (FFs) physical fitness condition.
METHODS


Sixty FFs run a 24 weeks intervention, divided into three groups (EG1 training with PPE+SCBA; EG2 training with regular equipment, and Control Group). FFs anthropometric and physical fitness (PF) were assessed pre- and post-intervention.
RESULTS


Significant differences were found between the training groups and control group. Both training groups interventions were effective in improving PF and lean mass. However, EG1 presented a higher percentage of improvement.
CONCLUSION


This 24-week FT intervention improved participants' muscle strength, endurance, and power, and it led to increases in lean body mass. Regularly FT with PPE+SCBA helps FFs maintain a healthy general physical condition and develop optimum fitness levels related to firefighting specific tasks, specially torso muscular endurance.",2021,"RESULTS


Significant differences were found between the training groups and control group.","['Portuguese Firefighters', 'Sixty FFs run a 24 weeks intervention, divided into three groups']","['FT intervention', 'specific functional training (FT) with and without personal protective equipment (PPE) and self-contained breathing apparatus (SCBA', 'Functional Training With or Without Personal Protective Equipment', 'Functional Training', 'EG1 training with PPE+SCBA; EG2 training with regular equipment, and Control Group']","['FFs anthropometric and physical fitness (PF', 'lean body mass', ""participants' muscle strength, endurance, and power"", 'PF and lean mass']","[{'cui': 'C0032730', 'cui_str': 'Portuguese'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",60.0,0.00412768,"RESULTS


Significant differences were found between the training groups and control group.","[{'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Lajoso-Silva', 'Affiliation': 'Polytechnic Institute of Viana do Castelo, Higher School of Sports and Leisure, Melgaço (Ms Lajoso-Silva, Dr Bezerra, Dr Silva); Faculty of Educational Sciences & Sports Sciences, University of Vigo, Pontevedra, Spain (Ms Lajoso-Silva, Dr Cancela Carral); Research Center in Sports Sciences Health Sciences and Human Development, CIDESD, Vila Real (Dr Bezerra, Dr Silva), Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Bezerra', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'José Maria Cancela', 'Initials': 'JMC', 'LastName': 'Carral', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000002141']
468,33771233,Contamination within trials of community-based public health interventions: lessons from the HENRY feasibility study.,"INTRODUCTION


Contamination occurs when participants allocated to trial control arms receive elements of the active intervention. Randomisation at cluster level, rather than individual level, may reduce or eliminate contamination, avoiding the dilution of intervention effectiveness that it may cause. However, cluster randomisation can result in selection bias and may not be feasible to deliver. We explored the extent of contamination in a qualitative study nested within a feasibility study of HENRY (Health, Exercise and Nutrition for the Really Young); a UK community-based child obesity prevention programme. We aimed to determine the nature and impact of contamination to inform a larger planned trial and other trials in community based public health settings.
METHOD


We invited participants to take part in the nested qualitative study who were already involved in the HENRY feasibility study. Semi-structured interviews/focus groups were conducted with children's centre managers (n=7), children's centre staff (n=15), and parents (n=29). Data were transcribed and analysed using an integrative approach. First, deductively organised using a framework guided by the topic guide and then organised using inductive thematic analysis.
RESULTS


Potential for contamination between treatment arms was recognised by all stakeholder groups. Staff within the intervention centres presented the greatest risk of contamination, predominantly because they were often asked to work in other children centre's (including control group centres). 'Sharing of best practice' by staff was reported to be a common and desirable phenomenon within community based settings. Parental sharing of HENRY messages was reported inconsistently; though some parents indicated a high degree of knowledge transfer within their immediate circles.
CONCLUSIONS


The extent of contamination identified has influenced the design of a future effectiveness trial of HENRY which will be clustered at the centre level (with geographically distinct clusters). The common practice of knowledge sharing amongst community teams means that this clustering approach is also likely to be most suitable for other trials based within these settings. We provide recommendations (e.g. cluster randomisation, training intervention facilitators on implications of contamination) to help reduce the impact of contamination in public health intervention trials with or without clustering, whilst enabling transfer of knowledge where appropriate.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017.",2021,"Randomisation at cluster level, rather than individual level, may reduce or eliminate contamination, avoiding the dilution of intervention effectiveness that it may cause.","['invited participants to take part in the nested qualitative study who were already involved in the HENRY feasibility study', ""children's centre managers (n=7), children's centre staff (n=15), and parents (n=29""]","['HENRY (Health, Exercise and Nutrition']",[],"[{'cui': 'C0949415', 'cui_str': 'Qualitative Research'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0582517', 'cui_str': 'henry'}, {'cui': 'C0015730', 'cui_str': 'Feasibility Studies'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0582517', 'cui_str': 'henry'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]",[],,0.0992464,"Randomisation at cluster level, rather than individual level, may reduce or eliminate contamination, avoiding the dilution of intervention effectiveness that it may cause.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Stamp', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK. e.stamp@lboro.ac.uk.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Schofield', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Victoria Laurina', 'Initials': 'VL', 'LastName': 'Roberts', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Burton', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Collinson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'Department of Nutrition, Gillings School of Public Health, University of North Carolina, Chapel Hill, 27599, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Rutter', 'Affiliation': 'Department of Social & Policy Sciences, University of Bath, Bath, BA2 7AY, Somerset, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bryant', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-021-00805-3']
469,33771205,"Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer's disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial.","BACKGROUND


Our previous studies showed that GV1001 has various protective effects against β-amyloid and other stressors. Based on these findings, we hypothesized that GV1001 might have beneficial effects in patients with Alzheimer's disease (AD).
METHODS


A phase 2, double-blind, parallel-group, placebo-controlled, 6-month randomized clinical trial was performed to evaluate the safety and efficacy of subcutaneously administered GV1001. Between September 2017 and September 2019, 13 centers in South Korea recruited participants. A total of 106 patients were screened, and 96 patients with moderate-to-severe AD were randomized 1:1:1 to the placebo (group 1, n = 31), GV1001 0.56 mg (group 2, n = 33), and 1.12 mg (group 3, n = 32) groups. GV1001 was administered every week for 4 weeks (4 times), followed by every 2 weeks until week 24 (10 times). The primary endpoint was the change in the Severe Impairment Battery (SIB) score from baseline to week 24. The key secondary efficacy endpoints were the change in the Clinical Dementia Rating Sum of Box (CDR-SOB), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI), Mini-Mental State Examination, and Global Deterioration Scale scores. The safety endpoints were also assessed based on adverse events, laboratory test results, vital signs, and other observations related to safety.
RESULTS


Group 3 showed less decrease in the SIB score at 12 and 24 weeks compared with group 1 (P < 0.05). These were not significantly observed in group 2. Among the secondary endpoints, only the NPI score showed significantly better improvement in group 2 than in group 3 at week 12; however, there were no other significant differences between the groups. Although the ADCS-ADL and CDR-SOB scores showed a pattern similar to SIB scores, a statistically significant result was not found. Adverse events were similar across all three groups.
CONCLUSIONS


The results indicate that GV1001 1.12 mg met the primary endpoint of a statistically significant difference. GV1001 was well tolerated without safety concerns. This study warrants a larger clinical trial.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03184467 . Registered on June 12, 2017.",2021,"RESULTS


Group 3 showed less decrease in the SIB score at 12 and 24 weeks compared with group 1 (P < 0.05).","['106 patients were screened, and 96 patients with moderate-to-severe AD', 'Between September 2017 and September 2019, 13 centers in South Korea recruited participants', ""patients with Alzheimer's disease (AD"", ""patients with moderate-to-severe Alzheimer's disease already receiving""]","['donepezil', 'subcutaneously administered GV1001', 'placebo', 'GV1001']","['NPI score', 'safety and efficacy', ""Clinical Dementia Rating Sum of Box (CDR-SOB), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI), Mini-Mental State Examination, and Global Deterioration Scale scores"", 'SIB score', 'Adverse events', 'change in the Severe Impairment Battery (SIB) score', 'ADCS-ADL and CDR-SOB scores', 'adverse events, laboratory test results, vital signs, and other observations related to safety', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C4537573', 'cui_str': 'Global Deterioration Scale'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",106.0,0.677917,"RESULTS


Group 3 showed less decrease in the SIB score at 12 and 24 weeks compared with group 1 (P < 0.05).","[{'ForeName': 'Seong-Ho', 'Initials': 'SH', 'LastName': 'Koh', 'Affiliation': 'Department of Neurology, Hanyang University Guri Hospital, Hanyang University College of Medicine, 153, Gyeongchun-ro, Guri, 11923, South Korea. ksh213@hanyang.ac.kr.'}, {'ForeName': 'Hyuk Sung', 'Initials': 'HS', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Hanyang University Guri Hospital, Hanyang University College of Medicine, 153, Gyeongchun-ro, Guri, 11923, South Korea.'}, {'ForeName': 'Seong Hye', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Neurology, Inha University School of Medicine, Incheon, 22332, South Korea.'}, {'ForeName': 'Jee Hyang', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Neurology, Ewha Womans University School of Medicine, Seoul, 07985, South Korea.'}, {'ForeName': 'Hae Ri', 'Initials': 'HR', 'LastName': 'Na', 'Affiliation': 'Department of Neurology, Bobath Memorial Hospital, Seongnam, 13552, South Korea.'}, {'ForeName': 'Chan Nyoung', 'Initials': 'CN', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Korea University Anam Hospital, Seoul, 02856, South Korea.'}, {'ForeName': 'YoungSoon', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Veterans Health Service Medical Center, Seoul, 05368, South Korea.'}, {'ForeName': 'Ae Young', 'Initials': 'AY', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Chungnam National University Hospital, Daejeon, 35015, South Korea.'}, {'ForeName': 'Jae-Hong', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Asan Medical Center, Seoul, 05505, South Korea.'}, {'ForeName': 'Kyung Won', 'Initials': 'KW', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Dong-A University Hospital, Busan, 49201, South Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Han', 'Affiliation': 'Department of Neurology, Myongji Hospital, Hanyang University College of Medicine, Goyang, 10475, South Korea.'}, {'ForeName': 'Byeong C', 'Initials': 'BC', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Chonnam National University Hospital, Gwangju, 61469, South Korea.'}, {'ForeName': 'Jin Se', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Inje University Haeundae Paik Hospital, Buasn, 48108, South Korea.'}, {'ForeName': 'Jee-Young', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Seoul National University Boramae Medical Center, Seoul, 07061, South Korea.'}, {'ForeName': 'Sangjae', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Teloid Inc., 920 Westholme Ave, Los Angeles, CA, 90024, USA.'}, {'ForeName': 'Kyu-Yong', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Hanyang University Guri Hospital, Hanyang University College of Medicine, 153, Gyeongchun-ro, Guri, 11923, South Korea.'}]",Alzheimer's research & therapy,['10.1186/s13195-021-00803-w']
470,33771192,Is there a renoprotective value to leukodepletion during heart valve surgery? A randomized controlled trial (ROLO).,"BACKGROUND


Acute Kidney Injury (AKI) adversely affects outcomes after cardiac surgery. A major mediator of AKI is the activation of leukocytes through exposure to the cardiopulmonary bypass circuit. We evaluate the use of leukodepletion filters throughout bypass to protect against post-operative AKI by removing activated leukocytes during cardiac surgery.
METHODS


This is a single-centre, double-blind, randomized controlled trial comparing the use of leukodepletion versus a standard arterial filter throughout bypass. Elective adult patients undergoing heart valve surgery with or without concomitant procedures were investigated. The primary clinical outcome measured was the development of AKI according to the KDIGO criteria. Secondary measures included biomarkers of renal tubular damage (urinary Retinol Binding Protein and Kidney Injury Molecule-1), glomerular kidney injury (urinary Micro Albumin and serum Cystatin C) and urinary Neutrophil Gelatinase Associated Lipocalin, as well as the length of hospital stay and quality of life measures through EQ-5D-5L questionnaires.
RESULTS


The ROLO trial randomized 64 participants with a rate of recruitment higher than anticipated (57% achieved, 40% anticipated). The incidence of AKI was greater in the leukodepletion filter group (44% versus 23%, risk difference 21, 95% CI - 2 to 44%). This clinical finding was supported by biomarker levels especially by a tendency toward glomerular insult at 48 h, demonstrated by a raised serum Cystatin C (mean difference 0.11, 95% CI 0.00 to 0.23, p = 0.068) in the leukodepleted group. There was however no clear association between the incidence or severity of AKI and length of hospital stay. On average, health related quality of life returned to pre-operative levels in both groups within 3 months of surgery.
CONCLUSIONS


Leukocyte depletion during cardiopulmonary bypass does not significantly reduce the incidence of AKI after valvular heart surgery. Other methods to ameliorate renal dysfunction after cardiac surgery need to be investigated.
TRIAL REGISTRATION


The trial was registered by the International Standard Randomized Controlled Trial Number Registry ISRCTN42121335 . Registered on the 18 February 2014. The trial was run by the Bristol Clinical Trials and Evaluation Unit. This trial was financially supported by the National Institute of Health Research (Research for Patient Benefit), award ID: PB-PG-0711-25,090.",2021,"The incidence of AKI was greater in the leukodepletion filter group (44% versus 23%, risk difference 21, 95% CI - 2 to 44%).","['64 participants with a rate of recruitment higher than anticipated (57% achieved, 40% anticipated', 'Elective adult patients undergoing heart valve surgery with or without concomitant procedures']","['leukodepletion filters', 'leukodepletion']","['average, health related quality of life', 'incidence or severity of AKI and length of hospital stay', 'biomarkers of renal tubular damage (urinary Retinol Binding Protein and Kidney Injury Molecule-1), glomerular kidney injury (urinary Micro Albumin and serum Cystatin C) and urinary Neutrophil Gelatinase Associated Lipocalin, as well as the length of hospital stay and quality of life measures through EQ-5D-5L questionnaires', 'development of AKI according to the KDIGO criteria', 'incidence of AKI', 'raised serum Cystatin C', 'renal dysfunction']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0180860', 'cui_str': 'Filter'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0035342', 'cui_str': 'Retinol binding protein'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0022663', 'cui_str': 'Glomerulus structure'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]",64.0,0.601715,"The incidence of AKI was greater in the leukodepletion filter group (44% versus 23%, risk difference 21, 95% CI - 2 to 44%).","[{'ForeName': 'Espeed', 'Initials': 'E', 'LastName': 'Khoshbin', 'Affiliation': 'Department of Cardiothoracic Surgery, Freeman Hospital, High Heaton, Newcastle upon Tyne, NE7 7DN, UK. Espeed.Khoshbin1@nhs.net.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Spencer', 'Affiliation': 'School of Health and Medicine, Lancaster University, Bailing, Upper Market Street, Lancaster, Lancashire, LA1 4YW, UK.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Solomon', 'Affiliation': 'Renal Unit, Lancashire Teaching Hospitals NHS Foundation Trust, Sharoe Green Lane, Fulwood, Preston, Lancashire, PR2 9HT, UK.'}, {'ForeName': 'Augustine', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiothoracic Surgery, Blackpool Victoria Hospital, Blackpool, FY3 8NR, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Department of Cardiothoracic Surgery, Freeman Hospital, High Heaton, Newcastle upon Tyne, NE7 7DN, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Stokes', 'Affiliation': 'Department of Public Health, University of Oxford, Rosemary Rue Building, Old Road Campus, Headington, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wordsworth', 'Affiliation': 'Department of Public Health, University of Oxford, Rosemary Rue Building, Old Road Campus, Headington, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Dabner', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, BS2 8HW, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Edwards', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, BS2 8HW, UK.'}, {'ForeName': 'Barnaby', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, BS2 8HW, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, BS2 8HW, UK.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-021-01402-4']
471,33771149,Dapagliflozin effect on endothelial dysfunction in diabetic patients with atherosclerotic disease: a randomized active-controlled trial.,"BACKGROUND


The glucose-lowering independent effect of sodium glucose cotransporter-2 inhibitors (SGLT2i) on arterial wall function has not yet been clarified. This study aims to assess whether SGLT2i treatment can attenuate endothelial dysfunction related to type 2 diabetes mellitus (T2D) compared with glucose-lowering equivalent therapy.
METHODS


In a prospective, open-label, single-center, randomized clinical trial, 98 patients with T2DM and carotid intima-media thickness above the 75th percentile were randomized 1:1 to 12 weeks of therapy with dapagliflozin or glibenclamide in addition to metformin in glucose-lowering equivalent regimens. The coprimary endpoints were 1-min flow-mediated dilation (FMD) at rest and 1-min FMD after 15 min of ischemia followed by 15 min of reperfusion time (I/R).
RESULTS


Ninety-seven patients (61% males, 57 ± 7 years) completed the study. The median HbA1c decreased by - 0.8 (0.7)% and -0.7 (0.95)% following dapagliflozin and glibenclamide, respectively. The first coprimary endpoint, i.e., rest FMD changed by + 3.3(8.2)% and - 1.2(7.5)% for the dapagliflozin and glibenclamide arms, respectively (p = 0.0001). Differences between study arms in the second coprimary endpoint were not significant. Plasma nitrite 1 min after rest FMD was higher for dapagliflozin [308(220) nmol/L] than for glibenclamide (258[110] nmol/L; p = 0.028). The resistive indices at 1 min [0.90 (0.11) vs. 0.93 (0.07); p = 0.03] and 5 min [0.93 (0.07) vs. 0.95 (0.05); p = 0.02] were higher for the glibenclamide group than for the dapagliflozin group. Plasma biomarkers for inflammation and oxidative stress did not differ between the treatments.
CONCLUSIONS


Dapagliflozin improved micro- and macrovascular endothelial function compared to glibenclamide, regardless of glycemic control in patients with T2DM and subclinical carotid atherosclerotic disease.",2021,"Plasma biomarkers for inflammation and oxidative stress did not differ between the treatments.
","['Ninety-seven patients (61% males, 57\u2009±\u20097\xa0years) completed the study', 'diabetic patients with atherosclerotic disease', '98 patients with T2DM and carotid intima-media thickness above the 75th percentile', 'patients with T2DM and subclinical carotid atherosclerotic disease']","['dapagliflozin or glibenclamide', 'SGLT2i treatment', 'glibenclamide', 'sodium glucose cotransporter-2 inhibitors (SGLT2i', 'glucose-lowering equivalent therapy', 'dapagliflozin', 'Dapagliflozin', 'metformin in glucose-lowering equivalent regimens']","['1-min flow-mediated dilation (FMD) at rest and 1-min FMD after 15\xa0min of ischemia followed by 15\xa0min of reperfusion time (I/R', 'resistive indices', 'Plasma biomarkers for inflammation and oxidative stress', 'rest FMD', 'micro- and macrovascular endothelial function', 'median HbA1c', 'Plasma nitrite 1\xa0min after rest FMD', 'endothelial dysfunction']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}]",98.0,0.0755486,"Plasma biomarkers for inflammation and oxidative stress did not differ between the treatments.
","[{'ForeName': 'Andrei C', 'Initials': 'AC', 'LastName': 'Sposito', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil. sposito@unicamp.br.'}, {'ForeName': 'Ikaro', 'Initials': 'I', 'LastName': 'Breder', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Alexandre A S', 'Initials': 'AAS', 'LastName': 'Soares', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Sheila T', 'Initials': 'ST', 'LastName': 'Kimura-Medorima', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Munhoz', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Riobaldo M R', 'Initials': 'RMR', 'LastName': 'Cintra', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Bonilha', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Oliveira', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Jessica Cunha', 'Initials': 'JC', 'LastName': 'Breder', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Cavalcante', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Moreira', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Filipe A', 'Initials': 'FA', 'LastName': 'Moura', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Jose Carlos', 'Initials': 'JC', 'LastName': 'de Lima-Junior', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Helison R P', 'Initials': 'HRP', 'LastName': 'do Carmo', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Barreto', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Nadruz', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Luiz Sergio F', 'Initials': 'LSF', 'LastName': 'Carvalho', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Quinaglia', 'Affiliation': 'Aterosclerose and Vascular Biology Laboratory (Aterolab), Cardiology Division, State University of Campinas Medical School, Rua Tessalia Vieira de Camargo 126, Cidade Universitaria Zeferino Vaz, Campinas, SP, 13084-971, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular diabetology,['10.1186/s12933-021-01264-z']
472,33771116,"Effect of 0.9% NaCl compared to plasma-lyte on biomarkers of kidney injury, sodium excretion and tubular transport proteins in patients undergoing primary uncemented hip replacement - a randomized trial.","BACKGROUND


Isotonic saline (IS) is widely used to secure perioperative cardiovascular stability. However, the high amount of chloride in IS can induce hyperchloremic acidosis. Therefore, IS is suspected to increase the risk of acute kidney injury (AKI). Biomarkers may have potential as indicators.
METHODS


In a double-blinded, placebo-controlled study, 38 patients undergoing primary uncemented hip replacement were randomized to IS or PlasmaLyte (PL). Infusion was given during surgery as 15 ml/kg the first hour and 5 ml/kg the following two hours. Urinary samples were collected upon admission and the day after surgery. As surgery was initiated, urine was collected over the course of 4 h. Hereafter, another urine collection proceeded until the morning. Urine was analyzed for markers of AKI neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1). Arterious and venous blood samples for measurements of pH and plasma electrolytes including chloride (p-Cl) were collected as surgery was initiated, at the end of surgery and the following morning.
RESULTS


IS induced an increase in p-Cl (111 ± 2 mmol/L after IS and 108 ± 3 after PL, p = 0.004) and a decrease in pH (7.39 ± 0.02 after IS and 7.43 ± 0.03 after PL, p = 0.001). Urinary NGAL excretion increased in both groups (ΔNGAL: 5.5 [4.1; 11.7] μg/mmol creatinine p = 0.004 after IS vs. 5.5 [2.1;9.4] μg/mmol creatinine after PL, p < 0.001). No difference was found between the groups (p = 0.839). Similarly, urinary KIM-1 excretion increased in both groups (ΔKIM-1: IS 115.8 [74.1; 156.2] ng/mmol creatinine, p < 0.001 vs. PL 152.4 [120.1; 307.9] ng/mmol creatinine, p < 0.001). No difference between the groups (p = 0.064). FE Na  increased (1.08 ± 0.52% after IS and 1.66 ± 1.15% after PL, p = 0.032). ENaC excretion was different within groups (p = 0.019).
CONCLUSION


A significantly higher plasma chloride and a lower pH was present in the group receiving isotonic saline. However, u-NGAL and u-KIM-1 increased significantly in both groups after surgery despite absence of changes in creatinine. These results indicate that surgery induced subclinical kidney injury. Also, the IS group had a delayed sodium excretion as compared to the PL group which may indicate that IS affects renal sodium excretion differently from PL.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier:  NCT02528448 , 19/08/2015.",2021,"However, u-NGAL and u-KIM-1 increased significantly in both groups after surgery despite absence of changes in creatinine.","['38 patients undergoing primary uncemented hip replacement', 'patients undergoing primary uncemented hip replacement - a randomized trial']","['Isotonic saline (IS', 'placebo', 'IS or PlasmaLyte (PL', 'isotonic saline', 'NaCl']","['urinary KIM-1 excretion', 'p-Cl', 'kidney injury, sodium excretion and tubular transport proteins', 'ENaC excretion', 'Urinary NGAL excretion', 'AKI neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1', 'renal sodium excretion', 'u-NGAL and u-KIM-1', 'delayed sodium excretion', 'FE Na']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0392806', 'cui_str': 'Insertion of hip prosthesis'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071213', 'cui_str': 'Plasmalyte A'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0858120', 'cui_str': 'Plasma electrolytes NOS'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0007292', 'cui_str': 'Carrier protein'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",38.0,0.317167,"However, u-NGAL and u-KIM-1 increased significantly in both groups after surgery despite absence of changes in creatinine.","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Østergaard', 'Affiliation': 'University Clinic in Nephrology and Hypertension and University of Aarhus, Gødstrup Hospital, Laegaardvej 12, 7500, Holstebro, Denmark. anaoet@rm.dk.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Jørgensen', 'Affiliation': 'University Clinic in Nephrology and Hypertension and University of Aarhus, Gødstrup Hospital, Laegaardvej 12, 7500, Holstebro, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bøvling', 'Affiliation': 'Department of Orthopaedic Surgery, Gødstrup Hospital, Holstebro, Denmark.'}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Ekeløf', 'Affiliation': 'Department of Anaesthesiology, Gødstrup Hospital, Holstebro, Denmark.'}, {'ForeName': 'F H', 'Initials': 'FH', 'LastName': 'Mose', 'Affiliation': 'University Clinic in Nephrology and Hypertension and University of Aarhus, Gødstrup Hospital, Laegaardvej 12, 7500, Holstebro, Denmark.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Bech', 'Affiliation': 'University Clinic in Nephrology and Hypertension and University of Aarhus, Gødstrup Hospital, Laegaardvej 12, 7500, Holstebro, Denmark.'}]",BMC nephrology,['10.1186/s12882-021-02310-4']
473,33773476,"Instructional interventions for improving COVID-19 knowledge, attitudes, behaviors: Evidence from a large-scale RCT in India.","Seeking ways to encourage broad compliance with health guidelines during the pandemic, especially among youth, we test two hypotheses pertaining to the optimal design of instructional interventions for improving COVID-19-related knowledge, attitudes, and behaviors. We randomly assigned 8376 lower-middle income youth in urban India to three treatments: a concentrated and targeted fact-based, instructional intervention; a longer instructional intervention that provided the same facts along with underlying scientific concepts; and a control. Relative to existing efforts, we find that both instructional interventions increased COVID-19-related knowledge immediately after intervention. Relative to the shorter fact-based intervention, the longer intervention resulted in sustained improvements in knowledge, attitudes, and self-reported behavior. Instead of reducing attention and comprehension by youth, the longer scientific based treatment appears to have increased understanding and retention of the material. The findings are instrumental to understanding the design of instruction and communication in affecting compliance during this and future pandemics.",2021,"Relative to the shorter fact-based intervention, the longer intervention resulted in sustained improvements in knowledge, attitudes, and self-reported behavior.",['8376 lower-middle income youth in urban India to three treatments: a'],"['concentrated and targeted fact-based, instructional intervention; a longer instructional intervention that provided the same facts along with underlying scientific concepts; and a control']","['COVID-19-related knowledge', 'knowledge, attitudes, and self-reported behavior']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",8376.0,0.0284802,"Relative to the shorter fact-based intervention, the longer intervention resulted in sustained improvements in knowledge, attitudes, and self-reported behavior.","[{'ForeName': 'Dinsha', 'Initials': 'D', 'LastName': 'Mistree', 'Affiliation': 'Stanford University, Law School, 559 Nathan Abbott Way, Stanford, CA, 94305, USA. Electronic address: dmistree@law.stanford.edu.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Loyalka', 'Affiliation': 'Stanford University, Graduate School of Education and Freeman Spogli Institute for International Studies, Encina Hall East Wing Room 413, 616 Serra St., Stanford, CA, 94305, USA. Electronic address: loyalka@stanford.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fairlie', 'Affiliation': 'University of California, Department of Economics, Santa Cruz, CA, 95064, USA. Electronic address: rfairlie@ucsc.edu.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Bhuradia', 'Affiliation': 'Freedom Employability Academy, Valmiki Temple One, Vasant Gaon, New Delhi, 110057, India; Harvard University, Graduate School of Education, 13 Appian Way, Cambridge, MA, 02138, USA. Electronic address: ashutosh_bhuradia@gsas.harvard.edu.'}, {'ForeName': 'Manyu', 'Initials': 'M', 'LastName': 'Angrish', 'Affiliation': 'Freedom Employability Academy, Valmiki Temple One, Vasant Gaon, New Delhi, 110057, India. Electronic address: manyuangrish@gmail.com.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Harker School, 500 Saratoga Ave., San Jose, CA, 95129, USA. Electronic address: jclin2.2009@gmail.com.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Karoshi', 'Affiliation': 'Harker School, 500 Saratoga Ave., San Jose, CA, 95129, USA. Electronic address: wildkrattscrazy@gmail.com.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Yen', 'Affiliation': 'Harker School, 500 Saratoga Ave., San Jose, CA, 95129, USA. Electronic address: sarayen418@gmail.com.'}, {'ForeName': 'Jamsheed', 'Initials': 'J', 'LastName': 'Mistri', 'Affiliation': 'University of California, Department of Electrical Engineering and Computer Science, Berkeley, CA, 94720, USA. Electronic address: jmistri7@gmail.com.'}, {'ForeName': 'Vafa', 'Initials': 'V', 'LastName': 'Bayat', 'Affiliation': 'Bitscopic, Inc., 715 Colorado Avenue Suite B, Palo Alto, CA, 94303, USA. Electronic address: vafa@bitscopic.com.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2021.113846']
474,33773361,Transcranial direct current stimulation (tDCS) may reduce the expired CO concentration among opioid users who smoke cigarettes: a randomized sham-controlled study.,"Transcranial direct current stimulation (tDCS) could be a potential treatment for nicotine dependency. Little is known with regards to the efficacy of this treatment in cigarette-smoking patients with heroin dependency. In this sham-controlled study, we probed the effect of 5-day, 20-min, 2-mA-intensity tDCS treatment on the outcomes of cigarette-smoking. Our objectives are to examine the effects of tDCS on two outcomes: objective expired CO concentration and subjective self-reported number of cigarettes smoked per day. A total of 30 patients were randomized into active or sham control groups. The stimulation site was randomized to anodal stimulation of the left dorsal lateral prefrontal cortex or the orbital frontal cortex. The expired CO concentration was recorded. The patients also reported their cigarette consumption and level of craving prior to each 5-day treatment period and after 5 days of follow-up. tDCS was found to be effective in terms of reducing the expired CO concentration, and both groups demonstrated reduced numbers of cigarettes smoked. However, no significant group difference was found with regards to craving tendency. tDCS may affect objective outcomes related to cigarette-smoking among patients with heroin dependence.",2021,"tDCS was found to be effective in terms of reducing the expired CO concentration, and both groups demonstrated reduced numbers of cigarettes smoked.","['cigarette-smoking patients with heroin dependency', '30 patients', 'opioid users who smoke cigarettes', 'patients with heroin dependence']","['Transcranial direct current stimulation (tDCS', 'tDCS', '2-mA-intensity tDCS treatment']","['cigarette consumption and level of craving', 'craving tendency', 'expired CO concentration']","[{'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0019337', 'cui_str': 'Heroin dependence'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",30.0,0.0376573,"tDCS was found to be effective in terms of reducing the expired CO concentration, and both groups demonstrated reduced numbers of cigarettes smoked.","[{'ForeName': 'Shih-Hsien', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Po See', 'Initials': 'PS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Psychiatry, National Cheng Kung University Hospital, Dou-Liou Branch, Yunlin, Taiwan.'}, {'ForeName': 'Kao Chin', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Wei Hung', 'Initials': 'WH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Psychiatry, National Cheng Kung University Hospital, Dou-Liou Branch, Yunlin, Taiwan.'}, {'ForeName': 'Tzu-Yun', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yen Kuang', 'Initials': 'YK', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Psychiatry, Tainan Hospital, Ministry of Health and Welfare, Tainan, Taiwan. Electronic address: ykyang@mail.ncku.edu.tw.'}]",Psychiatry research,['10.1016/j.psychres.2021.113874']
475,33776855,Testing the Efficacy of the Red-Light Purple-Light Games in Preprimary Classrooms in Kenya.,"This study adapted and tested the efficacy of the Red-Light Purple-Light (RLPL) games for improving executive function (EF) skills in preprimary classrooms in Nairobi, Kenya. A cluster randomized controlled trial was used to evaluate the efficacy of the adapted RLPL intervention. Specifically, 24 centers (including 48 classrooms) were randomized to the RLPL or a wait-list control condition. Consistent with previous studies, participating classrooms delivered 16 lessons across an 8-week intervention period. A total of 479 children were recruited into the study. After exclusions based on child age and data quality, 451 and 404 children (90% retention) had completed computerized assessments of EF skills at pre- and posttest assessments, respectively. Children in the RLPL centers did not demonstrate any improvements in EF skills relative to their peers in the wait-list control condition (Cohen's  ds  = -0.14 to 0.03, all  p s > 0.20). Exploratory tests of moderators (language of assessment, grade, school type, baseline ability) were also all null. Results are discussed with respect to measurement limitations and contextual factors that may explain the null results of RLPL on EF skills in young children in Kenya.",2021,"Children in the RLPL centers did not demonstrate any improvements in EF skills relative to their peers in the wait-list control condition (Cohen's  ds  = -0.14 to 0.03, all  p s > 0.20).","['young children in Kenya', 'Preprimary Classrooms in Kenya', 'preprimary classrooms in Nairobi, Kenya', '24 centers (including 48 classrooms', 'A total of 479 children were recruited into the study']","['Red-Light Purple-Light Games', 'adapted RLPL intervention', 'RLPL or a wait-list control condition', 'Red-Light Purple-Light (RLPL) games']","['EF skills relative', 'EF skills', 'executive function (EF) skills']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C0439542', 'cui_str': 'Purple'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",479.0,0.0473312,"Children in the RLPL centers did not demonstrate any improvements in EF skills relative to their peers in the wait-list control condition (Cohen's  ds  = -0.14 to 0.03, all  p s > 0.20).","[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Willoughby', 'Affiliation': 'Education and Workforce Development, RTI International, Research Triangle Park, NC, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Piper', 'Affiliation': 'International Education, RTI International, Nairobi, Kenya.'}, {'ForeName': 'Katherine Merseth', 'Initials': 'KM', 'LastName': 'King', 'Affiliation': 'International Education, RTI International, Washington, DC, United States.'}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Nduku', 'Affiliation': 'International Education, RTI International, Nairobi, Kenya.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Henny', 'Affiliation': 'International Education, RTI International, Research Triangle Park, NC, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Zimmermann', 'Affiliation': 'Research Computing Division, RTI International, Research Triangle Park, NC, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.633049']
476,33776848,Using Virtual Reality to Assess and Promote Transfer of Memory Training in Older Adults With Memory Complaints: A Randomized Controlled Trial.,"In this proof-of-concept study, we assessed the potential for immersive virtual reality (VR) to measure transfer following strategic memory training, and whether efficacy and transfer are increased when training is complemented by practice in an immersive virtual environment. Forty older adults with subjective memory complaints were trained with the method of loci. They were randomized to either a condition where they practiced the strategy in VR ( n  = 20) or a control condition where they were familiarized with VR using a non-memory task ( n  = 20). Training efficacy was measured with word recall, and transfer of the training benefit was measured with a recall task completed in two VR tasks (primary outcomes) as well as a self-report memory questionnaire (secondary outcomes). Testing was administered before (PRE), midway (POST 3), and after (POST 6) training. Participants improved their scores on word recall. Regarding transfer measures, participants improved their performance in the two VR recall tasks but not on the self-report memory questionnaire. No significant group effect was observed. Improvement was found when comparing PRE to POST 3 with no further improvement at POST 6. Thus, strategic memory training improved the memory of seniors with memory complaints on word recall and a transfer task relying on a VR scenario that resembles real-life. However, no evidence supporting an increase in transfer effects was found when enriching training with VR memory exercises.",2021,"Regarding transfer measures, participants improved their performance in the two VR recall tasks but not on the self-report memory questionnaire.","['Forty older adults with subjective memory complaints', 'Older Adults With Memory Complaints']","['immersive virtual reality (VR', 'control condition where they were familiarized with VR using a non-memory task', 'Memory Training', 'strategic memory training']","['scores on word recall', 'memory of seniors with memory complaints on word recall and a transfer task relying', 'Training efficacy', 'transfer effects', 'word recall, and transfer of the training benefit', 'self-report memory questionnaire']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0729377', 'cui_str': 'Memory skills training'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",40.0,0.0076045,"Regarding transfer measures, participants improved their performance in the two VR recall tasks but not on the self-report memory questionnaire.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Boller', 'Affiliation': 'Department of Psychology, Université du Québec à Trois-Rivières, Trois-Rivières, QC, Canada.'}, {'ForeName': 'Émilie', 'Initials': 'É', 'LastName': 'Ouellet', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Belleville', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.627242']
477,33776798,Effectiveness of a Virtual Exercise Program During COVID-19 Confinement on Blood Pressure Control in Healthy Pregnant Women.,"Background


The situation caused by COVID-19 has led to movement restrictions for the majority of the population due to the confinement established by the health authorities. This new situation has changed people's habits and significantly affected the pregnant population. Decreased exercise and increased psychophysical stress are associated with excessive weight gain, diabetes, and gestational cardiovascular complications that affect the mother, fetus, and newborn. Recent research shows that the dynamics of maternal blood pressure is one of the most important control factors during pregnancy. Thus, prevention of these type of pathologies through interventions without maternal-fetal risks is important.
Objectives


To examine the influence of a virtual exercise program on maternal blood pressure during pregnancy.
Materials and Methods


A randomized clinical trial design was used (NCT04563065). Data from 72 pregnant women without obstetric contraindications under confinement conditions in the Madrid area were collected. Women were randomly assigned to the intervention (IG) or control group (CG). They previously signed informed consent forms. A moderate exercise program was performed as an intervention from 8-10 to 38-39 weeks of pregnancy. Systolic (SBP) and diastolic (DBP) maternal blood pressure were measured during the first, second and third trimesters of pregnancy, as well as before and immediately after delivery in both study groups.
Results


No differences in systolic and diastolic blood pressure during the first, second and third trimesters were found between groups. Significant differences in SBP were found immediately before delivery (IG = 119.83 ± 10.16 vs. CG = 125.6 ± 10.91;  p  = 0.047) and immediately after delivery (IG = 115.00 ± 11.18 vs. CG = 122.24 ± 15.71;  p  = 0.045).
Conclusions


Results show lower SBP values for the IG during delivery than CG. A virtual exercise program throughout pregnancy during COVID-19 confinement can help to control systolic blood pressure before and immediately after delivery in healthy pregnant women.",2021,"No differences in systolic and diastolic blood pressure during the first, second and third trimesters were found between groups.","['Healthy Pregnant Women', 'healthy pregnant women', '72 pregnant women without obstetric contraindications under confinement conditions in the Madrid area were collected']","['COVID-19 Confinement', 'Virtual Exercise Program', 'virtual exercise program', 'intervention (IG) or control group (CG']","['Blood Pressure Control', 'maternal blood pressure', 'systolic and diastolic blood pressure', 'SBP values', 'excessive weight gain, diabetes, and gestational cardiovascular complications', 'control systolic blood pressure', 'SBP', 'Systolic (SBP) and diastolic (DBP) maternal blood pressure', 'Decreased exercise and increased psychophysical stress']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0000765', 'cui_str': 'Excessive weight gain'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",72.0,0.0236651,"No differences in systolic and diastolic blood pressure during the first, second and third trimesters were found between groups.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Silva-Jose', 'Affiliation': 'Actividad Físico-Deportiva en Poblaciones Específicas (AFIPE) Research Group, Facultad de Ciencias de la Actividad Física y el Deporte, Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sánchez-Polán', 'Affiliation': 'Actividad Físico-Deportiva en Poblaciones Específicas (AFIPE) Research Group, Facultad de Ciencias de la Actividad Física y el Deporte, Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Ángeles', 'Initials': 'Á', 'LastName': 'Diaz-Blanco', 'Affiliation': 'Servicio de Obstetricia y Ginecología, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Coterón', 'Affiliation': 'Actividad Físico-Deportiva en Poblaciones Específicas (AFIPE) Research Group, Facultad de Ciencias de la Actividad Física y el Deporte, Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Barakat', 'Affiliation': 'Actividad Físico-Deportiva en Poblaciones Específicas (AFIPE) Research Group, Facultad de Ciencias de la Actividad Física y el Deporte, Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Refoyo', 'Affiliation': 'Actividad Físico-Deportiva en Poblaciones Específicas (AFIPE) Research Group, Facultad de Ciencias de la Actividad Física y el Deporte, Universidad Politécnica de Madrid, Madrid, Spain.'}]",Frontiers in physiology,['10.3389/fphys.2021.645136']
478,33776792,Disturbed Blood Flow Acutely Increases Endothelial Microparticles and Decreases Flow Mediated Dilation in Patients With Heart Failure With Reduced Ejection Fraction.,"Introduction


Disturbed blood flow, characterized by high retrograde and oscillatory shear rate (SR), is associated with a proatherogenic phenotype. The impact of disturbed blood flow in patients with heart failure with reduced ejection fraction (HFrEF) remains unknown. We tested the hypothesis that acute elevation to retrograde and oscillatory SR provoked by local circulatory occlusion would increase endothelial microparticles (EMPs) and decrease brachial artery flow-mediated dilation (FMD) in patients with HFrEF.
Methods


Eighteen patients with HFrEF aged 55 ± 2 years, with left ventricular ejection fraction (LVEF) 26 ± 1%, and 14 control subjects aged 49 ± 2 years with LVEF 65 ± 1 randomly underwent experimental and control sessions. Brachial artery FMD (Doppler) was evaluated before and after 30 min of disturbed forearm blood flow provoked by pneumatic cuff (Hokanson) inflation to 75 mm Hg. Venous blood samples were collected at rest, after 15 and 30 min of disturbed blood flow to assess circulating EMP levels (CD42b-/CD31+; flow cytometry).
Results


At rest, FMD was lower in patients with HFrEF compared with control subjects ( P  < 0.001), but blood flow patterns and EMPs had no differences ( P  > 0.05). The cuff inflation provoked a greater retrograde SR both groups ( P  < 0.0001). EMPs responses to disturbed blood flow significantly increased in patients with HFrEF ( P  = 0.03). No changes in EMPs were found in control subjects ( P  > 0.05). Disturbed blood flow decreased FMD both groups. No changes occurred in control condition.
Conclusion


Collectively, our findings suggest that disturbed blood flow acutely decreases FMD and increases EMP levels in patients with HFrEF, which may indicate that this set of patients are vulnerable to blood flow disturbances.",2021,"At rest, FMD was lower in patients with HFrEF compared with control subjects ( P  < 0.001), but blood flow patterns and EMPs had no differences ( P  > 0.05).","['Patients With Heart Failure With Reduced Ejection Fraction', 'patients with heart failure with reduced ejection fraction (HFrEF) remains unknown', 'patients with HFrEF', 'patients with HFrEF.\nMethods\n\n\nEighteen patients with HFrEF aged 55 ± 2 years, with left ventricular ejection fraction (LVEF) 26 ± 1%, and 14 control subjects aged 49 ± 2 years with LVEF 65 ± 1 randomly underwent']",['experimental and control sessions'],"['EMPs responses to disturbed blood flow', 'Disturbed blood flow decreased FMD', 'circulating EMP levels (CD42b-/CD31+; flow cytometry', 'Brachial artery FMD (Doppler', 'endothelial microparticles (EMPs) and decrease brachial artery flow-mediated dilation (FMD', 'Disturbed Blood Flow', 'EMP levels', 'Venous blood samples', 'blood flow patterns and EMPs', 'EMPs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282604', 'cui_str': 'Lymphocyte antigen CD42b'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",18.0,0.0163623,"At rest, FMD was lower in patients with HFrEF compared with control subjects ( P  < 0.001), but blood flow patterns and EMPs had no differences ( P  > 0.05).","[{'ForeName': 'Thiago O C', 'Initials': 'TOC', 'LastName': 'Silva', 'Affiliation': 'Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Allan R K', 'Initials': 'ARK', 'LastName': 'Sales', 'Affiliation': 'Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Gustavo S M', 'Initials': 'GSM', 'LastName': 'Araujo', 'Affiliation': 'Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Guilherme W P', 'Initials': 'GWP', 'LastName': 'Fonseca', 'Affiliation': 'Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Pedro G S', 'Initials': 'PGS', 'LastName': 'Braga', 'Affiliation': 'Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Faria', 'Affiliation': ""D'OR Institute for Research and Education, São Paulo, Brazil.""}, {'ForeName': 'Helena N M', 'Initials': 'HNM', 'LastName': 'Rocha', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Niteroi, Brazil.'}, {'ForeName': 'Natalia G', 'Initials': 'NG', 'LastName': 'Rocha', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Niteroi, Brazil.'}, {'ForeName': 'Marta F', 'Initials': 'MF', 'LastName': 'Lima', 'Affiliation': 'Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Mady', 'Affiliation': 'Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Negrão', 'Affiliation': 'Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Maria Janieire N N', 'Initials': 'MJNN', 'LastName': 'Alves', 'Affiliation': 'Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}]",Frontiers in physiology,['10.3389/fphys.2021.629674']
479,33776381,"""Staying Home - Feeling Positive"": Effectiveness of an on-line positive psychology group intervention during the COVID-19 pandemic.","The current study investigated the effectiveness of a group on-line positive psychology intervention (OPPI) designed to mitigate the psychological impact of the COVID-19 pandemic and the subsequent measures to control it. Study participants ( N  = 82,  M   age   = 33.07,  SD  = 9.55) were all Greek adults divided into an intervention ( n  = 44) and a control group ( n  = 38). The intervention group attended a voluntary, online, two-week, six-session (each 50 min), group intervention. The intervention aimed at enhancing participants' personal strengths and resilience in order to cope more effectively with the psychological impact of social distancing (e.g., feelings of anxiety, sadness, fear, and/or loneliness). All participants completed an online questionnaire one week before the intervention's implementation, which included scales measuring their: demographic characteristics, empathy, resilience, affectivity, feelings of loneliness, depression and anxiety levels, and feelings of fear regarding the outbreak. Participants in both the intervention and control group completed the same measures the week following the intervention's termination to examine its effects, and two weeks later to examine its long-term effectiveness. The intervention was found to be effective in alleviating the impact of the pandemic and in strengthening participants' resilience. More specifically, the results showed significant decreases for the intervention group in all measures of psychosocial distress (anxiety, depression, loneliness and fear) and significant increases in empathy, resilience, and experience of positive emotions. The study's implications for the development and implementation of online psychological interventions during a crisis are discussed.",2021,"More specifically, the results showed significant decreases for the intervention group in all measures of psychosocial distress (anxiety, depression, loneliness and fear) and significant increases in empathy, resilience, and experience of positive emotions.","['Study participants ( N \u2009=\u200982,  M   age  \u2009=\u200933.07,  SD \u2009=\u20099.55) were all Greek adults divided into an intervention ( n \u2009=\u200944) and a control group ( n \u2009=\u200938']",['line positive psychology intervention (OPPI'],"['psychosocial distress (anxiety, depression, loneliness and fear', 'empathy, resilience, and experience of positive emotions', 'demographic characteristics, empathy, resilience, affectivity, feelings of loneliness, depression and anxiety levels, and feelings of fear regarding the outbreak']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0337806', 'cui_str': 'Greeks'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}]",,0.0100498,"More specifically, the results showed significant decreases for the intervention group in all measures of psychosocial distress (anxiety, depression, loneliness and fear) and significant increases in empathy, resilience, and experience of positive emotions.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Brouzos', 'Affiliation': 'Laboratory of Educational Psychology, Counselling and Research, Department of Primary Education, University of Ioannina, 45110 Ioannina, Greece.'}, {'ForeName': 'Stephanos P', 'Initials': 'SP', 'LastName': 'Vassilopoulos', 'Affiliation': 'Department of Educational Sciences and Social Work, University of Patras, 26110 Patras, Greece.'}, {'ForeName': 'Vasiliki C', 'Initials': 'VC', 'LastName': 'Baourda', 'Affiliation': 'Laboratory of Educational Psychology, Counselling and Research, Department of Primary Education, University of Ioannina, 45110 Ioannina, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tassi', 'Affiliation': 'Laboratory of Educational Psychology, Counselling and Research, Department of Primary Education, University of Ioannina, 45110 Ioannina, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Stavrou', 'Affiliation': 'Laboratory of Educational Psychology, Counselling and Research, Department of Primary Education, University of Ioannina, 45110 Ioannina, Greece.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Moschou', 'Affiliation': 'Laboratory of Educational Psychology, Counselling and Research, Department of Primary Education, University of Ioannina, 45110 Ioannina, Greece.'}, {'ForeName': 'Katia Ourania', 'Initials': 'KO', 'LastName': 'Brouzou', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}]","Current psychology (New Brunswick, N.J.)",['10.1007/s12144-021-01613-x']
480,33769294,A Smartphone-Delivered Ecological Momentary Intervention for Problem Gambling (GamblingLess: Curb Your Urge): Single-Arm Acceptability and Feasibility Trial.,"BACKGROUND


Low uptake rates of traditional gambling treatments highlight the need for innovative treatment modalities. Smartphone apps can provide unprecedented access to real-time ecological momentary interventions (EMIs) delivered in people's everyday lives.
OBJECTIVE


This study aims to examine the acceptability, feasibility, and preliminary effectiveness of GamblingLess: Curb Your Urge, the first smartphone app-delivered EMI that aims to prevent gambling episodes by reducing craving intensity in people seeking help for gambling problems.
METHODS


This study was a single-arm, 5-week acceptability and feasibility trial (1-week baseline and 4-week intervention periods) involving ecological momentary assessments (EMAs) delivered 3 times daily. The EMAs measured gambling episodes, cravings, and self-efficacy. Web-based evaluations at baseline, postintervention, and 1-month follow-up measured gambling outcomes (severity, cravings, frequency, expenditure, and self-efficacy) and the intervention's perceived helpfulness, relevance, burden, satisfaction, and impact in relation to gambling cravings.
RESULTS


A total of 36 participants, of whom 22/36 (61%) were male and 34/36 (94%) were problem gamblers, completed the baseline measures, with 61% (22/36) completing the postintervention evaluation and 58% (21/36) completing the follow-up evaluation. The intervention was considered acceptable, as participants perceived all intervention content to be above average in helpfulness and the EMA to be highly relevant but somewhat burdensome. Participants reported that they were satisfied with the intervention and that the intervention improved their knowledge, attitudes, awareness, behavior change, intention to change, and help-seeking behavior for gambling cravings. Regarding the intervention's feasibility, compliance rates for the EMA (51%) and EMI (15%) were low; however, the intervention was used 166 times, including 59 uses within 60 minutes of EMA completion and 107 on-demand uses. Regarding the intervention's preliminary effectiveness, descriptive EMA data showed that, compared with the baseline period, 71% and 72% reductions in the average number of gambling episodes and craving occurrences were reported in the intervention period, respectively. In addition, clustered paired-sample two-tailed t tests revealed a significant 5.4% reduction in real-time craving intensity (P=.01) immediately after intervention use, which increased to 10.5% (P=.01), where use was recommended based on craving occurrence. At the group level, significant medium-to-large reductions were observed in mean gambling symptom severity (P=.01 and .003), cravings (P=.03 and .02), frequency (P=.01 and .004), and expenditure (P=.04 and .003) at postintervention and follow-up; moreover, increased mean gambling self-efficacy and craving self-efficacy (P=.01 and .01) were observed at postintervention and increased gambling self-efficacy (P=.04) was observed at follow-up. At the individual level, over a quarter of participants (6/22, 27% to 10/21, 48%) could be categorized as recovered or improved regarding their gambling symptom severity and cravings.
CONCLUSIONS


The results support the acceptability, feasibility, and preliminary effectiveness of this app-delivered EMI for preventing gambling episodes through craving management in people with gambling problems, which has implications for extending the reach of evidence-based treatment to moments of vulnerability in people's everyday lives.",2021,"Participants reported that they were satisfied with the intervention and that the intervention improved their knowledge, attitudes, awareness, behavior change, intention to change, and help-seeking behavior for gambling cravings.","['Problem Gambling', 'Curb Your Urge', 'people with gambling problems', 'A total of 36 participants, of whom 22/36 (61%) were male and 34/36 (94%) were problem gamblers, completed the baseline measures, with 61% (22/36) completing the postintervention evaluation and 58% (21/36) completing the follow-up evaluation', 'GamblingLess']","['EMI', 'Smartphone-Delivered Ecological Momentary Intervention', 'GamblingLess']","['gambling outcomes (severity, cravings, frequency, expenditure, and self-efficacy', 'gambling symptom severity and cravings', 'mean gambling symptom severity', 'expenditure', 'frequency', 'cravings', 'helpfulness, relevance, burden, satisfaction, and impact in relation to gambling cravings', 'real-time craving intensity', 'mean gambling self-efficacy and craving self-efficacy', 'gambling self-efficacy', 'average number of gambling episodes and craving occurrences', 'EMAs measured gambling episodes, cravings, and self-efficacy', 'knowledge, attitudes, awareness, behavior change, intention to change, and help-seeking behavior for gambling cravings']","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0683301', 'cui_str': 'Help-Seeking Behavior'}]",36.0,0.0357375,"Participants reported that they were satisfied with the intervention and that the intervention improved their knowledge, attitudes, awareness, behavior change, intention to change, and help-seeking behavior for gambling cravings.","[{'ForeName': 'Chloe O', 'Initials': 'CO', 'LastName': 'Hawker', 'Affiliation': 'Deakin University, Geelong, Australia.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Merkouris', 'Affiliation': 'Deakin University, Geelong, Australia.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Youssef', 'Affiliation': 'Deakin University, Geelong, Australia.'}, {'ForeName': 'Nicki A', 'Initials': 'NA', 'LastName': 'Dowling', 'Affiliation': 'Deakin University, Geelong, Australia.'}]",Journal of medical Internet research,['10.2196/25786']
481,33769293,Blended Acceptance and Commitment Therapy Versus Face-to-face Cognitive Behavioral Therapy for Older Adults With Anxiety Symptoms in Primary Care: Pragmatic Single-blind Cluster Randomized Trial.,"BACKGROUND


Anxiety symptoms in older adults are prevalent and disabling but often go untreated. Most trials on psychological interventions for anxiety in later life have examined the effectiveness of face-to-face cognitive behavioral therapy (CBT). To bridge the current treatment gap, other treatment approaches and delivery formats should also be evaluated.
OBJECTIVE


This study is the first to examine the effectiveness of a brief blended acceptance and commitment therapy (ACT) intervention for older adults with anxiety symptoms, compared with a face-to-face CBT intervention.
METHODS


Adults aged between 55-75 years (n=314) with mild to moderately severe anxiety symptoms were recruited from general practices and cluster randomized to either blended ACT or face-to-face CBT. Assessments were performed at baseline (T0), posttreatment (T1), and at 6- and 12-month follow-ups (T2 and T3, respectively). The primary outcome was anxiety symptom severity (Generalized Anxiety Disorder-7). Secondary outcomes were positive mental health, depression symptom severity, functional impairment, presence of Diagnostic and Statistical Manual of Mental Disorders V anxiety disorders, and treatment satisfaction.
RESULTS


Conditions did not differ significantly regarding changes in anxiety symptom severity during the study period (T0-T1: B=.18, P=.73; T1-T2: B=-.63, P=.26; T1-T3: B=-.33, P=.59). Large reductions in anxiety symptom severity (Cohen d≥0.96) were found in both conditions post treatment, and these were maintained at the 12-month follow-up. The rates of clinically significant changes in anxiety symptoms were also not different for the blended ACT group and CBT group (χ 2 1 =0.2, P=.68). Regarding secondary outcomes, long-term effects on positive mental health were significantly stronger in the blended ACT group (B=.27, P=.03, Cohen d=0.29), and treatment satisfaction was significantly higher for blended ACT than CBT (B=3.19, P<.001, Cohen d=0.78). No other differences between the conditions were observed in the secondary outcomes.
CONCLUSIONS


The results show that blended ACT is a valuable treatment alternative to CBT for anxiety in later life.
TRIAL REGISTRATION


Netherlands Trial Register TRIAL NL6131 (NTR6270); https://www.trialregister.nl/trial/6131.",2021,"The rates of clinically significant changes in anxiety symptoms were also not different for the blended ACT group and CBT group (χ 2 1 =0.2, P=.68).","['older adults with anxiety symptoms', 'older adults', 'Older Adults With Anxiety Symptoms in Primary Care', 'Adults aged between 55-75 years (n=314) with mild to moderately severe anxiety symptoms were recruited from general practices and cluster randomized to either']","['blended acceptance and commitment therapy (ACT) intervention', 'psychological interventions', 'blended ACT or face-to-face CBT', 'Blended Acceptance and Commitment Therapy Versus Face-to-face Cognitive Behavioral Therapy', 'blended ACT']","['positive mental health', 'anxiety symptom severity', 'positive mental health, depression symptom severity, functional impairment, presence of Diagnostic and Statistical Manual of Mental Disorders V anxiety disorders, and treatment satisfaction', 'treatment satisfaction', 'anxiety symptom severity (Generalized Anxiety Disorder-7', 'anxiety symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0350279,"The rates of clinically significant changes in anxiety symptoms were also not different for the blended ACT group and CBT group (χ 2 1 =0.2, P=.68).","[{'ForeName': 'Maartje', 'Initials': 'M', 'LastName': 'Witlox', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Section of Clinical Psychology, Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Garnefski', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Section of Clinical Psychology, Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Kraaij', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Section of Clinical Psychology, Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Margot W M', 'Initials': 'MWM', 'LastName': 'de Waal', 'Affiliation': 'Department Public Health & Primary Care, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Smit', 'Affiliation': 'Department of Mental Health & Prevention, Netherlands Institute of Mental Health and Addiction, Utrecht, Netherlands.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Bohlmeijer', 'Affiliation': 'Department of Psychology, Health and Technology, University of Twente, Enschede, Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Spinhoven', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Section of Clinical Psychology, Institute of Psychology, Leiden University, Leiden, Netherlands.'}]",Journal of medical Internet research,['10.2196/24366']
482,33770629,Induction of labor using balloon catheter as an outpatient versus prostaglandin as an inpatient: A cost-effectiveness analysis.,"OBJECTIVE


The aim of this work was to assess the cost-effectiveness of induction of labor with outpatient balloon catheter cervical priming versus inpatient prostaglandin vaginal gel or tape.
STUDY DESIGN


Economic evaluation alongside a multi-centre, randomized controlled trial at eight Australian maternity hospitals. The trial reported on 448 women with live singleton term pregnancies, undergoing induction of labor for low-risk indications between September 2015 and October 2018. An economic decision tree model was designed from a health services perspective from time of induction of labor to hospital discharge. Sensitivity and subgroup analyses were performed to test the robustness of model outcomes. We estimated resource use, collected data on health outcomes (using EQ-5D-3 L questionnaire) and reported cost (Australian Dollars) per quality-adjusted life year gained, incremental cost-effect ratio and net monetary benefit.
RESULTS


Deterministic analysis showed lower mean costs ($7294 versus $7585) in the outpatient-balloon (n = 205) compared to the inpatient-prostaglandin group (n = 243), with similar health outcomes (0.75 vs 0.74 quality-adjusted life years gained) and overall higher net monetary benefit ($30,054 vs $29,338). In probabilistic analyses outpatient-balloon induction of labor was cost-effective in 55.3 % of all simulations and 59.1 % for women with favourable cervix (modified Bishop score >3) and 64.5 % for nulliparous women.
CONCLUSIONS


Outpatient-balloon induction of labor may be cost-saving compared to inpatient induction of labor with prostaglandin and is most likely to be cost-effective for nulliparous women, but more research is warranted in other settings to explore the generalisability of results.",2021,"In probabilistic analyses outpatient-balloon induction of labor was cost-effective in 55.3 % of all simulations and 59.1 % for women with favourable cervix (modified Bishop score >3) and 64.5 % for nulliparous women.
","['448 women with live singleton term pregnancies, undergoing induction of labor for low-risk indications between September 2015 and October 2018', 'eight Australian maternity hospitals', 'nulliparous women']",['labor with outpatient balloon catheter cervical priming versus inpatient prostaglandin vaginal gel or tape'],"['mean costs', 'health outcomes (using EQ-5D-3 L questionnaire) and reported cost (Australian Dollars) per quality-adjusted life year gained, incremental cost-effect ratio and net monetary benefit']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0562019', 'cui_str': 'dollar'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]",448.0,0.128009,"In probabilistic analyses outpatient-balloon induction of labor was cost-effective in 55.3 % of all simulations and 59.1 % for women with favourable cervix (modified Bishop score >3) and 64.5 % for nulliparous women.
","[{'ForeName': 'Katharina M D', 'Initials': 'KMD', 'LastName': 'Merollini', 'Affiliation': 'School of Health and Behavioural Sciences, University of the Sunshine Coast, Queensland, Australia; Sunshine Coast Health Institute, Sunshine Coast University Hospital, Queensland, Australia. Electronic address: kmerolli@usc.edu.au.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Beckmann', 'Affiliation': 'Mater Research, The University of Queensland, Queensland, Australia; University of Queensland, School of Medicine, Queensland, Australia; Mater Mothers Hospitals, Queensland, Australia.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2021.03.020']
483,33770484,"Dexamethasone plus oseltamivir versus dexamethasone in treatment-naive primary immune thrombocytopenia: a multicentre, randomised, open-label, phase 2 trial.","BACKGROUND


Primary immune thrombocytopenia is an autoimmune bleeding disorder. Preclinical reports suggest that the sialidase inhibitor oseltamivir induces a platelet response in the treatment of immune thrombocytopenia. This study investigated the activity and safety of dexamethasone plus oseltamivir versus dexamethasone alone as initial treatment in adult patients with primary immune thrombocytopenia.
METHODS


This multicentre, randomised, open-label, parallel group, phase 2 trial was done in five tertiary medical hospitals in China. Eligible patients were aged 18 years or older with newly diagnosed, treatment-naive primary immune thrombocytopenia. Participants were randomly assigned (1:1), using block randomisation, to receive either dexamethasone (orally at 40 mg per day for 4 days) plus oseltamivir (orally at 75 mg twice a day for 10 days) or dexamethasone monotherapy (orally at 40 mg a day for 4 days). Patients who did not respond to treatment (platelet counts remained <30 × 10 9  cells per L or showed bleeding symptoms by day 10) were given an additional cycle of dexamethasone for 4 days in each group. Patients in the dexamethasone plus oseltamivir group who relapsed (platelet counts reduced again to <30 × 10 9  cells per L) after an initial response were allowed a supplemental course of oseltamivir (75 mg twice a day for 10 days). The coprimary endpoints were 14-day initial overall response and 6-month overall response. Complete response was defined as a platelet count at or above 100 × 10 9  cells per L and an absence of bleeding. Partial response was defined as a platelet count at or above 30 × 10 9  cells per L but less than 100 × 10 9  cells per L and at least a doubling of the baseline platelet count and an absence of bleeding. A response lasting for at least 6 months without any additional primary immune thrombocytopenia-specific intervention was defined as sustained response. All patients who were randomly assigned and received the allocated intervention were included in the modified intention-to-treat population analysis. This study has been completed and is registered with ClinicalTrials.gov, number NCT01965626.
FINDINGS


From Feb 1, 2016, to May 1, 2019, 120 patients were screened for eligibility, of whom 24 were ineligible and excluded, 96 were enrolled and randomly assigned to receive dexamethasone plus oseltamivir (n=47) or dexamethasone (n=49), and 90 were included in the modified intention-to-treat analysis. Six patients did not receive the allocated intervention. Patients in the dexamethasone plus oseltamivir group had a significantly higher initial response rate (37 [86%] of 43 patients) than did those in the dexamethasone group (31 [66%] of 47 patients; odds ratio [OR] 3·18; 95 CI% 1·13-9·23; p=0·030) at day 14. The 6-month sustained response rate in the dexamethasone plus oseltamivir group was also significantly higher than that in the dexamethasone group (23 [53%] vs 14 [30%]; OR 2·17; 95 CI% 1·16-6·13; p=0·032). During the median follow-up of 8 months (IQR 5-14), two of 90 patients discontinued treatment due to serious adverse events (grade 3); one (2%) patient with general oedema in the dexamethasone plus oseltamivir group and one (2%) patient with fever in the dexamethasone group. The most frequently observed adverse events of any grade were fatigue (five [12%] of 43 in the dexamethasone plus oseltamivir group vs eight [17%] of 47 in the dexamethasone group), gastrointestinal reactions (eight [19%] vs three [6%]), insomnia (seven [16%] vs four [9%]), and anxiety (five [12%] vs three [6%]). There were no grade 4 or 5 adverse events and no treatment-related deaths.
INTERPRETATION


Dexamethasone plus oseltamivir offers a readily available combination therapy in the management of newly diagnosed primary immune thrombocytopenia. The preliminary activity of this combination warrants further investigation. Multiple cycles of oseltamivir, as a modification of current first-line treatment, might be more effective in maintaining the platelet response.
FUNDING


National Natural Science Foundation of China.",2021,"INTERPRETATION


Dexamethasone plus oseltamivir offers a readily available combination therapy in the management of newly diagnosed primary immune thrombocytopenia.","['120 patients were screened for eligibility, of whom 24 were ineligible and excluded, 96 were enrolled', 'newly diagnosed primary immune thrombocytopenia', 'Eligible patients were aged 18 years or older with newly diagnosed, treatment-naive primary immune thrombocytopenia', 'adult patients with primary immune thrombocytopenia', 'treatment-naive primary immune thrombocytopenia', 'n=49), and 90 were included in the modified intention-to-treat analysis', 'five tertiary medical hospitals in China']","['dexamethasone', 'dexamethasone plus oseltamivir', 'Dexamethasone plus oseltamivir versus dexamethasone', 'oseltamivir', 'Dexamethasone plus oseltamivir', 'dexamethasone plus oseltamivir versus dexamethasone', 'dexamethasone monotherapy']","['bleeding symptoms', 'Partial response', 'anxiety', 'insomnia', 'initial response rate', '14-day initial overall response and 6-month overall response', 'general oedema', 'gastrointestinal reactions', 'Complete response', '6-month sustained response rate', 'activity and safety', 'platelet count', 'grade 4 or 5 adverse events and no treatment-related deaths']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",120.0,0.291107,"INTERPRETATION


Dexamethasone plus oseltamivir offers a readily available combination therapy in the management of newly diagnosed primary immune thrombocytopenia.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Haematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Haematology, Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University, Qingdao, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Shao', 'Affiliation': 'Department of Haematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Chenglu', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Department of Haematology, Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University, Qingdao, China.'}, {'ForeName': 'Hongguo', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Haematology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Daqi', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Haematology, Jinan Central Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Zhencheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Haematology, Zibo Central Hospital, Zibo, China.'}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Han', 'Affiliation': 'Department of Haematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Haematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Haematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Haematology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Jihua', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Department of Haematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Haematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Xinguang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Haematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Department of Haematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China. Electronic address: houyu2009@sina.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Department of Haematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'Department of Haematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}]",The Lancet. Haematology,['10.1016/S2352-3026(21)00030-2']
484,33770483,"Intensified treatment of patients with early stage, unfavourable Hodgkin lymphoma: long-term follow-up of a randomised, international phase 3 trial of the German Hodgkin Study Group (GHSG HD14).","BACKGROUND


To improve the long-term tumour control in early, unfavourable Hodgkin Lymphoma, the German Hodgkin Study Group (GHSG) HD14 trial compared four cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) with an intensified chemotherapy regimen consisting of two cycles of escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (escalated BEACOPP) plus two cycles of ABVD. The final analysis of the trial showed a significant advantage in terms of freedom from treatment failure (difference 7·2% [95% CI 3·8-10·5] at 5 years) for patients who received two cycles of escalated BEACOPP and two cycles of ABVD. However, there was no difference in overall survival between the two groups. To evaluate long-term efficacy and toxicity of this strategy, we did a follow-up analysis.
METHODS


Patients aged 18-60 years with performance status of 2 or less and primary diagnosis of early, unfavourable Hodgkin lymphoma (all histologies) were included in an international, randomised, open-label, phase 3 trial. Patients were randomly assigned to receive four cycles of ABVD (ABVD group) or two cycles of escalated BEACOPP and two cycles of ABVD (2 + 2 group), both groups also received 30 Gy involved field radiotherapy. The ABVD dosing regimen was doxorubicin 25 mg/m 2  (days 1 and 15), bleomycin 10 mg/m 2  (days 1 and 15), vinblastine 6 mg/m 2  (days 1 and 15), and dacarbazine 375 mg/m 2  (days 1 and 15), repeated on day 29. The escalated BEACOPP dosing regimen was cyclophosphamide 1250 mg/m 2  (day 1), doxorubicin 35 mg/m 2  (day 1), etoposide 200 mg/m 2  (days 1-3), procarbazine 100 mg/m 2  (days 1-7), prednisone 40 mg/m 2  (days 1-14), vincristine 1·4 mg/m 2  (day 8; maximum 2 mg), and bleomycin 10 mg/m 2  (day 8), repeated on day 22. After closure of the ABVD group according to prespecified rules, patients were assigned to receive two cycles of escalated BEACOPP and two cycles of ABVD (non-randomised 2 + 2 group), which continued until the end of the predefined 5-year recruitment period. In this prespecified long-term follow-up analysis, we aimed to evaluate the secondary endpoints progression-free survival, overall survival, and long-term toxicity. To this end, we did a descriptive intention-to-treat analysis of all qualified HD14 patients and on the predefined subsets of randomised qualified HD14 patients and patients in the non-randomised 2 + 2 group. The trial was registered on the International Standard Randomised Controlled Trial database, 04761296.
FINDINGS


Between Jan 28, 2003, and Dec 29, 2009, 1686 patients were randomly assigned to the ABVD group (847 [50·2%] patients) and the 2 + 2 group (839 [49·8%] patients). 370 additional patients were recruited to the non-randomised 2 + 2 group. 1550 (92%) randomly assigned patients (median observation time 112 months [IQR 80-132]) and 339 (92%) patients in the non-randomised 2 + 2 group (median observation time 74 months [58-100]) were included in the qualified analysis set. 10-year overall survival in the randomly assigned patients was 94·1% (95% CI 92·0-95·7) for the ABVD group and 94·1% (91·8-95·7) for the 2 + 2 group (HR 1·0 [95% CI 0·6-1·5]; p=0·88). 8-year overall survival in the non-randomised 2 + 2 group was 95·1% (95% CI 91·6-97·2). 10-year progression-free survival in the randomly assigned patients was 85·6% (95% CI 82·6-88·1) for the ABVD group and 91·2% (88·4-93·3) for the 2 + 2 group (HR 0·5% [95% CI 0·4-0·7]; p=0·0001), accounting for a significant difference of 5·6% (95% CI 1·9-9·2) favouring the 2 + 2 group (p=0·0001). In the non-randomised 2 + 2 group, 8-year progression-free survival was 94·5% (95% CI 91·1-96·6). Standardised incidence ratios of second primary malignancies were similar between the ABVD group (2·3 [95% CI 1·6-3·1]) and the 2 + 2 group (2·5 [1·8-3·4]; Gray's p=0·80). Standardised incidence ratio of second primary malignancies was 3·1 (95% CI 1·7-5·0) in the non-randomised 2 + 2 group.
INTERPRETATION


This long-term analysis confirms superior tumour control in the 2 + 2 group compared with the ABVD group without translating into an overall survival difference. At longer follow-up, there is no difference regarding second primary malignancies between groups. In conclusion, the 2 + 2 regimen spares a significant number of patients from the burden of relapse and additional treatment without increased long-term toxicity.
FUNDING


Deutsche Krebshilfe eV and Swiss Federal Government.",2021,Standardised incidence ratio of second primary malignancies was 3·1,"['Patients aged 18-60 years with performance status of 2 or less and primary diagnosis of early, unfavourable Hodgkin lymphoma (all histologies', 'Between Jan 28, 2003, and Dec 29, 2009, 1686 patients', 'qualified HD14 patients and on the predefined subsets of randomised qualified HD14 patients and patients in the non-randomised 2\u2008+\u20082 group', 'patients with early stage, unfavourable Hodgkin lymphoma', '370 additional patients']","['etoposide', 'vincristine', 'doxorubicin', 'cyclophosphamide 1250', 'bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (escalated BEACOPP', 'BEACOPP', 'vinblastine', 'ABVD (ABVD group) or two cycles of escalated BEACOPP and two cycles of ABVD (2\u2008+\u20082 group), both groups also received 30 Gy involved field radiotherapy', 'dacarbazine', 'procarbazine', 'doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD', 'bleomycin', 'prednisone']","['secondary endpoints progression-free survival, overall survival, and long-term toxicity', '10-year progression-free survival', '10-year overall survival', 'Standardised incidence ratios of second primary malignancies', 'overall survival difference', 'burden of relapse and additional treatment without increased long-term toxicity', 'Standardised incidence ratio of second primary malignancies', '8-year overall survival', '8-year progression-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C4517743', 'cui_str': '370'}]","[{'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4517554', 'cui_str': '1250'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0050380', 'cui_str': 'ABVD-I protocol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0751623', 'cui_str': 'Second primary malignancy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",1686.0,0.386207,Standardised incidence ratio of second primary malignancies was 3·1,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gillessen', 'Affiliation': 'German Hodgkin Study Group, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany; Cancer Center Cologne Essen-Partner Site Cologne, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Plütschow', 'Affiliation': 'German Hodgkin Study Group, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany; Cancer Center Cologne Essen-Partner Site Cologne, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'German Hodgkin Study Group, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany; Cancer Center Cologne Essen-Partner Site Cologne, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Markova', 'Affiliation': 'Third Faculty of Medicine, Charles University Prague, University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III, University Hospital Salzburg, Salzburg, Austria.'}, {'ForeName': 'Max S', 'Initials': 'MS', 'LastName': 'Topp', 'Affiliation': 'Department of Internal Medicine II, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Meissner', 'Affiliation': 'Fifth Department of Internal Medicine, University Hospital Heidelberg, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Josée M', 'Initials': 'JM', 'LastName': 'Zijlstra', 'Affiliation': 'Vrije Universiteit, University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Dennis A', 'Initials': 'DA', 'LastName': 'Eichenauer', 'Affiliation': 'German Hodgkin Study Group, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany; Cancer Center Cologne Essen-Partner Site Cologne, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Bröckelmann', 'Affiliation': 'German Hodgkin Study Group, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany; Cancer Center Cologne Essen-Partner Site Cologne, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Diehl', 'Affiliation': 'German Hodgkin Study Group, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': 'German Hodgkin Study Group, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany; Cancer Center Cologne Essen-Partner Site Cologne, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': 'German Hodgkin Study Group, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany; Cancer Center Cologne Essen-Partner Site Cologne, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'von Tresckow', 'Affiliation': 'German Hodgkin Study Group, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Germany; Department of Hematology and Stem Cell Transplantation and Cancer Center Cologne Essen-Partner Site Essen, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany. Electronic address: bastian.vontresckow@uk-essen.de.'}]",The Lancet. Haematology,['10.1016/S2352-3026(21)00029-6']
485,33776788,"Impact of Low Hemoglobin on Body Composition, Strength, and Redox Status of Older Hemodialysis Patients Following Resistance Training.","Introduction


The purpose of this study was to: (i) investigate the effect of six months of resistance training (RT) on body composition, muscle strength, hematological patterns, and redox profile in maintenance hemodialysis (HD) patients, and; (ii) evaluate the effects of baseline concentrations of hemoglobin on the RT response.
Methods


One hundred fifty-seven subjects with chronic kidney disease (CKD) were randomly allocated into two groups: Control [CTL, ( n  = 76)] and RT ( n  = 81). A first visit was required for anamnesis and anthropometric measurements. Venous blood samples were collected at baseline and after twenty-four weeks of training in all patients for the analysis of clinical and redox balance markers. The RT program spanned six months and consisted of three sets of 8-12 repetitions with a rating of perceived exertion between 5 and 8 for three weekly sessions. Each exercise session was performed in twelve resistance exercises and it least for approximately 40 min.
Results


The main results demonstrated that RT decreased waist circumference by 3%, and decreased thiobarbituric reactive species (TBARS) by 28%. Moreover, RT increased handgrip strength by 28.4%, fat-free mass by 4.1%, hemoglobin by 5%, iron by 33.4%, glutathione by 121%, and Trolox equivalent antioxidant capacity by 14.2% ( p  < 0.05). Low hemoglobin concentrations impaired the effect of RT on fat-free mass gain.
Conclusion


Six months of RT in HD patients improved clinical parameters, such as hemoglobin, iron, body composition, and redox balance, while low hemoglobin concentration impaired exercise-benefits on fat-free mass in patients with CKD. These findings can contribute to a better clinical application of RT in the maintenance of hemodialysis patients.",2021,"Six months of RT in HD patients improved clinical parameters, such as hemoglobin, iron, body composition, and redox balance, while low hemoglobin concentration impaired exercise-benefits on fat-free mass in patients with CKD.","['Older Hemodialysis Patients Following Resistance Training', 'Methods\n\n\nOne hundred fifty-seven subjects with chronic kidney disease (CKD', 'hemodialysis patients']","['Low Hemoglobin', 'resistance training (RT', 'Control [CTL']","['RT decreased waist circumference', 'hemoglobin', 'clinical parameters, such as hemoglobin, iron, body composition, and redox balance', 'Venous blood samples', 'handgrip strength', 'thiobarbituric reactive species (TBARS', 'body composition, muscle strength, hematological patterns, and redox profile', 'Body Composition, Strength, and Redox Status', 'Trolox equivalent antioxidant capacity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0147003', 'cui_str': 'Trolox C'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",157.0,0.00429393,"Six months of RT in HD patients improved clinical parameters, such as hemoglobin, iron, body composition, and redox balance, while low hemoglobin concentration impaired exercise-benefits on fat-free mass in patients with CKD.","[{'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'da Silva', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Corrêa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Neves', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Lysleine', 'Initials': 'L', 'LastName': 'Deus', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Souza', 'Affiliation': 'Department of Nephrology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cláudio', 'Initials': 'C', 'LastName': 'Dos Santos', 'Affiliation': 'Federal University of Tocantins, Tocantins, Brazil.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'de Castro', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Honorato', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Simões', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Moraes', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Health Sciences, University of New York City, New York City, NY, United States.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Rosa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}]",Frontiers in physiology,['10.3389/fphys.2021.619054']
486,33776768,"The Bioequivalence of Emulsified Isoflurane With a New Formulation of Emulsion: A Single-Center, Single-Dose, Double-Blinded, Randomized, Two-Period Crossover Study.","Background:  Emulsified isoflurane is a novel intravenous general anesthetic obtained by encapsulating isoflurane molecules into emulsion. The formulation of emulsion has been improved according to the latest regulations of the China Food and Drug Administration. This study was designed to compare the bioequivalence of the new and previous formulation emulsion of isoflurane.  Methods:  In a single-center, single-dose, double-blinded, randomized, two-period crossover study, healthy volunteers received intravenous injection of 30 mg/kg of isoflurane with either previous formulation of emulsion isoflurane (PFEI) or new formulation of emulsion isoflurane (NFEI). Arterial and venous blood samples were obtained for geometric mean test/reference ratios of C max , AUC 0-t , and AUC 0-∞,  as well as their 90% confidence interval (CI90) as the primary outcome. The secondary outcomes were safety measurements such as vital signs, 12-lead electrocardiography, adverse effects, and laboratory tests; and anesthesia efficacy was assessed by Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score, bispectral index (BIS), and loss/recovery of eyelash reflex.  Results:  24 subjects were eligible, of which 21 completed the whole experiment (NFEI n = 21, PFEI n = 23). Arterial geometric mean test/reference ratios of C max , AUC 0-t , and AUC 0-∞  were 104.50% (CI90 92.81%-117.65%), 108.23% (94.51%-123.96%), and 106.53% (93.94%∼120.80%), respectively. The most commonly seen adverse effects for NFEI and PFEI were injection pain (38.1% vs. 34.8%), hypotension (19.0% vs. 13.0%), apnea (14.3% vs. 17.4%), and upper airway obstruction (14.3% vs. 13.0%). No severe adverse effect was observed. The effectiveness of general anesthesia was similar between the two formulations.  Conclusion:  The CI90 of C max , AUC 0-t , AUC 0-∞ , NFEI, and PFEI were within the range of 80%-125%, suggesting bioequivalence between NFEI and PFEI. The safety and anesthesia effectiveness were also similar.",2021,The effectiveness of general anesthesia was similar between the two formulations.  ,"['24 subjects were eligible, of which 21 completed the whole experiment (NFEI n = 21, PFEI n = 23']","['Emulsified isoflurane', 'isoflurane', 'Emulsified Isoflurane', 'Emulsion', 'intravenous injection of 30\xa0mg/kg of isoflurane with either previous formulation of emulsion isoflurane (PFEI) or new formulation of emulsion isoflurane (NFEI']","['severe adverse effect', 'safety and anesthesia effectiveness', 'safety measurements such as vital signs, 12-lead electrocardiography, adverse effects, and laboratory tests; and anesthesia efficacy', 'CI90 of C max , AUC 0-t , AUC 0-∞ , NFEI, and PFEI', 'injection pain', 'Arterial and venous blood samples', 'upper airway obstruction', 'apnea', 'hypotension', ""Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score, bispectral index (BIS), and loss/recovery of eyelash reflex"", 'Arterial geometric mean test/reference ratios of C max , AUC 0-t , and AUC 0-∞']","[{'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0740852', 'cui_str': 'Upper airway obstruction'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0422906', 'cui_str': 'Eyelash reflex'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",24.0,0.262257,The effectiveness of general anesthesia was similar between the two formulations.  ,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qinqin', 'Initials': 'Q', 'LastName': 'Yin', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Luying', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Clinical Research Center, Yichang Humanwell Pharmaceutical CO., LTD, Yichang, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Clinical Research Center, Yichang Humanwell Pharmaceutical CO., LTD, Yichang, China.'}, {'ForeName': 'Qirong', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Lingcan', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}]",Frontiers in pharmacology,['10.3389/fphar.2021.626307']
487,33776672,Remedial Training of the Less-Impaired Arm in Chronic Stroke Survivors With Moderate to Severe Upper-Extremity Paresis Improves Functional Independence: A Pilot Study.,"The ipsilesional arm of stroke patients often has functionally limiting deficits in motor control and dexterity that depend on the side of the brain that is lesioned and that increase with the severity of paretic arm impairment. However, remediation of the ipsilesional arm has yet to be integrated into the usual standard of care for upper limb rehabilitation in stroke, largely due to a lack of translational research examining the effects of ipsilesional-arm intervention. We now ask whether ipsilesional-arm training, tailored to the hemisphere-specific nature of ipsilesional-arm motor deficits in participants with moderate to severe contralesional paresis, improves ipsilesional arm performance and generalizes to improve functional independence. We assessed the effects of this intervention on ipsilesional arm unilateral performance [Jebsen-Taylor Hand Function Test (JHFT)], ipsilesional grip strength, contralesional arm impairment level [Fugl-Meyer Assessment (FM)], and functional independence [Functional independence measure (FIM)] ( N  = 13). Intervention occurred over a 3 week period for 1.5 h/session, three times each week. All sessions included virtual reality tasks that targeted the specific motor control deficits associated with either left or right hemisphere damage, followed by graded dexterity training in real-world tasks. We also exposed participants to 3 weeks of sham training to control for the non-specific effects of therapy visits and interactions. We conducted five test-sessions: two pre-tests and three post-tests. Our results indicate substantial improvements in the less-impaired arm performance, without detriment to the paretic arm that transferred to improved functional independence in all three posttests, indicating durability of training effects for at least 3 weeks. We provide evidence for establishing the basis of a rehabilitation approach that includes evaluation and remediation of the ipsilesional arm in moderately to severely impaired stroke survivors. This study was originally a crossover design; however, we were unable to complete the second arm of the study due to the COVID-19 pandemic. We report the results from the first arm of the planned design as a longitudinal study.",2021,"We assessed the effects of this intervention on ipsilesional arm unilateral performance [Jebsen-Taylor Hand Function Test (JHFT)], ipsilesional grip strength, contralesional arm impairment level [Fugl-Meyer Assessment (FM)], and functional independence [Functional independence measure (FIM)]","['participants with moderate to severe contralesional paresis', 'Chronic Stroke Survivors With Moderate to Severe Upper-Extremity Paresis Improves Functional Independence']","['virtual reality tasks that targeted the specific motor control deficits associated with either left or right hemisphere damage, followed by graded dexterity training in real-world tasks', 'Remedial Training of the Less-Impaired Arm']","['ipsilesional arm unilateral performance [Jebsen-Taylor Hand Function Test (JHFT)], ipsilesional grip strength, contralesional arm impairment level [Fugl-Meyer Assessment (FM)], and functional independence [Functional independence measure (FIM', 'functional independence']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0228175', 'cui_str': 'Right cerebral hemisphere structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}]",,0.0100262,"We assessed the effects of this intervention on ipsilesional arm unilateral performance [Jebsen-Taylor Hand Function Test (JHFT)], ipsilesional grip strength, contralesional arm impairment level [Fugl-Meyer Assessment (FM)], and functional independence [Functional independence measure (FIM)]","[{'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Maenza', 'Affiliation': 'Department of Neurology, Pennsylvania State University College of Medicine, Hershey, PA, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wagstaff', 'Affiliation': 'Department of Human Development and Family Studies, Pennsylvania State University, State College, PA, United States.'}, {'ForeName': 'Rini', 'Initials': 'R', 'LastName': 'Varghese', 'Affiliation': 'Department of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Carolee', 'Initials': 'C', 'LastName': 'Winstein', 'Affiliation': 'Department of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Good', 'Affiliation': 'Department of Neurology, Pennsylvania State University College of Medicine, Hershey, PA, United States.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Sainburg', 'Affiliation': 'Department of Neurology, Pennsylvania State University College of Medicine, Hershey, PA, United States.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2021.645714']
488,33776653,Influence of iTBS on the Acute Neuroplastic Change After BCI Training.,"Objective:  Brain-computer interface (BCI) training is becoming increasingly popular in neurorehabilitation. However, around one third subjects have difficulties in controlling BCI devices effectively, which limits the application of BCI training. Furthermore, the effectiveness of BCI training is not satisfactory in stroke rehabilitation. Intermittent theta burst stimulation (iTBS) is a powerful neural modulatory approach with strong facilitatory effects. Here, we investigated whether iTBS would improve BCI accuracy and boost the neuroplastic changes induced by BCI training.  Methods:  Eight right-handed healthy subjects (four males, age: 20-24) participated in this two-session study (BCI-only session and iTBS+BCI session in random order). Neuroplastic changes were measured by functional near-infrared spectroscopy (fNIRS) and single-pulse transcranial magnetic stimulation (TMS). In BCI-only session, fNIRS was measured at baseline and immediately after BCI training. In iTBS+BCI session, BCI training was followed by iTBS delivered on the right primary motor cortex (M1). Single-pulse TMS was measured at baseline and immediately after iTBS. fNIRS was measured at baseline, immediately after iTBS, and immediately after BCI training. Paired-sample  t -tests were used to compare amplitudes of motor-evoked potentials, cortical silent period duration, oxygenated hemoglobin (HbO2) concentration and functional connectivity across time points, and BCI accuracy between sessions.  Results:  No significant difference in BCI accuracy was detected between sessions ( p  > 0.05). In BCI-only session, functional connectivity matrices between motor cortex and prefrontal cortex were significantly increased after BCI training ( p 's < 0.05). In iTBS+BCI session, amplitudes of motor-evoked potentials were significantly increased after iTBS ( p 's < 0.05), but no change in HbO2 concentration or functional connectivity was observed throughout the whole session ( p 's > 0.05).  Conclusions:  To our knowledge, this is the first study that investigated how iTBS targeted on M1 influences BCI accuracy and the acute neuroplastic changes after BCI training. Our results revealed that iTBS targeted on M1 did not influence BCI accuracy or facilitate the neuroplastic changes after BCI training. Therefore, M1 might not be an effective stimulation target of iTBS for the purpose of improving BCI accuracy or facilitate its effectiveness; other brain regions (i.e., prefrontal cortex) are needed to be further investigated as potentially effective stimulation targets.",2021,"In BCI-only session, functional connectivity matrices between motor cortex and prefrontal cortex were significantly increased after BCI training ( p 's < 0.05).","['Eight right-handed healthy subjects (four males, age: 20-24']","['BCI training', 'iTBS', 'Brain-computer interface (BCI) training', 'Intermittent theta burst stimulation (iTBS']","['fNIRS', 'amplitudes of motor-evoked potentials, cortical silent period duration, oxygenated hemoglobin (HbO2) concentration and functional connectivity across time points, and BCI accuracy', 'HbO2 concentration or functional connectivity', 'Single-pulse TMS', 'amplitudes of motor-evoked potentials', 'Neuroplastic changes', 'Acute Neuroplastic Change', 'functional connectivity matrices between motor cortex and prefrontal cortex', 'BCI accuracy']","[{'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C2742590', 'cui_str': '2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0425943', 'cui_str': 'Duration of menstrual flow'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2742590', 'cui_str': '2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",24.0,0.017087,"In BCI-only session, functional connectivity matrices between motor cortex and prefrontal cortex were significantly increased after BCI training ( p 's < 0.05).","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Ding', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Tuo', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Manfeng', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Wanqi', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Jing', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Yulai', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Sichuan Provincial Rehabilitation Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Guangqing', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': ""Department of Rehabilitation Medicine, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Lan', 'Affiliation': ""Department of Rehabilitation Medicine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}]",Frontiers in cellular neuroscience,['10.3389/fncel.2021.653487']
489,33776633,Reduction of Pressure Pain Sensitivity as Novel Non-pharmacological Therapeutic Approach to Type 2 Diabetes: A Randomized Trial.,"Background


Autonomic nervous system dysfunction (ANSD) is known to affect glucose metabolism in the mammalian body. Tradition holds that glucose homeostasis is regulated by the peripheral nervous system, and contemporary therapeutic intervention reflects this convention.
Objectives


The present study tested the role of cerebral regulation of ANSD as consequence of novel understanding of glucose metabolism and treatment target in type 2 diabetes (T2D), suggested by the claim that the pressure pain sensitivity (PPS) of the chest bone periosteum may be a measure of cerebral ANSD.
Design


In a randomized controlled trial of 144 patients with T2D, we tested the claim that 6 months of this treatment would reduce PPS and improve peripheral glucose metabolism.
Results


In the active treatment group, mean glycated hemoglobin A1c (HbA1c) declined from 53.8 to 50.5 mmol/mol (intragroup  p  = 0.001), compared with the change from 53.8 to 53.4 mmol/mol in the control group, with the same level of diabetes treatment but not receiving the active treatment (between group  p  = 0.036). Mean PPS declined from 76.6 to 56.1 units ( p  < 0.001) in the active treatment group and from 77.5 to 72.8 units ( p  = 0.02; between group  p  < 0.001) in the control group. Changes of PPS and HbA1c were correlated ( r  = 0.37;  p  < 0.001).
Conclusion


We conclude that the proposed approach to treatment of T2D is a potential supplement to conventional therapy.
Clinical Trial Registration


www.clinicaltrials.gov (NCT03576430).",2021,Mean PPS declined from 76.6 to 56.1 units ( p  < 0.001) in the active treatment group and from 77.5 to 72.8 units ( p  = 0.02; between group  p  < 0.001) in the control group.,"['144 patients with T2D', 'Diabetes']",[],"['peripheral glucose metabolism', 'Pressure Pain Sensitivity', 'mean glycated hemoglobin A1c (HbA1c', 'Mean PPS', 'Changes of PPS and HbA1c']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",[],"[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0445074', 'cui_str': 'Mean pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",144.0,0.109522,Mean PPS declined from 76.6 to 56.1 units ( p  < 0.001) in the active treatment group and from 77.5 to 72.8 units ( p  = 0.02; between group  p  < 0.001) in the control group.,"[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Endocrine Unit, Department of Medicine, Herlev Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Ebbe', 'Initials': 'E', 'LastName': 'Eldrup', 'Affiliation': 'Endocrine Unit, Department of Medicine, Herlev Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Selmer', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Pichat', 'Affiliation': 'Endocrine Unit, Department of Medicine, Herlev Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Sofie Korsgaard', 'Initials': 'SK', 'LastName': 'Hecquet', 'Affiliation': 'Endocrine Unit, Department of Medicine, Herlev Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Torquil', 'Initials': 'T', 'LastName': 'Watt', 'Affiliation': 'Endocrine Unit, Department of Medicine, Herlev Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Svend', 'Initials': 'S', 'LastName': 'Kreiner', 'Affiliation': 'Institute of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Karpatschof', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gyntelberg', 'Affiliation': 'The National Research Center for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Ballegaard', 'Affiliation': 'Endocrine Unit, Department of Medicine, Herlev Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Gjedde', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen, Denmark.'}]",Frontiers in neuroscience,['10.3389/fnins.2021.613858']
490,33775985,Potential use of silver diammine fluoride in detection of carious dentin.,"This study aimed to examine whether discoloration of carious dentin after silver-diammine-fluoride (SDF) application might be used as a mean to detect demineralized-dentin. Fourty specimens were obtained from 20 human permanent teeth. Teeth were sectioned through the center of carious lesions to create 2-halves in which each half was assigned to a treatment group. Specimens were divided into two groups (n=20) (each half was assigned to one group) according to solution, namely Caries Check (CC), or SDF. SDF group was subdivided into 2 groups: light-cured and 2-day storage groups. The specimens were tested using light-microscope, microhardness test and SEM/EDS analysis. Repeated-measures ANOVA was used for statistical analysis. The light-microscope showed superficial discoloration in the CC-group while SDF (2-day storage) group showed deeper discoloration for the lesion area. SDF showed significant increase in the hardness compared with the CC-group. SDF showed potentiality to be used as an assisting-tool for caries detection.",2021,The light-microscope showed superficial discoloration in the CC-group while SDF (2-day storage) group showed deeper discoloration for the lesion area.,['carious dentin'],"['solution, namely Caries Check (CC), or SDF', 'silver diammine fluoride', 'SDF', 'silver-diammine-fluoride (SDF']","['hardness', 'superficial discoloration']","[{'cui': 'C1707305', 'cui_str': 'Carious Dentin'}]","[{'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C2713451', 'cui_str': 'caries check'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}]","[{'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}]",20.0,0.0237815,The light-microscope showed superficial discoloration in the CC-group while SDF (2-day storage) group showed deeper discoloration for the lesion area.,"[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Sayed', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU).'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Nikaido', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU).'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abdou', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU).'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Burrow', 'Affiliation': 'Faculty of Dentistry, University of Hong Kong.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tagami', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU).'}]",Dental materials journal,['10.4012/dmj.2020-308']
491,33775981,Efficacy of Extensive Ablation for Persistent Atrial Fibrillation With Trigger-Based vs. Substrate-Based Mechanisms　- A Prespecified Subanalysis of the EARNEST-PVI Trial.,"BACKGROUND


Extensive ablation in addition to pulmonary vein isolation (PVI) would be effective for modification of non-pulmonary vein (non-PV) substrates, whereas PVI might be sufficient for elimination of PV triggers. This study aimed to test the hypothesis that in patients with reproducible atrial fibrillation (AF) triggered by premature atrial contractions originating only from PVs, PVI alone can be sufficient to maintain sinus rhythm.Methods and Results:This study is a prespecified subanalysis of the EARNEST-PVI randomized controlled trial. This study investigated the efficacy of the PVI-alone strategy (PVI-alone) in comparison with the extensive strategy (PVI-plus) for persistent AF with a trigger-based mechanism vs. a substrate-based mechanism. Patients were stratified into 3 groups based on AF mechanisms: (1) Substrate group (N=236); (2) PV trigger group (N=236); and (3) non-PV trigger group (N=24). The hazard ratios for AF recurrence of the PVI-alone strategy with reference to the PVI-plus strategy were 1.456 (95% confidence interval [CI] [0.864-2.452]) in the substrate group, 1.648 (95% CI 0.969-2.801) in the PV trigger group, and 0.937 (95% CI 0.252-3.488) in the non-PV trigger group. No significant interaction between ablation strategy and AF mechanism was observed (P for interaction=0.748).
CONCLUSIONS


This study indicated that the efficacies of the PVI-alone strategy compared with the PVI-plus strategy were consistent across persistent AF with trigger-based and substrate-based mechanisms.",2021,"No significant interaction between ablation strategy and AF mechanism was observed (P for interaction=0.748).
",['patients with reproducible atrial fibrillation (AF) triggered by premature atrial contractions originating only from PVs'],"['PVI-alone strategy (PVI-alone', 'PV trigger group (N=236); and (3) non-PV trigger group', 'PVI alone', 'Extensive Ablation']","['hazard ratios for AF recurrence', 'ablation strategy and AF mechanism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}]","[{'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}]",,0.0986377,"No significant interaction between ablation strategy and AF mechanism was observed (P for interaction=0.748).
","[{'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Sotomi', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Masuda', 'Affiliation': 'Cardiovascular Center, Kansai Rosai Hospital.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Furukawa', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Hirata', 'Affiliation': 'Cardiovascular Division, Osaka Police Hospital.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Egami', 'Affiliation': 'Division of Cardiology, Osaka Rosai Hospital.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Minamiguchi', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Cardiology, Osaka Hospital, Japan Community Healthcare Organization.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Oka', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kanda', 'Affiliation': 'Cardiovascular Center, Kansai Rosai Hospital.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Cardiovascular Center, Kansai Rosai Hospital.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kawasaki', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center.'}, {'ForeName': 'Tetsuhisa', 'Initials': 'T', 'LastName': 'Kitamura', 'Affiliation': 'Department of Environmental Medicine and Population Sciences, Department of Social and Environmental Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Dohi', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Sunaga', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Mizuno', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Daisaku', 'Initials': 'D', 'LastName': 'Nakatani', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Shungo', 'Initials': 'S', 'LastName': 'Hikoso', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-21-0126']
492,33775930,"Proximal Optimisation Technique Versus Final Kissing Balloon Inflation in Coronary Bifurcation Lesions: the Randomised, Multicenter PROPOT Trial.","BACKGROUND


Clinical implications of proximal optimisation technique (POT) for bifurcation lesions have not been investigated in a randomised controlled trial.
AIMS


This study aimed to investigate whether proximal optimisation technique (POT) is superior in terms of stent apposition compared with the conventional kissing balloon technique (KBT) in real-life bifurcation lesions using optical coherence tomography (OCT).
METHODS


A total of 120 patients from 15 centres were randomised into two groups: POT followed by side branch dilation or KBT. Finally, 57 and 58 patients in the POT and KBT groups, respectively, were analysed. OCT was performed at baseline, immediately after wire recrossing to the side branch, and at the final procedure.
RESULTS


The primary endpoint was the rate of malapposed struts assessed by the final OCT. The rate of malapposed struts did not differ between the POT and KBT groups (in-stent proximal site: 10.4% vs. 7.7%, p=0.33; bifurcation core: 1.4% vs. 1.1%, p=0.67; core's distal edge: 6.2% vs. 5.3%, p=0.59). More additional treatments were required among the POT group (40.4% vs. 6.9%, p&lt;0.01). At 1-year follow-up, only one patient in each group underwent target lesion revascularisation (2.0% vs. 1.9%).
CONCLUSIONS


POT followed by side branch dilation did not show any advantages over conventional KBT in terms of stent apposition, however, the excellent mid-term clinical outcomes were observed in both strategies.",2021,"CONCLUSIONS


POT followed by side branch dilation did not show any advantages over conventional KBT in terms of stent apposition, however, the excellent mid-term clinical outcomes were observed in both strategies.","['120 patients from 15 centres', 'Coronary Bifurcation Lesions']","['optical coherence tomography (OCT', 'POT followed by side branch dilation or KBT', 'Proximal Optimisation Technique Versus Final Kissing Balloon Inflation', 'proximal optimisation technique (POT', 'conventional kissing balloon technique (KBT']","['rate of malapposed struts', 'rate of malapposed struts assessed by the final OCT']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0233926', 'cui_str': 'Kissing'}]","[{'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]",120.0,0.125096,"CONCLUSIONS


POT followed by side branch dilation did not show any advantages over conventional KBT in terms of stent apposition, however, the excellent mid-term clinical outcomes were observed in both strategies.","[{'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Department of Medicine, Division of Cardiology, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Murasato', 'Affiliation': ''}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Yamawaki', 'Affiliation': ''}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': ''}, {'ForeName': 'Munenori', 'Initials': 'M', 'LastName': 'Okubo', 'Affiliation': ''}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Yumoto', 'Affiliation': ''}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': ''}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Otake', 'Affiliation': ''}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Aoki', 'Affiliation': ''}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Nakazawa', 'Affiliation': ''}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Numasawa', 'Affiliation': ''}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': ''}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Shite', 'Affiliation': ''}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Okamura', 'Affiliation': ''}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Takagi', 'Affiliation': ''}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': ''}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lefèvre', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Louvard', 'Affiliation': ''}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': ''}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-01386']
493,33775867,Long-chain monounsaturated fatty acids improve endothelial function with altering microbial flora.,"Fish oil-derived long-chain monounsaturated fatty acids (LCMUFAs) with a carbon chain length longer than 18 units ameliorate cardiovascular risk in mice. In this study, we investigated whether LCMUFAs could improve endothelial functions in mice and humans. In a double-blind, randomized, placebo-controlled, parallel-group, multi-center study, healthy subjects were randomly assigned to either an LCMUFA oil (saury oil) or a control oil (olive and tuna oils) group. Sixty subjects were enrolled and administrated each oil for 4 weeks. For the animal study, ApoE -/-  mice were fed a Western diet supplemented with 3% of either gadoleic acid (C20:1) or cetoleic acid (C22:1) for 12 weeks. Participants from the LCMUFA group showed improvements in endothelial function and a lower trimethylamine-N-oxide level, which is a predictor of coronary artery disease. C20:1 and C22:1 oils significantly improved atherosclerotic lesions and plasma levels of several inflammatory cytokines, including IL-6 and TNF-α. These beneficial effects were consistent with an improvement in the gut microbiota environment, as evident from the decreased ratio of Firmicutes/Bacteroidetes, increase in the abundance of Akkermansia, and upregulation of short-chain fatty acid (SCFA)-induced glucagon-like peptide-1 (GLP-1) expression and serum GLP-1 level. These data suggest that LCMUFAs alter the microbiota environment that stimulate the production of SCFAs, resulting in the induction of GLP-1 secretion. Fish oil-derived long-chain monounsaturated fatty acids might thus help to protect against cardiovascular disease.",2021,"Participants from the LCMUFA group showed improvements in endothelial function and a lower trimethylamine-N-oxide level, which is a predictor of coronary artery disease.","['healthy subjects', 'Sixty subjects', 'mice and humans']","['Long-chain monounsaturated fatty acids', 'LCMUFA oil (saury oil) or a control oil (olive and tuna oils', 'gadoleic acid (C20:1) or cetoleic acid (C22:1', 'LCMUFAs', 'placebo', 'Fish oil-derived long-chain monounsaturated fatty acids (LCMUFAs', 'LCMUFA', 'Fish oil-derived long-chain monounsaturated fatty acids']","['atherosclerotic lesions and plasma levels of several inflammatory cytokines, including IL-6 and TNF-α', 'endothelial function and a lower trimethylamine-N-oxide level', 'abundance of Akkermansia, and upregulation of short-chain fatty acid (SCFA)-induced glucagon-like peptide-1 (GLP-1) expression and serum', 'endothelial functions', 'GLP-1 level', 'endothelial function']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0328541', 'cui_str': 'Family Scomberesocidae'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0228539', 'cui_str': 'Olivary nucleus structure'}, {'cui': 'C0041382', 'cui_str': 'Tuna'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0055148', 'cui_str': 'cetoleic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C1490589', 'cui_str': 'Akkermansia'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",60.0,0.245374,"Participants from the LCMUFA group showed improvements in endothelial function and a lower trimethylamine-N-oxide level, which is a predictor of coronary artery disease.","[{'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Takeo', 'Affiliation': 'Central Research Laboratory, Nippon Suisan Kaisha, Ltd, Tokyo, Japan 192-0991.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Miyahara', 'Affiliation': 'Central Research Laboratory, Nippon Suisan Kaisha, Ltd, Tokyo, Japan 192-0991.'}, {'ForeName': 'Mayu', 'Initials': 'M', 'LastName': 'Sebe', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Bando', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503.'}, {'ForeName': 'Yousuke', 'Initials': 'Y', 'LastName': 'Tanba', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503.'}, {'ForeName': 'Yuna', 'Initials': 'Y', 'LastName': 'Mishima', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Takeji', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503.'}, {'ForeName': 'Nanako', 'Initials': 'N', 'LastName': 'Ueshima', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kuroda', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503.'}, {'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Masumoto', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503.'}, {'ForeName': 'Nagakatsu', 'Initials': 'N', 'LastName': 'Harada', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503.'}, {'ForeName': 'Daiju', 'Initials': 'D', 'LastName': 'Fukuda', 'Affiliation': 'Department of Cardiovascular Medicine, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Yoshimoto', 'Affiliation': 'Tokushima Prefectural Industrial Technology Centre, Tokushima, Japan 770-8021.'}, {'ForeName': 'Yasuo M', 'Initials': 'YM', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Anesthesiology and Critical Care, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan,734-8551.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Aihara', 'Affiliation': 'Department of Community Medicine and Medical Science, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503; Diabetes Therapeutics and Research Centre, Tokushima University, Tokushima, Japan 770-8503.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Sata', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503; Central Research Laboratory, Nippon Suisan Kaisha, Ltd, Tokyo, Japan 192-0991; Department of Cardiovascular Medicine, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503; Tokushima Prefectural Industrial Technology Centre, Tokushima, Japan 770-8021; Department of Anesthesiology and Critical Care, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan,734-8551; Department of Community Medicine and Medical Science, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503; Diabetes Therapeutics and Research Centre, Tokushima University, Tokushima, Japan 770-8503.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sakaue', 'Affiliation': 'Department of Nutrition and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan 770-8503; Diabetes Therapeutics and Research Centre, Tokushima University, Tokushima, Japan 770-8503. Electronic address: hsakaue@tokushima-u.ac.jp.'}]",Translational research : the journal of laboratory and clinical medicine,['10.1016/j.trsl.2021.03.016']
494,33775745,Different neurocognitive profiles of risperidone and aripiprazole in the FIRST episode of psychosis: A 3-year follow-up comparison.,"Cognitive deficits have been recognized as a central feature of schizophrenia spectrum disorders. These deficits are often related to more severe negative symptoms, as well as a poorer adjustment in social functioning. Therefore, it is important to improve cognitive performance from the onset of the disease. In this study, we compared the effects of two atypical antipsychotics, risperidone and aripiprazole, on cognition. The data used in the present investigation were obtained from a large epidemiological cohort of patients with a first episode of psychosis who were treated in a longitudinal intervention programme. The patients included in the program were randomized to treatment with risperidone or aripiprazole and were assessed for cognitive function at baseline and 3 years later. The final sample consisted of 115 patients, 55 of whom were initially assigned to risperidone and 60 to aripiprazole. The groups did not show significant differences in their sociodemographic or clinical characteristics at intake. Longitudinal analyses showed that risperidone-treated patients improved in the processing speed domain at the 3-year follow-up, while the aripiprazole group showed better scores for the executive function domain. Our study shows slight differences between the effects of risperidone and aripiprazole on cognition, suggesting different patterns of efficacy on cognitive function that may warrant more thorough research to determine the beneficial effects of these drugs on cognition. Future studies should evaluate the effects of these treatments over longer follow-up periods using standardized tools for the assessment of cognitive function.",2021,"Longitudinal analyses showed that risperidone-treated patients improved in the processing speed domain at the 3-year follow-up, while the aripiprazole group showed better scores for the executive function domain.","['patients with a first episode of psychosis who were treated in a longitudinal intervention programme', '115 patients, 55 of whom were initially assigned to']","['risperidone or aripiprazole', 'atypical antipsychotics, risperidone and aripiprazole', 'risperidone', 'aripiprazole', 'risperidone and aripiprazole']","['cognitive performance', 'processing speed domain', 'cognitive function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",115.0,0.0170887,"Longitudinal analyses showed that risperidone-treated patients improved in the processing speed domain at the 3-year follow-up, while the aripiprazole group showed better scores for the executive function domain.","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Setién-Suero', 'Affiliation': 'University Hospital Marqués de Valdecilla, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain; IDIVAL, Valdecilla Biomedical Research Institute, Santander, Spain.. Electronic address: setiensuero@hotmail.com.'}, {'ForeName': 'Víctor Ortiz-García', 'Initials': 'VO', 'LastName': 'de la Foz', 'Affiliation': 'University Hospital Marqués de Valdecilla, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain; IDIVAL, Valdecilla Biomedical Research Institute, Santander, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Suárez-Pinilla', 'Affiliation': 'University Hospital Marqués de Valdecilla, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain.'}, {'ForeName': 'Benedicto', 'Initials': 'B', 'LastName': 'Crespo-Facorro', 'Affiliation': 'CIBERSAM, Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain; University Hospital Virgen del Rocío, Department of Psychiatry, Instituto de Investigación Sanitaria de Sevilla, IBiS, Sevilla, Spain; University of Sevilla, Sevilla, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Ayesa-Arriola', 'Affiliation': 'University Hospital Marqués de Valdecilla, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain; IDIVAL, Valdecilla Biomedical Research Institute, Santander, Spain.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2021.110309']
495,33775127,Effect of Intensive Blood Pressure Control on Aortic Stiffness in the SPRINT-HEART.,"In a subgroup of 337 participants (mean age 64±9 years; 45% women) from the SPRINT (Systolic Blood Pressure Intervention Trial), where participants were randomly assigned to intensive treatment (target systolic blood pressure <120 mm Hg) versus standard treatment (<140 mm Hg), we examined the effect of intensive blood pressure lowering on indexes of aortic stiffness. Carotid-femoral pulse wave velocity, a validated global measure of aortic stiffness, was measured by echo-guided Doppler at baseline and 18-month follow-up visit. Aortic elastance, distensibility, and compliance were measured by cardiac magnetic resonance imaging. During follow-up, the intensive treatment produced a mean between-group reduction in systolic blood pressure of 12.7 mm Hg (95% CI, 11.1-14.3 mm Hg). During follow-up, intensive treatment significantly attenuated the increase in carotid-femoral pulse wave velocity compared with standard treatment (adjusted follow-up least square mean=9.0 m/s [95% CI, 8.7-9.3] versus 10.0 m/s [9.6-10.3];  P <0.001), an effect that persisted even after adjusting for mean arterial pressure. Intensive treatment also decreased the aortic elastance index (least square mean, 1.38 mm Hg/mL per m 2  [95% CI, 1.34-1.41] versus 1.48 mm Hg/mL per m 2  [95% CI, 1.44-1.51],  P =0.002) compared with standard treatment. No significant between-group differences were observed for aortic distensibility and compliance. We conclude that intensive treatment significantly attenuated increases in carotid-femoral pulse wave velocity and aortic elastance index. Attenuation of increases in aortic stiffness may be one of the mechanisms contributing to the benefit of intensive blood pressure treatment observed in SPRINT. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01206062.",2021,"Intensive treatment also decreased the aortic elastance index (least square mean, 1.38 mm Hg/mL per m 2  [95% CI, 1.34-1.41] versus 1.48 mm",['337 participants (mean age 64±9 years; 45% women) from the SPRINT (Systolic Blood Pressure Intervention Trial'],"['intensive blood pressure lowering', 'intensive treatment (target systolic blood pressure <120 mm Hg) versus standard treatment', 'Intensive Blood Pressure Control']","['carotid-femoral pulse wave velocity', 'systolic blood pressure', 'carotid-femoral pulse wave velocity and aortic elastance index', 'aortic distensibility and compliance', 'Aortic elastance, distensibility, and compliance', 'mean arterial pressure', 'aortic elastance index']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1277632', 'cui_str': 'Target systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",337.0,0.162406,"Intensive treatment also decreased the aortic elastance index (least square mean, 1.38 mm Hg/mL per m 2  [95% CI, 1.34-1.41] versus 1.48 mm","[{'ForeName': 'Bharathi', 'Initials': 'B', 'LastName': 'Upadhya', 'Affiliation': 'Cardiovascular Medicine Section, Wake Forest School of Medicine, Winston-Salem, NC. (B.U., D.W.K.).'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC. (N.M.P.).'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Nephrology Section, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC. (M.V.R.).'}, {'ForeName': 'W Gregory', 'Initials': 'WG', 'LastName': 'Hundley', 'Affiliation': 'Pauley Heart Center Department of Internal Medicine at Virginia Commonwealth University Health Sciences Richmond (W.G.H.).'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Aurigemma', 'Affiliation': 'Cardiovascular Medicine Section, University of Massachusetts Medical School, Worcester (G.A.).'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Hamilton', 'Affiliation': 'Biomedical Engineering, Wake Forest School of Medicine, Winston-Salem, NC. (C.A.H.).'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': 'Department of Medicine, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, TX (J.T.B., A.T.).'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Division of Nephrology & Hypertension, Tulane University School of Public Health and Tropical Medicine, Department of Medicine, Tulane University, New Orleans, LA (J.H., J.C.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Division of Nephrology & Hypertension, Tulane University School of Public Health and Tropical Medicine, Department of Medicine, Tulane University, New Orleans, LA (J.H., J.C.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora (M.C.).'}, {'ForeName': 'Steve P', 'Initials': 'SP', 'LastName': 'Glasser', 'Affiliation': 'UAB School of Public Health, University of Alabama, Birmingham (S.P.G.).'}, {'ForeName': 'Adriana M', 'Initials': 'AM', 'LastName': 'Hung', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN (A.M.H.).'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pisoni', 'Affiliation': 'Nephrology Section, Medical University of South Carolina, Ralph H. Johnson VA Medical Center, Charleston (R.P.).'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Internal Medicine, Trinity Hypertension and Metabolic Research Institute, Punzi Medical Center, Carrollton, TX (H.P.).'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Supiano', 'Affiliation': 'Geriatrics Division, VA Salt Lake City Geriatric Research, Education, and Clinical Center, University of Utah School of Medicine University of Utah School of Medicine, Salt Lake City (M.A.S.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Toto', 'Affiliation': 'Nephrology Section, University of Texas Southwestern Medical Center, Dallas (R.T.).'}, {'ForeName': 'Addison', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, TX (J.T.B., A.T.).'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Cardiovascular Medicine Section, Wake Forest School of Medicine, Winston-Salem, NC. (B.U., D.W.K.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.16676']
496,33775122,"Associations Between Relative Morning Blood Pressure, Cerebral Blood Flow, and Memory in Older Adults Treated and Controlled for Hypertension.","Hypertension, elevated morning blood pressure (BP) surges, and circadian BP variability constitute risk factors for cerebrovascular events. Nevertheless, while evidence indicates that hypertension is associated with cognitive dysfunctions, the link between BP variability and cognitive performance during aging is not clear. The purpose of this study is to determine the interaction between relative morning BP, cerebral blood flow (CBF) levels, and cognitive performance in hypertensive older adults with controlled BP under antihypertensive treatment. Eighty-four participants aged between 60 and 75 years old were separated into normotensive (n=51) and hypertensive (n=33) groups and underwent 24-hour ambulatory BP monitoring. They were also examined for CBF in the gray matter (CBF-GM) by magnetic resonance imaging and 5 cognitive domains: global cognition, working memory, episodic memory, processing speed, and executive functions. There was no difference in cognitive performance and CBF between normotensive and controlled hypertensive participants. Through a sensitivity analysis, we identified that, among relative morning BP variables, the best fit for CBF values in this cohort was the morning-evening difference in BP. The relative morning BP was negatively associated with CBF-GM in these hypertensive older adults only. In turn, CBF-GM levels were negatively associated with working and episodic memory scores in hypertensive older adults. This is the first extended study demonstrating an association between high relative morning BP and lower levels of CBF-GM, including the further impact of CBF-GM levels on the cognitive performance of specific domains in a community-based cohort of older adults with hypertension.",2021,There was no difference in cognitive performance and CBF between normotensive and controlled hypertensive participants.,"['Eighty-four participants aged between 60 and 75 years old were separated into normotensive (n=51) and hypertensive (n=33) groups and underwent', 'hypertensive older adults with controlled BP under antihypertensive treatment', 'Older Adults Treated and Controlled for Hypertension', 'older adults with hypertension', 'hypertensive older adults']",['24-hour ambulatory BP monitoring'],"['Hypertension, elevated morning blood pressure (BP) surges, and circadian BP variability constitute risk factors for cerebrovascular events', 'relative morning BP, cerebral blood flow (CBF) levels, and cognitive performance', 'CBF values', 'BP variability and cognitive performance', 'relative morning BP', 'CBF-GM levels', 'working and episodic memory scores', 'cognitive domains: global cognition, working memory, episodic memory, processing speed, and executive functions', 'Relative Morning Blood Pressure, Cerebral Blood Flow, and Memory', 'cognitive performance and CBF']","[{'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",84.0,0.0901245,There was no difference in cognitive performance and CBF between normotensive and controlled hypertensive participants.,"[{'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Noriega de la Colina', 'Affiliation': ""Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM), Montreal, QC, Canada (A.N.C. A.B., M.-C.R.-G., C.G., L.B., J.C.-A., H.G.).""}, {'ForeName': 'Atef', 'Initials': 'A', 'LastName': 'Badji', 'Affiliation': ""Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM), Montreal, QC, Canada (A.N.C. A.B., M.-C.R.-G., C.G., L.B., J.C.-A., H.G.).""}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Robitaille-Grou', 'Affiliation': ""Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM), Montreal, QC, Canada (A.N.C. A.B., M.-C.R.-G., C.G., L.B., J.C.-A., H.G.).""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Gagnon', 'Affiliation': ""Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM), Montreal, QC, Canada (A.N.C. A.B., M.-C.R.-G., C.G., L.B., J.C.-A., H.G.).""}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Boshkovski', 'Affiliation': 'NeuroPoly Laboratory, Institute of Biomedical Engineering, Polytechnique Montréal, QC, Canada (A.B., T.B., J.C.-A.).'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Lamarre-Cliche', 'Affiliation': 'Institut de Recherches Cliniques de Montreal (IRCM), Université de Montreal, QC, Canada. (M.L.-C.).'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Joubert', 'Affiliation': 'Department of Psychology, Faculty of Arts and Science, Université de Montreal, QC, Canada.s (S.J.).'}, {'ForeName': 'Claudine J', 'Initials': 'CJ', 'LastName': 'Gauthier', 'Affiliation': 'Montreal Heart Institute (MHI), Montreal, QC, Canada (A.N.C., C.G., C.J.G., L.B.).'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bherer', 'Affiliation': ""Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM), Montreal, QC, Canada (A.N.C. A.B., M.-C.R.-G., C.G., L.B., J.C.-A., H.G.).""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Cohen-Adad', 'Affiliation': ""Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM), Montreal, QC, Canada (A.N.C. A.B., M.-C.R.-G., C.G., L.B., J.C.-A., H.G.).""}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Girouard', 'Affiliation': ""Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM), Montreal, QC, Canada (A.N.C. A.B., M.-C.R.-G., C.G., L.B., J.C.-A., H.G.).""}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.16124']
497,33775120,Pregnancy Outcomes and Blood Pressure Visit-to-Visit Variability and Level in Three Less-Developed Countries.,"In pregnancy in well-resourced settings, limited data suggest that higher blood pressure (BP) visit-to-visit variability may be associated with adverse pregnancy outcomes. Included were pregnant women in 22 intervention clusters of the CLIP (Community-Level Interventions for Preeclampsia) cluster randomized trials, who had received at least 2 prenatal contacts from a community health worker, including standardized BP measurement. Mixed-effects adjusted logistic regression assessed relationships between pregnancy outcomes and both BP level (median [interquartile range]) and visit-to-visit variability (SD and average real variability [ARV], adjusted for BP level), among all women and those who became hypertensive. The primary outcome was the CLIP composite of maternal and perinatal mortality and morbidity. Among 17 770 pregnancies, higher systolic and diastolic BP levels were associated with increased odds of the composite outcome per 5 mm Hg increase in BP (odds ratio [OR], 1.05 [95% CI, 1.03-1.07] and OR, 1.08 [1.06-1.11], respectively). Higher BP visit-to-visit variability was associated with increased odds, per a SD increase in BP variability measure, of (1) hypertension (systolic: OR, 2.09 [1.98-2.21] for SD and 1.52 [1.45-1.60] for ARV; diastolic: OR, 2.70 [2.54-2.87] for SD and 1.86 [1.76-1.96] for ARV); and (2) the composite outcome (systolic: OR, 1.10 [1.06-1.14] for SD and 1.06 [1.02-1.10] for ARV; diastolic: OR, 1.07 [1.03-1.11] for SD and 1.06 [1.02-1.09] for ARV). In 3 less-developed countries, higher BP level and visit-to-visit variability predicted adverse pregnancy outcomes, providing an opportunity for high-definition medicine.",2021,"Higher BP visit-to-visit variability was associated with increased odds, per a SD increase in BP variability measure, of (1) hypertension (systolic: OR, 2.09 [1.98-2.21] for SD and 1.52","['Included were pregnant women in 22 intervention clusters of the CLIP (Community-Level Interventions for Preeclampsia) cluster randomized trials, who had received at least 2 prenatal contacts from a community health worker, including standardized BP measurement', '17 770 pregnancies']",[],"['BP', 'Pregnancy Outcomes and Blood Pressure Visit-to-Visit Variability and Level', 'systolic and diastolic BP levels', 'BP level and visit-to-visit variability predicted adverse pregnancy outcomes', 'BP level (median [interquartile range]) and visit-to-visit variability (SD and average real variability [ARV], adjusted for BP level', 'blood pressure (BP) visit-to-visit variability', 'BP variability measure, of (1) hypertension', 'CLIP composite of maternal and perinatal mortality and morbidity', 'Higher BP visit-to-visit variability']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.456949,"Higher BP visit-to-visit variability was associated with increased odds, per a SD increase in BP variability measure, of (1) hypertension (systolic: OR, 2.09 [1.98-2.21] for SD and 1.52","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, United Kingdom. (L.A.M., H.L.N., A.H.S., P.v.D.).""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, Canada. (L.A.M., J.B., M.V., P.v.D.).""}, {'ForeName': 'Salwa Banoo', 'Initials': 'SB', 'LastName': 'Owasil', 'Affiliation': ""GKT School of Biomedical Sciences, King's College London, United Kingdom. (S.B.O.).""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, Vancouver, Canada. (J.S., T.L.).'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, Vancouver, Canada. (J.S., T.L.).'}, {'ForeName': 'Mrutunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Belagavi, Karnataka, India (M.B.B., S.S.G.).""}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Belagavi, Karnataka, India (M.B.B., S.S.G.).""}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Logan', 'Affiliation': 'Department of Medicine, University of Toronto, Canada (A.G.L.).'}, {'ForeName': 'Salésio E', 'Initials': 'SE', 'LastName': 'Macuacua', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça, Manhiça, Mozambique (S.E.M., E.S., A.V.).'}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': 'S Nijalingappa Medical College, Hanagal Shree Kumareshwar Hospital and Research Centre, Bagalkote, Karnataka, India (A.A.M.).'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, United Kingdom. (L.A.M., H.L.N., A.H.S., P.v.D.).""}, {'ForeName': 'Rahat N', 'Initials': 'RN', 'LastName': 'Qureshi', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Karachi, Pakistan (R.N.Q., Z.A.B.).'}, {'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça, Manhiça, Mozambique (S.E.M., E.S., A.V.).'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, United Kingdom. (L.A.M., H.L.N., A.H.S., P.v.D.).""}, {'ForeName': 'Anifa', 'Initials': 'A', 'LastName': 'Valá', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça, Manhiça, Mozambique (S.E.M., E.S., A.V.).'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, Canada. (L.A.M., J.B., M.V., P.v.D.).""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Karachi, Pakistan (R.N.Q., Z.A.B.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, United Kingdom. (L.A.M., H.L.N., A.H.S., P.v.D.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.16851']
498,33775118,Visit-to-Visit Blood Pressure Variability and Clinical Outcomes in Patients With Heart Failure With Preserved Ejection Fraction.,"Whether visit-to-visit blood pressure variability (BPV) is associated with adverse outcomes in patients with heart failure (HF) with preserved ejection fraction is unclear. We assessed these associations in 3184 patients with HF (51.0% women; mean age, 68.6 years) with preserved ejection fraction (≥45%) enrolled in the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist). BPV indexes were the SD, variability independent of the mean, and average real variability. The primary end point consisted of total mortality, myocardial infarction, stroke, and hospitalized HF. We computed hazard ratios for the risks associated with 1-SD increase in BPV indexes, using multivariable Cox regression to adjust for the BP level and confounders. In the placebo group (n=1577), the primary composite end point, stroke, and hospitalized HF were significantly associated with systolic and diastolic BPV (hazard ratios, ≥1.28;  P ≤0.008) and total mortality with systolic BPV (hazard ratios ≥1.20;  P ≤0.010). In the spironolactone group (n=1607), the primary end point and hospitalized HF were associated with both systolic and diastolic BPV (hazard ratios ≥1.17;  P ≤0.006). Sensitivity analyses stratified by sex, median age, and region generated confirmatory results. Most of the interactions between randomized group and BPV indexes were not significant. In conclusion, in patients with HF with preserved ejection fraction, greater systolic and diastolic BPV were associated with adverse health outcomes over and beyond the BP level.",2021,Most of the interactions between randomized group and BPV indexes were not significant.,"['patients with heart failure (HF', 'Patients With Heart Failure With Preserved Ejection Fraction', '3184 patients with HF (51.0% women; mean age, 68.6 years) with preserved ejection fraction (≥45%) enrolled in the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist']","['placebo', 'spironolactone']","['total mortality with systolic BPV (hazard ratios', 'systolic and diastolic BPV', 'stroke, and hospitalized HF', 'total mortality, myocardial infarction, stroke, and hospitalized HF', 'BPV indexes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",3184.0,0.258738,Most of the interactions between randomized group and BPV indexes were not significant.,"[{'ForeName': 'Fang-Fei', 'Initials': 'FF', 'LastName': 'Wei', 'Affiliation': 'Department of Cardiology, Sun Yat-sen University, Guangzhou, Guangdong, China. (F.-F.W., Y.Z., R.X., B.D., X.H., W.L., Y.W., J.J., J.H., Y.D., J.Z., C.L.).'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, Sun Yat-sen University, Guangzhou, Guangdong, China. (F.-F.W., Y.Z., R.X., B.D., X.H., W.L., Y.W., J.J., J.H., Y.D., J.Z., C.L.).'}, {'ForeName': 'Lutgarde', 'Initials': 'L', 'LastName': 'Thijs', 'Affiliation': 'Studies Coordinating Centre, Research Unit Hypertension and Cardiovascular Epidemiology, Department of Cardiovascular Sciences, University of Leuven, Belgium. (L.T.).'}, {'ForeName': 'Ruicong', 'Initials': 'R', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiology, Sun Yat-sen University, Guangzhou, Guangdong, China. (F.-F.W., Y.Z., R.X., B.D., X.H., W.L., Y.W., J.J., J.H., Y.D., J.Z., C.L.).'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, Sun Yat-sen University, Guangzhou, Guangdong, China. (F.-F.W., Y.Z., R.X., B.D., X.H., W.L., Y.W., J.J., J.H., Y.D., J.Z., C.L.).'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, Sun Yat-sen University, Guangzhou, Guangdong, China. (F.-F.W., Y.Z., R.X., B.D., X.H., W.L., Y.W., J.J., J.H., Y.D., J.Z., C.L.).'}, {'ForeName': 'Weihao', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, Sun Yat-sen University, Guangzhou, Guangdong, China. (F.-F.W., Y.Z., R.X., B.D., X.H., W.L., Y.W., J.J., J.H., Y.D., J.Z., C.L.).'}, {'ForeName': 'Yuzhong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Sun Yat-sen University, Guangzhou, Guangdong, China. (F.-F.W., Y.Z., R.X., B.D., X.H., W.L., Y.W., J.J., J.H., Y.D., J.Z., C.L.).'}, {'ForeName': 'Jingzhou', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Sun Yat-sen University, Guangzhou, Guangdong, China. (F.-F.W., Y.Z., R.X., B.D., X.H., W.L., Y.W., J.J., J.H., Y.D., J.Z., C.L.).'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Sun Yat-sen University, Guangzhou, Guangdong, China. (W.T.).'}, {'ForeName': 'Jiangui', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, Sun Yat-sen University, Guangzhou, Guangdong, China. (F.-F.W., Y.Z., R.X., B.D., X.H., W.L., Y.W., J.J., J.H., Y.D., J.Z., C.L.).'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Staessen', 'Affiliation': 'Biomedical Science Group, University of Leuven, Belgium. (J.A.S.).'}, {'ForeName': 'Yugang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, Sun Yat-sen University, Guangzhou, Guangdong, China. (F.-F.W., Y.Z., R.X., B.D., X.H., W.L., Y.W., J.J., J.H., Y.D., J.Z., C.L.).'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Sun Yat-sen University, Guangzhou, Guangdong, China. (F.-F.W., Y.Z., R.X., B.D., X.H., W.L., Y.W., J.J., J.H., Y.D., J.Z., C.L.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Sun Yat-sen University, Guangzhou, Guangdong, China. (F.-F.W., Y.Z., R.X., B.D., X.H., W.L., Y.W., J.J., J.H., Y.D., J.Z., C.L.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.16757']
499,33775082,Altered squat movement pattern in patients with chronic low back pain.,"INTRODUCTION AND OBJECTIVE


Low back pain (LBP) is a problem which causes human suffering and entails costs for treatment. Chronic LBP is considered a civilization diseases in developed countries and one of the major public health problem worldwide. Squatting is a part of such daily activities as sitting down, standing up or lifting objects. In this study, hip, knee, and ankle joint motions during squatting are analyzed in the sagittal plane. The aim of the study was to find a relationship between the function of the lower limb during squatting and LBP incidence.
MATERIAL AND METHODS


Eleven healthy subjects and eight subjects suffering from low back pain were enrolled in tes study. Participants performed squat while maintaining heel contact with the ground throughout the movement. The participants attempted to make a squat as deep as possible. Kinematic data were captured using a Vicon optical motion capture system.
RESULTS


The low back pain group had a greater range of motion of the hip and knee with reference to the ankle joint motion, compared to the control group. There was no statistically significant difference in ankle dorsiflexion between groups. Control group reached maximal ankle dorsiflexion at higher point of descent than LBP group.
CONCLUSIONS


The findings support the hypothesis that the strategy of movement is different in subjects with and without back pain. They may suggest that subjects with low back pain in maximal squat use the hip joint and knee joint to a greater extent than subjects without back pain, with comparable ankle dorsiflexion. Clinicians should take into consideration the influence of ankle motion and timing on exercise biomechanics in persons suffering from low back pain.",2021,"The low back pain group had a greater range of motion of the hip and knee with reference to the ankle joint motion, compared to the control group.","['Eleven healthy subjects and eight subjects suffering from low back pain were enrolled in tes study', 'subjects with and without back pain', 'persons suffering from low back pain', 'patients with chronic low back pain']",[],"['range of motion of the hip and knee with reference to the ankle joint motion', 'ankle dorsiflexion', 'maximal ankle dorsiflexion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]",[],"[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",11.0,0.0359999,"The low back pain group had a greater range of motion of the hip and knee with reference to the ankle joint motion, compared to the control group.","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Zawadka', 'Affiliation': 'Department of Sports Medicine, Faculty of Health Sciences, Medical University, Lublin, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Smołka', 'Affiliation': 'Department of Computer Science, Faculty of Electrical Engineering and Computer Science, University of Technology, Lublin, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Skublewska-Paszkowska', 'Affiliation': 'Department of Computer Science, Faculty of Electrical Engineering and Computer Science, University of Technology, Lublin, Poland.'}, {'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Łukasik', 'Affiliation': 'Department of Computer Science, Faculty of Electrical Engineering and Computer Science, University of Technology, Lublin, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Zieliński', 'Affiliation': 'Department of Sports Medicine, Faculty of Health Sciences, Medical University, Lublin, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Byś', 'Affiliation': 'Department of Sports Medicine, Faculty of Health Sciences, Medical University, Lublin, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Gawda', 'Affiliation': 'Department of Sports Medicine, Faculty of Health Sciences, Medical University, Lublin, Poland.'}]",Annals of agricultural and environmental medicine : AAEM,['10.26444/aaem/117708']
500,33775019,Emollient Therapy in Preterm & Low Birth Weight Neonates: A Randomised Clinical Trial.,"OBJECTIVE


To assess the impact of emollient therapy on gain in weight and length among preterm and low birth weight babies.
STUDY DESIGN


Randomised controlled trial.
PLACE AND DURATION OF STUDY


Department of Pediatric Medicine, KEMU / Mayo Hospital Lahore, from January till June 2018.
METHODOLOGY


Infants with birth weight between 1.5 and 2.5 Kgs or preterm neonates born between 28 and 37 completed weeks of gestation were included in the study. Neonates with genetic syndrome, infection or with a history of admission in NICU due to any reason, were excluded. They were randomly divided into two groups-A and B, by lottery method. Mothers of the neonates in group A were advised massage with sunflower oil; while mothers of the neonates in group B were advised massage without any emollient. Babies were closely followed up and their weight and length were measured at two months of age and were analysed using SPSS version 23.0.
RESULTS


For 140 neonates, the mean increase in weight was 489.84 ± 297.48 grams among group-A neonates (emollient therapy group) and it was 373.43 ± 276.31 grams among group-B neonates (p = 0.018). The mean increase in length was 6.5 ± 1.1 cm, among group-A neonates and 4.8 ± 1.3 cm in group-B neonates (p ˂0.001).  Conclusion: Massage with emollient therapy leads to significantly more increase in weight and length compared to massage alone, among preterm and low birth weight neonates. Emollient therapy is an effective non-pharmacological intervention for increasing weight and length in low birth weight and preterm neonates. Key Words:  Emollient, Massage, Low birth weight, Preterm neonates, Weight, Length.",2021,Emollient therapy is an effective non-pharmacological intervention for increasing weight and length in low birth weight and preterm neonates.,"['preterm and low birth weight babies', 'Infants with birth weight between 1.5 and 2.5 Kgs or preterm neonates born between 28 and 37 completed weeks of gestation were included in the study', 'low birth weight and preterm neonates', 'Preterm & Low Birth Weight Neonates', 'Neonates with genetic syndrome, infection or with a history of admission in NICU due to any reason, were excluded']","['Emollient therapy', 'emollient therapy', 'Emollient Therapy', 'advised massage without any emollient', 'Massage with emollient therapy', 'advised massage with sunflower oil']","['mean increase in weight', 'mean increase in length', 'gain in weight and length', 'weight and length']","[{'cui': 'C1963897', 'cui_str': 'Low birth weight baby'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0019247', 'cui_str': 'Hereditary disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0013983', 'cui_str': 'Emollient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",,0.212759,Emollient therapy is an effective non-pharmacological intervention for increasing weight and length in low birth weight and preterm neonates.,"[{'ForeName': 'Abdul Ahad', 'Initials': 'AA', 'LastName': 'Jamshaid', 'Affiliation': 'Department of Paediatric Medicine, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Muhammad Haroon', 'Initials': 'MH', 'LastName': 'Hamid', 'Affiliation': 'Department of Paediatric Medicine, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Tehreem', 'Initials': 'T', 'LastName': 'Fatima', 'Affiliation': 'Department of Paediatric Medicine, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Misbah', 'Initials': 'M', 'LastName': 'Noor', 'Affiliation': 'Department of Paediatric Medicine, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Areeba', 'Initials': 'A', 'LastName': 'Wasim', 'Affiliation': 'Department of Paediatric Medicine, King Edward Medical University, Lahore, Pakistan.'}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2021.03.298']
501,33774971,Effect Of Interpersonal Communication Training Program On Child's Immunization Among Mothers Living In Kebbi State Of Nigeria.,"BACKGROUND


Sharing of information through health education training of mothers on child vaccination has proved an effective intervention for better outcome and increased immunization coverage. This study aimed to examine the effect of interpersonal communication (IPC) training program on mothers' knowledge of child's vaccination and routine childhood immunization uptake in local government areas (LGAs) of Kebbi State, Nigeria.
METHODS


A quasi-experimental study was conducted in two local government areas in Kebbi State, from October 2016 to March 2017. Four hundred twenty mothers participated in the study and were allocated equally (210) in both intervention and control group (n=210) and data were collected on vaccination status of the children after intervention from children's vaccination cards and mother's verbal reports. Independent t test and Chi-square were used to test the effect of intervention on mother's knowledge of child's vaccination and routine childhood immunization uptake between intervention and control group. Study was ethically approved from the review board of Ministry of Health, Nigeria.
RESULTS


Mean knowledge scores has improved in the intervention group (M = 5.42, SD = 3.35) and control group (M=1.96, SD=2.37) after intervention with p<0.001. Routine childhood immunization uptake fully immunized (53.8% vs. 9.5%), partially immunized (16.6% vs. 32.8%) and un-immunized (29.5% vs. 57.6%) in both group after intervention with p<0.001. Approximately fifty-four percentages of children in the intervention group were fully immunized after intervention. However, there was minimal change of 2% has been observed in control group. Percentage of unimmunized children was high in both groups at pre-intervention (66%) but this decreased to 29.5% in the intervention group and 57.6% in the control group.
CONCLUSIONS


This study concludes that, IPC skill is an effective intervention and a sustainable service for improving the knowledge and uptake of mother's face-to-face education, social mobilization and reminder services about routine childhood immunization within entire population.",2021,"Mean knowledge scores has improved in the intervention group (M = 5.42, SD = 3.35) and control group (M=1.96, SD=2.37) after intervention with p<0.001.","['A quasi-experimental study was conducted in two local government areas in Kebbi State, from October 2016 to March 2017', 'Mothers Living', ""mothers' knowledge of child's vaccination and routine childhood immunization uptake in local government areas (LGAs) of Kebbi State, Nigeria"", ""Four hundred twenty mothers participated in the study and were allocated equally (210) in both intervention and control group (n=210) and data were collected on vaccination status of the children after intervention from children's vaccination cards and mother's verbal reports""]","['Interpersonal Communication Training Program', 'interpersonal communication (IPC) training program']",['Mean knowledge scores'],"[{'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026788', 'cui_str': 'Government, Local'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0857209', 'cui_str': 'Routine childhood immunization'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1443394', 'cui_str': 'Vaccination status'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0460109', 'cui_str': 'Verbal report'}]","[{'cui': 'C0086792', 'cui_str': 'Personal Communication'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",420.0,0.00504715,"Mean knowledge scores has improved in the intervention group (M = 5.42, SD = 3.35) and control group (M=1.96, SD=2.37) after intervention with p<0.001.","[{'ForeName': 'Saudat Abdullahi', 'Initials': 'SA', 'LastName': 'Basheer', 'Affiliation': 'College of Public Health, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'College of Public Health, Chulalongkorn University, Bangkok, Thailand and Health Services Academy, Islamabad, Pakistan.'}, {'ForeName': 'Pramon', 'Initials': 'P', 'LastName': 'Viwattanakulvanid', 'Affiliation': 'College of Public Health, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Muhammad Basheer', 'Initials': 'MB', 'LastName': 'Yaha', 'Affiliation': 'Faculty of Pharmaceutical Sciences, Gombe State University, Gombe, Nigeria.'}, {'ForeName': 'Ratana', 'Initials': 'R', 'LastName': 'Somrongthong', 'Affiliation': 'College of Public Health, Chulalongkorn University, Bangkok, Thailand.'}]","Journal of Ayub Medical College, Abbottabad : JAMC",[]
502,33774968,Topical Diltiazem Ointment For Post- Hemorrhoidectomy Pain.,"BACKGROUND


Hemorrhoids are one of the most common anal pathology affecting millions of people around the world. Milligan-Morgan open hemorrhoidectomy is the most effective hemorrhoidectomy method used as gold standard procedure. Post-operative pain is recognized as a distressing complication of hemorrhoidectomy leading to increase hospital stay and psychological stress to both patient and surgeon. This study is designed to determine the efficacy of diltiazem gel in relieving pain after hemorrhoidectomy caused by anal muscle spasm. This will lead to decreased hospital stay and save both patient and surgeon from stress in postoperative period.
Objective


To compare mean post-operative pain in patients undergoing hemorrhoidectomy with vs. without topical application of diltiazem gel.
METHODS


Total 80 patients who were diagnosed with third- and fourth-degree hemorrhoids and undergo hemorrhoidectomy were included in the study. Patients were randomly allocated to two groups using opaque sealed envelope method. Group A and B both have 40 patients in each group. Pain score was measured on visual analogue scale (VAS) by asking the patients to fill a questionnaire or by the help of the doctor.
RESULTS


The patient's average age was 39.98±7.98 years. At 24 hours, mean pain score was significantly high in group B than group A [7.23±0.95 vs. 5.38±1.06; p=0.0005]. At 3rd post-operative day, mean pain score was significantly high in group B than group A [5±0.78 vs. 3.08±0.99; p=0.0005]. Seventy percent cases were observed in group B which required rescue analgesia.
CONCLUSIONS


It is concluded that application of diltiazem ointment at perianal area with standard treatment considerably decreases pain after haemorrhoidectomy.",2021,"At 24 hours, mean pain score was significantly high in group B than group A","['patients undergoing hemorrhoidectomy with vs. without topical application of', 'Total 80 patients who were diagnosed with third- and fourth-degree hemorrhoids and undergo hemorrhoidectomy were included in the study']","['Topical Diltiazem Ointment', 'Milligan-Morgan open hemorrhoidectomy', 'diltiazem ointment', 'diltiazem gel']","['Pain score', 'pain', 'hospital stay', 'visual analogue scale (VAS', 'hospital stay and psychological stress', 'mean pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3264452', 'cui_str': 'Internal hemorrhoids grade IV'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0582521', 'cui_str': 'Morgan'}, {'cui': 'C0473074', 'cui_str': 'Open hemorrhoidectomy'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",80.0,0.0137255,"At 24 hours, mean pain score was significantly high in group B than group A","[{'ForeName': 'Syeda Sakina', 'Initials': 'SS', 'LastName': 'Abidi', 'Affiliation': 'Department of Surgery, Dow University OF Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Nighat', 'Initials': 'N', 'LastName': 'Bakhtiar', 'Affiliation': 'Department of Surgery, Dow University OF Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Asad Ali', 'Initials': 'AA', 'LastName': 'Kerawala', 'Affiliation': 'Department of Surgery, Dow University OF Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Awan', 'Affiliation': 'Department of Surgery, Dow University OF Health Sciences, Karachi, Pakistan.'}]","Journal of Ayub Medical College, Abbottabad : JAMC",[]
503,33774956,Effectiveness Of Oral Omega 3 In Reducing Mucocutaneous Side Effects Of Oral Isotretinoin In Patients With Acne Vulgaris.,"BACKGROUND


Acne vulgaris has been a common clinical condition. Due to. high prevalence and unclear etio-pathogenesis of acne vulgaris, large number of treatment options have been available across the globe. Limited work has been done to explore the options which may manage or prevent these adverse effects and improve the adherence to the prescribed medications. We therefore conducted this trial to look for effectiveness of oral omega 3 in reducing mucocutaneous side effects of oral isotretinoin in patients with acne vulgaris.
Objective


To look for effectiveness of oral omega 3 in reducing mucocutaneous side effects of oral isotretinoin in patients with acne vulgaris. It was a randomized control trial conducted at Department of Dermatology Pak Emirates Military Hospital Rawalpindi. Ten months, June 2019 to May 2020.
Methods


A total of 60 patients of acne vulgaris put on oral isotretinoin by consultant dermatologist were included in the study. Patients were randomized into groups by lottery method. Group A received the placebo along with oral isotretinoin while Group B received oral omega 3 in standard dose in addition to oral isotretinoin. Comparison was made in both the groups regarding common mucocutaneous side effects.
RESULTS


Out of 60patients with acne vulgaris and put on isotretinoin included in the study, 26 (43.3%) received placebo in addition to isotretinoin while 34 (56.7%) received omega 3 in addition to isotretinoin. Forty (66.7%) patients were female while 20 (33.3%) were male. Cheilitis 35 (58.3%) was the commonest side effect followed by lip dryness 33 (55%). Application of chi-square test revealed that cheilitis, lip dryness and xerosis were significantly found in more patients who received placebo as compared to those who received omega 3 along with isotretinoin.
Conclusion


Mucocutaneous side effects were a very common finding among patients of acne vulgaris managed with isotretinoin. Cheilitis was the most reported mucocutaneous side effects among the target population. This RCT demonstrated that omega 3 was superior to placebo in order to prevent or manage cheilitis, xerosis or dry lips.",2021,"Application of chi-square test revealed that cheilitis, lip dryness and xerosis were significantly found in more patients who received placebo as compared to those who received omega 3 along with isotretinoin.
","['Forty (66.7%) patients were female while 20 (33.3%) were male', '60 patients of acne vulgaris put on oral isotretinoin by consultant dermatologist were included in the study', 'Patients With Acne Vulgaris', 'patients with acne vulgaris', 'Department of Dermatology Pak Emirates Military Hospital Rawalpindi']","['Oral Omega 3', 'oral isotretinoin while Group B received oral omega 3 in standard dose in addition to oral isotretinoin', 'Oral Isotretinoin', 'placebo', 'oral isotretinoin']","['cheilitis, lip dryness and xerosis']","[{'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517716', 'cui_str': '33.3'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0259831', 'cui_str': 'Dermatologist'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007971', 'cui_str': 'Cheilitis'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0259817', 'cui_str': 'Xerosis'}]",,0.0680847,"Application of chi-square test revealed that cheilitis, lip dryness and xerosis were significantly found in more patients who received placebo as compared to those who received omega 3 along with isotretinoin.
","[{'ForeName': 'Zarnab', 'Initials': 'Z', 'LastName': 'Zainab', 'Affiliation': 'Department of Dermatology, Pak Emirates Military Hospital, Rawalpindi, Pakistan.'}, {'ForeName': 'Naveed Akhtar', 'Initials': 'NA', 'LastName': 'Malik', 'Affiliation': 'Department of Dermatology, Pak Emirates Military Hospital, Rawalpindi.'}, {'ForeName': 'Shanza', 'Initials': 'S', 'LastName': 'Obaid', 'Affiliation': 'Department of Dermatology, Pak Emirates Military Hospital, Rawalpindi, Pakistan.'}, {'ForeName': 'Saqib', 'Initials': 'S', 'LastName': 'Malik', 'Affiliation': 'Department of Medicine, Ayub Medical College, Abbottabad, Pakistan.'}, {'ForeName': 'Kanza', 'Initials': 'K', 'LastName': 'Aftab', 'Affiliation': 'Department of Dermatology, Pak Emirates Military Hospital, Rawalpindi, Pakistan.'}, {'ForeName': 'Maimoona', 'Initials': 'M', 'LastName': 'Mumtaz', 'Affiliation': 'Department of Dermatology, Pak Emirates Military Hospital, Rawalpindi, Pakistan.'}, {'ForeName': 'Alia', 'Initials': 'A', 'LastName': 'Pervez', 'Affiliation': 'COMSAT, Islamabad, Pakistan.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Syed', 'Affiliation': 'Department of Medicine, Ayub Medical College, Abbottabad, Pakistan.'}]","Journal of Ayub Medical College, Abbottabad : JAMC",[]
504,33774921,Venous thrombosis with oral postmenopausal hormone therapy: roles of activated protein C resistance and tissue factor pathway inhibitor.,"BACKGROUND


Oral postmenopausal hormone therapy (HT) increases the risk of venous thrombosis (VT). We postulated that activated protein C (APC) resistance induced by HT is one of the mechanisms causing VT, and also assessed the role of one of the main determinants of APC resistance, i.e., tissue factor pathway inhibitor (TFPI).
METHODS


We performed a nested case-control study embedded within two Women's Health Initiative (WHI) hormone trials. Women were randomized to hormone therapy or placebo. Biomarkers were measured at baseline and after one-year, in 217 cases and 817 controls.
RESULTS


Increased APC resistance and decreased TFPI at baseline were associated with VT (OR ranging from 1.20 to 2.06). However, women with such prothrombotic profile at baseline did not have further increased risk of VT when randomized to HT compared with placebo. While there was no change in APC resistance or TFPI in placebo group after one-year, HT group showed prothrombotic changes in the biomarkers, i.e., an increase in APC resistance (mean(sd):0.39 (0.54)) and decrease in TFPI (-0.21(0.50): free TFPI, -0.24(0.22): TFPI activity and -0.22(0.20): total TFPI). However, HT induced prothrombotic change in biomarkers did not increase risk of VT.
CONCLUSION


Women with prothrombotic levels of APC resistance and TFPI at baseline were not at increased risk of VT when randomized to HT compared with placebo. This suggests that testing for these biomarkers prior to starting HT is not required. HT led to prothrombotic change in these biomarkers after one year, but this did not relate to increased risk of VT.",2021,"HT led to prothrombotic change in these biomarkers after one year, but this did not relate to increased risk of VT.","[""nested case-control study embedded within two Women's Health Initiative (WHI) hormone trials""]","['hormone therapy or placebo', 'placebo', 'oral postmenopausal hormone therapy', 'HT', 'Oral postmenopausal hormone therapy (HT']","['risk of venous thrombosis (VT', 'APC resistance', 'APC resistance and decreased TFPI', 'risk of VT', 'TFPI (-0.21(0.50): free TFPI, -0.24(0.22): TFPI activity and -0.22(0.20): total TFPI', 'APC resistance and TFPI', 'APC resistance or TFPI']","[{'cui': 'C0007328', 'cui_str': 'Case Control Studies'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0600433', 'cui_str': 'Resistance to activated protein C due to Factor V Leiden'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.181739,"HT led to prothrombotic change in these biomarkers after one year, but this did not relate to increased risk of VT.","[{'ForeName': 'Deeksha', 'Initials': 'D', 'LastName': 'Khialani', 'Affiliation': 'Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Sowmya', 'Initials': 'S', 'LastName': 'Vasan', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Cushman', 'Affiliation': 'Department of Medicine, Larner College of Medicine, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Anders Erik Astrup', 'Initials': 'AEA', 'LastName': 'Dahm', 'Affiliation': 'Department of Haematology, Akershus University Hospital, P.O. BOX 1000, N-1478, Lørenskog, Norway.'}, {'ForeName': 'Per Morten', 'Initials': 'PM', 'LastName': 'Sandset', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, P.O. BOX. 1171, Blindern, N-0318, Oslo, Norway.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Rossouw', 'Affiliation': 'National Heart, Lung, and Blood Institute, 6701 Rockledge Ave, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'van Hylckama Vlieg', 'Affiliation': 'Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.15319']
505,33774892,An integrative healthcare model with heartfulness meditation and care coordination improves outcomes in cyclic vomiting syndrome.,"BACKGROUND


Cyclic vomiting syndrome (CVS) is associated with psychosocial comorbidity and often triggered by stress. Since the current disease-centered care model does not address psychosocial factors, we hypothesized that holistic, patient-centered care integrating meditation and addressing psychosocial needs through a care coordinator will improve healthcare outcomes in CVS.
METHODS


We conducted a prospective randomized controlled trial: 49 patients with CVS (mean age: 34 ± 14 years; 81% female) were randomized to conventional health care (controls) or Integrative Health care (IHC) (27: controls, 22: IHC). The IHC group was assigned a care coordinator and received meditation with a certified instructor. Outcomes including psychological distress, coping strategies to manage chronic stress, cognitive symptom management, and Health-Related Quality of Life (HRQoL) were measured.
KEY RESULTS


In intention-to-treat analyses, patients receiving IHC showed significant improvement in multiple domains of coping including positive reframing, planning, and reduction in self-blame (p values ≤0.05), and physical HRQoL (p = 0.03) at 6 months. They also leaned toward spirituality/religion as a coping measure (p ≤ 0.02 at 3 and 6 months). Subgroup analysis of compliant patients showed additional benefit with significant reduction in psychological distress (p = 0.04), improvement in sleep quality (p = 0.03), reduction in stress levels (0.02), improvement in physical HRQoL (0.04), and further improvement in other domains of coping (p < 0.05).
CONCLUSIONS AND INFERENCES


An IHC model incorporating meditation and care coordination improves patient outcomes in CVS and is a useful adjunct to standard treatment. Studies to determine the independent effects of meditation and care coordination are warranted.",2021,"In intention-to-treat analyses, patients receiving IHC showed significant improvement in multiple domains of coping including positive reframing, planning, and reduction in self-blame (p values ≤0.05), and physical HRQoL (p = 0.03) at 6 months.",['49 patients with CVS (mean age: 34\xa0±\xa014\xa0years; 81% female'],"['heartfulness meditation and care coordination', 'conventional health care (controls) or Integrative Health care (IHC', 'care coordinator and received meditation with a certified instructor']","['sleep quality', 'psychological distress', 'physical HRQoL', 'psychological distress, coping strategies to manage chronic stress, cognitive symptom management, and Health-Related Quality of Life (HRQoL', 'multiple domains of coping including positive reframing, planning, and reduction in self-blame', 'cyclic vomiting syndrome', 'reduction in stress levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152164', 'cui_str': 'Cyclical vomiting syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C4708569', 'cui_str': 'Care coordinator'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0152164', 'cui_str': 'Cyclical vomiting syndrome'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",49.0,0.0887831,"In intention-to-treat analyses, patients receiving IHC showed significant improvement in multiple domains of coping including positive reframing, planning, and reduction in self-blame (p values ≤0.05), and physical HRQoL (p = 0.03) at 6 months.","[{'ForeName': 'Thangam', 'Initials': 'T', 'LastName': 'Venkatesan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Porcelli', 'Affiliation': 'Department of Psychology, Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'Anagha', 'Initials': 'A', 'LastName': 'Matapurkar', 'Affiliation': 'Heartfulness Institute, Austin, TX, USA.'}, {'ForeName': 'Vishnu Charan', 'Initials': 'VC', 'LastName': 'Suresh Kumar', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Aniko', 'Initials': 'A', 'LastName': 'Szabo', 'Affiliation': 'Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Wieloch', 'Affiliation': 'Froedtert Hospital, Milwaukee, WI, USA.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14132']
506,33774886,"Alcohol and other drug health-care providers and their client's perceptions of e-cigarette use, safety and harm reduction.","INTRODUCTION


E-cigarettes containing nicotine may potentially assist cessation in a heavily nicotine-dependent population with high relapse and tobacco-related burden. This study aims to determine alcohol and other drug (AOD) health-care provider and client awareness, use and attitudes regarding harm reduction and safety of e-cigarettes.
METHODS


The study was part of a larger cluster randomised controlled trial with 32 Australian AOD services. At a post-intervention survey conducted October 2016, health-care providers were asked whether they believed e-cigarettes could help smokers quit tobacco, whether they believe e-cigarettes are safer than tobacco smoking and whether they would recommend e-cigarettes to clients who are interested in quitting smoking. At the 6-month follow-up survey conducted January 2015-March 2016, AOD clients were asked about their e-cigarette knowledge, ever use, current use, reasons for use and place of purchase.
RESULTS


One hundred and eighty health-care providers and 427 AOD clients responded. A minority of health-care providers agreed with the statements that e-cigarettes could help smokers quit tobacco (30%), while just under one-third (25%) agreed that e-cigarettes were safer than tobacco smoking. However, only 19% would recommend e-cigarettes. Most AOD clients (93%) reported awareness of e-cigarettes, 39% reported ever use; however, only 7% reported current use. Of those reporting ever use, 52% used a nicotine e-cigarette. The most common reasons for e-cigarette use were 'wanted to try' (72%) and 'help cut down smoking' (70%).
DISCUSSION AND CONCLUSIONS


Both AOD health-care providers and clients are aware of e-cigarettes but are cautious in using and recommending their use.",2021,"The most common reasons for e-cigarette use were 'wanted to try' (72%) and 'help cut down smoking' (70%).
","['32 Australian AOD services', 'One hundred and eighty health-care providers and 427 AOD clients responded']",[],"['smokers quit tobacco', 'awareness of e-cigarettes']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}]",,0.0500663,"The most common reasons for e-cigarette use were 'wanted to try' (72%) and 'help cut down smoking' (70%).
","[{'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Skelton', 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, The University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Guillaumier', 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, The University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, The University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Walsberger', 'Affiliation': 'Tobacco Control Unit, Cancer Council NSW, Sydney, Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, The University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Adrian J', 'Initials': 'AJ', 'LastName': 'Dunlop', 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, The University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Kerrin', 'Initials': 'K', 'LastName': 'Palazzi', 'Affiliation': 'Hunter Medical Research Institute, Newcastle, Australia.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, The University of Newcastle, Newcastle, Australia.'}]",Drug and alcohol review,['10.1111/dar.13276']
507,33774878,Transplant Trial Watch.,"AIMS


This study aimed to examine the effect of N-acetylcysteine (NAC) infusion after live donor liver transplantation.
INTERVENTIONS


Participants were randomised to either the NAC group or the placebo group.
PARTICIPANTS


150 live donor liver transplant recipients.
OUTCOMES


The primary outcome was the incidence of acute kidney injury (AKI) and early allograft dysfunction (EAD). The secondary outcomes were primary graft non-function, international normalized ratio, post-transplant hospital stay, intraoperative bleeding, mortality (in-hospital), and levels of bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine.",2021,"The secondary outcomes were primary graft non-function, international normalized ratio, post-transplant hospital stay, intraoperative bleeding, mortality (in-hospital), and levels of bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine.",['150 live donor liver transplant recipients'],"['N-acetylcysteine (NAC', 'placebo', 'NAC']","['incidence of acute kidney injury (AKI) and early allograft dysfunction (EAD', 'primary graft non-function, international normalized ratio, post-transplant hospital stay, intraoperative bleeding, mortality (in-hospital), and levels of bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C3544287', 'cui_str': 'Living donor liver transplant'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",,0.371062,"The secondary outcomes were primary graft non-function, international normalized ratio, post-transplant hospital stay, intraoperative bleeding, mortality (in-hospital), and levels of bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine.","[{'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Knight', 'Affiliation': 'Centre for Evidence in Transplantation, Department of Surgical Sciences, University of Oxford, Nuffield, UK.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13871']
508,33774848,"Insulin Resistance in Type 1 Diabetes Managed with Metformin (INTIMET): study protocol of a double-blind placebo-controlled, randomised trial.","BACKGROUND


Insulin resistance is an under-recognised metabolic defect and cardiovascular risk factor in type 1 diabetes. Whether metformin improves hepatic, muscle or adipose tissue insulin sensitivity has not been studied in adults with Type 1 diabetes. We initiated the INTIMET study (INsulin resistance in Type 1 diabetes managed with METformin), a double-blind randomised, placebo-controlled trial to measure the effect of metformin on tissue-specific insulin resistance in adults with Type 1 diabetes.
METHODS


We will study 40 adults aged 20-55 years with Type 1 diabetes (HbA1c ≤ 80mmol/mol [9.5%], fasting C-peptide <0.3nmol/L) and 20 age-, gender- and BMI-matched controls. Insulin sensitivity will be determined by the 2-step hyperinsulinaemic-euglycaemic clamp method with deuterated glucose to document liver, muscle and adipose insulin sensitivity. Subjects with Type 1 diabetes will be randomised to metformin extended-release 1500mg daily or matched placebo for 26 weeks. The primary outcome is change in hepatic insulin sensitivity, assessed by change in basal rate of appearance (Ra) of glucose and suppression of endogenous glucose production (EGP) during the low-dose stage of the clamp.
CONCLUSION


The INTIMET study is the first clinical trial to quantify the impact of metformin on liver, muscle and adipose insulin resistance in adults with Type 1 diabetes. This study may identify factors that predict an individual's response to metformin in Type 1 diabetes.",2021,"We initiated the INTIMET study (INsulin resistance in Type 1 diabetes managed with METformin), a double-blind randomised, placebo-controlled trial to measure the effect of metformin on tissue-specific insulin resistance in adults with Type 1 diabetes.
","['Type 1 diabetes', 'Type 1 Diabetes Managed with', '40 adults aged 20-55 years with Type 1 diabetes (HbA1c ≤ 80mmol/mol [9.5%], fasting C-peptide <0.3nmol/L) and 20 age-, gender- and BMI-matched controls', 'Type 1 diabetes managed with', 'adults with Type 1 diabetes', 'Subjects with Type 1 diabetes']","['METformin', 'metformin extended-release 1500mg daily or matched placebo', 'metformin', 'placebo', 'Metformin']","['tissue-specific insulin resistance', 'hepatic, muscle or adipose tissue insulin sensitivity', 'liver, muscle and adipose insulin resistance', 'Insulin sensitivity', 'Insulin Resistance', 'change in hepatic insulin sensitivity, assessed by change in basal rate of appearance (Ra) of glucose and suppression of endogenous glucose production (EGP']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0903677', 'cui_str': 'TACSTD1 protein, human'}]",40.0,0.528017,"We initiated the INTIMET study (INsulin resistance in Type 1 diabetes managed with METformin), a double-blind randomised, placebo-controlled trial to measure the effect of metformin on tissue-specific insulin resistance in adults with Type 1 diabetes.
","[{'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Snaith', 'Affiliation': 'Garvan Institute of Medical Research, Healthy Ageing, Darlinghurst, NSW, Australia.'}, {'ForeName': 'Dorit', 'Initials': 'D', 'LastName': 'Samocha-Bonet', 'Affiliation': 'Garvan Institute of Medical Research, Healthy Ageing, Darlinghurst, NSW, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': 'Garvan Institute of Medical Research, Healthy Ageing, Darlinghurst, NSW, Australia.'}, {'ForeName': 'Zhixin', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'University of New South Wales, Stats Central, Sydney, NSW, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Kowalski', 'Affiliation': 'Deakin University, School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Geelong, Australia.'}, {'ForeName': 'Clinton', 'Initials': 'C', 'LastName': 'Bruce', 'Affiliation': 'Deakin University, School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Geelong, Australia.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Holmes-Walker', 'Affiliation': 'Westmead Hospital, Department of Diabetes and Endocrinology, Westmead, NSW, Australia.'}, {'ForeName': 'Jerry R', 'Initials': 'JR', 'LastName': 'Greenfield', 'Affiliation': 'Garvan Institute of Medical Research, Healthy Ageing, Darlinghurst, NSW, Australia.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14564']
509,33774765,Evaluating the impact of pharmaceutical care services on the clinical outcomes of epilepsy: a randomised controlled trial.,"BACKGROUND


The involvement of pharmacists in the provision of specialised care to patients with epilepsy is poor.
OBJECTIVE


To evaluate the impact of pharmaceutical care services on the clinical outcomes of epilepsy.
SETTING


Two selected major referral epilepsy treatment centres in southern Nigeria were used for the study. Patients were recruited from the Neurology and Medical out-patient clinics of the hospitals.
METHOD


An open randomised controlled study was carried out on epilepsy patients receiving clinical care at the selected hospitals. Patients in the intervention group were offered pharmaceutical care services. The impact of the pharmaceutical care services on the clinical outcomes of epilepsy (seizure frequency and severity) was evaluated.
MAIN OUTCOME MEASURE


The effect of pharmaceutical care services on seizure frequency and severity in patients with epilepsy.
RESULTS


There was a statistically significant difference between the usual care (UC) and the pharmaceutical care (PC) group on the clinical outcomes of epilepsy post-PC intervention. Comparison between the groups (UC versus PC) revealed that patients in the PC group had a significantly lower seizure frequency score than those in the UC group at 3 months and 6 months-(pre-intervention: 3.09 versus 3.34; t = -1.685; p = 0.094) (3 months 2.45 versus 1.68; t = 4.494; p = 0.001), (6 months: 1.97 versus 0.92; t = -3.137; p = 0.001). Also, comparisons between the groups (UC versus PC) showed that patients in the PC group had a significantly lower seizure severity score than those in the UC group at 3 months and 6 months-(pre-intervention 18.46 versus 20.38; t = -3.102; p = 0.01) (3 months: 17.51 versus 14.79; t = 4.202; p = 0.001) (6 months 16.41 versus 11.66; t = 8.930; p = 0.001).
CONCLUSION


Pharmaceutical care interventions may significantly reduce seizure frequency and severity in patients with epilepsy.
IMPACT OF FINDINGS ON PRACTICE


These findings provide justification for the integration of pharmaceutical care services with other elements of health care for epilepsy patients.",2021,"Comparison between the groups (UC versus PC) revealed that patients in the PC group had a significantly lower seizure frequency score than those in the UC group at 3 months and 6 months-(pre-intervention: 3.09 versus 3.34; t = -1.685; p = 0.094) (3 months 2.45 versus 1.68; t = 4.494; p = 0.001), (6 months: 1.97 versus 0.92; t = -3.137; p = 0.001).","['Patients were recruited from the Neurology and Medical out-patient clinics of the hospitals', 'Two selected major referral epilepsy treatment centres in southern Nigeria were used for the study', 'epilepsy', 'patients with epilepsy', 'epilepsy patients receiving clinical care at the selected hospitals', 'epilepsy patients']",['pharmaceutical care services'],"['seizure frequency score', 'seizure severity score', 'seizure frequency and severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C1449618', 'cui_str': 'Pharmaceutical Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.132314,"Comparison between the groups (UC versus PC) revealed that patients in the PC group had a significantly lower seizure frequency score than those in the UC group at 3 months and 6 months-(pre-intervention: 3.09 versus 3.34; t = -1.685; p = 0.094) (3 months 2.45 versus 1.68; t = 4.494; p = 0.001), (6 months: 1.97 versus 0.92; t = -3.137; p = 0.001).","[{'ForeName': 'Unyime Israel', 'Initials': 'UI', 'LastName': 'Eshiet', 'Affiliation': 'Department of Clinical Pharmacy and Biopharmacy, University of Uyo, Uyo, Nigeria. unyimeeshiet@uniuyo.edu.ng.'}, {'ForeName': 'Jegbgefume Matthew', 'Initials': 'JM', 'LastName': 'Okonta', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Management, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Chinwe Victoria', 'Initials': 'CV', 'LastName': 'Ukwe', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Management, University of Nigeria, Nsukka, Nigeria.'}]",Irish journal of medical science,['10.1007/s11845-021-02599-y']
510,33774741,Resilience Intervention for Parents of Children with Autism: Findings from a Randomized Controlled Trial of the AMOR Method.,"Parents of children with autism spectrum disorder (ASD) experience elevated stress, yet parent-specific interventions are sparse. Thirty-five parents of children with ASD were randomized to the novel 8-week AMOR (Acceptance, Mindfulness, Optimism, Resilience) Method parent group or waitlist control group. Significant gains in resilience were reported by AMOR parents only (d = 1.42, p < 0.001, 95% CI [2.152, 10.083]). AMOR parents exhibited significant gains in stress management and reductions in mental health symptoms, along with parent-reported improvements in martial, family, and child functioning. AMOR group follow-up data showed some maintenance of treatment gains. Findings demonstrate promise for resilience interventions in parents of children with ASD. The trial was registered (clinicaltrials.gov; NCT03513419; May 1, 2018) and approved by the Stanford University Institutional Review Board.",2021,"Significant gains in resilience were reported by AMOR parents only (d = 1.42, p < 0.001, 95% CI [2.152, 10.083]).","['Thirty-five parents of children with ASD', 'parents of children with ASD', 'Parents of children with autism spectrum disorder (ASD', 'Parents of Children with Autism']",['Resilience Intervention'],"['Significant gains in resilience', 'martial, family, and child functioning', 'mental health symptoms']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.11153,"Significant gains in resilience were reported by AMOR parents only (d = 1.42, p < 0.001, 95% CI [2.152, 10.083]).","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Schwartzman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA, 94305-5719, USA. jschwartzman@paloaltou.edu.'}, {'ForeName': 'Maria Estefania', 'Initials': 'ME', 'LastName': 'Millan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA, 94305-5719, USA.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Uljarevic', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA, 94305-5719, USA.'}, {'ForeName': 'Grace W', 'Initials': 'GW', 'LastName': 'Gengoux', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA, 94305-5719, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-021-04977-y']
511,33774715,"Effects of charcoal-based whitening toothpastes on human enamel in terms of color, surface roughness, and microhardness: an in vitro study.","OBJECTIVE


Charcoal based oral care products have gained popularity in the last few years. The aim of this in vitro study was to compare the effects of different charcoal based whitening toothpastes on color, surface roughness and microhardness of human enamel.
MATERIALS AND METHODS


Forty-eight specimens obtained from human permanent upper incisor teeth were randomly divided into 4 groups(n=12):Group-1:Colgate Total 12(CT); Group-2:Body Kingdom(BK); Group-3:Black is White(BW), Group-4:Colgate optic white(COW). Following 4 days cycle of darkening(2-min chlorhexidine and 60-min black tea per day), a 12- week brushing(twice daily for 1 min)was performed. Color of specimens was measured using a spectrophotometer. A contact type profilometer was used to measure surface roughness (Ra) and Vicker's hardness tester was used for the changes in microhardness(VHN). A representative sample from each group was visualized by SEM. Data were analyzed by One-way ANOVA, Welch, Fisher's, Kruskall-Wallis, Wilcoxon Sign Rank and Paired t-tests(p<0.05).
RESULTS


After 12- week brushing, no differences were found among the groups in terms of color change(p=0.989). All toothpastes tested showed no clinically acceptable whitening performances. A substantial increase in surface roughness was found in all groups, except BW(p<0.05). An increase was found in microhardness with CT(p=0.013), while no changes were found with BK, BW and COW(p>0.05).Only few scratches were observed on the enamel surfaces by SEM evaluations.
CONCLUSION


Twelve week brushing with charcoal based whitening toothpastes and a regular fluoridated toothpaste presented similar effects in color of enamel. Surface roughness was increased(except BW) while microhardness was not affected(except CT) with charcoal based whitening toothpastes.
CLINICAL RELEVANCE


Charcoal based whitening toothpastes do not promise to whiten the human permanent teeth and their effects on enamel abrasion should not be disregarded.",2021,"An increase was found in microhardness with CT(p=0.013), while no changes were found with BK, BW and COW(p>0.05).Only few scratches were observed on the enamel surfaces by SEM evaluations.
",['Forty-eight specimens obtained from human permanent upper incisor teeth'],"['darkening(2-min chlorhexidine and 60-min black tea per day', 'Total 12(CT', 'charcoal-based whitening toothpastes', 'charcoal based whitening toothpastes']","['color of enamel', 'surface roughness', 'color, surface roughness, and microhardness']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C2711204', 'cui_str': 'Structure of maxillary incisor tooth'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0452440', 'cui_str': 'Black tea'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",,0.0147251,"An increase was found in microhardness with CT(p=0.013), while no changes were found with BK, BW and COW(p>0.05).Only few scratches were observed on the enamel surfaces by SEM evaluations.
","[{'ForeName': 'Uzay', 'Initials': 'U', 'LastName': 'Koc Vural', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hacettepe University, 06100 Sıhhıye, Ankara, Turkey. uzaykoc@gmail.com.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Bagdatli', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hacettepe University, 06100 Sıhhıye, Ankara, Turkey.'}, {'ForeName': 'Ayfer Ezgi', 'Initials': 'AE', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Statistics, Hacettepe University, 06800, Beytepe, Ankara, Turkey.'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Yalçın Çakır', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hacettepe University, 06100 Sıhhıye, Ankara, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Altundaşar', 'Affiliation': 'Department of Endodontics, Hacettepe University, 06100 Sıhhıye, Ankara, Turkey.'}, {'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Gurgan', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hacettepe University, 06100 Sıhhıye, Ankara, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-021-03903-x']
512,33774680,Efficacy of intermittent exposure to bright light for treating maladaptation to night work on a counterclockwise shift work rotation.,"Objectives Rotating shift work is associated with adverse outcomes due to circadian misalignment, sleep curtailment, work-family conflicts, and other factors. We tested a bright light countermeasure to enhance circadian adaptation on a counterclockwise rotation schedule. Methods Twenty-nine adults (aged 20-40 years; 15 women) participated in a 4-week laboratory simulation with weekly counterclockwise transitions from day, to night, to evening, to day shifts. Each week consisted of five 8-hour workdays including psychomotor vigilance tests, two days off, designated 8-hour sleep episodes every day, and an assessment of circadian melatonin secretion. Participants were randomized to a treatment group (N=14), receiving intermittent bright light during work designed to facilitate circadian adaptation, or a control group (N=15) working in indoor light. Adaptation was measured by how much of the melatonin secretion episode overlapped with scheduled sleep timing. Results On the last night shift, there was a greater overlap between melatonin secretion and scheduled sleep time in the treatment group [mean 4.90, standard deviation (SD) 2.8 hours] compared to the control group (2.62, SD 2.8 hours; P=0.002), with night shift adaptation strongly influenced by baseline melatonin timing (r  2 =-0.71, P=0.01). While the control group exhibited cognitive deficits on the last night shift, the treatment group's cognitive deficits on the last night and evening shifts were minimized. Conclusions In this laboratory setting, intermittent bright light during work hours enhanced adaptation to night work and subsequent readaptation to evening and day work. Light regimens scheduled to shift circadian timing should be tested in actual shift workers on counterclockwise schedules as a workplace intervention.",2021,"On the last night shift, there was a greater overlap between melatonin secretion and scheduled sleep time in the treatment group [mean 4.90, standard deviation (SD) 2.8 hours] compared to the control group (2.62, SD 2.8 hours; P=0.002), with night shift adaptation strongly influenced by baseline melatonin timing (r  2 =-0.71, P=0.01).",['Methods Twenty-nine adults (aged 20-40 years; 15 women'],"['receiving intermittent bright light during work designed to facilitate circadian adaptation, or a control group (N=15) working in indoor light', 'bright light countermeasure']","['cognitive deficits', 'melatonin secretion and scheduled sleep time']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557351', 'cui_str': 'Employed'}]","[{'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",29.0,0.0471726,"On the last night shift, there was a greater overlap between melatonin secretion and scheduled sleep time in the treatment group [mean 4.90, standard deviation (SD) 2.8 hours] compared to the control group (2.62, SD 2.8 hours; P=0.002), with night shift adaptation strongly influenced by baseline melatonin timing (r  2 =-0.71, P=0.01).","[{'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Lammers-van der Holst', 'Affiliation': 'Division of Sleep and Circadian Disorders, 221 Longwood Avenue, Boston, MA 02115, USA. jduffy@research.bwh.harvard.edu.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Wyatt', 'Affiliation': ''}, {'ForeName': 'Todd S', 'Initials': 'TS', 'LastName': 'Horowitz', 'Affiliation': ''}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Wise', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Ronda', 'Affiliation': ''}, {'ForeName': 'Jeanne F', 'Initials': 'JF', 'LastName': 'Duffy', 'Affiliation': ''}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ''}]","Scandinavian journal of work, environment & health",['10.5271/sjweh.3953']
513,33774639,"Oral Supplementation of Collagen Peptides Improves Skin Hydration by Increasing the Natural Moisturizing Factor Content in the Stratum Corneum: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","INTRODUCTION


We aimed to investigate the effect of orally ingested collagen peptides (CPs) on skin condition and elucidate their mechanism of action.
METHODS


A randomized, placebo-controlled, double-blind trial was conducted in 99 healthy Japanese women, aged 35-50 years. The subjects were randomized into 3 groups (33 subjects/group) to receive 1 or 5 g of CP or placebo once daily for 12 weeks. Skin water content, transepidermal water loss (TEWL), skin elasticity, and skin thickness were evaluated before treatment and after 4, 8, and 12 weeks of treatment. The level of natural moisturizing factor (NMF) constituents in the stratum corneum (SC) was quantified before treatment and after 12 weeks of treatment.
RESULTS


Oral ingestion of CP increased the water content in the SC and epidermis and decreased TEWL. Furthermore, the NMF level in the SC was increased. However, skin elasticity and skin thickness remained unchanged.
CONCLUSIONS


The improvement in skin water content following the oral ingestion of CP can be attributed to an increase in the level of NMF in the SC.
TRIAL REGISTRATION


UMIN000030375 (retrospectively registered).",2021,"The improvement in skin water content following the oral ingestion of CP can be attributed to an increase in the level of NMF in the SC.
","['99 healthy Japanese women, aged 35-50 years']","['CP or placebo', 'placebo', 'Collagen Peptides', 'Placebo', 'orally ingested collagen peptides (CPs']","['skin elasticity and skin thickness', 'skin water content', 'Skin water content, transepidermal water loss (TEWL), skin elasticity, and skin thickness', 'level of natural moisturizing factor (NMF) constituents', 'level of NMF', 'water content in the SC and epidermis and decreased TEWL', 'NMF level']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0423761', 'cui_str': 'Skin elasticity'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0221921', 'cui_str': 'Stratum corneum structure'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",99.0,0.258483,"The improvement in skin water content following the oral ingestion of CP can be attributed to an increase in the level of NMF in the SC.
","[{'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Miyanaga', 'Affiliation': 'Shiseido Global Innovation Center, Shiseido Co., Ltd., Yokohama, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Uchiyama', 'Affiliation': 'Shiseido Global Innovation Center, Shiseido Co., Ltd., Yokohama, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Motoyama', 'Affiliation': 'Shiseido Global Innovation Center, Shiseido Co., Ltd., Yokohama, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Ochiai', 'Affiliation': 'Shiseido Global Innovation Center, Shiseido Co., Ltd., Yokohama, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ueda', 'Affiliation': 'Shiseido Global Innovation Center, Shiseido Co., Ltd., Yokohama, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Ogo', 'Affiliation': 'Shiseido Global Innovation Center, Shiseido Co., Ltd., Yokohama, Japan.'}]",Skin pharmacology and physiology,['10.1159/000513988']
514,33774634,Effect of a Home-Based Exercise Program on Indices of Physical Function and Quality of Life in Elderly Maintenance Hemodialysis Patients.,"BACKGROUND


Patients on maintenance hemodialysis (MHD) exhibit muscle wasting and impaired physical function which can be reversed with regular exercise, but accessibility to exercise programs for this unique population is lacking. We assessed the efficacy of a home-based exercise program on a broad range of indices of physical function, quality of life (QoL), and cognitive decline in patients with MHD.
DESIGN AND METHODS


Twenty-eight MHD patients, mean age 66 ± 7 years, were randomized to a 12-week home-based, case-managed aerobic and resistance exercise program or to usual care (13 exercise and 15 usual care). Comparisons were made for peak VO2, ventilatory inefficiency, 6-min walk test (6MWT), 1-min sit-to-stand (1STS), muscle strength, body composition, QoL, and cognitive measures.
RESULTS


Peak VO2 improved significantly in the exercise group (p = 0.01 between groups); exercise time improved by 41 and 36% at the ventilatory threshold and peak exercise, respectively (p < 0.01 between groups), but there were no differences in ventilatory efficiency. Trends for improvements in 6MWT and 1STS in the exercise group were observed, but no differences were observed in strength or body composition. Among measures of QoL, general health determined by the SF-36 improved in the exercise group, but there were no differences between groups in cognitive function.
CONCLUSIONS


MHD patients improved exercise capacity and some indices of QoL following a 12-week home-based exercise program. Home-based exercise is feasible for patients undergoing MHD and may help to obviate accessibility barriers to regular exercise.",2021,"RESULTS


Peak VO2 improved significantly in the exercise group (p = 0.01 between groups); exercise time improved by 41 and 36% at the ventilatory threshold and peak exercise, respectively (p < 0.01 between groups), but there were no differences in ventilatory efficiency.","['patients with MHD', 'Twenty-eight MHD patients, mean age 66 ± 7 years', 'Elderly Maintenance Hemodialysis Patients', 'patients undergoing MHD']","['Home-Based Exercise Program', 'Home-based exercise', 'case-managed aerobic and resistance exercise program or to usual care (13 exercise and 15 usual care', 'home-based exercise program']","['peak VO2, ventilatory inefficiency, 6-min walk test (6MWT), 1-min sit-to-stand (1STS), muscle strength, body composition, QoL, and cognitive measures', 'SF-36', 'ventilatory efficiency', 'exercise capacity', 'physical function, quality of life (QoL), and cognitive decline', 'Peak VO2', '6MWT and 1STS', 'exercise time', 'strength or body composition', 'Physical Function and Quality of Life', 'QoL, general health', 'cognitive function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0231184', 'cui_str': 'Inefficiency'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",28.0,0.00607894,"RESULTS


Peak VO2 improved significantly in the exercise group (p = 0.01 between groups); exercise time improved by 41 and 36% at the ventilatory threshold and peak exercise, respectively (p < 0.01 between groups), but there were no differences in ventilatory efficiency.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Myers', 'Affiliation': 'Cardiology Division, Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Khin', 'Initials': 'K', 'LastName': 'Chan', 'Affiliation': 'Cardiology Division, Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Cardiology Division, Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Lit', 'Affiliation': 'Nephrology Section, Veterans Affairs Palo Alto Health Care System, Stanford, California, USA.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Patti', 'Affiliation': 'Division of Sports and Exercise Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Massaband', 'Affiliation': 'Division of Sports and Exercise Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'B Jenny', 'Initials': 'BJ', 'LastName': 'Kiratli', 'Affiliation': 'Spinal Cord Injury Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Manju', 'Initials': 'M', 'LastName': 'Tamura', 'Affiliation': 'Nephrology Section, Veterans Affairs Palo Alto Health Care System, Stanford, California, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Nephrology Division, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Rabkin', 'Affiliation': 'Nephrology Section, Veterans Affairs Palo Alto Health Care System, Stanford, California, USA.'}]",Kidney & blood pressure research,['10.1159/000514269']
515,33774594,Systemic methylprednisolone for hearing preservation during cochlear implant surgery: A double blinded placebo-controlled trial.,"AIM


To assess whether a single, peri-operative, high dose of methylprednisolone can improve the preservation of residual acoustic hearing following cochlear implantation (CI).
METHODS


This was a double blinded placebo-controlled trial, performed in a tertiary academic centre. The hypothesis was that methylprednisolone would improve the preservation of hearing, and lower electrode impedances. Adult patients (18-85 years) with hearing at 85 dB or better at 500 Hz in the ear to be implanted were randomly allocated to either treatment (methylprednisolone, 1g administered intravenously upon induction of anaesthesia) or control (normal saline infusion). As per standard clinical practice, all patients received a routine dose of dexamethasone (8 mg intravenously) on induction of anaesthesia. Implantation was undertaken with a slim and flexible lateral wall electrode via the round window. Surgical technique was routine, with adherence to soft surgical principles. The primary outcome was hearing preservation within 20 dB at 500 Hz, 12 months following cochlear implantation. Secondary outcomes included hearing preservation at 6 weeks and 3 months, monopolar electrode impedance, and Consonant-Vowel-Consonant (CVC) Phoneme scores at 3 and 12 months after surgery.
RESULTS


Forty-five patients were enrolled into the control group and 48 patients received the steroid. The number of patients achieving hearing preservation at 12 months did not differ significantly between those receiving methylprednisolone treatment and the controls. There were no differences in hearing preservation at any frequency at either 6 weeks or 3 months after implantation. Neither CVC phoneme scores nor electrode impedances differed between the groups.
CONCLUSIONS


This paper demonstrates that high-dose local steroid injection at surgery was not effective in preventing a loss of residual hearing, improving speech perception, or lowering electrode impedances. The findings were contrary to the experimental literature, and emerging clinical evidence that steroid elution from implant electrodes influences cochlear biology in humans. We found no evidence to support the widely-held practice of administering intravenous steroids in the perioperative period, in an attempt to preserve residual hearing.",2021,The number of patients achieving hearing preservation at 12 months did not differ significantly between those receiving methylprednisolone treatment and the controls.,"['hearing preservation during cochlear implant surgery', 'Forty-five patients were enrolled into the control group and 48 patients received the', 'residual acoustic hearing following cochlear implantation (CI', 'Adult patients (18-85 years) with hearing at 85 dB or better at 500 Hz in the ear to be implanted']","['dexamethasone', 'steroid', 'treatment (methylprednisolone, 1g administered intravenously upon induction of anaesthesia) or control (normal saline infusion', 'placebo', 'Systemic methylprednisolone', 'methylprednisolone']","['preservation of hearing, and lower electrode impedances', 'number of patients achieving hearing preservation', 'hearing preservation', 'CVC phoneme scores nor electrode impedances', 'hearing preservation at 6 weeks and 3 months, monopolar electrode impedance, and Consonant-Vowel-Consonant (CVC) Phoneme scores']","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0302559', 'cui_str': 'Implantation of cochlear prosthetic device'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",45.0,0.478748,The number of patients achieving hearing preservation at 12 months did not differ significantly between those receiving methylprednisolone treatment and the controls.,"[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia; Cochlear Implant Clinic, Royal Victorian Eye and Ear Hospital, 32 Gisborne St, Melbourne East 3002, Australia. Electronic address: sjoleary@unimelb.edu.au.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia; Department of Otorhinolaryngology - Head & Neck Surgery, Ansan Hospital, College of Medicine, Korea University, 123, Jeokgeum-ro (Street), Gojan-dong, Danwon-gu, Ansan-si, Gyeonggi-do 15355, Republic of Korea.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Brady', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Matthews', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Katie Boncza', 'Initials': 'KB', 'LastName': 'Ozdowska', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Payne', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'McLean', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rousset', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Creber', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Tari', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dowell', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia; Department of Audiology and Speech Sciences, University of Melbourne, 550 Swanston St, Carlton 3053, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Briggs', 'Affiliation': 'Department of Surgery - Otolaryngology, The University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne St RVEEH, Melbourne East 3002,Victoria, Australia; Cochlear Implant Clinic, Royal Victorian Eye and Ear Hospital, 32 Gisborne St, Melbourne East 3002, Australia.'}]",Hearing research,['10.1016/j.heares.2021.108224']
516,33774558,Internet-delivered exposure therapy versus internet-delivered cognitive behavioral therapy for panic disorder: A pilot randomized controlled trial.,"AIM


To compare the efficacy and acceptability of internet-delivered exposure therapy for panic disorder, to multi-component internet-delivered cognitive behavioral therapy (iCBT) that included controlled breathing, cognitive restructuring and exposure.
METHODS


Participants with panic disorder, with or without agoraphobia, were randomized to internet-delivered exposure therapy (n = 35) or iCBT (n = 34). Both programs were clinician guided, with six lessons delivered over eight weeks. Outcomes included panic disorder and agoraphobia symptom severity, as well as depression symptom severity, functional impairment and days out of role.
RESULTS


Participants in both conditions displayed a large reduction in panic disorder symptom severity (ds >1.30) from pre- to post-treatment. Participants in both conditions displayed medium to large reduction in agoraphobia and depression symptom severity, functional impairment and days out of role. Effects were maintained at three- and six-month follow-up. There was no significant difference between the interventions in clinical outcomes, adherence or treatment satisfaction.
CONCLUSIONS


Internet-delivered exposure therapy appeared to be as acceptable and efficacious as more established iCBT, despite including less strategies. However, a fully powered replication is now needed to compare the two approaches.",2021,"Participants in both conditions displayed medium to large reduction in agoraphobia and depression symptom severity, functional impairment and days out of role.","['panic disorder', 'Participants with panic disorder, with or without agoraphobia']","['multi-component internet-delivered cognitive behavioral therapy (iCBT', 'internet-delivered exposure therapy', 'internet-delivered exposure therapy (n\u202f=\u202f35) or iCBT', 'Internet-delivered exposure therapy versus internet-delivered cognitive behavioral therapy']","['efficacy and acceptability', 'panic disorder and agoraphobia symptom severity, as well as depression symptom severity, functional impairment and days out of role', 'clinical outcomes, adherence or treatment satisfaction', 'panic disorder symptom severity', 'agoraphobia and depression symptom severity, functional impairment']","[{'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0567498,"Participants in both conditions displayed medium to large reduction in agoraphobia and depression symptom severity, functional impairment and days out of role.","[{'ForeName': 'Eileen P', 'Initials': 'EP', 'LastName': 'Stech', 'Affiliation': ""School of Psychology, University of New South Wales Sydney, NSW 2052, Australia; Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW 2010, Australia. Electronic address: eileen.stech@unsw.edu.au.""}, {'ForeName': 'Aileen Z', 'Initials': 'AZ', 'LastName': 'Chen', 'Affiliation': ""School of Psychiatry, University of New South Wales Sydney, NSW 2052, Australia; Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW 2010, Australia.""}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Sharrock', 'Affiliation': ""School of Psychiatry, University of New South Wales Sydney, NSW 2052, Australia; Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW 2010, Australia.""}, {'ForeName': 'Ashlee B', 'Initials': 'AB', 'LastName': 'Grierson', 'Affiliation': ""School of Psychiatry, University of New South Wales Sydney, NSW 2052, Australia; Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW 2010, Australia.""}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Upton', 'Affiliation': 'School of Psychology, University of New South Wales Sydney, NSW 2052, Australia.'}, {'ForeName': 'Alison E J', 'Initials': 'AEJ', 'LastName': 'Mahoney', 'Affiliation': ""School of Psychiatry, University of New South Wales Sydney, NSW 2052, Australia; Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW 2010, Australia.""}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Grisham', 'Affiliation': 'School of Psychology, University of New South Wales Sydney, NSW 2052, Australia.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Newby', 'Affiliation': ""School of Psychology, University of New South Wales Sydney, NSW 2052, Australia; Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW 2010, Australia; Black Dog Institute, University of New South Wales Sydney, NSW 2052, Australia.""}]",Journal of anxiety disorders,['10.1016/j.janxdis.2021.102382']
517,33774503,Structuralist mental representation of dual-action demands: Evidence for compositional coding from dual tasks with low cross-task dimensional overlap.,"The present study asks how behavioral (dual-action) demands in dual tasks are mentally represented and whether changes in representation might govern practice-related dual-task performance improvements. Three different representation accounts were empirically tested based on the idea that dual-action demands required in a dual-task trial might be represented in different ways. According to a compositional (Structuralist) account, component tasks remain structurally intact when combined with another task. In contrast, a holistic (Gestalt) account posits that dual-action requirements in dual tasks are represented holistically and entirely distinct from its component action requirements. Finally, a contextual change account assumes that a change in context (e.g., from single- to dual-action requirement) generally impedes response retrieval, similar to repeating a response while the task context switches. To address this issue, we analyzed trial-by-trial effects in a single/dual switch paradigm (SDS paradigm, involving a randomized mix of single- and dual-task trials within blocks). Specifically, we analyzed performance in an extensive dual-task training setting (involving training sessions across several days) combining an auditory-vocal task and a visual-manual task. The results indicated that, throughout practice, nearly all relevant comparisons of performance between complete switch trials (e.g., between the two single tasks) and partial repetition trials (e.g., from dual to single task) revealed partial repetition benefits, that is, for both the auditory-vocal and the visual-manual task, and for both single- and dual-task performance analyses. Therefore, dual-action requirements in the present dual-task setting are mentally represented in a compositional, Structuralist fashion, probably due to low between-task dimensional overlap.",2021,Three different representation accounts were empirically tested based on the idea that dual-action demands required in a dual-task trial might be represented in different ways.,[],"['dual switch paradigm (SDS paradigm', 'extensive dual-task training setting (involving training sessions across several days) combining an auditory-vocal task and a visual-manual task']",['partial repetition benefits'],[],"[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C3845714', 'cui_str': 'Several days'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",,0.0782191,Three different representation accounts were empirically tested based on the idea that dual-action demands required in a dual-task trial might be represented in different ways.,"[{'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Huestegge', 'Affiliation': 'University of Würzburg, Würzburg, Germany. Electronic address: lynn.huestegge@uni-wuerzburg.de.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Strobach', 'Affiliation': 'MSH Medical School, Hamburg, Germany.'}]",Acta psychologica,['10.1016/j.actpsy.2021.103298']
518,33774192,Evaluation of the effects of methods of methylene blue removal from the post space after photodynamic therapy on the bonding interface using different resin cementation systems.,"BACKGROUND


To evaluate the effects of three protocols for removing 0.01% methylene blue from the post space after photodynamic therapy on bond strength and tag formation in the dentin of the fiber post space, using a conventional cementation system with an etch-and-rinse or universal adhesive system.
METHODS


Sixty human canines were endodontically treated for fiber post cementation. The specimens were randomized into 6 groups (n = 10): G1, G2, G3, G4, G5, and G6. The G1, G2, and G3 groups were irrigated with saline solution, 2.5% sodium hypochlorite (NaOCl), and 2.5% NaOCl, agitated by passive ultrasonic irrigation (PUI), respectively. In these groups, a conventional cementation system with etch-and-rinse adhesive was used. The G4, G5, and G6 groups were irrigated with the respective solutions mentioned above and cemented using a conventional cementation system with universal adhesive. Tag formation in the dentin was evaluated by confocal laser scanning microscopy. The push-out bond strength test was performed on three thirds of the specimens.
RESULTS


In the cervical and middle thirds, the greatest extent of dentin tag formation occurred in the G1 (p = 0.023 and p = 0.033, respectively). In the apical third, G1, G2, and G3 demonstrated similar tag formation between themselves (p = 0.089). In the cervical and middle thirds, G4 demonstrated the highest bond strength when compared to the other groups (p < 0.05).
CONCLUSION


The protocols for removing 0.01% methylene blue with NaOCl, irrespective of the involvement of passive ultrasonic irrigation, negatively affects the bond strength and tag formation in the dentin of the post space.",2021,"In the cervical and middle thirds, G4 demonstrated the highest bond strength when compared to the other groups (p < 0.05).
",['Sixty human canines'],"['saline solution, 2.5% sodium hypochlorite (NaOCl), and 2.5% NaOCl, agitated by passive ultrasonic irrigation (PUI', 'methylene blue removal']","['bond strength and tag formation', 'dentin tag formation', 'highest bond strength']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0037293', 'cui_str': 'Skin tag'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205250', 'cui_str': 'High'}]",60.0,0.0449185,"In the cervical and middle thirds, G4 demonstrated the highest bond strength when compared to the other groups (p < 0.05).
","[{'ForeName': 'Cristiane', 'Initials': 'C', 'LastName': 'de Melo Alencar', 'Affiliation': 'Department of Restorative Dentistry, Araraquara School of Dentistry, Paulista State University - UNESP, Humaitá Street, No. 1680, 14801-385, Araraquara, SP, Brazil.'}, {'ForeName': 'Joatan Lucas', 'Initials': 'JL', 'LastName': 'de Sousa Gomes Costa', 'Affiliation': 'Department of Restorative Dentistry, Araraquara School of Dentistry, Paulista State University - UNESP, Humaitá Street, No. 1680, 14801-385, Araraquara, SP, Brazil.'}, {'ForeName': 'Fernanda Ferreira', 'Initials': 'FF', 'LastName': 'de Albuquerque Jassé', 'Affiliation': 'School of Dentistry, Federal University of Pará - UFPA, Augusto Corrêa Street, No. 1 - Guamá, 66075-110, Belém, PA, Brazil.'}, {'ForeName': 'Edson Alves', 'Initials': 'EA', 'LastName': 'de Campos', 'Affiliation': 'Department of Restorative Dentistry, Araraquara School of Dentistry, Paulista State University - UNESP, Humaitá Street, No. 1680, 14801-385, Araraquara, SP, Brazil.'}, {'ForeName': 'Andréa Abi Rached', 'Initials': 'AAR', 'LastName': 'Dantas', 'Affiliation': 'Department of Restorative Dentistry, Araraquara School of Dentistry, Paulista State University - UNESP, Humaitá Street, No. 1680, 14801-385, Araraquara, SP, Brazil.'}, {'ForeName': 'Milton Carlos', 'Initials': 'MC', 'LastName': 'Kuga', 'Affiliation': 'Department of Restorative Dentistry, Araraquara School of Dentistry, Paulista State University - UNESP, Humaitá Street, No. 1680, 14801-385, Araraquara, SP, Brazil. Electronic address: miltoncarloskuga@hotmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102264']
519,33774172,OPERATIVE VS. CONSERVATIVE TREATMENT OF SMALL NON-TRAUMATIC SUPRASPINATUS TEARS IN PATIENTS OVER 55 YEARS: OVER 5-YEAR FOLLOW-UP OF A RANDOMIZED CONTROLLED TRIAL.,"BACKGROUND


Non-traumatic rotator cuff tear is a common shoulder problem which can be treated either conservatively or operatively. In the previous publications of the 1 and 2-year results of this trial, we found no significant between group clinical differences. The aim of this study was to investigate the difference in mid-term clinical and radiological outcomes in patients aged over 55 years.
MATERIALS AND METHODS


180 shoulders with symptomatic, non-traumatic supraspinatus tears were randomly assigned to one of the three cumulatively designed treatment groups: physiotherapy (Group 1), acromioplasty and physiotherapy (Group 2) and rotator cuff repair, acromioplasty and physiotherapy (Group 3). The change in Constant score was the primary outcome measure. Secondary outcome measures were change in visual analog scale for pain and patient satisfaction. Radiological analysis included evaluation of glenohumeral osteoarthritis and rotator cuff tear arthropathy.
RESULTS


150 shoulders (mean age 71) were available for analysis after a mean follow-up of 6.2 years. The mean sagittal tear size of the supraspinatus tendon tear was at baseline 10 mm in all groups (p=0.33). Eight shoulders in Group 1 and two shoulders in Group 2 crossed over to rotator cuff repair during the follow-up. The mean baseline Constant score values were 57.1, 58.2 and 58.7, respectively (p=0.85). There were no significant differences (p=0.84) in the mean change of Constant score: 18.5 points in Group 1, 17.9 points in Group 2 and 20.0 points in Group 3. There were no statistically significant differences in the change of visual analog scale for pain (p=0.74) and patient satisfaction (p=0.83). At follow-up there were no statistically significant differences in the mean progression of glenohumeral osteoarthritis (p=0.538) or cuff tear arthropathy (p=0.485) between the groups. However, there was a statistically significant mean progression of glenohumeral osteoarthritis from baseline to follow-up in the trial population (p=0.0045).
CONCLUSIONS


On the basis of this study operative treatment is no better than conservative treatment with regard to small non-traumatic single tendon supraspinatus tears in patients over 55 years of age. Operative treatment does not protect against degeneration of the glenohumeral joint or cuff tear arthropathy. Conservative treatment is a reasonable option for the primary initial treatment of this condition.",2021,"There were no significant differences (p=0.84) in the mean change of Constant score: 18.5 points in Group 1, 17.9 points in Group 2 and 20.0 points in Group 3.","['patients aged over 55 years', '150 shoulders (mean age 71', '180 shoulders with symptomatic, non-traumatic supraspinatus tears']","['physiotherapy (Group 1), acromioplasty and physiotherapy (Group 2) and rotator cuff repair, acromioplasty and physiotherapy']","['mean progression of glenohumeral osteoarthritis', 'mean sagittal tear size of the supraspinatus tendon tear', 'patient satisfaction', 'rotator cuff repair', 'change of visual analog scale for pain', 'glenohumeral osteoarthritis', 'change in visual analog scale for pain and patient satisfaction', 'change in Constant score', 'mean baseline Constant score values', 'mean change of Constant score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0439059', 'cui_str': 'Supraspinatus tear'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0186663', 'cui_str': 'Acromioplasty of shoulder'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0224868', 'cui_str': 'Structure of tendon of supraspinatus muscle'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",180.0,0.283836,"There were no significant differences (p=0.84) in the mean change of Constant score: 18.5 points in Group 1, 17.9 points in Group 2 and 20.0 points in Group 3.","[{'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Kukkonen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Turku University Hospital and University of Turku, Turku, Finland. Electronic address: jupeku@utu.fi.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Ryösä', 'Affiliation': 'Department of Orthopaedics and Traumatology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Joukainen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Lehtinen', 'Affiliation': 'Orthopaedic Unit, Tays Hatanpää Hospital, Tampere, Finland.'}, {'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Kauko', 'Affiliation': 'Auria Clinical Informatics, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Mattila', 'Affiliation': 'Department of Radiology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Äärimaa', 'Affiliation': 'Department of Orthopaedics and Traumatology, Turku University Hospital and University of Turku, Turku, Finland.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2021.03.133']
520,33774169,Effect of Perioperative Acetaminophen on Pain Management in Patients Undergoing Rotator Cuff Repair: A Prospective Randomized Study.,"BACKGROUND


Limiting opioid use in perioperative pain management is currently an important focus in orthopedic surgery. The ability of acetaminophen to reduce postoperative opioid consumption while providing acceptable pain management has not been thoroughly investigated in patients undergoing rotator cuff repair (RCR).
METHODS


Patients undergoing primary arthroscopic RCR were prospectively randomized to one of three treatment groups. Group 1 (control) received both oxycodone 5 mg every 6 hours as needed and PO acetaminophen 1,000 mg every 6 hours as needed following surgery and had the option to take either medication or both. Group 2 received only oxycodone 5 mg every 6 hours as needed without any additional acetaminophen following surgery. Group 3 received 1,000 mg of acetaminophen PO every 6 hours for 1 day prior to and following surgery, which was subsequently decreased to every 8 hours during postoperative days 2-5. Group 3 patients were also allowed to take oxycodone 5 mg every 6 hours as needed following surgery. All patients received interscalene blocks with liposomal bupivacaine (Exparel). Opioid use, pain scores, side effects, and overall satisfaction were assessed daily following surgery for the first week.
RESULTS


57 patients (mean age, 57.8 ± 9.55 years) were included in this study. Baseline demographics including age, gender and body mass index (BMI) were similar between the groups (P > .05). Patients in group 3 took significantly fewer narcotics overall (P = .017) and took significantly fewer pills each day compared to group 2. Group 3 also reported significantly better overall pain control compared to the other groups (P = .040). There were no significant differences in overall patient satisfaction between the groups (P > .05). Additionally, there were no significant differences between groups regarding postoperative medication associated side-effects (P > .05).
CONCLUSION


Perioperative acetaminophen represents an important component of multimodal analgesia in appropriately selected patients undergoing shoulder surgery. This study demonstrated a significant decrease in opioid consumption and resulted in improved overall pain control following primary arthroscopic rotator cuff repair.",2021,Patients in group 3 took significantly fewer narcotics overall (P = .017) and took significantly fewer pills each day compared to group 2.,"['Patients undergoing primary arthroscopic RCR', 'patients undergoing shoulder surgery', 'Patients', 'Undergoing Rotator Cuff Repair', 'primary arthroscopic rotator cuff repair', '57 patients (mean age, 57.8 ± 9.55 years', 'patients undergoing rotator cuff repair (RCR']","['acetaminophen', 'interscalene blocks with liposomal bupivacaine (Exparel', 'acetaminophen PO', 'oxycodone', 'oxycodone 5 mg every 6 hours as needed and PO acetaminophen', 'Perioperative Acetaminophen']","['overall patient satisfaction', 'postoperative medication associated side-effects', 'Opioid use, pain scores, side effects, and overall satisfaction', 'overall pain control', 'narcotics overall', 'Pain Management', 'Baseline demographics including age, gender and body mass index (BMI', 'opioid consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C3247216', 'cui_str': 'Exparel'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C3873170', 'cui_str': 'Every six hours as required'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0842697,Patients in group 3 took significantly fewer narcotics overall (P = .017) and took significantly fewer pills each day compared to group 2.,"[{'ForeName': 'Arjun M', 'Initials': 'AM', 'LastName': 'Singh', 'Affiliation': 'Department of Orthopaedic Surgery, The Rothman Orthopaedic Institute, Thomas Jefferson University Hospitals, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107, USA.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Kirsch', 'Affiliation': 'Department of Orthopaedic Surgery, The Rothman Orthopaedic Institute, Thomas Jefferson University Hospitals, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107, USA.'}, {'ForeName': 'Manan S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Department of Orthopaedic Surgery, The Rothman Orthopaedic Institute, Thomas Jefferson University Hospitals, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gutman', 'Affiliation': 'Department of Orthopaedic Surgery, The Rothman Orthopaedic Institute, Thomas Jefferson University Hospitals, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Harper', 'Affiliation': 'Penn State University, College of Medicine, 700 HMC Crescent Road, Hershey, PA 17033.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lazarus', 'Affiliation': 'Department of Orthopaedic Surgery, The Rothman Orthopaedic Institute, Thomas Jefferson University Hospitals, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Horneff', 'Affiliation': 'Department of Orthopaedic Surgery, The Rothman Orthopaedic Institute, Thomas Jefferson University Hospitals, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107, USA.'}, {'ForeName': 'Surena', 'Initials': 'S', 'LastName': 'Namdari', 'Affiliation': 'Department of Orthopaedic Surgery, The Rothman Orthopaedic Institute, Thomas Jefferson University Hospitals, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107, USA.'}, {'ForeName': 'Armen', 'Initials': 'A', 'LastName': 'Voskeridjian', 'Affiliation': 'Department of Orthopaedic Surgery, The Rothman Orthopaedic Institute, Thomas Jefferson University Hospitals, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Abboud', 'Affiliation': 'Department of Orthopaedic Surgery, The Rothman Orthopaedic Institute, Thomas Jefferson University Hospitals, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107, USA. Electronic address: joseph.abboud@rothmanortho.com.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2021.03.132']
521,33774144,A comparison of physical exercise and cognitive training interventions to improve determinants of functional mobility in healthy older adults.,"OBJECTIVES


Mobility is a complex but crucial clinical outcome in older adults. Past observational studies have highlighted that cardiorespiratory fitness (CRF), energy cost of walking (ECW), and cognitive switching abilities are associated with mobility performance, making these key determinants of mobility intervention targets to enhance mobility in older adults. The objective of this study was to compare, in the same design, the impact of three training methods - each known to improve either CRF, ECW, or cognitive switching abilities - on mobility in healthy older adults.
METHODS


Seventy-eight participants (69.28 ± 4.85yo) were randomly assigned to one of three twelve-week interventions: Aerobic Exercise (AE; n = 26), Gross Motor Abilities (GMA; n = 27), or Cognitive (COG; n = 25) training. Each intervention was designed to improve one of the three key determinants of mobility (CRF, ECW, and cognitive switching). Primary outcomes (usual gait speed, and TUG performance) and the three mobility determinants were measured before and after the intervention.
RESULTS


Repeated-measures ANOVAs showed a time effect for TUG performance (F (1,75)  = 14.92, p < .001): all groups equally improved after the intervention (Δ TUGpost-pre , in seconds, with 95% CI: AE = -0.44 [-0.81 to -0.08]; GMA = -0.60 [-1.10 to -0.10]; COG = -0.33 [-0.71 to 0.05]). No significant between group differences were observed. CRF was improved in the AE group only (Hedges' G = 0.27, small effect), ECW and cognitive switching improved the most in the GMA (Hedges' G = -0.78, moderate effect) and COG groups (Hedges' G = -1.93, large effect) respectively. Smaller improvements in ECW were observed following AE and COG trainings (Hedges' G: AE = -0.39, COG = -0.36, both small effects) as well as in cognitive switching following AE and GMA training (Hedges' G: AE = -0.42, GMA = -0.21, both small effects).
DISCUSSION


This study provides further support to the notion that multiple interventional approaches (aerobic, gross motor exercise, or cognitive training) can be employed to improve functional mobility in older adults, giving them, and professionals, more options to promote healthy ageing.",2021,"CRF was improved in the AE group only (Hedges' G = 0.27, small effect), ECW and cognitive switching improved the most in the GMA","['older adults', 'Seventy-eight participants (69.28\u202f±\u202f4.85yo', 'healthy older adults']","['Aerobic Exercise (AE; n\u202f=\u202f26), Gross Motor Abilities (GMA; n\u202f=\u202f27), or Cognitive (COG; n\u202f=\u202f25) training', 'multiple interventional approaches (aerobic, gross motor exercise, or cognitive training', 'physical exercise and cognitive training interventions', 'GMA']","['time effect for TUG performance', 'functional mobility', 'Primary outcomes (usual gait speed, and TUG performance) and the three mobility determinants', 'ECW', 'ECW and cognitive switching', 'CRF']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",78.0,0.0239213,"CRF was improved in the AE group only (Hedges' G = 0.27, small effect), ECW and cognitive switching improved the most in the GMA","[{'ForeName': 'Kristell', 'Initials': 'K', 'LastName': 'Pothier', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; PERFORM Centre, Concordia University, Montréal, Canada; EA 2114, Psychologie des Âges de la Vie et Adaptation, University of Tours, Tours, France. Electronic address: kpothier@univ-tours.fr.'}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Vrinceanu', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; Research Centre, Montreal Heart Institute, Montréal, Canada; Department of Medicine, University of Montréal, Montréal, Canada.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Intzandt', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; PERFORM Centre, Concordia University, Montréal, Canada; Research Centre, Montreal Heart Institute, Montréal, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bosquet', 'Affiliation': 'Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, Poitiers, France.'}, {'ForeName': 'Antony D', 'Initials': 'AD', 'LastName': 'Karelis', 'Affiliation': ""Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; Département des Sciences de l'Activité Physique, Université du Québec à Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Lussier', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; Rehabilitation Science, Faculty of Medicine, University of Montréal, Montréal, Canada.'}, {'ForeName': 'T T Minh', 'Initials': 'TTM', 'LastName': 'Vu', 'Affiliation': ""Department of Medicine, University of Montréal, Montréal, Canada; Research Centre, Centre hospitalier de l'Université de Montréal, Montréal, Canada.""}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Nigam', 'Affiliation': 'Research Centre, Montreal Heart Institute, Montréal, Canada; Department of Medicine, University of Montréal, Montréal, Canada.'}, {'ForeName': 'Karen Z H', 'Initials': 'KZH', 'LastName': 'Li', 'Affiliation': 'PERFORM Centre, Concordia University, Montréal, Canada; Department of Psychology, Concordia University, Montreal, QC, Canada; Centre for Research in Human Development, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Berryman', 'Affiliation': ""Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; Laboratory MOVE (EA 6314), Faculty of Sport Sciences, University of Poitiers, Poitiers, France; Département des Sciences de l'Activité Physique, Université du Québec à Montréal, Montréal, QC, Canada; Department of Sports Studies, Bishop's University, Sherbrooke, Canada.""}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bherer', 'Affiliation': 'Research Centre, Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; PERFORM Centre, Concordia University, Montréal, Canada; Research Centre, Montreal Heart Institute, Montréal, Canada; Department of Medicine, University of Montréal, Montréal, Canada. Electronic address: louis.bherer@umontreal.ca.'}]",Experimental gerontology,['10.1016/j.exger.2021.111331']
522,33774140,The Net Benefit of a treatment should take the correlation between benefits and harms into account.,"OBJECTIVE


The assessment of benefits and harms from experimental treatments often ignores the association between outcomes. Generalized pairwise comparisons (GPC) can be used to assess the Net Benefit of treatment in a randomized trial accounting for that association.
STUDY DESIGN AND SETTINGS


We use GPC to analyze a fictitious trial of treatment versus control, with a binary efficacy outcome (response) and a binary toxicity outcome, as well as data from two actual randomized trials in oncology. In all cases, we compute the Net Benefit for scenarios with different orders of priority between response and toxicity, and a range of odds ratios (ORs) for the association between outcomes.
RESULTS


The GPC Net Benefit was quite different from the benefit/harm computed using marginal treatment effects on response and toxicity. In the fictitious trial using response as first priority, treatment had an unfavorable Net Benefit if OR<1, but favorable if OR>1. With OR=1, the Net Benefit was 0. Results changed drastically using toxicity as first priority.
CONCLUSION


Even in a simple situation, marginal treatment effects can be misleading. In contrast, GPC assesses the Net Benefit as a function of the treatment effects on each outcome, the association between outcomes, and individual patient priorities.",2021,The GPC Net Benefit was quite different from the benefit/harm computed using marginal treatment effects on response and toxicity.,[],[],['response and toxicity'],[],[],"[{'cui': 'C0040539', 'cui_str': 'TO'}]",2.0,0.0785812,The GPC Net Benefit was quite different from the benefit/harm computed using marginal treatment effects on response and toxicity.,"[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Buyse', 'Affiliation': 'International Drug Development Institute, San Francisco, CA, USA; Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), Hasselt University, Diepenbeek, Belgium. Electronic address: marc.buyse@iddi.com.'}, {'ForeName': 'Everardo D', 'Initials': 'ED', 'LastName': 'Saad', 'Affiliation': 'International Drug Development Institute, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Peron', 'Affiliation': 'Hospices Civils de Lyon, departments of Oncology and Biostatistics, Pierre-Benite, France; University of Lyon 1, CNRS UMR 5558, Biometry and Evolutive Biology Laboratory, Biostatistics-Health Team, Villeurbanne, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Chiem', 'Affiliation': 'International Drug Development Institute, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Mickaël', 'Initials': 'M', 'LastName': 'De Backer', 'Affiliation': 'Institut de statistique, biostatistique et sciences actuarielles, Université Catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Cantagallo', 'Affiliation': 'European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.'}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Ciani', 'Affiliation': 'CERGAS - Università Commerciale L. Bocconi, Milan, Italy; University of Exeter Medical School, Evidence Synthesis & Modelling for Health Improvement, Exeter, UK.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2021.03.018']
523,33774105,Duration or technique to improve the effectiveness of children' hand hygiene: A randomised controlled trial.,"BACKGROUND


How to wash hands is as important as when and how often to wash hands for acquiring proper hand hygiene habits.
METHODS


The study aimed to compare the effect of education based on technique or duration for developing children's handwashing skills. The double-blind randomized controlled study was conducted in a primary school between the 10 th  and 28 th  of December, 2018 with 155 children who were divided into Group-I, Group-II, and Control groups. One group was taught by a multi-stage technique, the other was by duration-based teaching, and the control group was provided with usual training. Handwashing efficacy was assessed by variance analysis on fluorescent residue after using glo-germ.
RESULTS


The students' mean age was 9.74±0.69 years, 53.6% of them were girls. Effective handwashing was highest in the Group-I. There was a difference between Group-I and Group-II, and Group-I and Control group in terms of hand cleanness. The frequently missed areas when cleaning hands were palmar surface, dorsal metacarpal area, and fingertips.
CONCLUSIONS


Teaching hand hygiene to children by multi-step technique may increase the handwashing effectiveness. Conducting comparative studies with new techniques including fewer stages is recommended.",2021,Effective handwashing was highest in the Group-I.,"[""children' hand hygiene"", ""students' mean age was 9.74±0.69 years, 53.6% of them were girls"", 'primary school between the 10 th  and 28 th  of December, 2018 with 155 children']",[],['Handwashing efficacy'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}]",[],"[{'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",155.0,0.0325123,Effective handwashing was highest in the Group-I.,"[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Öncü', 'Affiliation': 'Community Health Nursing Department, Faculty of Nursing, Mersin University, Mersin, Turkey.. Electronic address: eeoncu@gmail.com.'}, {'ForeName': 'Sümbüle Köksoy', 'Initials': 'SK', 'LastName': 'Vayısoğlu', 'Affiliation': 'Community Health Nursing Department, Faculty of Nursing, Mersin University, Mersin, Turkey.'}]",American journal of infection control,['10.1016/j.ajic.2021.03.012']
524,33773988,The effect of a quality improvement intervention on sleep and delirium in critically ill patients in a surgical intensive care unit.,"BACKGROUND


Delirium is a deleterious condition affecting up to 60% of patients in the surgical intensive care unit (SICU). Few SICU-focused delirium interventions have been implemented, including those addressing sleep-wake disruption, a modifiable delirium risk factor common in critically ill patients.
RESEARCH QUESTION


What is the effect on delirium and sleep quality of a multicomponent non-pharmacological intervention aimed at improving sleep-wake disruption in patients in the SICU setting?
STUDY DESIGN AND METHODS


Using a staggered pre-post design, we implemented a quality improvement intervention in two SICUs (general surgery/trauma and cardiovascular) in an academic medical center. After a pre-intervention (baseline) period, a multicomponent unit-wide nighttime (i.e., efforts to minimize unnecessary sound and light, provision of earplugs and eye masks) and daytime (i.e., raising blinds, promotion of physical activity) intervention bundle was implemented. A daily checklist was used to prompt staff to complete intervention bundle elements. Delirium was evaluated twice-daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Patient sleep quality ratings were evaluated daily using the Richards-Campbell Sleep Questionnaire (RCSQ).
RESULTS


Six hundred and forty-six SICU admissions (332 baseline, 314 intervention) were analyzed. Median [IQR) age was 61 [49, 70] years with 35% females and 83% white race. During the intervention period, patients experienced fewer days of delirium (proportion [±SD] of intensive care unit days = 15% [±27]) as compared to the pre-intervention period (20% [±31]; p=0.022), with an adjusted pre-post decrease of 4.9% [95% CI, 0.5-9.2%], p=0.03). Overall RCSQ perceived sleep quality ratings did not change, but the RCSQ noise subscore increased (9.5% [95% CI, 1.1-17.5%], p=0.02).
INTERPRETATION


Our multicomponent intervention was associated with a significant reduction in the proportion of days patients experienced delirium, reinforcing the feasibility and effectiveness of a non-pharmacological sleep-wake bundle to reduce delirium in critically ill patients in the SICU.",2021,"Overall RCSQ perceived sleep quality ratings did not change, but the RCSQ noise subscore increased (9.5% [95% CI, 1.1-17.5%], p=0.02).
","['patients in the SICU setting', 'Six hundred and forty-six', 'critically ill patients', 'patients in the surgical intensive care unit (SICU', 'two SICUs (general surgery/trauma and cardiovascular) in an academic medical center', 'Median [IQR) age was 61 [49, 70] years with 35% females and 83% white race', 'critically ill patients in a surgical intensive care unit']",['quality improvement intervention'],"['RCSQ noise subscore', 'sleep and delirium', 'Campbell Sleep Questionnaire (RCSQ', 'Patient sleep quality ratings', 'Delirium', 'Overall RCSQ perceived sleep quality ratings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0198121,"Overall RCSQ perceived sleep quality ratings did not change, but the RCSQ noise subscore increased (9.5% [95% CI, 1.1-17.5%], p=0.02).
","[{'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Tonna', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Utah Health, Salt Lake City, UT, USA; Division of Emergency Medicine, Department of Surgery, University of Utah Health, Salt Lake City, UT, USA. Electronic address: joseph.tonna@hsc.utah.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dalton', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Angela P', 'Initials': 'AP', 'LastName': 'Presson', 'Affiliation': 'Division of Epidemiology, Department of Medicine, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Division of Epidemiology, Department of Medicine, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Colantuoni', 'Affiliation': 'Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD, USA; Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Lander', 'Affiliation': 'Cardiovascular Intensive Care Unit, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Sullivan', 'Initials': 'S', 'LastName': 'Howard', 'Affiliation': 'Surgical Intensive Care Unit, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Beynon', 'Affiliation': 'Critical Care, AirMed & Emergency Nursing, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Biren B', 'Initials': 'BB', 'LastName': 'Kamdar', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, UC San Diego School of Medicine, La Jolla, CA, USA.'}]",Chest,['10.1016/j.chest.2021.03.030']
525,33773984,Phase 3 Randomized Study of Efficacy and Safety of a Dexamethasone Intracanalicular Insert in Patients With Allergic Conjunctivitis.,"PURPOSE


To evaluate the efficacy and safety of a dexamethasone intracanalicular ocular insert for treatment of allergic conjunctivitis.
DESIGN


Multicenter, randomized, double-masked, placebo-controlled, Phase 3 clinical trial.
METHODS


Subjects with allergic conjunctivitis were randomized 1:1 to dexamethasone insert or placebo insert to both eyes and evaluated using a modified version of the Ora-CAC® (conjunctival allergen challenge) model. After in-office insert placement, a series of 4 closely spaced post-insertion CACs at Weeks 1, 2, and 4 were conducted across approximately 30 days. Primary efficacy endpoints, assessed at Week 1 CAC Day 8, were subject-reported ocular itching at 3, 5, and 7 minutes post-CAC and investigator-evaluated conjunctival redness at 7, 15, and 20 minutes post-CAC.
RESULTS


For the primary endpoints, dexamethasone insert showed statistically significantly lower mean ocular itch scores compared with placebo at all time points (P<.001), with differences favoring dexamethasone insert over placebo (0.86, 0.98, and 0.96 units at 3, 5, and 7 minutes, respectively), and statistically significantly lower conjunctival redness scores at 20 minutes (P<.05) but not at 7 or 15 minutes (P≥.05). Results also showed statistically significantly less itching and conjunctival redness at 31 and 29 of 33 other time points, respectively (P<.05). There were no serious AEs; one subject had elevated intraocular pressure in both eyes.
CONCLUSIONS


The data presented in this study demonstrate the potential for a single, physician-administered dexamethasone intracanalicular insert to provide relief of ocular itching for up to 4 weeks in subjects with allergic conjunctivitis, while maintaining a favorable safety profile.",2021,"For the primary endpoints, dexamethasone insert showed statistically significantly lower mean ocular itch scores compared with placebo at all time points (P<.001), with differences favoring dexamethasone insert over placebo (0.86, 0.98, and 0.96 units at 3, 5, and 7 minutes, respectively), and statistically significantly lower conjunctival redness scores at 20 minutes (P<.05) but not at 7 or 15 minutes (P≥.05).","['Patients With Allergic Conjunctivitis', 'subjects with allergic conjunctivitis', 'Subjects with allergic conjunctivitis']","['dexamethasone', 'Dexamethasone Intracanalicular Insert', 'dexamethasone intracanalicular ocular insert', 'dexamethasone insert or placebo insert to both eyes and evaluated using a modified version of the Ora-CAC® (conjunctival allergen challenge) model', 'placebo']","['itching and conjunctival redness', 'ocular itching at 3, 5, and 7 minutes post-CAC and investigator-evaluated conjunctival redness', 'efficacy and safety', 'elevated intraocular pressure', 'mean ocular itch scores', 'conjunctival redness scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009766', 'cui_str': 'Allergic conjunctivitis'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.300857,"For the primary endpoints, dexamethasone insert showed statistically significantly lower mean ocular itch scores compared with placebo at all time points (P<.001), with differences favoring dexamethasone insert over placebo (0.86, 0.98, and 0.96 units at 3, 5, and 7 minutes, respectively), and statistically significantly lower conjunctival redness scores at 20 minutes (P<.05) but not at 7 or 15 minutes (P≥.05).","[{'ForeName': 'Eugene B', 'Initials': 'EB', 'LastName': 'McLaurin', 'Affiliation': 'Total Eye Care, P.A., 6060 Primacy Pkwy #200, Memphis, TN 38119.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Evans', 'Affiliation': 'Total Eye Care, P.A., 6060 Primacy Pkwy #200, Memphis, TN 38119.'}, {'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Repke', 'Affiliation': 'Philadelphia Eye Associates, 1703 South Broad Street Suite 103, Philadelphia, PA 19148.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Sato', 'Affiliation': 'East West Eye Institute, 1045 W. Redondo Beach Blvd. Suite 400, Gardena, CA 90247.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Gomes', 'Affiliation': 'Ora, Inc., 300 Brickstone Square, Andover, MA 01810.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Reilly', 'Affiliation': 'Ocular Therapeutix, Inc., 24 Crosby Drive, Bedford, MA 01730.'}, {'ForeName': 'Nysha', 'Initials': 'N', 'LastName': 'Blender', 'Affiliation': 'Ocular Therapeutix, Inc., 24 Crosby Drive, Bedford, MA 01730.'}, {'ForeName': 'Fabiana Q', 'Initials': 'FQ', 'LastName': 'Silva', 'Affiliation': 'Ocular Therapeutix, Inc., 24 Crosby Drive, Bedford, MA 01730.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Vantipalli', 'Affiliation': 'Ocular Therapeutix, Inc., 24 Crosby Drive, Bedford, MA 01730.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Metzinger', 'Affiliation': 'Ocular Therapeutix, Inc., 24 Crosby Drive, Bedford, MA 01730. Electronic address: JHart@ocutx.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gibson', 'Affiliation': 'Ocular Therapeutix, Inc., 24 Crosby Drive, Bedford, MA 01730.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Goldstein', 'Affiliation': 'Ocular Therapeutix, Inc., 24 Crosby Drive, Bedford, MA 01730.'}]",American journal of ophthalmology,['10.1016/j.ajo.2021.03.017']
526,33773924,Chest CT in patients with shortness of breath: Comparing high pitch CT and conventional CT on respiratory artefacts and dose.,"INTRODUCTION


To investigate chest respiratory artefact reduction using High Pitch Dual Source Computed Tomography (HPCT) compared to conventional CT (CCT) in symptomatic patients with shortness of breath.
METHODS


Forty patients were prospectively examined on a second-generation Dual Source scanner. They were randomly divided into two groups: twenty patients underwent an experimental HPCT protocol and twenty control cases CCT protocol. Respiratory artefacts were evaluated using an ordinal score (0, 1 and 2) assigned by two readers with five and thirty years of experience. A qualitative assessment was performed using two categorical groups, group 1 = acceptable and group 2 = unacceptable. Dose Length Product (DLP) was compared.
RESULTS


The two groups showed a statistical difference in artefacts reduction (p < 0.0001). HPCT demonstrated no artefacts in 82% of cases, while CCT showed no artefacts in 39% of cases. DLP showed no statistical differences (p = 0.6) with mean = 266.9 for HPCT and mean = 282.65 for CCT. HPCT provides high table speed in the z-direction allowing a high temporal resolution, which reduces respiratory artefacts during free-breathing acquisition. Despite the use of two x-ray tubes, the HPCT did not increase the dose to the patient but provided the highest images quality.
CONCLUSIONS


In the emergency setting, HPCTs have been critical for achieving good image quality in uncooperative patients.
IMPLICATIONS FOR PRACTICE


Acute respiratory failure is a common emergency department presentation, and the choice of high-speed acquisition CT may increase image quality.",2021,DLP showed no statistical differences (p = 0.6) with mean = 266.9 for HPCT and mean = 282.65 for CCT.,"['symptomatic patients with shortness of breath', 'Forty patients were prospectively examined on a second-generation Dual Source scanner', 'Acute', 'uncooperative patients', 'patients with shortness of breath']","['experimental HPCT protocol and twenty control cases CCT protocol', 'High Pitch Dual Source Computed Tomography (HPCT', 'conventional CT (CCT', 'DLP', 'Dose Length Product (DLP', 'CT and conventional CT', 'HPCT', 'Chest CT']",['artefacts reduction'],"[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0424350', 'cui_str': 'Uncooperative behavior'}]","[{'cui': 'C0241703', 'cui_str': 'High pitched voice'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0056574', 'cui_str': 'CT protocol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}]","[{'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",40.0,0.0149358,DLP showed no statistical differences (p = 0.6) with mean = 266.9 for HPCT and mean = 282.65 for CCT.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Varchetta', 'Affiliation': 'Department of Radiology Pineta Grande Hospital, Via Domitiana Km 30.00, Castel Volturno, Italy. Electronic address: francesco84vark@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cosson', 'Affiliation': 'Teesside University, Middlesbrough, United Kingdom.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Widdowfield', 'Affiliation': 'Teesside University, Middlesbrough, United Kingdom.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Danzi', 'Affiliation': 'Department of Radiology Pineta Grande Hospital, Via Domitiana Km 30.00, Castel Volturno, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Orlando', 'Affiliation': 'Department of Radiology Pineta Grande Hospital, Via Domitiana Km 30.00, Castel Volturno, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Natale', 'Affiliation': 'Department of Radiology Pineta Grande Hospital, Via Domitiana Km 30.00, Castel Volturno, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Laurenza', 'Affiliation': 'Department of Radiology Pineta Grande Hospital, Via Domitiana Km 30.00, Castel Volturno, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Scaglione', 'Affiliation': 'Department of Radiology Pineta Grande Hospital, Via Domitiana Km 30.00, Castel Volturno, Italy; Teesside University, Middlesbrough, United Kingdom; Department of Radiology James Cook University Hospital, Marton Road, Middlesbrough, TS4 3BW, United Kingdom. Electronic address: mariano.scaglione1@nhs.net.'}]","Radiography (London, England : 1995)",['10.1016/j.radi.2021.02.013']
527,33773873,"Re: Jens-Uwe Stolzenburg, Sigrun Holze, Petra Neuhaus, et al. Robotic-assisted Versus Laparoscopic Surgery: Outcomes from the First Multicentre, Randomised, Patient-blinded Controlled Trial in Radical Prostatectomy (LAP-01). Eur Urol. In press. https://doi.org/10.1016/j.eururo.2021.01.030.",,2021,,[],"['Robotic-assisted Versus Laparoscopic Surgery', 'Radical Prostatectomy (LAP-01']",[],[],"[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]",[],,0.351934,,"[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Bertolo', 'Affiliation': 'Urology Department, San Carlo di Nancy Hospital, Rome, Italy. Electronic address: riccardobertolo@hotmail.it.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Bove', 'Affiliation': 'Urology Department, San Carlo di Nancy Hospital, Rome, Italy; Urology Unit, Department of Surgery, Tor Vergata University of Rome, Rome, Italy.'}]",European urology,['10.1016/j.eururo.2021.03.003']
528,33773855,Nano-Bio Fusion Gingival Gel in the management of fixed orthodontic treatment-induced gingivitis: An empirical study.,"INTRODUCTION


This research aimed to investigate the effect of Nano-Bio Fusion Gingival Gel ([NBFG] NanoCgureTech, Gangdong-gu, Seoul, Korea) as an aid along with oral hygiene advice and routine scaling in patients with malocclusion to control treatment-induced gingivitis and periodontitis in patients undergoing fixed orthodontic treatment.
METHODS


A split-mouth design, prospective analysis after application of NBFG in 32 subjects with fixed orthodontic treatment-induced gingivitis was conducted. Patients applied NBFG to their gingiva twice daily, after brushing, for 90 consecutive days. Outcomes measured included: the plaque index (PI), papillary bleeding gingival index (PBI), probing depth (PD), and clinical attachment loss using standard assessment. PI, PBI, PD, and clinical attachment loss were measured at baseline, on the seventh day of gel application, at the next visit at the orthodontic clinic (28th day), and after 90 days.
RESULTS


From baseline to the seventh day to the 90th day till 3 months, the treatment group showed significant improvement in PI, PBI, and PD over time compared with the placebo group.
CONCLUSIONS


NBFG showed positive clinical effects in patients undergoing fixed orthodontic treatment. Clinical outcomes were measured in a comparatively short period.",2021,", the treatment group showed significant improvement in PI, PBI, and PD over time compared with the placebo group.
","['patients with malocclusion to control treatment-induced gingivitis and periodontitis in patients undergoing fixed orthodontic treatment', 'fixed orthodontic treatment-induced gingivitis', '32 subjects with fixed orthodontic treatment-induced gingivitis was conducted', 'patients undergoing fixed orthodontic treatment']","['placebo', 'NBFG', 'Nano-Bio Fusion Gingival Gel', 'Nano-Bio Fusion Gingival Gel ([NBFG']","['plaque index (PI), papillary bleeding gingival index (PBI), probing depth (PD), and clinical attachment loss using standard assessment', 'PI, PBI, and PD over time', 'positive clinical effects', 'PI, PBI, PD, and clinical attachment loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C1276322', 'cui_str': 'Gingival gel'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",32.0,0.0435721,", the treatment group showed significant improvement in PI, PBI, and PD over time compared with the placebo group.
","[{'ForeName': 'Mohammad Khursheed', 'Initials': 'MK', 'LastName': 'Alam', 'Affiliation': 'Orthodontic Department, College of Dentistry, Jouf University, Sakākā, Saudi Arabia. Electronic address: dralam@gmail.com.'}, {'ForeName': 'Kiran Kumar', 'Initials': 'KK', 'LastName': 'Ganji', 'Affiliation': 'Periodontics Department, College of Dentistry, Jouf University, Sakākā, Saudi Arabia.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.02.022']
529,33773851,Multicenter phase III trial of regenerative treatment for chronic tympanic membrane perforation.,"OBJECTIVE


To evaluate the efficacy and safety of regenerative treatment for tympanic membrane perforation (TMP) using gelatin sponge, basic fibroblast growth factor (bFGF), and fibrin glue.
METHODS


This was a multicenter, non-randomized, single-arm study conducted at tertiary referral centers. Twenty patients with chronic TMP (age 23-78 years, 6 males, 14 females) were registered from three institutions. All treated patients were included in the safety analysis population. The edges of the TMP were disrupted mechanically by myringotomy and several pieces of gelatin sponge immersed in bFGF were placed and fixed with fibrin glue to cover the perforation. The TMP was examined 4 ± 1 weeks later. The protocol was repeated up to four times until closure was complete. The main outcome measures were closure or a decrease in size of the TMP, hearing improvement, and air-bone gap evaluated 16 weeks after the final regenerative procedure (FRP). Adverse events (AEs) were monitored throughout the study.
RESULTS


Total closure of the TMP at 16 weeks was achieved in 15 out of 20 patients (75.0%, 95% confidence interval [CI]: 50.9%-91.3%) and the mean decrease in size was 92.2% (95%CI: 82.9%-100.0%). The ratio of hearing improvement and the air-bone gap at 16 weeks after FRP were 100% (20/20; 95%CI: 83.2%-100%) and 5.3 ± 4.2 dB (p <0.0001), respectively. Thirteen out of 20 patients (65.0%) experienced at least one AE, but no serious AEs occurred.
CONCLUSION


The results indicate that the current regenerative treatment for TMP using gelatin sponge, bFGF, and fibrin glue is safe and effective.",2021,"RESULTS


Total closure of the TMP at 16 weeks was achieved in 15 out of 20 patients (75.0%, 95% confidence interval [CI]: 50.9%-91.3%) and the mean decrease in size was 92.2% (95%CI: 82.9%-100.0%).","['chronic tympanic membrane perforation', 'Twenty patients with chronic TMP (age 23-78 years, 6 males, 14 females']","['tympanic membrane perforation (TMP) using gelatin sponge, basic fibroblast growth factor (bFGF), and fibrin glue', 'regenerative treatment', 'TMP using gelatin sponge, bFGF, and fibrin glue']","['efficacy and safety', 'ratio of hearing improvement and the air-bone gap', 'Adverse events (AEs', 'Total closure of the TMP', 'closure or a decrease in size of the TMP, hearing improvement, and air-bone gap evaluated 16 weeks after the final regenerative procedure (FRP']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0206504', 'cui_str': 'Perforation of tympanic membrane'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0206504', 'cui_str': 'Perforation of tympanic membrane'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0380603', 'cui_str': 'Fibroblast Growth Factor-2'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0206504', 'cui_str': 'Perforation of tympanic membrane'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",20.0,0.14376,"RESULTS


Total closure of the TMP at 16 weeks was achieved in 15 out of 20 patients (75.0%, 95% confidence interval [CI]: 50.9%-91.3%) and the mean decrease in size was 92.2% (95%CI: 82.9%-100.0%).","[{'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Kanemaru', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Medical Research Institute, Kitano Hospital, 2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan; Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, 1-5-4 Minatojima-minamimachi, Chuo-ku, Kobe 650-0047, Japan. Electronic address: kanemaru@ent.kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Kanai', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Medical Research Institute, Kitano Hospital, 2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Omori', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Okano', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan.'}, {'ForeName': 'Ippei', 'Initials': 'I', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Kanzaki', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Fujioka', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Oishi', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Naito', 'Affiliation': 'Department of Otolaryngology, Kobe City Medical Center General Hospital, 2-1-1, Minatojima Minamimachi, Chuo-ku, Kobe 650-0047, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Kakehata', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Yamagata University School of Medicine, 2-2-2 Iida-Nishi, Yamagata 990-9585, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Otsu Red Cross Hospital, 1-1-35 Nagara, Otsu 520-8511, Japan.'}, {'ForeName': 'Shinobu', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Nobelpharma Co., Ltd., 1-17-24, Shinkawa, Chuo-ku, Tokyo 104-0033, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Omae', 'Affiliation': 'Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, 1-5-4 Minatojima-minamimachi, Chuo-ku, Kobe 650-0047, Japan.'}, {'ForeName': 'Atsuhiko', 'Initials': 'A', 'LastName': 'Kawamoto', 'Affiliation': 'Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, 1-5-4 Minatojima-minamimachi, Chuo-ku, Kobe 650-0047, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Fukushima', 'Affiliation': 'Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, 1-5-4 Minatojima-minamimachi, Chuo-ku, Kobe 650-0047, Japan.'}]","Auris, nasus, larynx",['10.1016/j.anl.2021.02.007']
530,33773809,Randomized trial of exercise on depressive symptomatology and brain derived neurotrophic factor (BDNF) in ovarian cancer survivors: The Women's Activity and Lifestyle Study in Connecticut (WALC).,"OBJECTIVES


Depression is one of the most prevalent mental disorders, and rates are higher among cancer survivors than the general population, and higher in ovarian cancer patients compared to cohorts of other cancer survivors. Physical activity has been associated with lower depressive symptoms in cancer survivors, yet no trial has examined this association in women with ovarian cancer. We examined the effect of exercise on depression symptomatology and serum brain derived neurotrophin factor (BDNF) which has been associated with depression, in women with ovarian cancer.
METHODS


We conducted a 6-month home-based randomized trial of exercise vs. attention-control (AC) in 144 ovarian cancer survivors. Depressive symptomatology was measured via the Center for Epidemiologic Studies Depression Scale (CES-D). Serum total and free BDNF was measured at baseline and 6-months. Student's t-statistic and mixed-model repeated measures analysis was used to evaluate six-month change between arms in CES-D scores and BDNF.
RESULTS


Women were 57.3 ± 8.6 (mean ± SD) years old, 1.7 ± 1.0 years post-diagnosis with a baseline CES-D score of 11.79 ± 10.21. The majority (55%) were diagnosed with stage III/IV ovarian cancer. CES-D scores decreased in the exercise arm by 2.7 points (95% CI: -4.4, -0.9) or a 21% decrease compared to a 0.3 point decrease (-2.2, 1.5) (3% decrease) in the AC arm (P = 0.05). There was no difference in change in total or free BDNF between the exercise and AC arms.
CONCLUSIONS


Ovarian cancer survivors are able to exercise at recommended levels, and exercise was associated with a significant reduction in depressive symptomatology.",2021,"CES-D scores decreased in the exercise arm by 2.7 points (95% CI: -4.4, -0.9) or a 21% decrease compared to a 0.3 point decrease (-2.2, 1.5) (3% decrease) in the AC arm (P = 0.05).","['Ovarian cancer survivors', '144 ovarian cancer survivors', 'Women were 57.3\u202f±\u202f8.6 (mean\u202f±\u202fSD) years old, 1.7\u202f±\u202f1.0\u202fyears post-diagnosis with a baseline CES-D score of 11.79\u202f±\u202f10.21', 'women with ovarian cancer', 'cancer survivors', 'ovarian cancer survivors']","['exercise', 'exercise vs. attention-control (AC']","['depressive symptomatology and brain derived neurotrophic factor (BDNF', 'change in total or free BDNF', 'Serum total and free BDNF', 'CES-D scores', 'depressive symptomatology', 'Depressive symptomatology']","[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",144.0,0.30055,"CES-D scores decreased in the exercise arm by 2.7 points (95% CI: -4.4, -0.9) or a 21% decrease compared to a 0.3 point decrease (-2.2, 1.5) (3% decrease) in the AC arm (P = 0.05).","[{'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cartmel', 'Affiliation': 'Yale School of Public Health, New Haven, CT, United States of America; Yale Cancer Center, New Haven, CT, United States of America. Electronic address: brenda.cartmel@yale.edu.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Hughes', 'Affiliation': 'Yale School of Public Health, New Haven, CT, United States of America.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Ercolano', 'Affiliation': 'Yale School of Public Health, New Haven, CT, United States of America.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Gottlieb', 'Affiliation': 'Yale School of Public Health, New Haven, CT, United States of America.'}, {'ForeName': 'Fangyong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Yale School of Public Health, New Haven, CT, United States of America.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Yale School of Public Health, New Haven, CT, United States of America.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Harrigan', 'Affiliation': 'Yale School of Public Health, New Haven, CT, United States of America.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Ligibel', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, United States of America.'}, {'ForeName': 'Vivian E', 'Initials': 'VE', 'LastName': 'von Gruenigen', 'Affiliation': 'Division of Gynecologic Oncology, NEOMED, Akron, OH, United States of America.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Gogoi', 'Affiliation': 'Geisinger Health System, Danville, PA, United States of America.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Schwartz', 'Affiliation': 'Yale Cancer Center, New Haven, CT, United States of America; Yale School of Medicine, New Haven, CT, United States of America.'}, {'ForeName': 'Harvey A', 'Initials': 'HA', 'LastName': 'Risch', 'Affiliation': 'Yale School of Public Health, New Haven, CT, United States of America; Yale Cancer Center, New Haven, CT, United States of America.'}, {'ForeName': 'Lingeng', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Yale School of Public Health, New Haven, CT, United States of America; Yale Cancer Center, New Haven, CT, United States of America.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Irwin', 'Affiliation': 'Yale School of Public Health, New Haven, CT, United States of America; Yale Cancer Center, New Haven, CT, United States of America.'}]",Gynecologic oncology,['10.1016/j.ygyno.2021.02.036']
531,33773802,Video-Assisted Simulation Training in Burn Management: A Comparative Cohort Study on the Assessment of Technical and Non-technical Competencies.,"BACKGROUND


Written material remains one of the most common methods of education, however the current generation of learners may benefit from additional different media. In our study, we aim to quantify the effects of an innovative video instruction on subsequent resident performance in a burn patient simulation.
METHODS


Following IRB approval, 60 Plastic Surgery residents were randomly assigned to two groups. The control group (""non-video"" group) (n = 30) was given only written material as preparation. The experimental group (""video"" group) (n = 30) was provided access to video training materials in addition to the written material on technical and non-technical skills. Their videotaped performances on simulation were evaluated by a blinded surgical faculty member. The comparison of variables between the two groups was performed using a Mann-Whitney test for non-normal distributions of quantitative variables, and Fisher's Exact Probability test for qualitative data. Statistical significance was set at p < 0.05.
RESULTS


Compared to the non-video group, the video group achieved significantly higher scores in the technical skills of assessment of breathing (p = 0.015), disability (p = 0.023), and exposure (p = 0.005) and in the non-technical skills of decision-making (p = 0.035).
CONCLUSIONS


In residents participating in burn patient simulations, video training in advance of the simulation significantly improved their assessments of breathing, disability, and exposure as well as decision-making. Our video is a valuable tool to enhance trainees' technical and non-technical competencies in managing burn patient simulations.",2021,"Compared to the non-video group, the video group achieved significantly higher scores in the technical skills of assessment of breathing (p = 0.015), disability (p = 0.023), and exposure (p = 0.005) and in the non-technical skills of decision-making (p = 0.035).
","['60 Plastic Surgery residents', 'Burn Management']","['video training', 'innovative video instruction', 'control group (""non-video"" group) (n\xa0=\xa030) was given only written material as preparation', 'Video-Assisted Simulation Training', 'video training materials in addition to the written material on technical and non-technical skills']","['disability', 'assessments of breathing, disability, and exposure as well as decision-making', 'technical skills of assessment of breathing']","[{'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1318600', 'cui_str': 'Burns care'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0449851', 'cui_str': 'Technique'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0449851', 'cui_str': 'Technique'}]",60.0,0.0127307,"Compared to the non-video group, the video group achieved significantly higher scores in the technical skills of assessment of breathing (p = 0.015), disability (p = 0.023), and exposure (p = 0.005) and in the non-technical skills of decision-making (p = 0.035).
","[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Gasteratos', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Papageorgiou General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Joseph Robert', 'Initials': 'JR', 'LastName': 'Paladino', 'Affiliation': 'Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, United States.'}, {'ForeName': 'W Bosseau', 'Initials': 'WB', 'LastName': 'Murray', 'Affiliation': 'Anesthesiology, Pennsylvania State University College of Medicine at Milton S. Hershey Medical Center, Hershey, PA, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Goverman', 'Affiliation': 'Massachusetts General Hospital, Burns Center, Harvard Medical School, Boston, MA, United States. Electronic address: JGOVERMAN@mgh.harvard.edu.'}]",Injury,['10.1016/j.injury.2021.03.032']
532,33765656,Efficacy of Multidomain Intervention Against Physio-cognitive Decline Syndrome: A Cluster-randomized Trial.,"BACKGROUNDS


To investigate the efficacy of a community group-based intervention among community-dwelling older adults with physio-cognitive decline syndrome (PCDS).
METHODS


A prospective cluster randomized controlled trial included 733 community-dwelling older adults with adjusted Montreal Cognitive Assessment (MoCA adj) scores >18 from 40 community-based sites across Taiwan. PCDS was defined as the concomitant presence of physical declines, i.e., slowness and/or weakness plus dysfunction in any cognitive domain. The multidomain intervention integrated physical exercise, cognitive training, nutritional advices and health education lessons. Conventional health education in control group entailed periodic telephone calls to offer participants health education and advice. The primary outcome was the mean differences of MoCA adj total scores and all domains of MoCA adj between baseline and 6- and 12-month follow-up in each group of PCDS, cognitive dysfunction, mobility-type frailty and normal functioning, and the secondary outcomes included the changes of frailty score, handgrip strength, gait speed and physical activity. Intervention effects were analysed using a generalized linear mixed model.
RESULTS


Overall, 18.9% of the study sample had PCDS. Multidomain intervention for 12 months significantly improved cognitive performance in people with PCDS, and those with cognitive dysfunction only. An early benefit on visuo-spatial executive function was seen in older adults with mobility-type frailty. Intervention also improved frailty scores among participants with mobility-type frailty, handgrip strength for participants with PCDS, and gait speed in the normal group.
CONCLUSIONS


PCDS is a potentially reversible condition that may prevent subsequent disability and dementia, which deserves further investigation to confirm the long-term effects.",2021,"Intervention also improved frailty scores among participants with mobility-type frailty, handgrip strength for participants with PCDS, and gait speed in the normal group.
","['Against Physio-cognitive Decline Syndrome', 'participants with mobility-type frailty, handgrip strength for participants with PCDS, and gait speed in the normal group', 'older adults with mobility-type frailty', 'participants health education and advice', '733 community-dwelling older adults with adjusted Montreal Cognitive Assessment (MoCA adj) scores >18 from 40 community-based sites across Taiwan', 'community-dwelling older adults with physio-cognitive decline syndrome (PCDS']","['community group-based intervention', 'Multidomain intervention', 'Multidomain Intervention', 'multidomain intervention integrated physical exercise, cognitive training, nutritional advices and health education lessons']","['cognitive performance', 'PCDS', 'frailty scores', 'PCDS, cognitive dysfunction, mobility-type frailty and normal functioning, and the secondary outcomes included the changes of frailty score, handgrip strength, gait speed and physical activity', 'mean differences of MoCA adj total scores and all domains of MoCA adj']","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",733.0,0.0392909,"Intervention also improved frailty scores among participants with mobility-type frailty, handgrip strength for participants with PCDS, and gait speed in the normal group.
","[{'ForeName': 'Chih-Kuang', 'Initials': 'CK', 'LastName': 'Liang', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. No.386, Dazhong 1st Rd., Zuoying Dist., Kaohsiung City 81362, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General hospital, Kaohsiung, Taiwan. No.386, Dazhong 1st Rd., Zuoying Dist., Kaohsiung City 81362, Taiwan; Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan.'}, {'ForeName': 'Wei-Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan; Department of Family Medicine, Taipei Veterans General Hospital, Yuanshan Branch, Yilan, Taiwan. No.386, Rongguang Rd., Neicheng, Yuanshan Township, Yilan County 264, Taiwan. Electronic address: leewju@gmail.com.'}, {'ForeName': 'An-Chun', 'Initials': 'AC', 'LastName': 'Hwang', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan; Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan. No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City 11217, Taiwan.'}, {'ForeName': 'Chu-Sheng', 'Initials': 'CS', 'LastName': 'Lin', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan; Department of Family Medicine, Taichung Veterans General Hospital, Taichung, Taiwan. 1650 Taiwan Boulevard Sect. 4, Taichung 407204, Taiwan; Center for Geriatrics and Gerontology, Taichung Veterans General Hospital, Taichung, Taiwan. 1650 Taiwan Boulevard Sect. 4, Taichung 407204, Taiwan.'}, {'ForeName': 'Ming-Yueh', 'Initials': 'MY', 'LastName': 'Chou', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. No.386, Dazhong 1st Rd., Zuoying Dist., Kaohsiung City 81362, Taiwan; Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan.'}, {'ForeName': 'Li-Ning', 'Initials': 'LN', 'LastName': 'Peng', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan; Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan. No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City 11217, Taiwan.'}, {'ForeName': 'Ming-Hsien', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan; Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan. No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City 11217, Taiwan.'}, {'ForeName': 'Liang-Kung', 'Initials': 'LK', 'LastName': 'Chen', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. No. 155, Sec.2, Linong Street, Taipei 112 Taiwan; Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan. No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City 11217, Taiwan.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2021.104392']
533,33765633,The Effects of Upper Extremity Isokinetic Strengthening in Post-Stroke Hemiplegia: A Randomized Controlled Trial.,"OBJECTIVE


The aim of this study was to evaluate the efficacy of isokinetic strengthening in paretic upper extremity among patients with post-stroke hemiplegia.
METHODS


Hemiplegic patients with at least 6 months post-stroke and those with arm and hand Brunnstrom motor recovery stage ≥ 3 were included to the study. Patients were randomized into two groups. Isokinetic training group received 4 weeks (3 days/week) of isokinetic strengthening, while the control group was tailored strengthening exercises with exercise bands. Outcome measures were the isokinetic peak torque of wrist flexor and extensors, Fugl-Meyer Assessment of upper extremity, Stroke Impact Scale (SIS), Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, hand grip strength, peak isometric strength of wrist flexor and extensors. Outcome measures were evaluated before treatment, after treatment (at the end of week 4) and 4 weeks after the end of treatment (at the end of week 8). The trial was registered at ClinicalTtrials.gov (ID: NCT03834311).
RESULTS


After 4 weeks, changes in extensor peak torque at 60°/sn (p=0.007) and extensor peak isometric muscle strength (p=0.007) were higher in the isokinetic group (n=12) than those in the control group (n=12). At the end of week 8, only DASH score revealed a significantly higher improvement in the isokinetic group than that in the control group (p=0.014).
CONCLUSIONS


Isokinetic strengthening may provide motor and functional improvement in paretic upper extremity among patients with post-stroke hemiplegia.",2021,(p=0.007) and extensor peak isometric muscle strength (p=0.007) were higher in the isokinetic group (n=12) than those in the control group (n=12).,"['patients with post-stroke hemiplegia', 'Post-Stroke Hemiplegia', 'Hemiplegic patients with at least 6 months post-stroke and those with arm and hand Brunnstrom motor recovery stage ≥ 3 were included to the study']","['Upper Extremity Isokinetic Strengthening', 'Isokinetic training', 'Isokinetic strengthening', 'isokinetic strengthening, while the control group was tailored strengthening exercises with exercise bands', 'isokinetic strengthening']","['extensor peak isometric muscle strength', 'DASH score', 'extensor peak torque', 'isokinetic peak torque of wrist flexor and extensors, Fugl-Meyer Assessment of upper extremity, Stroke Impact Scale (SIS), Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, hand grip strength, peak isometric strength of wrist flexor and extensors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0175723', 'cui_str': 'Band'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}]",,0.0263856,(p=0.007) and extensor peak isometric muscle strength (p=0.007) were higher in the isokinetic group (n=12) than those in the control group (n=12).,"[{'ForeName': 'Kerim', 'Initials': 'K', 'LastName': 'Kerimov', 'Affiliation': 'Cukurova University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Adana, Turkey. Electronic address: kkerimov81@gmail.com.'}, {'ForeName': 'Ilke', 'Initials': 'I', 'LastName': 'Coskun Benlidayi', 'Affiliation': 'Cukurova University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Adana, Turkey. Electronic address: icbenlidayi@hotmail.com.'}, {'ForeName': 'Cigdem', 'Initials': 'C', 'LastName': 'Ozdemir', 'Affiliation': 'Cukurova University Faculty of Medicine, Department of Physiology, Adana, Turkey. Electronic address: cozdemir@cu.edu.tr.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Gunasti', 'Affiliation': 'Cukurova University Faculty of Medicine, Department of Physiology, Adana, Turkey. Electronic address: ogunasti@cu.edu.tr.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2021.105729']
534,33765619,Autonomy support and preference-performance dissociation in choice-reaction time tasks.,"The purpose of the current study was threefold: (a) to examine the effects of participants having the autonomy to choose the practice order of two reaction time (RT) tasks - a choice-RT task and a Simon task - on performance, (b) to examine whether one order of practice is better than the other, and (c) to examine whether participants might choose a practice order that hinders their performance. The study was conducted online and participants completed the tasks on their own computer. Fifty-nine participants were randomly assigned into three groups: (a) autonomy - participants chose which task they would like to practice first, (b) choice-first - participants practiced the choice-RT task first, and (c) Simon-first - participants practiced the Simon task first. Out of these three groups we created an autonomy group (n = 17) and a no-autonomy (yoked) group (n = 17). All participants performed eight familiarization trials of each task, practiced 160 trials (8 blocks × 20 trials) of each task, and performed a post-test of 20 additional trials of each task after a three-minute rest. The main findings were that (a) participants in the autonomy group had faster RTs compared with participants in the no-autonomy group, (b) performing the choice-RT task first led to faster RTs compared with performing the Simon task first, and (c) nine of the 17 participants in the autonomy group chose to practice the Simon task first. The findings of this study suggest that providing participants with autonomy can lead to improved performance. However, there may be a dissociation between participants' preference of practice order and their performance.",2021,"The main findings were that (a) participants in the autonomy group had faster RTs compared with participants in the no-autonomy group, (b) performing the choice-RT task first led to faster RTs compared with performing the Simon task first, and (c) nine of the 17 participants in the autonomy group chose to practice the Simon task first.",['Fifty-nine participants'],"['autonomy - participants chose which task they would like to practice first, (b) choice-first - participants practiced the choice-RT task first, and (c']",['faster RTs'],"[{'cui': 'C3830128', 'cui_str': '59'}]","[{'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}]",59.0,0.176945,"The main findings were that (a) participants in the autonomy group had faster RTs compared with participants in the no-autonomy group, (b) performing the choice-RT task first led to faster RTs compared with performing the Simon task first, and (c) nine of the 17 participants in the autonomy group chose to practice the Simon task first.","[{'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Ziv', 'Affiliation': 'Motor Behavior Laboratory, The Academic College at Wingate, Netanya, Israel. Electronic address: galziv@wincol.ac.il.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Lidor', 'Affiliation': 'Motor Behavior Laboratory, The Academic College at Wingate, Netanya, Israel.'}]",Human movement science,['10.1016/j.humov.2021.102786']
535,33765581,"Epilobium angustifolium L. extract with high content in oenothein B on benign prostatic hyperplasia: A monocentric, randomized, double-blind, placebo-controlled clinical trial.","Benign prostatic hyperplasia (BPH) is a common condition in adult men. Especially in Europe, increasing attention has been focused on E. angustifolium extracts (EAEs), which are widely used for their positive effects on the symptoms of BPH, although human clinical trials are limited. The aim of this monocentric, randomized, double-blind, placebo-controlled clinical trial is to evaluate if a daily intake of hard, gastric-resistant capsules containing a chemically characterized EAE (500 mg) for 6 months may allow a significant improvement in symptoms in subjects with BPH. This study was conducted in 128 adult men, randomly assigned to receive either EAE food supplement (N = 70) or placebo (N = 58), who underwent four visits (baseline = t0, after 15 days = t1, after 2 months = t2 and after 6 months = t3) in an outpatient setting to evaluate post-void residual (PVR) and prostate volume (PV) by means of prostate ultrasound, prostate-specific antigen (PSA) and neutrofile/lymphocyte ratio (N/L), nocturia before the clinical visits and International Prostate Specific Score (IPSS) registered by the physicians. EAE food supplement induced a significant decrease in the PVR and consequently nocturia improving the quality of life as suggested by the decrease of IPSS. No subjects reported adverse effects related to oral intake of EAE food supplement. Moreover, EAE food supplement did not show hepatic or renal toxicity. In conclusion, EAE food supplements can be used in subjects with BPH, to improve their quality of life and general renal function.",2021,EAE food supplement induced a significant decrease in the PVR and consequently nocturia improving the quality of life as suggested by the decrease of IPSS.,"['Benign prostatic hyperplasia (BPH', '128 adult men', 'subjects with BPH', 'oenothein B on benign prostatic hyperplasia', 'adult men']","['placebo', 'EAE food supplement (N\u202f=\u202f70) or placebo', 'Epilobium angustifolium L. extract']","['prostate-specific antigen (PSA) and neutrofile/lymphocyte ratio (N/L), nocturia before the clinical visits and International Prostate Specific Score (IPSS', 'PVR and consequently nocturia improving the quality of life', 'hepatic or renal toxicity', 'quality of life and general renal function', 'IPSS']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0214099', 'cui_str': 'oenothein B'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014072', 'cui_str': 'Allergic encephalomyelitis'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1081274', 'cui_str': 'Epilobium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",128.0,0.201661,EAE food supplement induced a significant decrease in the PVR and consequently nocturia improving the quality of life as suggested by the decrease of IPSS.,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Esposito', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Santarcangelo', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Raffaello', 'Initials': 'R', 'LastName': 'Masselli', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Buonomo', 'Affiliation': 'Samnium Medical Soc. Cooperative, viale Cristoforo Colombo 18, 82100 Benevento, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Nicotra', 'Affiliation': 'EPO S.r.l., Via Stadera 19, 20141 Milan, Italy.'}, {'ForeName': 'Violetta', 'Initials': 'V', 'LastName': 'Insolia', 'Affiliation': 'EPO S.r.l., Via Stadera 19, 20141 Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Avino"", 'Affiliation': 'Department of Internal Medicine, Hospital Cardarelli, via Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Caruso', 'Affiliation': 'Department of Internal Medicine, Hospital Cardarelli, via Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Antonio Riccardo', 'Initials': 'AR', 'LastName': 'Buonomo', 'Affiliation': 'Department of Clinical Medicine and Surgery - Section of Infectious Diseases, University of Naples Federico II, via Sergio Pansini 5, 80131 Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Applied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, viale Taramelli 24, 27100 Pavia, Italy.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sommella', 'Affiliation': 'Department of Pharmacy, University of Salerno, 84084 Fisciano, SA, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Campiglia', 'Affiliation': 'Department of Pharmacy, University of Salerno, 84084 Fisciano, SA, Italy; European Biomedical Research Institute of Salerno, via De Renzi 50, I-84125 Salerno, Italy.'}, {'ForeName': 'Gian Carlo', 'Initials': 'GC', 'LastName': 'Tenore', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Daglia', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy; International Research Center for Food Nutrition and Safety, Jiangsu University, 212013 Zhenjiang, China. Electronic address: maria.daglia@unina.it.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2021.111414']
536,33765549,A randomized control trial to study the effect of integrated yoga on pregnancy outcome in hypertensive disorder of pregnancy.,"OBJECTIVE


The study aimed to evaluate the effects of integrated yoga on blood pressure and pregnancy outcome in hypertensive disorder of pregnancy.
METHODS


Seventy-nine patients were randomized into study and control groups. The study group received the intervention in the form of integrated yoga for 4 weeks. Final analysis was done on 30 patients each of study and control group.
RESULTS


The mean systolic BP declined by 7.43 ± 5.86 mmHg in the study group as compared to 2.50 ± 5.21 mm Hg in the control group (p value 0.002). The mean diastolic BP prior to delivery was 88.00 ± 3.71 mmHg in the study group and 92.20 ± 5.02 mmHg in the control group (p = 0.001). The maternal comfort in labor was significantly higher and the duration of labor significantly reduced in the study group.
CONCLUSION


Integrated yoga effectively reduced systolic and diastolic blood pressures and increased maternal comfort during labor in hypertensive disorder of pregnancy.",2021,"The maternal comfort in labor was significantly higher and the duration of labor significantly reduced in the study group.
","['30 patients each of study and control group', 'Seventy-nine patients', 'hypertensive disorder of pregnancy']",['integrated yoga'],"['mean diastolic BP prior to delivery', 'duration of labor', 'maternal comfort in labor', 'blood pressure and pregnancy outcome', 'maternal comfort', 'mean systolic BP', 'systolic and diastolic blood pressures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",79.0,0.0524521,"The maternal comfort in labor was significantly higher and the duration of labor significantly reduced in the study group.
","[{'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Makhija', 'Affiliation': 'Department of Obstetrics and Gynecology, Lady Hardinge Medical College, New Delhi, India. Electronic address: amritamakhija@gmail.com.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Khatik', 'Affiliation': 'Department of Obstetrics and Gynecology, Lady Hardinge Medical College, New Delhi, India.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Raghunandan', 'Affiliation': 'Department of Obstetrics and Gynecology, Lady Hardinge Medical College, New Delhi, India.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101366']
537,33771289,Mechanisms of change in an adapted marijuana e-CHECKUP TO GO intervention on decreased college student cannabis use.,"The objective of this study was to test indirect effects of the Marijuana e-CHECKUP TO GO program on college students' frequent marijuana use through decreased use in specific social and academic activities. This study randomly assigned college students who reported frequent marijuana use (i.e., approximately five times per week) in fall 2016 to receive Marijuana e-CHECKUP TO GO or healthy stress management (HSM) strategies. The final baseline sample included 298 participants. Path analyses tested direct program effects on marijuana use at six-week posttest, as well as the indirect effect via use within four activities frequently participated in by college students: socializing, being physically active, studying, and being in class. Direct Marijuana e-CHECKUP TO GO effects on reductions in frequent use were transmitted by decreased marijuana use while studying and no use while socializing, being physically active, or in class. Marijuana e-CHECKUP TO GO may be most effective at reducing use of marijuana among college students while studying.",2021,Marijuana e-CHECKUP TO GO may be most effective at reducing use of marijuana among college students while studying.,"[""college students' frequent marijuana"", 'college students who reported frequent marijuana use (i.e., approximately five times per week) in fall 2016 to receive', '298 participants']","['TO GO intervention', 'CHECKUP', 'Marijuana e-CHECKUP TO GO program', 'Marijuana e-CHECKUP TO GO or healthy stress management (HSM) strategies', 'Direct Marijuana e-CHECKUP']",[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]",[],298.0,0.00558988,Marijuana e-CHECKUP TO GO may be most effective at reducing use of marijuana among college students while studying.,"[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Prince', 'Affiliation': 'Department of Psychology, Colorado State University, United States of America. Electronic address: Mark.Prince@colostate.edu.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Tyskiewicz', 'Affiliation': 'Department of Psychology, Colorado State University, United States of America.'}, {'ForeName': 'Bradley T', 'Initials': 'BT', 'LastName': 'Conner', 'Affiliation': 'Department of Psychology, Colorado State University, United States of America.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Parnes', 'Affiliation': 'Department of Psychology, Colorado State University, United States of America.'}, {'ForeName': 'Audrey M', 'Initials': 'AM', 'LastName': 'Shillington', 'Affiliation': 'College of Health and Human Sciences, San Jose State University, United States of America.'}, {'ForeName': 'Melissa W', 'Initials': 'MW', 'LastName': 'George', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, United States of America.'}, {'ForeName': 'Nathaniel R', 'Initials': 'NR', 'LastName': 'Riggs', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2021.108308']
538,33771287,Association between methadone or buprenorphine use during medically supervised opioid withdrawal and extended-release injectable naltrexone induction failure.,"BACKGROUND


Extended-release naltrexone (XR-NTX) is an effective maintenance treatment for opioid use disorder, but induction from active opioid use is a challenge as individuals must complete detoxification before induction. We aimed to determine whether use of methadone or buprenorphine, long acting agonist opioids commonly used for detoxification, were associated with decreased likelihood of induction onto XR-NTX.
METHODS


We performed a secondary analysis of a large open-label randomized trial of buprenorphine versus XR-NTX for treatment of individuals with opioid use disorder recruited from eight short term residential (detoxification) units. This analysis only included individuals randomized to the XR-NTX arm of the trial (N = 283). The method of detoxification varied according to usual practices at each inpatient program. Logistic regression models estimating the log-odds of induction onto XR-NTX were fit, with detoxification regimen received as the predictor.
RESULTS


In the unadjusted logistic regression model, detoxification drug received (either methadone or buprenorphine) was significantly associated with decreased likelihood of induction onto XR-NTX compared to receiving non-opioid detoxification (Overall: P < 0.001); buprenorphine vs non-opioid detoxification: OR (95% CI) = 0.32 (0.15-0.67); methadone vs non-opioid detoxification: OR (95% CI) = 0.23 (0.11-0.46). After controlling for site as a random effect, the association of detoxification drug with induction success lost statistical significance.
CONCLUSIONS


Use of agonist medication during detoxification was associated with XR-NTX induction failure. Medication choice was determined by each site's clinical practice and therefore this association could not be separated from other site level variables.
CLINICAL TRIAL REGISTRATION


NCT02032433.",2021,"After controlling for site as a random effect, the association of detoxification drug with induction success lost statistical significance.
",['individuals with opioid use disorder recruited from eight short term residential (detoxification) units'],"['buprenorphine versus XR-NTX', 'methadone', 'methadone or buprenorphine', 'naltrexone (XR-NTX', 'buprenorphine', 'XR-NTX']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]",[],,0.0721109,"After controlling for site as a random effect, the association of detoxification drug with induction success lost statistical significance.
","[{'ForeName': 'Matisyahu', 'Initials': 'M', 'LastName': 'Shulman', 'Affiliation': 'New York State Psychiatric Institute, United States of America; Department of Psychiatry, Columbia University Medical Center, United States of America. Electronic address: matisyahu.shulman@nyspi.columbia.edu.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'New York State Psychiatric Institute, United States of America.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'New York State Psychiatric Institute, United States of America.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, United States of America.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wai', 'Affiliation': 'New York State Psychiatric Institute, United States of America; Department of Psychiatry, Columbia University Medical Center, United States of America.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Haenlein', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center, United States of America.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Tofighi', 'Affiliation': 'Department of Population Health, New York University, United States of America.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'New York State Psychiatric Institute, United States of America; Department of Psychiatry, Columbia University Medical Center, United States of America.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'Department of Population Health, New York University, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, United States of America.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, United States of America; Department of Psychiatry, Columbia University Medical Center, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2021.108292']
539,33771279,Substance use predictors of attendance among veterans in integrated PTSD and alcohol use disorder treatment.,"Comorbid post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) is common, defined by greater severity and impairment than either disorder alone, and associated with poor treatment attendance. Exposure therapies are effective in treating PTSD+AUD, yet substance use is still cited as a potential contraindication for exposure. This study examined substance use-related predictors of session attendance among veterans (N = 119) randomized to receive integrated exposure therapy (Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure [COPE]; Back et al., 2015) or integrated coping skills therapy (Seeking Safety [SS]; Najavits, 2002) in a clinical trial for comorbid PTSD+AUD (Norman et al., 2019). At baseline, greater percentage of heavy drinking days (β = -0.23, p = .011) and greater AUD severity per structured clinical interview for DSM-IV-TR (β = -0.21, p = .019) predicted fewer sessions across both treatments. Treatment type did not moderate the relationship between predictors and attendance, except for a trend for craving (p = .057), where greater craving predicted fewer sessions in SS (β = -0.31, p = .02) but not COPE (β = 0.14, p = .28). Percentage of abstinence days, AUD duration, and living in a controlled environment (e.g., recovery home) at the start of therapy were not associated with attendance in either treatment condition. Only a subset of substance use characteristics predicted attendance. Findings did not support the notion that alcohol use leads to lower attendance in exposure therapy compared to nonexposure therapy.",2021,"Treatment type did not moderate the relationship between predictors and attendance, except for a trend for craving (p = .057), where greater craving predicted fewer sessions in SS","['veterans (N\xa0=\xa0119', 'veterans in integrated PTSD and alcohol use disorder treatment']","['integrated exposure therapy (Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure [COPE]; Back et al., 2015) or integrated coping skills therapy (Seeking Safety [SS', 'SS']","['percentage of heavy drinking days (β\xa0', 'Percentage of abstinence days, AUD duration, and living in a controlled environment (e.g., recovery home', 'greater AUD severity per structured clinical interview for DSM-IV-TR ']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0014409', 'cui_str': 'Controlled Environment'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}]",,0.0099091,"Treatment type did not moderate the relationship between predictors and attendance, except for a trend for craving (p = .057), where greater craving predicted fewer sessions in SS","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Kline', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, USA; University of California San Diego, School of Medicine, 9500 Gilman Drive, La Jolla, CA 92037, USA. Electronic address: alexander.kline@va.gov.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Straus', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, USA; University of California San Diego, School of Medicine, 9500 Gilman Drive, La Jolla, CA 92037, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Lyons', 'Affiliation': 'San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, 6363 Alvarado Court, Suite 103, San Diego, CA 92120, USA.'}, {'ForeName': 'Abigail C', 'Initials': 'AC', 'LastName': 'Angkaw', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, USA; University of California San Diego, School of Medicine, 9500 Gilman Drive, La Jolla, CA 92037, USA; San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, 6363 Alvarado Court, Suite 103, San Diego, CA 92120, USA; National Center for PTSD, 163 Veterans Drive, White River Junction, VT 05009, USA.'}, {'ForeName': 'Brittany C', 'Initials': 'BC', 'LastName': 'Davis', 'Affiliation': 'James A. Haley Veterans Hospital, 13000 Bruce B. Downs Boulevard, Tampa, FL 33612, USA; Department of Psychiatry and Behavioral Neurosciences, University of South Florida, 3515 E. Fletcher Avenue, Tampa, FL 33613, USA.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Haller', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, USA; University of California San Diego, School of Medicine, 9500 Gilman Drive, La Jolla, CA 92037, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hien', 'Affiliation': 'Center of Alcohol & Substance Use Studies, Rutgers University, 607 Allison Road, New Brunswick, NJ 08854, USA.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, USA; University of California San Diego, School of Medicine, 9500 Gilman Drive, La Jolla, CA 92037, USA; National Center for PTSD, 163 Veterans Drive, White River Junction, VT 05009, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2021.108278']
540,33771278,A randomized comparison of 4 vs. 16 weeks of psychosocial treatment for stimulant users.,"Controlled studies provide little empirical evidence to inform clinical recommendations for the optimal duration (i.e., ""dosage"") of psychosocial treatment for substance use disorders (SUDs). The current study prospectively examined the relationships among treatment dosage, participant adherence to the treatment regimen, and treatment outcomes in a population of adults with stimulant use disorder (cocaine and/or methamphetamine). The study randomly assigned eighty-five participants to receive either 4 weeks or 16 weeks of standardized outpatient treatment. The treatment consisted of cognitive behavioral therapy (CBT) and content covered was identical for each condition; only the planned duration of participation differed. Although both groups reduced stimulant use over time, participants in the 16-week condition were significantly more likely than those in the 4-week condition to provide stimulantnegative urine specimens 26 and 52 weeks following randomization. Participant adherence to treatment correlated significantly with drug-use outcomes: we observed a greater likelihood of stimulant-negative urine tests among those who completed treatment, irrespective of group assignment. Both the number of sessions attended and the percentage of prescribed sessions attended were associated with reductions in stimulant-use frequency 26 and 52 weeks after admission.",2021,Both the number of sessions attended and the percentage of prescribed sessions attended were associated with reductions in stimulant-use frequency 26 and 52 weeks after admission.,['population of adults with stimulant use disorder (cocaine and/or methamphetamine'],['cognitive behavioral therapy (CBT'],[],"[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],85.0,0.035254,Both the number of sessions attended and the percentage of prescribed sessions attended were associated with reductions in stimulant-use frequency 26 and 52 weeks after admission.,"[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rawson', 'Affiliation': 'Vermont Center for Behavior and Health, Department of Psychiatry, University of Vermont, Burlington, Vermont 05401, United States of America. Electronic address: rrawson@mednet.ucla.edu.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Glasner', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, University of California, Los Angeles, United States of America.'}, {'ForeName': 'Mary-Lynn', 'Initials': 'ML', 'LastName': 'Brecht', 'Affiliation': 'Department of Psychiatry & Biobehavioral Sciences, University of California, Los Angeles, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farabee', 'Affiliation': 'Grossman School of Medicine, New York University, 180 Madison Ave, 17th Floor, New York, NY 10016, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108274']
541,33772118,Can treatment of severe periodontitis in patients with ST-segment elevation myocardial infarction improve endothelial function?,"Design This is a parallel-group, unicentric, randomised, assessor-blinded, superiority trial with equal allocation ratio to evaluate and compare the effects of periodontal treatment on endothelial function, measured by a flow-mediated dilation of brachial artery, in patients with a recent ST-segment elevation myocardial infarction (STEMI).Study population The study population included a total of 48 patients who were recruited from a hospital in Brazil. Patients who had a recent episode of acute STEMI and also exhibited severe periodontal disease were included, while exclusion criteria included factors like patients who were <30 years old, HIV-positive, had chronic inflammatory or neoplastic diseases, pregnant, significant dental loss (<8 teeth remaining) etc. After seeking consent, patients were randomised to two groups: patients in the intervention group were provided with periodontal treatment while no treatment was given to patients in the control group. Patients were assessed for the primary outcome (flow-mediated dilation [FMD] in the brachial artery), secondary outcomes (periodontal health and inflammatory markers) and other safety outcomes after six months of intervention.Data analysis Data was analysed using the intention-to-treat principle, wherein t-tests and chi-square tests were used to compare baseline variables between groups, while dependent t-test was used for within-group comparisons. The Mann-Whitney test was used to compare cytokine levels from baseline to six-month follow-up. Effect sizes were presented along with their respective p values and confidence intervals. Lastly, a sensitivity analysis was also carried out by taking stringent p values for establishing significance (p = 0.025).Results Statistically significant improvement was seen in FMD values among patients who received periodontal treatment (from 9.0 ± 4.4% at baseline to 12.1 ± 5.6% at follow-up; p = 0.01), while the patients in the control group exhibited a non-significant change in FMD values (from 12.2 ± 7.2% at baseline to 11.9 ± 4.0% at follow-up; p = 0.79). Group difference for observed 'FMD variation' was initially found to be significant (3.4%, CI = 0.6-5.8% and using generalised estimating equation p = 0.03). However, on repeating the analysis by taking stringent p values for establishing significance (p = 0.025), non-significant difference in FMD variation was seen. In the intervention group, all periodontal health parameters significantly improved over a period of six months (p <0.001, for all parameters) while inflammatory markers in both groups exhibited non-significant differences for the study period. No adverse outcomes were reported.Conclusions Treatment of periodontitis among patients with a recent episode of STEMI significantly improves the endothelial function as shown by improved FMD.",2021,"In the intervention group, all periodontal health parameters significantly improved over a period of six months (p <0.001, for all parameters) while inflammatory markers in both groups exhibited non-significant differences for the study period.","['patients with a recent ST-segment elevation myocardial infarction (STEMI).Study population The study population included a total of 48 patients who were recruited from a hospital in Brazil', 'patients with ST-segment elevation myocardial infarction', 'Patients who had a recent episode of acute STEMI and also exhibited severe periodontal disease were included, while exclusion criteria included factors like patients who were <30 years old, HIV-positive, had chronic inflammatory or neoplastic diseases, pregnant, significant dental loss (<8 teeth remaining) etc']",['periodontal treatment while no treatment'],"[""observed 'FMD variation"", 'FMD variation', 'FMD values', 'cytokine levels', 'periodontal health parameters', 'inflammatory markers', 'endothelial function', 'primary outcome (flow-mediated dilation [FMD] in the brachial artery), secondary outcomes (periodontal health and inflammatory markers) and other safety outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",48.0,0.0879861,"In the intervention group, all periodontal health parameters significantly improved over a period of six months (p <0.001, for all parameters) while inflammatory markers in both groups exhibited non-significant differences for the study period.","[{'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Gugnani', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, DAV (C) Dental College Yamunanagar, Haryana, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Gugnani', 'Affiliation': 'Department of Periodontics and Oral Implantology, DAV (C) Dental College Yamunanagar, Haryana, India.'}]",Evidence-based dentistry,['10.1038/s41432-021-0157-3']
542,33771956,Contact Lens Adaption in Neophytes.,"SIGNIFICANCE


Clinicians commonly either recommend patients begin contact lens (CL) wear full time or suggest that patients should gradually increase their wear times during the first few days of wear. This study found no differences between these two wear schedules, suggesting that patient preference may be the best schedule.
PURPOSE


The purpose of this study was to determine if there are any clinical differences in neophyte, 2-week, reusable soft CL wearers who were randomized to either a full-time or a gradually increasing wear time schedule.
METHODS


This was an investigator-masked, three-visit, randomized, clinical trial. Participants were randomized to wear their CLs full time starting on the first day or gradually starting with 2 hours of wear on the first day and increasing wear by 2 hours each day until 8 hours or more of wear per day was achieved. Symptoms (Ocular Surface Disease Index and visual analog scale) and ocular surface signs (tear breakup time, extent of corneal staining, and Schirmer test I) were evaluated at each visit.
RESULTS


A total of 25 participants were randomized, with 21 participants completing at least 1 week of follow-up. Completed participants had a mean ± standard deviation age of 23.5 ± 3.0 years, and 48% were female. No significant between-group differences were found when comparing the full-time and gradual wear time schedule groups at 2 weeks (all, P > .32): Ocular Surface Disease Index (10.8 ± 8.5 vs. 16.3 ± 18.8), visual analog scale (89.0 ± 9.7 vs. 81.8 ± 18.7), tear breakup time (11.7 ± 7.0 vs. 9.8 ± 2.7), extent of corneal staining (0.0 ± 0.1 vs. 0.3 ± 0.5), or Schirmer test I (15.9 ± 8.8 vs. 21.2 ± 12.5).
CONCLUSIONS


No between-group differences were found for any metric evaluated, which suggests that the best wear schedule may be the one that best suits the neophyte CL wearer's lifestyle.",2021,"No significant between-group differences were found when comparing the full-time and gradual wear time schedule groups at 2 weeks (all, P > .32):","['Completed participants had a mean ± standard deviation age of 23.5 ± 3.0 years, and 48% were female', 'A total of 25 participants']",[],"['Ocular Surface Disease Index', 'full-time and gradual wear time schedule', 'Symptoms (Ocular Surface Disease Index and visual analog scale) and ocular surface signs (tear breakup time, extent of corneal staining, and Schirmer test', 'tear breakup time', 'visual analog scale']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],"[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}]",25.0,0.380057,"No significant between-group differences were found when comparing the full-time and gradual wear time schedule groups at 2 weeks (all, P > .32):","[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Pucker', 'Affiliation': ''}, {'ForeName': 'Kelsy', 'Initials': 'K', 'LastName': 'Steele', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, Ohio.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Rueff', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, Ohio.'}, {'ForeName': 'Quentin X', 'Initials': 'QX', 'LastName': 'Franklin', 'Affiliation': 'School of Optometry, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'McClure', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, Ohio.'}, {'ForeName': 'Keyur', 'Initials': 'K', 'LastName': 'Savla', 'Affiliation': 'School of Optometry, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Walline', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, Ohio.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001662']
543,33771952,Effect of Vergence/Accommodative Therapy on Attention in Children with Convergence Insufficiency: A Randomized Clinical Trial.,"SIGNIFICANCE


The results of this study suggest that clinicians providing vergence/accommodative therapy for convergence insufficiency in children should not suggest that such treatment will lead to improvements in attention when compared with placebo treatment.
PURPOSE


This study aimed to compare the effects of 16 weeks of vergence/accommodative therapy and placebo therapy on changes in attention for children in the Convergence Insufficiency Treatment Trial-Attention and Reading Trial.
METHODS


Three hundred ten children 9 to 14 years old with convergence insufficiency were assigned to receive treatment with office-based vergence/accommodative therapy or placebo therapy. Attention tests were administered at baseline and after 16 weeks of treatment. The primary measure of attention was the Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior (SWAN) scale. Other measures included the Swanson, Nolan, and Pelham checklist; the Homework Problems Checklist; and the d2 Test of Attention. Within and between-group differences are reported using Cohen d effect sizes.
RESULTS


For the SWAN, there was no significant difference between the groups for the inattention scale parental report (d = 0.036; 95% confidence interval, -0.21 to 0.28) or for the hyperactivity impulsivity scale parental report (d = -0.003; 95% confidence interval, -0.24 to 0.24). Similar results were found for teacher reports and the secondary measures (d estimates from -0.97 to +0.10). There were, however, large within-group changes with d ≥ 1 in both treatment groups for the SWAN, the Homework Problems Checklist, and the d2 Test of Attention.
CONCLUSIONS


These results suggest that vergence/accommodative therapy is no better than placebo therapy in improving attention. Large improvements in inattention, completing homework, and selective and sustained attention were found in each group. However, these improvements cannot be attributed to improvements in vergence and accommodation and are likely due to nonspecific effects of an intensive therapy regimen.",2021,"For the SWAN, there was no significant difference between the groups for the inattention scale parental report (d = 0.036; 95% confidence interval, -0.21 to 0.28) or for the hyperactivity impulsivity scale parental report (d = -0.003","['Three hundred ten children 9 to 14 years old with convergence insufficiency', 'children in the Convergence Insufficiency Treatment Trial-Attention and Reading Trial', 'Children with Convergence Insufficiency']","['placebo', 'vergence/accommodative therapy and placebo therapy', 'office-based vergence/accommodative therapy or placebo therapy', 'Vergence/Accommodative Therapy']","['Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior (SWAN) scale', 'hyperactivity impulsivity scale parental report', 'inattention, completing homework, and selective and sustained attention', 'Swanson, Nolan, and Pelham checklist; the Homework Problems Checklist; and the d2 Test of Attention']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0271379', 'cui_str': 'Convergence insufficiency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233512', 'cui_str': 'Normal behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",310.0,0.164722,"For the SWAN, there was no significant difference between the groups for the inattention scale parental report (d = 0.036; 95% confidence interval, -0.21 to 0.28) or for the hyperactivity impulsivity scale parental report (d = -0.003","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001659']
544,33773111,"Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials.","BACKGROUND


Although several COVID-19 vaccines have been developed so far, they will not be sufficient to meet the global demand. Development of a wider range of vaccines, with different mechanisms of action, could help control the spread of SARS-CoV-2 globally. We developed a protein subunit vaccine against COVID-19 using a dimeric form of the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein as the antigen. We aimed to assess the safety and immunogenicity of this vaccine, ZF2001, and determine the appropriate dose and schedule for an efficacy study.
METHODS


We did two randomised, double-blind, placebo-controlled, phase 1 and phase 2 trials. Phase 1 was done at two university hospitals in Chongqing and Beijing, China, and phase 2 was done at the Hunan Provincial Center for Disease Control and Prevention in Xiangtan, China. Healthy adults aged 18-59 years, without a history of SARS-CoV or SARS-CoV-2 infection, an RT-PCR-positive test result for SARS-CoV-2, a history of contact with confirmed or suspected COVID-19 cases, and severe allergies to any component of the vaccine were eligible for enrolment. In phase 1, participants were randomly assigned (2:2:1) to receive three doses of the vaccine (25 μg or 50 μg) or placebo intramuscularly, 30 days apart. In phase 2, participants were randomly assigned (1:1:1:1:1:1) to receive the vaccine (25 μg or 50 μg) or placebo intramuscularly, 30 days apart, in either a two-dose schedule or a three-dose schedule. Investigators, participants, and the laboratory team were masked to group allocation. For phase 1, the primary outcome was safety, measured by the occurrence of adverse events and serious adverse events. For phase 2, the primary outcome was safety and immunogenicity (the seroconversion rate and the magnitude, in geometric mean titres [GMTs], of SARS-CoV-2-neutralising antibodies). Analyses were done on an intention-to-treat and per-protocol basis. These trials are registered with ClinicalTrials.gov (NCT04445194 and NCT04466085) and participant follow-up is ongoing.
FINDINGS


Between June 22 and July 3, 2020, 50 participants were enrolled into the phase 1 trial and randomly assigned to receive three doses of placebo (n=10), the 25 μg vaccine (n=20), or the 50 μg vaccine (n=20). The mean age of participants was 32·6 (SD 9·4) years. Between July 12 and July 17, 2020, 900 participants were enrolled into the phase 2 trial and randomly assigned to receive two doses of placebo (n=150), 25 μg vaccine (n=150), or 50 μg vaccine (n=150), or three doses of placebo (n=150), 25 μg vaccine (n=150), or 50 μg vaccine (n=150). The mean age of participants was 43·5 (SD 9·2) years. In both phase 1 and phase 2, adverse events reported within 30 days after vaccination were mild or moderate (grade 1 or 2) in most cases (phase 1: six [60%] of ten participants in the placebo group, 14 [70%] of 20 in the 25 μg group, and 18 [90%] of 20 in the 50 μg group; phase 2: 37 [25%] of 150 in the two-dose placebo group, 43 [29%] of 150 in the two-dose 25 μg group, 50 [33%] of 150 in the two-dose 50 μg group, 47 [31%] of 150 in the three-dose placebo group, 72 [48%] of 150 in the three-dose 25 μg group, and 65 [43%] of 150 in the three-dose 50 μg group). In phase 1, two (10%) grade 3 or worse adverse events were reported in the 50 μg group. In phase 2, grade 3 or worse adverse events were reported by 18 participants (four [3%] in the two-dose 25 μg vaccine group, two [1%] in the two-dose 50 μg vaccine group, two [1%] in the three-dose placebo group, four [3%] in the three-dose 25 μg vaccine group, and six [4%] in the three-dose 50 μg vaccine group), and 11 were considered vaccine related (two [1%] in the two-dose 25 μg vaccine group, one [1%] in the two-dose 50 μg vaccine group, one [1%] in the three-dose placebo group, two [1%] in the three-dose 25 μg vaccine group, and five [3%] in the three-dose 50 μg vaccine group); seven participants reported serious adverse events (one [1%] in the two-dose 25 μg vaccine group, one [1%] in the two-dose 50 μg vaccine group, two [1%] in the three-dose placebo group, one [1%] in the three-dose 25 μg vaccine group, and two [1%] in the three-dose 50 μg vaccine group), but none was considered vaccine related. In phase 2, on the two-dose schedule, seroconversion rates of neutralising antibodies 14 days after the second dose were 76% (114 of 150 participants) in the 25 μg group and 72% (108 of 150) in the 50 μg group; on the three-dose schedule, seroconversion rates of neutralising antibodies 14 days after the third dose were 97% (143 of 148 participants) in the 25 μg group and 93% (138 of 148) in the 50 μg group. In the two-dose groups in phase 2, the SARS-CoV-2-neutralising GMTs 14 days after the second dose were 17·7 (95% CI 13·6-23·1) in the 25 μg group and 14·1 (10·8-18·3) in the 50 μg group. In the three-dose groups in phase 2, the SARS-CoV-2-neutralising GMTs 14 days after the third dose were 102·5 (95% CI 81·8-128·5) in the 25 μg group and 69·1 (53·0-90·0) in the 50 μg group.
INTERPRETATION


The protein subunit vaccine ZF2001 appears to be well tolerated and immunogenic. The safety and immunogenicity data from the phase 1 and 2 trials support the use of the 25 μg dose in a three-dose schedule in an ongoing phase 3 trial for large-scale evaluation of ZF2001's safety and efficacy.
FUNDING


National Program on Key Research Project of China, National Science and Technology Major Projects of Drug Discovery, Strategic Priority Research Program of the Chinese Academy of Sciences, and Anhui Zhifei Longcom Biopharmaceutical.
TRANSLATION


For the Chinese translation of the abstract see Supplementary Materials section.",2021,"In phase 1, two (10%) grade 3 or worse adverse events were reported in the 50 μg group.","['adults', 'mean age of participants was 43·5', 'Between June 22 and July 3, 2020', 'Healthy adults aged 18-59 years, without a history of SARS-CoV or SARS-CoV-2 infection, an RT-PCR-positive test result for SARS-CoV-2, a history of contact with confirmed or suspected COVID-19 cases, and severe allergies to any component of the vaccine were eligible for enrolment', 'Between July 12 and July 17, 2020, 900 participants were enrolled into the phase 2 trial', 'The mean age of participants was 32·6 (SD 9·4) years', '50 participants were enrolled into the phase 1 trial', 'Phase 1 was done at two university hospitals in Chongqing and Beijing, China, and phase 2 was done at the Hunan Provincial Center for Disease Control and Prevention in Xiangtan, China']","['recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001', 'placebo', '25 μg vaccine (n=150), or 50 μg vaccine (n=150), or three doses of placebo', 'vaccine']","['seroconversion rates of neutralising antibodies', 'safety and immunogenicity (the seroconversion rate and the magnitude, in geometric mean titres [GMTs], of SARS-CoV-2-neutralising antibodies', 'occurrence of adverse events and serious adverse events', 'adverse events', 'grade 3 or worse adverse events', 'serious adverse events', 'safety and immunogenicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}]","[{'cui': 'C0039290', 'cui_str': 'Tandem Repeats'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",50.0,0.434996,"In phase 1, two (10%) grade 3 or worse adverse events were reported in the 50 μg group.","[{'ForeName': 'Shilong', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Anhui Zhifei Longcom Biopharmaceutical, Hefei, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'CAS Key Laboratory of Pathogenic Microbiology and Immunology, Institute of Microbiology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Lianpan', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'CAS Key Laboratory of Pathogenic Microbiology and Immunology, Institute of Microbiology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Chenfei', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Enqi', 'Initials': 'E', 'LastName': 'Huang', 'Affiliation': 'Anhui Zhifei Longcom Biopharmaceutical, Hefei, China.'}, {'ForeName': 'Changwei', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Anhui Zhifei Longcom Biopharmaceutical, Hefei, China.'}, {'ForeName': 'Zaixin', 'Initials': 'Z', 'LastName': 'Zhong', 'Affiliation': 'Anhui Zhifei Longcom Biopharmaceutical, Hefei, China.'}, {'ForeName': 'Fengze', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'CAS Key Laboratory of Microbial Physiological and Metabolic Engineering, Institute of Microbiology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Duan', 'Affiliation': 'CAS Key Laboratory of Microbial Physiological and Metabolic Engineering, Institute of Microbiology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'CAS Key Laboratory of Microbial Physiological and Metabolic Engineering, Institute of Microbiology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'CAS Key Laboratory of Microbial Physiological and Metabolic Engineering, Institute of Microbiology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Chongqing Medleader Bio-Pharm, Chongqing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Beijing Keytech Statistical Technology, Beijing, China.'}, {'ForeName': 'Zhihai', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Center of Infectious Disease, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fangjun', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Hunan Provincial Center for Disease Control and Prevention, Changsha, China.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Hunan Provincial Center for Disease Control and Prevention, Changsha, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Meng', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Jinghua', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'CAS Key Laboratory of Microbial Physiological and Metabolic Engineering, Institute of Microbiology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Zhongyu', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Lidong', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Hunan Provincial Center for Disease Control and Prevention, Changsha, China. Electronic address: gldlj@hotmail.com.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Gao', 'Affiliation': 'CAS Key Laboratory of Pathogenic Microbiology and Immunology, Institute of Microbiology, Chinese Academy of Sciences, Beijing, China. Electronic address: gaof@im.ac.cn.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(21)00127-4']
545,33776461,"Comparison Between Pioglitazone/Metformin Combination Therapy and Sitagliptin/Metformin Combination Therapy on the Efficacy in Chinese Type 2 Diabetic Adults Insufficiently Controlled with Metformin: Study Protocol of an Open-Label, Multicenter, Non-Inferiority Parallel-Group Randomized Controlled Trial.","Introduction


The prevalence of type 2 diabetes (T2D) has risen substantially in China, where its pathophysiology is primarily characterized by insulin resistance (IR). Alleviating IR may help with the management of T2D in the Chinese population. Pioglitazone and sitagliptin are two hypoglycemic medications with different pharmacological actions, both of which are optimal choices for use in combination with metformin. Previous studies have yielded mixed findings regarding the differences in hypoglycemic effects between the two agents. Though pioglitazone is associated with weight gain, both drugs have been shown to decrease visceral adipose tissue (VAT) and improve IR in individuals with T2D. There is a lack of direct comparisons between pioglitazone and sitagliptin among Chinese individuals with T2D. Therefore, this paper describes a protocol for a randomized controlled trial (RCT) that investigates the differences in hypoglycemic efficacy, IR improvement, and safety profiles between these drugs.
Methods and Analysis


This is a 24-week, open-label, multicenter, non-inferiority parallel-group RCT with a 1:1 allocation ratio. It compares pioglitazone/metformin (15 mg/500 mg) combination therapy with sitagliptin/metformin (50 mg/500 mg) combination therapy in Chinese adults with T2D insufficiently controlled with metformin. The primary outcomes are HbA1c reduction, insulin level increase, and IR index change. The secondary outcomes are body weight and abdominal VAT decreases, lipid profiles, and inflammatory indicators. Tolerability and safety data will also be collected.
Conclusion


It is believed that the direct comparisons of the hypoglycemic effects, VAT reductions, and safety profiles between pioglitazone and sitagliptin will help to optimize treatments for Chinese adults with T2D who are primarily characterized by IR.
Trial Registration Number


Chinese Clinical Trial Registry (ChiCTR1900021861).",2021,There is a lack of direct comparisons between pioglitazone and sitagliptin among Chinese individuals with T2D.,"['Chinese adults with T2D insufficiently controlled with', 'Chinese individuals with T2D', 'Chinese Type 2 Diabetic Adults', 'Chinese adults with T2D who are primarily characterized by IR', 'individuals with T2D']","['Pioglitazone/Metformin Combination Therapy and Sitagliptin/Metformin Combination Therapy', 'sitagliptin/metformin', 'pioglitazone/metformin', 'metformin', 'pioglitazone', 'Pioglitazone', 'Metformin']","['hypoglycemic efficacy, IR improvement, and safety profiles', 'Tolerability and safety data', 'hypoglycemic effects', 'HbA1c reduction, insulin level increase, and IR index change', 'body weight and abdominal VAT decreases, lipid profiles, and inflammatory indicators', 'visceral adipose tissue (VAT']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2936720', 'cui_str': 'Hypoglycemic Effects'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.207063,There is a lack of direct comparisons between pioglitazone and sitagliptin among Chinese individuals with T2D.,"[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Division of Endocrinology and Metabolism, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Lizhi', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Division of Endocrinology and Metabolism, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Division of Endocrinology and Metabolism, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': ""Division of Endocrinology and Metabolism, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Division of Endocrinology and Metabolism, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Nanwei', 'Initials': 'N', 'LastName': 'Tong', 'Affiliation': ""Division of Endocrinology and Metabolism, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}]","Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S293307']
546,33776428,The Impact of Exacerbation History on the Safety and Efficacy of Aclidinium in Patients with Chronic Obstructive Pulmonary Disease and Increased Cardiovascular Risk: ASCENT-COPD Trial.,"Purpose


Chronic obstructive pulmonary disease (COPD) exacerbations are associated with increased risk of major adverse cardiovascular events (MACE) and mortality. Here, we investigate whether the safety and efficacy of aclidinium bromide differ due to exacerbation history in patients with COPD and increased cardiovascular risk.
Patients and Methods


ASCENT-COPD was a Phase 4, multicenter, double-blind, randomized, placebo-controlled, parallel-group study of patients with moderate-to-very severe COPD and increased cardiovascular risk. Patients were randomized 1:1 to receive aclidinium or placebo twice daily for up to 3 years. Outcomes included time to first MACE and all-cause mortality over 3 years, exacerbation rate during the first year on-treatment, and change in baseline pre-dose forced expiratory volume in 1 second (FEV 1 ) over 3 years. This pre-specified subgroup analysis compared outcomes in patients receiving aclidinium vs placebo. The comparison of patients with vs without an exacerbation history was added following a protocol amendment to increase enrollment in the primary study.
Results


Of 3589 patients, 2156 (60.1%) had ≥1 moderate or severe exacerbations in the prior year, compared with 1433 (39.9%) without prior exacerbations. Although patients with an exacerbation history had numerically higher rates of MACE and mortality regardless of treatment, aclidinium did not increase risk of MACE (≥1: hazard ratio [HR] 0.79, 95% confidence interval [CI]: 0.54-1.16; none: HR 1.27, 95% CI: 0.65-2.47; interaction  P =0.233) or all-cause mortality (≥1: HR 1.08, 95% CI: 0.81-1.43; none: HR 0.66, 95% CI: 0.36-1.22; interaction  P =0.154), regardless of exacerbation history. Aclidinium reduced the exacerbation rate vs placebo irrespective of exacerbation history (≥1: rate ratio [RR] 0.80, 95% CI: 0.68-0.94; none: RR 0.69, 95% CI: 0.54-0.89; interaction  P =0.340) and improved FEV 1  (interaction  P =0.633).
Conclusion


In patients with moderate-to-very severe COPD and increased cardiovascular risk, aclidinium did not increase risk of MACE or mortality and reduced exacerbation rate vs placebo, regardless of exacerbation history.
Clinical Trial Registration


ClinicalTrials.gov Identifier: NCT01966107.",2021,"Aclidinium reduced the exacerbation rate vs placebo irrespective of exacerbation history (≥1: rate ratio [RR] 0.80, 95% CI: 0.68-0.94; none: RR 0.69, 95% CI: 0.54-0.89; interaction  P =0.340) and improved FEV 1  (interaction  P =0.633).
","['patients with COPD and increased cardiovascular risk', 'patients with moderate-to-very severe COPD and increased cardiovascular risk', 'Patients with Chronic Obstructive Pulmonary Disease and Increased Cardiovascular Risk']","['aclidinium or placebo', 'aclidinium bromide', 'placebo', 'aclidinium vs placebo', 'Aclidinium']","['≥1 moderate or severe exacerbations', 'risk of MACE or mortality and reduced exacerbation rate', 'exacerbation rate', 'time to first MACE and all-cause mortality over 3 years, exacerbation rate during the first year on-treatment, and change in baseline pre-dose forced expiratory volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C2699757', 'cui_str': 'aclidinium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2699758', 'cui_str': 'aclidinium bromide'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]",3589.0,0.695091,"Aclidinium reduced the exacerbation rate vs placebo irrespective of exacerbation history (≥1: rate ratio [RR] 0.80, 95% CI: 0.68-0.94; none: RR 0.69, 95% CI: 0.54-0.89; interaction  P =0.340) and improved FEV 1  (interaction  P =0.633).
","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Medicine, Pulmonary and Critical Care, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Chapman', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Sami Z', 'Initials': 'SZ', 'LastName': 'Daoud', 'Affiliation': 'Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lythgoe', 'Affiliation': 'Statistics, Phastar, Chiswick, London, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Garcia-Gil', 'Affiliation': 'Respiratory & Immunology, BioPharmaceuticals Medical, AstraZeneca, Barcelona, Spain.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S285068']
547,33776391,Preventing Intimate Partner Violence Among Teen Mothers: A Pilot Study.,"Despite high rates of intimate partner violence (IPV) among teens who are pregnant or parenting, the field is lacking evidence-based prevention programs designed for this population. The purpose of this study was to comprehensively adapt the evidence-based  Safe Dates  IPV prevention program and conduct a pilot study of the adapted program with female teens who were pregnant or parenting. We completed formative research including a literature review, focus groups, and pre-testing of adapted content to inform the revised curriculum. We then conducted a randomized controlled trial with 32 teens (average age = 17) to compare the adapted program to the original program on implementation characteristics and outcomes, including IPV perpetration and victimization. Directions of effect favored the adapted program over the original program for 18 out of 21 implementation outcomes for which models could be estimated and for 11 of 12 participant outcomes. The strongest effects, all favoring the adapted program, were found for observer-reported adherence to the curriculum, participant ratings of the relevance of characters and scenarios, participant knowledge of ways to get help for abuse, and attitudes toward IPV. These findings demonstrate the feasibility and acceptability of the adapted program for this target population and suggest that the program may be efficacious when evaluated in a larger study.",2021,"The strongest effects, all favoring the adapted program, were found for observer-reported adherence to the curriculum, participant ratings of the relevance of characters and scenarios, participant knowledge of ways to get help for abuse, and attitudes toward IPV.","['female teens who were pregnant or parenting', '32 teens (average age = 17', 'Teen Mothers']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",[],[],32.0,0.0117352,"The strongest effects, all favoring the adapted program, were found for observer-reported adherence to the curriculum, participant ratings of the relevance of characters and scenarios, participant knowledge of ways to get help for abuse, and attitudes toward IPV.","[{'ForeName': 'Marni L', 'Initials': 'ML', 'LastName': 'Kan', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Lori-Ann', 'Initials': 'LA', 'LastName': 'Palen', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Judith W', 'Initials': 'JW', 'LastName': 'Herrman', 'Affiliation': 'University of Delaware, Newark, DE.'}, {'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Williams', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Feinberg', 'Affiliation': 'Pennsylvania State University, University Park, PA.'}]",Journal of child and family studies,['10.1007/s10826-020-01831-0']
548,33776390,The Impact of Default Options for Parent Participation in an Early Language Intervention.,"In this study we tested, via a randomized control study design, different enrollment options for a scaled city-wide text-based early learning program among 405 mothers who were receiving newborn home visiting services. We found that when automatically enrolled with a voluntary option to opt out, 88.7 percent of mothers in the experimental group stayed in the program and continued to receive the text-based content over the course of 26 weeks. In contrast, only 1 percent of mothers in the control group who heard about the text-based program through conventional recruitment flyers voluntarily enrolled in the program. Opt-out and opt-in patterns did not differ by characteristics typically considered as interfering with program participation: low income status, first-time motherhood status, total number of children, maternal language, flagging for depressive symptoms, and household residential instability. Findings suggest that automatic enrollment might be an effective engagement strategy for text- and similar digitally-based early childhood programs.",2020,Findings suggest that automatic enrollment might be an effective engagement strategy for text- and similar digitally-based early childhood programs.,['405 mothers who were receiving newborn home visiting services'],['scaled city-wide text-based early learning program'],[],"[{'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],405.0,0.0163854,Findings suggest that automatic enrollment might be an effective engagement strategy for text- and similar digitally-based early childhood programs.,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Gennetian', 'Affiliation': 'Duke University Sanford School of Public Policy, 212 Rubenstein Hall, 302 Towerview Road, Durham, NC 27708, USA.'}, {'ForeName': 'Lerzan Z', 'Initials': 'LZ', 'LastName': 'Coskun', 'Affiliation': 'New York University, 246 Greene Street, Floor 5E, New York, NY 10003, USA.'}, {'ForeName': 'Joy L', 'Initials': 'JL', 'LastName': 'Kennedy', 'Affiliation': 'Brooklyn College, 2900 Bedford Avenue, Brooklyn, NY 11210, USA.'}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Kuchirko', 'Affiliation': 'Brooklyn College, 2900 Bedford Avenue, Brooklyn, NY 11210, USA.'}, {'ForeName': 'J Lawrence', 'Initials': 'JL', 'LastName': 'Aber', 'Affiliation': 'New York University, 246 Greene Street, Floor 5E, New York, NY 10003, USA.'}]",Journal of child and family studies,['10.1007/s10826-020-01838-7']
549,33773535,The Effect of Exercise on Life Quality and Depression Levels of Breast Cancer Patients.,"INTRODUCTION


The aim of this study is to determine the effects of aerobic and stretching exercises on quality of life and depression levels of breast cancer patients.
METHODS


A total of 48 women (mean age 45.0±2.2 years) who were previously diagnosed with breast cancer and completed their treatment with no metastasis, were included in the study. Of these, 24 women who received the exercise program were assigned as the study group, while the remaining 24 women who did not receive the exercise program were assigned as the control group. The study group received a 12-week aerobic exercise program at the fitness club and home-based resistance exercise program designed by a sport scientist at the doctoral level. The control group was encouraged to maintain their normal level of physical activity and exercise habits throughout the study. The WHOQOL-BREF, EORTC-QLQ-C30 quality of life assessments and Beck depression inventory (BDI) were used to evaluate quality of life and the severity of depression before and after 12-week exercise programs.
RESULTS


EORTC QLQ-C30 scoring showed that in the study group aerobic exercise positively impacted quality of life on the functional scales (physical p=0.001, role p=0.039, emotional p=0.031, social functioning p=0.010) and symptoms (fatigue p=0.001, pain p=0.001, sleep disturbance p=0.038 and financial impact p=0.015). WHOQOL-BREF assessment areas, (general p=0.001, physical p=0.02, mental p=0.001 and social health p=0.017) relationships also improved as a result of exercise. BDI showed that severity of depression in the study group decreased significantly (p=0.001).
CONCLUSION


This study showed that aerobic and resistance exercises improved quality of life and decreased depression levels of women who previously received breast cancer treatments.<br />.",2021,"WHOQOL-BREF assessment areas, (general p=0.001, physical p=0.02, mental p=0.001 and social health p=0.017) relationships also improved as a result of exercise.","['24 women who received the exercise program were assigned as the study group, while the remaining 24 women who did not receive the', 'breast cancer patients', '48 women (mean age 45.0±2.2 years) who were previously diagnosed with breast cancer and completed their treatment with no metastasis, were included in the study', 'Breast Cancer Patients', 'women who previously received breast cancer treatments.<br ']","['Exercise', 'aerobic and stretching exercises', 'aerobic and resistance exercises', 'exercise program', 'aerobic exercise program at the fitness club and home-based resistance exercise program designed by a sport scientist at the doctoral level']","['quality of life on the functional scales', 'quality of life and depression levels', 'emotional p=0.031, social functioning p=0.010) and symptoms (fatigue p=0.001, pain p=0.001, sleep disturbance', 'severity of depression', 'Life Quality and Depression Levels', 'quality of life and decreased depression levels', 'WHOQOL-BREF, EORTC-QLQ-C30 quality of life assessments and Beck depression inventory (BDI', 'quality of life and the severity of depression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445092', 'cui_str': 'No metastases'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0402112', 'cui_str': 'Scientist'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",48.0,0.0294439,"WHOQOL-BREF assessment areas, (general p=0.001, physical p=0.02, mental p=0.001 and social health p=0.017) relationships also improved as a result of exercise.","[{'ForeName': 'Mensure', 'Initials': 'M', 'LastName': 'Aydin', 'Affiliation': 'Physical Education and Sport, Halic University, Istanbul, Turkey.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Kose', 'Affiliation': 'Department of Public Health, Sakarya University School of Medicine, Sakarya, Turkey.'}, {'ForeName': 'Ilhan', 'Initials': 'I', 'LastName': 'Odabas', 'Affiliation': 'Physical Education and Sport, Halic University, Istanbul, Turkey.'}, {'ForeName': 'Bergun', 'Initials': 'B', 'LastName': 'Meric Bingul', 'Affiliation': 'Physical Education and Sport, Halic University, Istanbul, Turkey.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Demirci', 'Affiliation': 'Faculty of Sport Sciences, Kocaeli University, Kocaeli, Turkey.'}, {'ForeName': 'Zeki', 'Initials': 'Z', 'LastName': 'Aydin', 'Affiliation': 'Faculty of Health Sciences, Bilgi University, Istanbul, Turkey.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2021.22.3.725']
550,33773533,Comparison of Interventional Methods to Motivate and Change the Behavioural Stage of Smokers to Quit Smoking- A Hospital Based Randomised Controlled Trial.,"OBJECTIVE


Addictions can be beaten if started off with a true motivation to quit it. Enhancing motivation is an important part of overall treatment for smoking cessation as it increases a smoker's courage and enthusiasm to quit smoke. This study aimed to assess effectiveness of various interventional methods to motivate unmotivated smokers with a focus on changing behavioural stage of  smokers to quit.
METHODOLOGY


A single blinded trial was conducted at the outpatient department of ITS dental college and hospital among precontemplation stage smokers allocated into 4 groups and given interventional therapies like general counselling only(group 1), counselling and intra oral camera assessment (Group 2), counselling as well as carbon monoxide monitoring(Group 3)whereas fourth group(Group 4) given a combination therapy of all of them. A baseline evaluation of nicotine dependence and behavioural stage of the smoker was assessed. The patients were then evaluated on presence on their scheduled follow up visits done at interval of 2 weeks and 4 weeks. Descriptive statistics were addressed and the association was evaluated using Pearson chi square test. Any p value less than 0.05 was considered statistically significant.
RESULTS


Majority of  smokers were males(88% ) and about 48.8% of them were highly dependent smokers . The change in precontemplation behavioural stage was assessed on basis of follow up visits after interventional therapy which was significantly higher in group 4 receiving combination therapy, followed by carbon monoxide therapy ,counselling and intra oral camera assessment and the least visits in behaviour counselling group (p <0.05).
CONCLUSION


A combination of counselling and other motivational aids therapy is best way possible to help smokers focusing a change on the behavioural stage of the patient from precontemplation to preparation stage.",2021,"The change in precontemplation behavioural stage was assessed on basis of follow up visits after interventional therapy which was significantly higher in group 4 receiving combination therapy, followed by carbon monoxide therapy ,counselling and intra oral camera assessment and the least visits in behaviour counselling group (p <0.05).
",['outpatient department of ITS dental college and hospital among precontemplation stage smokers allocated into 4 groups and given'],"['interventional therapies like general counselling only(group 1), counselling and intra oral camera assessment (Group 2), counselling as well as carbon monoxide monitoring(Group', 'counselling and other motivational aids therapy']",['precontemplation behavioural stage'],"[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1277197', 'cui_str': 'Precontemplation stage'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}]",,0.0581535,"The change in precontemplation behavioural stage was assessed on basis of follow up visits after interventional therapy which was significantly higher in group 4 receiving combination therapy, followed by carbon monoxide therapy ,counselling and intra oral camera assessment and the least visits in behaviour counselling group (p <0.05).
","[{'ForeName': 'Dipshikha', 'Initials': 'D', 'LastName': 'Das', 'Affiliation': 'I.T.S Centre for Dental Studies and Research, Delhi‑ Meerut Road, Murad Nagar,Ghaziabad ‑ 201206, Uttar Pradesh, India.'}, {'ForeName': 'Ipseeta', 'Initials': 'I', 'LastName': 'Menon', 'Affiliation': 'I.T.S Centre for Dental Studies and Research, Delhi‑ Meerut Road, Murad Nagar,Ghaziabad ‑ 201206, Uttar Pradesh, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'I.T.S Centre for Dental Studies and Research, Delhi‑ Meerut Road, Murad Nagar,Ghaziabad ‑ 201206, Uttar Pradesh, India.'}, {'ForeName': 'Anubhav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'I.T.S Centre for Dental Studies and Research, Delhi‑ Meerut Road, Murad Nagar,Ghaziabad ‑ 201206, Uttar Pradesh, India.'}, {'ForeName': 'Iram', 'Initials': 'I', 'LastName': 'Ahsan', 'Affiliation': 'I.T.S Centre for Dental Studies and Research, Delhi‑ Meerut Road, Murad Nagar,Ghaziabad ‑ 201206, Uttar Pradesh, India.'}, {'ForeName': 'Asifa', 'Initials': 'A', 'LastName': 'Ashraf', 'Affiliation': 'I.T.S Centre for Dental Studies and Research, Delhi‑ Meerut Road, Murad Nagar,Ghaziabad ‑ 201206, Uttar Pradesh, India.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2021.22.3.711']
551,33773532,Efficacy of Exercise Rehabilitation Program in Relieving Oxaliplatin Induced Peripheral Neurotoxicity.,"BACKGROUND


Peripheral neurotoxicity is common in patients with digestive malignancies receiving chemotherapy containing oxaliplatin, and there is still no effective drug to prevent or treat this complication.
METHODS


Seventy-nine patients receiving chemotherapy containing oxaliplatin were included, and the relationship between chemotherapy regimens, cycles, and cumulative dose of oxaliplatin and peripheral neurotoxicity was analyzed. Patients were divided into two groups of control or intervention. Twenty-eight patients in the control group received routine chemotherapy care, and 51 patients in the intervention group underwent two-week exercise rehabilitation program. Patients' Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-Ntx), functional tests, and Brief Pain Inventory(BPI) scores as well as interference life scores were assessed before intervention and two weeks after the intervention.
RESULTS


In the intervention group, 52.9% patients previously exercised regularly. The FOLFOX regimen was more common in peripheral neurotoxicity (73.4%), and the median oxaliplatin cycles for neurotoxicity was 9 (ranging from 1 to 16). The mean cumulative dose of oxaliplatin was 1080.02 ± 185.22 mg, both the cycles and cumulative dose were positively correlated with the occurrence of peripheral neurotoxicity. Compared with control, the scores of FACT/GOG-Ntx, functional tests, and BPI were significantly decreased in the intervention group (p < 0.05).
CONCLUSION


Chemotherapy cycles and cumulative doses were in relation with OIN  , and exercise rehabilitation program could effectively alleviate OIN.<br />.",2021,"Compared with control, the scores of FACT/GOG-Ntx, functional tests, and BPI were significantly decreased in the intervention group (p < 0.05).
","['Seventy-nine patients receiving', 'patients with digestive malignancies receiving chemotherapy containing']","['FOLFOX', 'oxaliplatin', 'routine chemotherapy care', 'Exercise Rehabilitation Program', 'exercise rehabilitation program', 'chemotherapy containing oxaliplatin']","['scores of FACT/GOG-Ntx, functional tests, and BPI', 'Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-Ntx), functional tests, and Brief Pain Inventory(BPI) scores', 'median oxaliplatin cycles for neurotoxicity', 'peripheral neurotoxicity', 'Peripheral Neurotoxicity']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0184613', 'cui_str': 'Chemotherapy care'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C2732532', 'cui_str': 'Brief pain inventory score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}]",79.0,0.00368246,"Compared with control, the scores of FACT/GOG-Ntx, functional tests, and BPI were significantly decreased in the intervention group (p < 0.05).
","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Gui', 'Affiliation': ""Departments of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, 215006, Jiangsu, People's Republic of China.""}, {'ForeName': 'Dapeng', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Departments of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, 215006, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhuge', 'Affiliation': ""Departments of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, 215006, Jiangsu, People's Republic of China.""}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Departments of Thoracic Surgery, The First Affiliated Hospital of Soochow University, Suzhou, 215006, Jiangsu, People's Republic of China.""}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2021.22.3.705']
552,33780173,"The Impact of Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Young Patients with Vasculogenic Mild-Erectile Dysfunction (ED): A Prospective Randomized Single-Blind, Sham Controlled Study.","BACKGROUND


Low-intensity extracorporeal shock wave therapy (ESWT) for the treatment of vasculogenic erectile dysfunction (ED) has emerged as a promising method directly targeting the underlying pathophysiology of the disease.
OBJECTIVES


To compare outcomes in ED patients after ESWT and placebo treatment.
MATERIALS AND METHODS


Prospective randomized placebo-controlled single-blinded trial on 66 patients with mild ED. The study comprised a 4-week washout phase, a 4-week treatment phase, and a 48-week follow-up. Inclusion criteria included age between 18 and 75 years and diagnosis of mild ED (IIEF-EF score= 17-25) being made at least six months prior to study inclusion and being confirmed by Penile Doppler ultrasonography (US) at baseline examination. Efficacy endpoints were changes from baseline in patient-reported outcomes of erectile function(International Index of Erectile Function domain scores [IIEF-EF]), as well as erection hardness and duration (Sexual Encounter Profile diary [SEP] and Global Assessment Questions [GAQ]). Safety was assessed throughout the study.
RESULTS


A total of 66 enrolled patients were allocated to ESWT (n=44) or placebo (n=22). Mean age of ESWT and placebo group were 42.32 ± 9.88 and 39.86 ± 11.64 (p=0.374) respectively. Mean baseline IIEF-EF scores of ESWT group and placebo were 20.32±2.32 and 19.68±1.55 respectively (p = 0.34). At 3-months follow-up, mean IIEF-EF scores were significantly higher in ESWT patients than in placebo patients (23.10 ± 2.82 vs. 20.95 ± 2.19, p = 0.003), and IIEF-EF scores of ESWT patients remained high during the 6- months (22.67 ± 3.35 vs. 19.82 ± 1.56) follow-up. The percentage of patients reporting both successful penetration (SEP2) and intercourse (SEP3) in more than 50% of attempts was significantly higher in ESWT-treated patients than in placebo patients (p = 0.001). A minimal clinically important difference between the IIEF=EF baseline and 3-months follow-up was found in 74 % of ESWT and 36 % of placebo. No serious adverse events were reported.
DISCUSSION


and Conclusion ESWT significantly improved the erectile function of relatively young patients with vasculogenic mild ED when compared to placebo, and the beneficial effect of this treatment up to 6 months. These findings suggest that ESWT could be a useful treatment option in vasculogenic ED.",2021,"At 3-months follow-up, mean IIEF-EF scores were significantly higher in ESWT patients than in placebo patients (23.10 ± 2.82 vs. 20.95 ± 2.19, p = 0.003), and IIEF-EF scores of ESWT patients remained high during the 6- months (22.67 ± 3.35 vs. 19.82 ± 1.56) follow-up.","['Young Patients with Vasculogenic Mild-Erectile Dysfunction (ED', '66 enrolled patients', 'ED patients after ESWT and placebo treatment', '66 patients with mild ED', 'vasculogenic erectile dysfunction (ED', 'Inclusion criteria included age between 18 and 75 years and diagnosis of mild ED (IIEF-EF score= 17-25) being made at least six months prior to study inclusion and being confirmed by Penile Doppler ultrasonography (US) at baseline examination']","['Extracorporeal Shock Wave Therapy (ESWT', 'placebo', 'Low-intensity extracorporeal shock wave therapy (ESWT', 'ESWT']","['percentage of patients reporting both successful penetration (SEP2) and intercourse (SEP3', 'erectile function', 'Safety', 'mean IIEF-EF scores', 'IIEF-EF scores', 'Mean baseline IIEF-EF scores', 'serious adverse events', 'erectile function(International Index of Erectile Function domain scores [IIEF-EF]), as well as erection hardness and duration (Sexual Encounter Profile diary [SEP] and Global Assessment Questions [GAQ']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",66.0,0.317102,"At 3-months follow-up, mean IIEF-EF scores were significantly higher in ESWT patients than in placebo patients (23.10 ± 2.82 vs. 20.95 ± 2.19, p = 0.003), and IIEF-EF scores of ESWT patients remained high during the 6- months (22.67 ± 3.35 vs. 19.82 ± 1.56) follow-up.","[{'ForeName': 'Mazhar', 'Initials': 'M', 'LastName': 'Ortac', 'Affiliation': 'Urology Department, Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Abdulkadir', 'Initials': 'A', 'LastName': 'Özmez', 'Affiliation': 'Urology Department, Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Nusret Can', 'Initials': 'NC', 'LastName': 'Cilesiz', 'Affiliation': 'Urology Department, Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Demirelli', 'Affiliation': 'Urology Department, Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Ateş', 'Initials': 'A', 'LastName': 'Kadıoğlu', 'Affiliation': 'Urology Department, Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}]",Andrology,['10.1111/andr.13007']
553,33780041,Service user involvement in a secure setting before and after the implementation of recovery-oriented practice: A quasi-experimental study.,"AIM


To measure change in service user involvement in secure mental health units, before and after the implementation of recovery-oriented practice.
DESIGN


Quasi-experimental study pretest-posttest design with non-equivalent comparison groups.
METHODS


Data were collected from May 2018 to December 2019 in four medium-/high-security units in Norway. Two intervention units that implemented recovery-oriented practice were compared with two comparison units that did not. Data were obtained using anonymous questionnaires at baseline and at 6-month follow-up. For intervention units, data were also obtained at a 12-month follow-up to measure sustainability of improvements over time. Twenty inpatients ('patients'; intervention group: 10, comparison group: 10) and 141 members of frontline staff ('service providers'; intervention group: 92, comparison group: 49) participated at baseline. Mann-Whitney U-tests and independent sample t-tests were applied at the group-level to analyse changes in mean scores in groups.
RESULTS


Among patients in the intervention units, findings indicated no improvements after 6 months, but significant improvements after 12 months in terms of patients' opportunities to participate in formulating their individual care plans, to influence decision-making about therapy and to receive information about complaint procedures. Opportunities to participate in discussions about medication and treatment regimens did not improve. After 6 months, service providers in the intervention units reported an increase in democratic patient involvement, patient collaboration and management support, but not in carer involvement and assisted patient involvement. The improvements in democratic patient involvement and management support were sustained over time. No changes were found in the comparison groups.
CONCLUSION


The patients and the service providers reported a higher degree of service user involvement after implementing recovery-oriented practice. Specific work is needed to ensure patients' involvement in all domains.
IMPACT


The findings are encouraging with respect to the potential to increase empowerment in a restricted setting through the implementation of recovery-oriented practice.",2021,"After 6 months, service providers in the intervention units reported an increase in democratic patient involvement, patient collaboration and management support, but not in carer involvement and assisted patient involvement.","['Data were collected from May 2018 to December 2019 in four medium-/high-security units in Norway', ""Twenty inpatients ('patients'; intervention group: 10, comparison group: 10) and 141 members of frontline staff ('service providers'; intervention group: 92, comparison group: 49) participated at baseline""]",[],"['democratic patient involvement, patient collaboration and management support', 'democratic patient involvement and management support']","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",[],"[{'cui': 'C0030699', 'cui_str': 'Client participation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",,0.0442367,"After 6 months, service providers in the intervention units reported an increase in democratic patient involvement, patient collaboration and management support, but not in carer involvement and assisted patient involvement.","[{'ForeName': 'Grethe Elly Ytreland', 'Initials': 'GEY', 'LastName': 'Hauso', 'Affiliation': 'Department of Welfare and Participation, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Alsaker', 'Affiliation': 'Department of Welfare and Participation, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Senneseth', 'Affiliation': 'Department of Welfare and Participation, Western Norway University of Applied Sciences, Bergen, Norway.'}]",Journal of advanced nursing,['10.1111/jan.14841']
554,33779991,Effects of High- versus Low-Intensity Clinician Training on Implementation of Family-Focused Therapy for Youth with Mood and Psychotic Disorders.,"The implementation of evidence-based psychotherapies often requires significant commitments of time and expense from mental health providers. Psychotherapy protocols with rapid and efficient training and supervision requirements may have higher levels of uptake in publicly funded clinics. Family-focused therapy (FFT) is a 4-month, 12-session treatment for bipolar and psychosis patients consisting of psychoeducation, communication training, and problem-solving skills training. In a pilot randomized trial, we compared two methods of training community clinicians in FFT: (a) high intensity (n = 24), consisting of a 6-hour in-person didactic workshop followed by telephone supervision for every session with training cases; or (b) low-intensity training (n = 23), consisting of a 4-hour online workshop covering the same material as the in-person workshop followed by telephone supervision after every third session with training cases. Of 47 clinician participants, 18 (11 randomly assigned to high intensity, 7 to low) enrolled 34 patients with mood or psychotic disorders (mean age 16.5 ± 2.0 years; 44.1% female) in an FFT implementation phase. Expert supervisors rated clinicians' fidelity to the FFT manual based on taped family sessions. We detected no differences in fidelity scores between clinicians in the two training conditions, nor did patients treated by clinicians in high- versus low-intensity training differ in end-of-treatment depression or mania symptoms. Levels of parent/offspring conflict improved in both conditions. Although based on a pilot study, the results suggest that low-intensity training of community clinicians in FFT is feasible and can result in rapid achievement of fidelity benchmarks without apparent loss of treatment efficacy.",2021,"We detected no differences in fidelity scores between clinicians in the two training conditions, nor did patients treated by clinicians in high- versus low-intensity training differ in end-of-treatment depression or mania symptoms.","['47 clinician participants, 18 (11 randomly assigned to high intensity, 7 to low) enrolled 34 patients with mood or psychotic disorders (mean age 16.5\xa0±\xa02.0\xa0years; 44.1% female) in an FFT implementation phase', 'Youth with Mood and Psychotic Disorders', 'bipolar and psychosis patients consisting of', 'training community clinicians in FFT: (a) high intensity (n = 24']","['consisting of a 6-hour in-person didactic workshop followed by telephone supervision for every session with training cases; or (b) low-intensity training (n\xa0=\xa023), consisting of a 4-hour online workshop covering the same material as the in-person workshop followed by telephone supervision', 'psychoeducation, communication training, and problem-solving skills training', 'Family-focused therapy (FFT', 'High- versus Low-Intensity Clinician Training']","['Levels of parent/offspring conflict', 'fidelity scores']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",34.0,0.00399496,"We detected no differences in fidelity scores between clinicians in the two training conditions, nor did patients treated by clinicians in high- versus low-intensity training differ in end-of-treatment depression or mania symptoms.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, UCLA Semel Institute for Neuroscience and Behavior, David Geffen School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weintraub', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, UCLA Semel Institute for Neuroscience and Behavior, David Geffen School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Posta', 'Affiliation': 'Estrella Mountain Community College, Avondale, AZ, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Denenny', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, UCLA Semel Institute for Neuroscience and Behavior, David Geffen School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, UCLA Semel Institute for Neuroscience and Behavior, David Geffen School of Medicine, Los Angeles, CA, USA.'}]",Family process,['10.1111/famp.12646']
555,33779986,Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period.,"BACKGROUND


Venous thromboembolism (VTE), although rare, is a major cause of maternal mortality and morbidity. Some women are at increased risk of VTE during pregnancy and the early postnatal period (e.g. caesarean section, family history of VTE, or thrombophilia), and so prophylaxis may be considered. As some methods of prophylaxis carry risks of adverse effects, and risk of VTE is often low, benefits of thromboprophylaxis may be outweighed by harms.
OBJECTIVES


To assess the effects of thromboprophylaxis during pregnancy and the early postnatal period on the risk of venous thromboembolic disease and adverse effects in women at increased risk of VTE.
SEARCH METHODS


We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (18 October 2019). In addition, we searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) for unpublished, planned and ongoing trial reports (18 October 2019).
SELECTION CRITERIA


Randomised trials comparing one method of thromboprophylaxis with placebo or no treatment, or two (or more) methods of thromboprophylaxis.
DATA COLLECTION AND ANALYSIS


At least two review authors assessed trial eligibility, extracted data, assessed risk of bias, and judged certainty of evidence for selected critical outcomes (using GRADE). We conducted fixed-effect meta-analysis and reported data (all dichotomous) as summary risk ratios (RRs) with 95% confidence intervals (CIs).
MAIN RESULTS


Twenty-nine trials (involving 3839 women), overall at moderate to high risk of bias were included. Trials were conducted across the antenatal, peripartum and postnatal periods, with most in high-income countries. Interventions included types and regimens of heparin (low molecular weight heparin (LMWH) and unfractionated heparin (UFH)), hydroxyethyl starch (HES), and compression stockings or devices. Data were limited due to a small number of trials in comparisons and/or few or no events reported. All critical outcomes (assessed for comparisons of heparin versus no treatment/placebo, and LMWH versus UFH) were considered to have very low-certainty evidence, downgraded mainly for study limitations and imprecise effect estimates.  Maternal death was not reported in most studies. Antenatal (± postnatal) prophylaxis For the primary outcomes symptomatic thromboembolic events pulmonary embolism (PE) and/or deep vein thrombosis (DVT), and the critical outcome of adverse effects sufficient to stop treatment, the evidence was very uncertain.  Symptomatic thromboembolic events: - heparin versus no treatment/placebo (RR 0.39; 95% CI 0.08 to 1.98; 4 trials, 476 women; very low-certainty evidence); - LMWH versus UFH (RR 0.47; 95% CI 0.09 to 2.49; 4 trials, 404 women; very low-certainty evidence); Symptomatic PE: - heparin versus no treatment/placebo (RR 0.33; 95% CI 0.02 to 7.14; 3 trials, 187 women; very low-certainty evidence); - LMWH versus UFH (no events; 3 trials, 287 women); Symptomatic DVT: - heparin versus no treatment/placebo (RR 0.33; 95% CI 0.04 to 3.10; 4 trials, 227 women; very low-certainty evidence); - LMWH versus UFH (no events; 3 trials, 287 women); Adverse effects sufficient to stop treatment: - heparin versus no treatment/placebo (RR 0.49; 95% CI 0.05 to 5.31; 1 trial, 139 women; very low-certainty evidence); - LMWH versus UFH (RR 0.07; 95% CI 0.01 to 0.54; 2 trials, 226 women; very low-certainty evidence). Peripartum/postnatal prophylaxis Vaginal or caesarean birth When UFH and no treatment were compared, the effects on symptomatic thromboembolic events (RR 0.16; 95% CI 0.02 to 1.36; 1 trial, 210 women; very low-certainty evidence), symptomatic PE (RR 0.16; 95% CI 0.01 to 3.34; 1 trial, 210 women; very low-certainty evidence), and symptomatic DVT  (RR 0.27; 95% CI 0.03 to 2.55; 1 trial, 210 women; very low-certainty evidence) were very uncertain.  Maternal death and adverse effects sufficient to stop treatment were not reported. Caesarean birth Symptomatic thromboembolic events: - heparin versus no treatment/placebo (RR 1.30; 95% CI 0.39 to 4.27; 4 trials, 840 women; very low-certainty evidence); - LMWH versus UFH (RR 0.33; 95% CI 0.01 to 7.99; 3 trials, 217 women; very low-certainty evidence); Symptomatic PE: - heparin versus no treatment/placebo (RR 1.10; 95% CI 0.25 to 4.87; 4 trials, 840 women; very low-certainty evidence); - LMWH versus UFH (no events; 3 trials, 217 women);  Symptomatic DVT: - heparin versus no treatment/placebo (RR 1.30; 95% CI 0.24 to 6.94; 5 trials, 1140 women; very low-certainty evidence); LMWH versus UFH (RR 0.33; 95% CI 0.01 to 7.99; 3 trials, 217 women; very low-certainty evidence); Maternal death: - heparin versus placebo (no events, 1 trial, 300 women); Adverse effects sufficient to stop treatment: - heparin versus placebo (no events;  1 trial, 140 women). Postnatal prophylaxis No events were reported for LMWH versus no treatment/placebo for: symptomatic thromboembolic events, symptomatic PE and symptomatic DVT (all 2 trials, 58 women), or maternal death (1 trial, 24 women). Adverse effects sufficient to stop treatment were not reported. We were unable to conduct subgroup analyses due to lack of data. Sensitivity analysis including the nine studies at low risk of bias did not impact overall findings.
AUTHORS' CONCLUSIONS


The evidence is very uncertain about benefits and harms of VTE thromboprophylaxis in women during pregnancy and the early postnatal period at increased risk of VTE. Further high-quality very large-scale randomised trials are needed to determine effects of currently used treatments in women with different VTE risk factors. As sufficiently large definitive trials are unlikely to be funded, secondary data analyses based on high-quality registry data are important.",2021,"No events were reported for LMWH versus no treatment/placebo for: symptomatic thromboembolic events, symptomatic PE and symptomatic DVT (all 2 trials, 58 women), or maternal death (1 trial, 24 women).","['women at increased risk of VTE', 'Twenty-nine trials (involving 3839 women', 'women at risk during pregnancy and the early postnatal period', 'women with different VTE risk factors']","['heparin', 'LMWH', 'Peripartum/postnatal prophylaxis Vaginal or caesarean birth', 'thromboprophylaxis with placebo', 'Antenatal (± postnatal) prophylaxis', 'placebo', 'Postnatal prophylaxis', 'VTE thromboprophylaxis', 'heparin (low molecular weight heparin (LMWH) and unfractionated heparin (UFH)), hydroxyethyl starch (HES), and compression stockings or devices', 'heparin versus placebo']","['maternal death', 'Maternal death and adverse effects', 'symptomatic thromboembolic events, symptomatic PE and symptomatic DVT', 'risk of venous thromboembolic disease and adverse effects', 'Maternal death', 'Symptomatic thromboembolic events', 'symptomatic thromboembolic events pulmonary embolism (PE) and/or deep vein thrombosis (DVT), and the critical outcome of adverse effects', 'Caesarean birth Symptomatic thromboembolic events']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C2936491', 'cui_str': 'Peripartum period'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0020352', 'cui_str': 'Hetastarch'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1997614', 'cui_str': 'Thromboembolism of vein'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",3839.0,0.59737,"No events were reported for LMWH versus no treatment/placebo for: symptomatic thromboembolic events, symptomatic PE and symptomatic DVT (all 2 trials, 58 women), or maternal death (1 trial, 24 women).","[{'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Middleton', 'Affiliation': 'Healthy Mothers, Babies and Children, South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Shepherd', 'Affiliation': 'Robinson Research Institute, Discipline of Obstetrics and Gynaecology, Adelaide Medical School, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'Gomersall', 'Affiliation': 'Women and Kids, South Australian Health and Medical Research Institute, Adelaide, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD001689.pub4']
556,33779943,Incident Gallstones During Somatostatin Analog Treatment are Associated with Acute Biliary Complications Especially After Discontinuation.,"INTRODUCTION


Gallstones are a known adverse effect of somatostatin analogs, but the exact incidence and clinical implications are unknown.
OBJECTIVES


The aim of this study was to investigate the incidence of gallstones on imaging and related complications in unbiased trial data.
METHODS


Data from the DIPAK 1 trial, in which 305 polycystic kidney disease patients were randomized to standard of care (SoC) or lanreotide for 120 weeks, were used. Magnetic resonance imaging (MRI) was performed at baseline and end of treatment and was assessed for the presence, number, and size of gallstones. For all patients who had gallstones at the end of the trial, we obtained follow-up after the trial.
RESULTS


Of 249 patients with data available, 11 patients randomized to lanreotide and four randomized to SoC had gallstones at baseline. During the study, new gallstones were formed in 19/124 patients using lanreotide (15%) and 1/125 patients receiving SoC (1%). The odds ratio for gallstone formation with lanreotide use was 25.9 (95% confidence interval 3.37-198.8; p < 0.001). Gallstones during lanreotide treatment were multiple (> 20 stones in 69% of patients) and small (≤ 3 mm in 63% of patients). Of the 19 patients with incident gallstones during lanreotide treatment, 9 experienced gallstone-associated complications, 8 of whom experienced gallstone-associated complications after discontinuation of treatment (median time after discontinuation 2.5 years). In patients with gallstones at baseline and in patients receiving SoC, no complications occurred.
CONCLUSIONS


Treatment with a somatostatin analog leads to the formation of multiple, small gallstones that are associated with severe complications, especially after discontinuation of therapy.
CLINICAL TRIAL REGISTRY WEBSITE AND TRIAL NUMBER


ClinicalTrials.gov ( https://clinicaltrials.gov ); NCT01616927.",2021,"During the study, new gallstones were formed in 19/124 patients using lanreotide (15%) and 1/125 patients receiving SoC (1%).","['Incident Gallstones', '249 patients with data available', '305 polycystic kidney disease patients', '19 patients with incident gallstones during']","['lanreotide', 'Magnetic resonance imaging (MRI', 'standard of care (SoC) or lanreotide']","['gallstone-associated complications', 'Gallstones', 'odds ratio for gallstone formation']","[{'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0022680', 'cui_str': 'Polycystic kidney, unspecified'}]","[{'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",305.0,0.31095,"During the study, new gallstones were formed in 19/124 patients using lanreotide (15%) and 1/125 patients receiving SoC (1%).","[{'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Aapkes', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Haas', 'Affiliation': 'Department of Radiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Lucas H P', 'Initials': 'LHP', 'LastName': 'Bernts', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Blijdorp', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology and Transplantation, Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Sosha E I', 'Initials': 'SEI', 'LastName': 'Dekker', 'Affiliation': 'Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Maatje D A', 'Initials': 'MDA', 'LastName': 'van Gastel', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Meijer', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Veldman', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Joost P H', 'Initials': 'JPH', 'LastName': 'Drenth', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. r.t.gansevoort@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drugs in R&D,['10.1007/s40268-021-00342-7']
557,33779579,Melancholic Features in Bipolar Depression and Response to Lamotrigine: A Pooled Analysis of Five Randomized Placebo-Controlled Trials.,"BACKGROUND


A pilot study suggested lamotrigine may be more effective for bipolar depression with melancholic features. We tested this hypothesis in a pooled analysis of 5 randomized double-blind placebo-controlled trials of lamotrigine for acute bipolar depression.
METHODS


The pooled sample consisted of 1072 adult outpatients. Depressive symptoms were assessed for 7 to 10 weeks with the Hamilton Depression Rating Scale and the Montgomery-Åsberg Depression Rating Scale. The outcome measure was end-trial response (score reduction ≥ 50%). Melancholic features were assessed with both the Structured Clinical Interview for DSM-IV and baseline depression scale items, according to DSM criteria.
RESULTS


The item-based melancholic specifier was associated with numerically larger treatment effects, although subgroup-treatment interactions in logistic regression models did not reach statistical significance. The small subgroup of patients with severe psychomotor retardation also appeared to benefit from lamotrigine. However, the Structured Clinical Interview for DSM-IV melancholic specifier was not associated with larger treatment effects. Baseline depression severity was inconsistently associated with response, depending on which scale was used to define severity. The 2 melancholia variables had poor agreement despite having similar prevalences.
CONCLUSIONS


Our results do not clearly support the original hypothesis but do reinforce the importance of replicating secondary analyses of clinical trials with additional data.",2021,"The item-based melancholic specifier was associated with numerically larger treatment effects, although subgroup-treatment interactions in logistic regression models did not reach statistical significance.",['1072 adult outpatients'],"['Placebo', 'placebo', 'Lamotrigine', 'lamotrigine']","['Baseline depression severity', 'Depressive symptoms', 'Structured Clinical Interview for DSM-IV and baseline depression scale items', 'Hamilton Depression Rating Scale and the Montgomery-Åsberg Depression Rating Scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",1072.0,0.337663,"The item-based melancholic specifier was associated with numerically larger treatment effects, although subgroup-treatment interactions in logistic regression models did not reach statistical significance.","[{'ForeName': 'Evyn M', 'Initials': 'EM', 'LastName': 'Peters', 'Affiliation': 'From the Department of Psychiatry, University of Saskatchewan, Saskatoon, SK Department of Psychiatry, University of Alberta, Edmonton, AB College of Nursing, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Lodhi', 'Affiliation': ''}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Balbuena', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001393']
558,33779577,"The efficacy of escitalopram in major depressive disorder: a multicenter randomized, placebo-controlled double-blind study.","The aim of the study was to conduct a multicenter randomized double-blinded placebo-controlled clinical study to evaluate the efficacy of a generic form of escitalopram in treating major depressive disorder (MDD). A total of 390 MDD patients admitted to hospitals in six cities in China were randomized to receive the generic version of escitalopram, the proprietary form of escitalopram (Lexapro) or placebo. During the 8-week treatment, the Hamilton rating scale for depression-17 (HAM-D17), Hamilton Anxiety Rating Scale (HAMA), Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impressions scale (CGI), current visual analogue scale pain levels (VAS-P1) and Sheehan Disability Scale (SDS) assessments were performed at week 0, 1, 2, 4, 6 and 8 to evaluate treatment responses. HAM-D17, MADRS, HAMA and CGI-S levels of patients who received escitalopram or Lexapro decreased steadily during 8 weeks' treatment, whereas the placebo group showed a relatively smaller reduction of these levels (P < 0.001). SDS and VAS-P1 both decreased after treatment with generic escitalopram or proprietary escitalopram Lexapro. Our results indicated that both the generic escitalopram and proprietary escitalopram Lexapro had potent efficacy in treating MDD.",2021,"HAM-D17, MADRS, HAMA and CGI-S levels of patients who received escitalopram or Lexapro decreased steadily during 8 weeks' treatment, whereas the placebo group showed a relatively smaller reduction of these levels (P < 0.001).","['major depressive disorder (MDD', '390 MDD patients admitted to hospitals in six cities in China', 'major depressive disorder']","['escitalopram', 'placebo', 'generic escitalopram or proprietary escitalopram Lexapro', 'generic version of escitalopram, the proprietary form of escitalopram (Lexapro) or placebo']","['SDS and VAS-P1', 'Hamilton rating scale for depression-17 (HAM-D17), Hamilton Anxiety Rating Scale (HAMA), Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impressions scale (CGI), current visual analogue scale pain levels (VAS-P1) and Sheehan Disability Scale (SDS) assessments', 'HAM-D17, MADRS, HAMA and CGI-S levels']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C1170371', 'cui_str': 'Lexapro'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",390.0,0.121525,"HAM-D17, MADRS, HAMA and CGI-S levels of patients who received escitalopram or Lexapro decreased steadily during 8 weeks' treatment, whereas the placebo group showed a relatively smaller reduction of these levels (P < 0.001).","[{'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine.'}, {'ForeName': 'Guanjun', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine.'}, {'ForeName': 'Huafang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000350']
559,33769732,Safety and efficacy of methotrexate (0.3 mg/kg/week) versus a combination of methotrexate (0.15 mg/kg/week) with cyclosporine (2.5 mg/kg/day) in chronic plaque psoriasis: A randomised non-blinded controlled trial.,"BACKGROUND


Psoriasis is a chronic, inflammatory, relapsing and remitting disease with no cure till date. There is a paucity of trials using a combination of methotrexate (MTX) and cyclosporine (CsA) in chronic plaque psoriasis, due to fear of added toxicity, although they are time tested treatment options for monotherapy.
AIMS


The study aimed to compare the efficacy and adverse effect profile of the standard recommended dose of MTX (i.e. 0.3mg/kg/week) versus a combination of reduced doses of MTX and CsA (i.e. MTX 0.15 mg/kg/week with CsA 2.5mg/kg/day) in patients with chronic plaque psoriasis.
METHODS


Study design was a non-blinded randomised controlled trial. Patients of chronic plaque psoriasis with PASI more than 10 were randomised in 1: 1 allocation to receive either 0.3 mg/kg/week of intramuscular MTX injection or a combination of 0.15 mg/kg/week of intramuscular MTX injection and 2.5 mg/kg/day of CsA rounded off to the nearest 25 mg. Patients were followed up at every 2 weeks for 12 weeks. The doses were kept fixed throughout the study period.
RESULTS


A total of 66 patients received MTX monotherapy, whereas 67 patients received the combination. At baseline, both groups were comparable in their BSA (P = 0.105, Student t-test) and PASI (P = 0.277, Student t-test), which reduced significantly at 12 weeks in both groups (P < 0.001, paired t-test). The achievement of PASI-75 (P = 0.005), PASI-90 (P < 0.001) and PASI-100 (P = 0.001) was more in the combination group (Chi square test). Intention to treat analysis using Chi square test also showed better outcomes for PASI-75 (P = 0.027), PASI-90 (P < 0.001) and PASI-100 (P = 0.001) in the combination group. Combination group also had earlier onset of action (P = 0.001, Chi square test). There was no significant difference between the groups in terms of laboratory and clinical adverse events.
LIMITATIONS


Non-blinded, no comparison with CsA monotherapy arm, no follow up beyond 12 weeks.
CONCLUSION


The combination of reduced doses of MTX and CsA is more efficacious with earlier onset of action and similar adverse effects as with MTX monotherapy.",2021,"Intention to treat analysis using Chi square test also showed better outcomes for PASI-75 (P = 0.027), PASI-90 (P < 0.001) and PASI-100 (P = 0.001) in the combination group.","['patients with chronic plaque psoriasis', '66 patients received', 'Patients of chronic plaque psoriasis with PASI more than 10', 'chronic plaque psoriasis']","['cyclosporine', 'MTX monotherapy', 'methotrexate', 'CsA monotherapy', 'MTX', 'methotrexate (MTX) and cyclosporine (CsA', 'MTX and CsA', 'intramuscular MTX injection or a combination of 0.15 mg/kg/week of intramuscular MTX injection', 'MTX and CsA (i.e. MTX']","['Safety and efficacy', 'earlier onset of action', 'laboratory and clinical adverse events', 'PASI-90', 'PASI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C4034144', 'cui_str': 'Methotrexate Injection'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",66.0,0.304421,"Intention to treat analysis using Chi square test also showed better outcomes for PASI-75 (P = 0.027), PASI-90 (P < 0.001) and PASI-100 (P = 0.001) in the combination group.","[{'ForeName': 'Satyendra Kumar', 'Initials': 'SK', 'LastName': 'Singh', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Sermili Rini', 'Initials': 'SR', 'LastName': 'Singnarpi', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}]","Indian journal of dermatology, venereology and leprology",['10.25259/IJDVL_613_19']
560,33770114,Does family planning counseling reduce unmet need for modern contraception among postpartum women: Evidence from a stepped-wedge cluster randomized trial in Nepal.,"BACKGROUND


Postpartum women have high rates of unmet need for modern contraception in the two years following birth in Nepal. We assessed whether providing contraceptive counseling during pregnancy and/or prior to discharge from the hospital for birth or after discharge from the hospital for birth was associated with reduced postpartum unmet need in Nepal.
METHODS


We used data from a larger a stepped-wedge, cluster randomized trial, including contraceptive counselling in six tertiary hospitals. Group 1 hospitals (three hospitals) initiated the intervention after three months of baseline data collection, while Group 2 hospitals (three hospitals) initiated the same intervention after nine months. We have enrolled 21,280 women in the baseline interviews and conducted two follow-up interviews with them, one and two years after they had delivered in one of our study hospitals. We estimated the effect of counseling and its timing (pre-discharge, post- discharge, both, or neither) on unmet need for modern contraception in the postpartum period, using random-effects logistic regressions.
RESULTS


Unmet need for modern contraception was high (54% at one year and 50% at two years). Women counseled in either the pre-discharge period (Odds ratio [OR] 0·86; 95% CI: 0·80, 0·93) or in the post-discharge period (OR 0·86; 95% CI: 0·79, 0·93) were less likely to have an unmet need in the postpartum period compared to women with no counseling. However, women who received counseling in both the pre- and post-discharge period were 27% less likely than women who had not received counseling to have unmet need (OR 0.73; 95% CI: 0·67, 0·80).
CONCLUSIONS


Counseling women either before or after discharge reduces unmet need for postpartum contraception but counseling in both periods is most effective.",2021,"CONCLUSIONS


Counseling women either before or after discharge reduces unmet need for postpartum contraception but counseling in both periods is most effective.","['postpartum women', 'Postpartum women', 'enrolled 21,280 women in the baseline interviews and conducted two follow-up interviews with them, one and two years after they had delivered in one of our study hospitals', 'in six tertiary hospitals']","['contraceptive counselling', 'contraceptive counseling']",[],"[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1443484', 'cui_str': 'Contraception care education'}]",[],21280.0,0.23006,"CONCLUSIONS


Counseling women either before or after discharge reduces unmet need for postpartum contraception but counseling in both periods is most effective.","[{'ForeName': 'Mahesh Chandra', 'Initials': 'MC', 'LastName': 'Puri', 'Affiliation': 'Center for Research on Environment Health and Population Activities (CREHPA), Kathmandu, Nepal.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Huber-Krum', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Canning', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Muqi', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Iqbal H', 'Initials': 'IH', 'LastName': 'Shah', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0249106']
561,33769998,Outcomes of Ambulatory Heart Failure Patients Managed With an Intra-aortic Balloon Pump Before Left Ventricular Assist Device Implantation.,"Patients are admitted to the hospital for hemodynamic optimization before left ventricular assist device (LVAD) implantation. The aim of this study was to evaluate the clinical outcomes of hemodynamic optimization using an intra-aortic balloon pump (IABP) in ambulatory heart failure patients before LVAD placement. This retrospective single-center study included 199 noninotrope-dependent patients who underwent durable LVAD implantation between January 1, 2007 and April 10, 2017. Invasive hemodynamic as well as the primary composite end-point of stage 2 or 3 acute kidney injury, right ventricular failure, and 30-day mortality were compared between patients with and without an IABP. Median age was 64 (interquartile range [IQR], 57-71) years and 165 (82.9%) were male; 72 (36.2%) received an IABP. Patients treated with an IABP had worse baseline exercise capacity and hemodynamic parameters. Patients with an IABP had greater relative reduction in pulmonary artery mean pressure (-16% vs. -2%; p ≤ 0.001). The primary composite end-point was not different between patients who had an IABP and those who did not (20.8% vs. 20.5%; p = 0.952), as were each of the individual end-points. Despite worse baseline hemodynamic parameters and exercise capacity, ambulatory heart failure patients who received an IABP before LVAD implantation had more favorable reductions in pulmonary artery pressures without an increase in the composite end-point. These results suggest that IABP use before LVAD implantation may mitigate the risk of postoperative complications in ambulatory patients.",2021,Patients with an IABP had greater relative reduction in pulmonary artery mean pressure (-16% vs. -2%; p ≤ 0.001).,"['ambulatory heart failure patients before LVAD placement', 'Patients are admitted to the hospital for hemodynamic optimization before left ventricular assist device (LVAD) implantation', 'ambulatory patients', 'Median age was 64 (interquartile range [IQR], 57-71) years and 165 (82.9%) were male; 72 (36.2%) received an', '199 noninotrope-dependent patients who underwent durable LVAD implantation between January 1, 2007 and April 10, 2017']","['LVAD implantation', 'Ambulatory Heart Failure Patients Managed With an Intra-aortic Balloon Pump', 'intra-aortic balloon pump (IABP', 'IABP', 'IABP before LVAD implantation']","['pulmonary artery pressures', 'pulmonary artery mean pressure', 'right ventricular failure, and 30-day mortality', 'postoperative complications', 'Invasive hemodynamic', 'baseline exercise capacity and hemodynamic parameters']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}]","[{'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0428645', 'cui_str': 'Pulmonary artery mean pressure'}, {'cui': 'C0235527', 'cui_str': 'Right heart failure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.14911,Patients with an IABP had greater relative reduction in pulmonary artery mean pressure (-16% vs. -2%; p ≤ 0.001).,"[{'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Ternus', 'Affiliation': 'From the Division of Cardiovascular Medicine, University of Wisconsin-Madison, Wisconsin.'}, {'ForeName': 'Atta', 'Initials': 'A', 'LastName': 'Behfar', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Schirger', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Barsness', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mackram', 'Initials': 'M', 'LastName': 'Eleid', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stulak', 'Affiliation': 'Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Jentzer', 'Affiliation': 'From the Division of Cardiovascular Medicine, University of Wisconsin-Madison, Wisconsin.'}]",ASAIO journal (American Society for Artificial Internal Organs : 1992),['10.1097/MAT.0000000000001249']
562,33771774,Differential effects of epidermal growth factor receptor inhibitors in a single patient with neuropathic pain.,"Neuropathic pain (NP) represents an unmet medical need, where analgesic responses to different epidermal growth factor receptor inhibitors (EGFR-Is) have been described. The human EGFR family of receptors consists of four members (human epidermal growth factor receptor, HER 1-4), signalling via different homodimer and heterodimer combinations. A 52-year-old man was treated with the EGFR-I cetuximab in a trial of severe NP. Pain scores decreased dramatically after blinded cetuximab, but not after placebo. On pain recurrence after the trial, he was prescribed the oral EGFR-Is erlotinib, gefitinib, and lapatinib without relief. However, treatment with the pan-HER-inhibitor afatinib was effective. After 4 years on afatinib, pain control remains excellent with manageable side effects. This is the first reported observation of differential effects of EGFR-Is on NP in the same patient and the first report describing NP relief with afatinib. Further understanding of the underlying pathophysiology could lead to development of EGFR-Is specifically targeting NP.",2021,"Pain scores decreased dramatically after blinded cetuximab, but not after placebo.",['single patient with neuropathic pain'],"['epidermal growth factor receptor inhibitors', 'placebo', 'EGFR-I cetuximab']","['pain recurrence', 'Pain scores', 'Neuropathic pain (NP']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}]","[{'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}]",,0.0805028,"Pain scores decreased dramatically after blinded cetuximab, but not after placebo.","[{'ForeName': 'Marte Grønlie', 'Initials': 'MG', 'LastName': 'Cameron', 'Affiliation': 'Center for Cancer Treatment, Southern Norway Hospital Trust, Kristiansand, Norway Marte.Gronlie.Cameron@sshf.no.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kersten', 'Affiliation': 'Center for Cancer Treatment, Southern Norway Hospital Trust, Kristiansand, Norway.'}]",BMJ case reports,['10.1136/bcr-2020-239385']
563,33771763,Lack of effect of  Lactobacillus rhamnosus  GG and  Bifidobacterium lactis  Bb12 on beta-cell function in children with newly diagnosed type 1 diabetes: a randomised controlled trial.,"INTRODUCTION


The gut microbiota may be relevant in the development of type 1 diabetes (T1D). We examined the effects of  Lactobacillus rhamnosus  GG and  Bifidobacterium lactis  Bb12 on beta-cell function in children with newly diagnosed T1D.
RESEARCH DESIGN AND METHODS


Children aged 8-17 years with newly (within 60 days) diagnosed T1D were enrolled in a double-blind, randomised controlled trial in which they received  L. rhamnosus  GG and  B. lactis  Bb12 at a dose of 10 9  colony-forming units or placebo, orally, once daily, for 6 months. The follow-up was for 12 months. The primary outcome measure was the area under the curve (AUC) of the C-peptide level during 2-hour responses to a mixed meal.
RESULTS


Ninety-six children were randomised (probiotics, n=48; placebo n=48; median age 12.3 years). Eighty-eight (92%) completed the 6-month intervention, and 87 (91%) completed the follow-up at 12 months. There was no significant difference between the study groups for the AUC of the C-peptide level. For the secondary outcomes at 6 months, there were no differences between the study groups. At 12 months, with one exception, there also were no significant differences between the groups. Compared with the placebo group, there was a significantly increased number of subjects with thyroid autoimmunity in the probiotic group. However, at baseline, there was also a higher frequency of thyroid autoimmunity in the probiotic group. There were no cases of severe hypoglycemia or ketoacidosis in any of the groups. No adverse events related to the study products were reported.
CONCLUSIONS


L. rhamnosus  GG and  B. lactis  Bb12, as administered in this study, had no significant effect in maintaining the residual pancreatic beta-cell function in children with newly diagnosed T1D. It remains unclear which probiotics, if any, alone or in combination, are potentially the most useful for management of T1D.
TRIAL REGISTRATION NUMBER


NCT03032354.",2021,There was no significant difference between the study groups for the AUC of the C-peptide level.,"['children with newly diagnosed type 1 diabetes', 'Children aged 8-17 years with newly (within 60 days) diagnosed T1D', 'children with newly diagnosed T1D', 'Ninety-six children were randomised (probiotics, n=48; placebo n=48; median age 12.3 years']","['Lactobacillus rhamnosus  GG and  Bifidobacterium lactis  Bb12', 'placebo']","['area under the curve (AUC) of the C-peptide level during 2-hour responses to a mixed meal', 'frequency of thyroid autoimmunity', 'residual pancreatic beta-cell function', 'severe hypoglycemia or ketoacidosis', 'number of subjects with thyroid autoimmunity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5191283', 'cui_str': '12.3'}]","[{'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",96.0,0.545389,There was no significant difference between the study groups for the AUC of the C-peptide level.,"[{'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Groele', 'Affiliation': ""Department of Paediatrics, The Children's Clinical Hospital Józef Polikarp Brudziński, Warsaw, Poland lgroele@wp.pl.""}, {'ForeName': 'Hania', 'Initials': 'H', 'LastName': 'Szajewska', 'Affiliation': 'Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Mieczysław', 'Initials': 'M', 'LastName': 'Szalecki', 'Affiliation': ""Clinic of Endocrinology and Diabetology, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Świderska', 'Affiliation': ""Clinic of Endocrinology and Diabetology, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Wysocka-Mincewicz', 'Affiliation': ""Clinic of Endocrinology and Diabetology, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Ochocińska', 'Affiliation': ""Department of Biochemistry, Radioimmunology and Experimental Medicine, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stelmaszczyk-Emmel', 'Affiliation': 'Deparment of Laboratory Diagnostics and Clinical Immunology of Developmental Age, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Demkow', 'Affiliation': 'Deparment of Laboratory Diagnostics and Clinical Immunology of Developmental Age, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szypowska', 'Affiliation': 'Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001523']
564,33686788,A comparative study of the effect of the Time for Dementia programme on medical students.,"BACKGROUND


Traditional healthcare education typically focuses on short block clinical placements based on acute care, investigations and technical aspects of diagnosis and treatment. It may therefore fail to build the understanding, compassion and person-centred empathy needed to help those with long-term conditions, like dementia. Time for Dementia was developed to address this.
METHOD


Parallel group comparison of two cohorts of UK medical students from universities, one participating in Time for Dementia (intervention group) and one not (control group). In Time for Dementia students visit a person with dementia and their family in pairs for 2 hours three times a year for 2 years, the control group received their normal curriculum.
RESULTS


In an adjusted multilevel model (intervention group n = 274, control n = 112), there was strong evidence supporting improvements for Time for Dementia participants in: total Approaches to Dementia Questionnaire score (coefficient: 2.19, p = 0.003) and its person-centredness subscale (1.32, p = 0.006) and weaker evidence in its hopefulness subscale (0.78, p = 0.070). There was also strong evidence of improvement in the Dementia Knowledge Questionnaire (1.63, p < 0.001) and Dementia Attitudes Scale (total score: 6.55, p < 0.001; social comfort subscale: 4.15, p < 0.001; dementia knowledge subscale: 3.38, p = 0.001) scores. No differences were observed on the Alzheimer's Disease Knowledge Scale, the Medical Condition Regard Scale or the Jefferson Scale of Empathy.
DISCUSSION


Time for Dementia may help improve the attitudes of medical students towards dementia promoting a person-centred approach and increasing social comfort. Such patient-focused programmes may be a useful complement to traditional medical education.",2021,"No differences were observed on the Alzheimer's Disease Knowledge Scale, the Medical Condition Regard Scale or the Jefferson Scale of Empathy.
","['Parallel group comparison of two cohorts of UK medical students from universities, one participating in Time for Dementia (intervention group) and one not (control group', 'medical students']",[],"['social comfort subscale', 'dementia knowledge subscale', 'Dementia Questionnaire score (coefficient', 'Dementia Knowledge Questionnaire', 'Dementia Attitudes Scale', 'person-centredness subscale', ""Alzheimer's Disease Knowledge Scale, the Medical Condition Regard Scale or the Jefferson Scale of Empathy""]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]",,0.0336411,"No differences were observed on the Alzheimer's Disease Knowledge Scale, the Medical Condition Regard Scale or the Jefferson Scale of Empathy.
","[{'ForeName': 'Sube', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Centre for Dementia Studies, Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Centre for Dementia Studies, Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Grosvenor', 'Affiliation': 'School of Health Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Hebditch', 'Affiliation': 'Centre for Dementia Studies, Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Hughes', 'Affiliation': 'Centre for Dementia Studies, Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Feeney', 'Affiliation': 'Centre for Dementia Studies, Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Farina', 'Affiliation': 'Centre for Dementia Studies, Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Mackrell', 'Affiliation': ""Time for Dementia Programme, Alzheimer's Society, Horsham, UK.""}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nilforooshan', 'Affiliation': 'Surrey and Borders Partnership NHS Foundation Trust, Surrey, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norfolk, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'Centre for Dementia Studies, Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Daley', 'Affiliation': 'Centre for Dementia Studies, Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}]",International journal of geriatric psychiatry,['10.1002/gps.5532']
565,33776935,Motivational Interviewing and Glycemic Control in Adolescents With Poorly Controlled Type 1 Diabetes: A Randomized Controlled Pilot Trial.,"A multicenter randomized controlled pilot trial investigated whether motivational interviewing (MI) by diabetes physicians improves glycemic control and variability in the context of follow-up for adolescent patients with poorly controlled type 1 diabetes. Patients ( n  = 47) aged 12 to 15.9 years who showed poor glycemic control (HbA1c >75 mmol/mol/9.0%) were randomized to standard education (SE) only or MI+SE, with study physicians randomized to employ MI+SE ( N  = 24 patients) or SE only ( N  = 23). For one year of follow-up, the main outcome measurements were obtained at three-month visits (HbA1c) or six-monthly: time in range (TIR) and glycemic variability (CV). Mean adjusted 12-month change in HbA1c was similar between the MI+SE and SE-only group (-3.6 vs. -1.0 mmol/mol), and no inter-group differences were visible in the mean adjusted 12-month change in TIR (-0.8 vs. 2.6%;  P  = 0.53) or CV (-0.5 vs. -6.2;  P  = 0.26). However, the order of entering the study correlated significantly with the 12-month change in HbA1c in the MI+SE group ( r  = -0.5;  P  = 0.006) and not in the SE-only group ( r  = 0.2;  P  = 0.4). No link was evident between MI and changes in quality of life. The authors conclude that MI's short-term use by diabetes physicians managing adolescents with poorly controlled type 1 diabetes was not superior to SE alone; however, improved skills in applying the MI method at the outpatient clinic may produce greater benefits in glycemic control.",2021,"Mean adjusted 12-month change in HbA1c was similar between the MI+SE and SE-only group (-3.6 vs. -1.0 mmol/mol), and no inter-group differences were visible in the mean adjusted 12-month change in TIR (-0.8 vs. 2.6%;  P  = 0.53) or CV","['adolescent patients with poorly controlled type 1 diabetes', 'Patients ( n  = 47) aged 12 to 15.9 years who showed poor glycemic control (HbA1c >75 mmol/mol/9.0', 'Adolescents With Poorly Controlled Type 1 Diabetes']","['MI+SE', 'CV', 'Motivational Interviewing and Glycemic Control', 'motivational interviewing (MI', 'standard education (SE) only or MI+SE']","['quality of life', 'time in range (TIR) and glycemic variability (CV', 'Mean adjusted 12-month change in HbA1c', 'glycemic control and variability']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0160344,"Mean adjusted 12-month change in HbA1c was similar between the MI+SE and SE-only group (-3.6 vs. -1.0 mmol/mol), and no inter-group differences were visible in the mean adjusted 12-month change in TIR (-0.8 vs. 2.6%;  P  = 0.53) or CV","[{'ForeName': 'Anna-Kaisa', 'Initials': 'AK', 'LastName': 'Tuomaala', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Hero', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Martti T', 'Initials': 'MT', 'LastName': 'Tuomisto', 'Affiliation': 'Faculty of Social Sciences (Psychology), Tampere University, Tampere, Finland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lähteenmäki', 'Affiliation': 'Faculty of Social Sciences (Psychology), Tampere University, Tampere, Finland.'}, {'ForeName': 'Päivi J', 'Initials': 'PJ', 'LastName': 'Miettinen', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laine', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Karoliina', 'Initials': 'K', 'LastName': 'Wehkalampi', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Kiiveri', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Ahonen', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Ojaniemi', 'Affiliation': 'Department of Pediatrics and Research Unit for Pediatrics, Pediatric Neurology, Pediatric Surgery, Child Psychiatry, Dermatology, Clinical Genetics, Obstetrics and Gynecology, Otorhinolaryngology and Ophthalmology, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Kaunisto', 'Affiliation': 'Department of Pediatrics and Research Unit for Pediatrics, Pediatric Neurology, Pediatric Surgery, Child Psychiatry, Dermatology, Clinical Genetics, Obstetrics and Gynecology, Otorhinolaryngology and Ophthalmology, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Tossavainen', 'Affiliation': 'Department of Pediatrics and Research Unit for Pediatrics, Pediatric Neurology, Pediatric Surgery, Child Psychiatry, Dermatology, Clinical Genetics, Obstetrics and Gynecology, Otorhinolaryngology and Ophthalmology, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Risto', 'Initials': 'R', 'LastName': 'Lapatto', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Taisto', 'Initials': 'T', 'LastName': 'Sarkola', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Mari-Anne', 'Initials': 'MA', 'LastName': 'Pulkkinen', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}]",Frontiers in endocrinology,['10.3389/fendo.2021.639507']
566,33776906,Insulin Therapy in Type 2 Diabetes Is Associated With Barriers to Activity and Worse Health Status: A Cross-Sectional Study in Primary Care.,"Introduction


Many individuals with type 2 diabetes mellitus (T2DM) experience ""psychological insulin resistance"". Consequently, it could be expected that insulin therapy may have negative effects on psychological outcomes and well-being. Therefore, this study compared health status and psychosocial functioning of individuals with T2DM using only oral antihyperglycemic agents (OHA) and on insulin therapy (with or without OHA).
Materials and Methods


In this cross-sectional study, we used baseline data of a cluster randomized controlled trial conducted in 55 Dutch general practices in 2005. Health status was measured with the Short Form (SF)-36 (scale 0-100) and psychosocial functioning with the Diabetes Health Profile (DHP, scale 0-100). To handle missing data, we performed multiple imputation. We used linear mixed models with random intercepts per general practice to correct for clustering at practice level and to control for confounding.
Results


In total, 2,794 participants were included in the analysis, their mean age was 65.8 years and 50.8% were women. Insulin-users (n = 212) had a longer duration of T2DM (11.0 versus 5.6 years) and more complications. After correcting for confounders and multiple comparisons, insulin-users reported significantly worse outcomes on vitality (SF-36, adjusted difference -5.7, p=0.033), general health (SF-36, adjusted difference -4.8, p=0.043), barriers to activity (DHP, adjusted difference -7.2, p<0.001), and psychological distress (DHP, adjusted difference -3.7, p=0.004), all on a 0-100 scale.
Discussion


While previous studies showed similar or better health status in people with type 2 diabetes receiving insulin therapy, we found that vitality, general health and barriers to activity were worse in those on insulin therapy. Although the causality of this association cannot be established, our findings add to the discussion on the effects of insulin treatment on patient-reported outcomes in daily practice.",2021,"After correcting for confounders and multiple comparisons, insulin-users reported significantly worse outcomes on vitality (SF-36, adjusted difference -5.7, p=0.033), general health (SF-36, adjusted difference -4.8, p=0.043), barriers to activity (DHP, adjusted difference -7.2, p<0.001), and psychological distress (DHP, adjusted difference -3.7, p=0.004), all on a 0-100 scale.
","['2,794 participants were included in the analysis, their mean age was 65.8 years and 50.8% were women', '55 Dutch general practices in 2005', 'people with type 2 diabetes receiving', 'individuals with type 2 diabetes mellitus (T2DM) experience ""psychological insulin resistance']","['Insulin Therapy', 'insulin therapy', 'T2DM using only oral antihyperglycemic agents (OHA) and on insulin therapy (with or without OHA']","['longer duration of T2DM', 'complications', 'psychological distress', 'Health status', 'vitality, general health and barriers to activity', 'health status', 'general health']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}]","[{'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",2794.0,0.189278,"After correcting for confounders and multiple comparisons, insulin-users reported significantly worse outcomes on vitality (SF-36, adjusted difference -5.7, p=0.033), general health (SF-36, adjusted difference -4.8, p=0.043), barriers to activity (DHP, adjusted difference -7.2, p<0.001), and psychological distress (DHP, adjusted difference -3.7, p=0.004), all on a 0-100 scale.
","[{'ForeName': 'Anne Meike', 'Initials': 'AM', 'LastName': 'Boels', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Rutten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'Cleveringa', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Mariëlle', 'Initials': 'M', 'LastName': 'van Avendonk', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Rimke', 'Initials': 'R', 'LastName': 'Vos', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.'}]",Frontiers in endocrinology,['10.3389/fendo.2021.573235']
567,33776878,Eye Movement Technique to Improve Executive Function in Patients With Stroke: A Randomized Controlled Trial.,"Objective:  To investigate the efficacy of eye movement technique for the treatment of executive dysfunction of patients with stroke.  Methods:  This was a prospective, single-blinded, randomized, controlled, single-center clinical trial conducted from June 2018 to December 2019 in patients with stroke. The patients were randomized 1:1 to the routine (conventional management) and eye-move group (routine management plus eye movement technique: 5-min goal management training, 5-min computer-aided working memory, and 10 min of inhibitory control training and set conversion training). The intervention lasted 6 weeks, followed by a 4-week follow-up. The primary endpoint was the Behavioral Assessment of the Dysexecutive Syndrome (BADS) score. The secondary endpoints mainly included the Montreal Cognitive Assessment (MoCA), Wisconsin Card Sorting Test (WCST), and modified Barthel Index (MBI) scores.  Results:  Sixty-four patients were enrolled (32/group). After the 6-week intervention, the BADS and WCST scores of the eye-move group were significantly improved than those of the routine group (all  P  < 0.05), but the effects were attenuated in certain subscores after follow-up (all  P  > 0.05). The MoCA and MBI scores of the eye-move group were significantly higher, and the reaction time was significantly lower than those of the routine group at 4 weeks after the intervention (all  P  < 0.05). After follow-up, the MBI scores of the eye-move group were still higher than that of the routine group ( P  < 0.001), but there were no differences for MoCA scores and reaction time (both  P  > 0.05).  Conclusion:  The eye movement technique could improve the executive function of patients with stroke. These results have to be confirmed. This was a prospective, single-blinded, randomized, controlled, single-center clinical trial (ChiCTR2000036393).  Clinical Trial Registration:  [www.chictr.org.cn], identifier [ChiCTR2000036393].",2021,"After follow-up, the MBI scores of the eye-move group were still higher than that of the routine group ( P  < 0.001), but there were no differences for MoCA scores and reaction time (both  P  > 0.05).  ","['June 2018 to December 2019 in patients with stroke', 'Sixty-four patients were enrolled (32/group', 'patients with stroke', 'Patients With Stroke']","['Eye Movement Technique', 'routine (conventional management) and eye-move group (routine management plus eye movement technique: 5-min goal management training, 5-min computer-aided working memory, and 10 min of inhibitory control training and set conversion training', 'eye movement technique']","['reaction time', 'executive function', 'Montreal Cognitive Assessment (MoCA), Wisconsin Card Sorting Test (WCST), and modified Barthel Index (MBI) scores', 'Executive Function', 'certain subscores', 'MoCA and MBI scores', 'MBI scores', 'MoCA scores and reaction time', 'BADS and WCST scores', 'Behavioral Assessment of the Dysexecutive Syndrome (BADS) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C2959822', 'cui_str': 'Behavioral assessment of the dysexecutive syndrome score'}]",64.0,0.0323264,"After follow-up, the MBI scores of the eye-move group were still higher than that of the routine group ( P  < 0.001), but there were no differences for MoCA scores and reaction time (both  P  > 0.05).  ","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Rehabilitation Department, Shanghai Fourth Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Yazheng', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Rehabilitation Department, Shanghai Fourth Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Xiating', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Rehabilitation Department, Shanghai Fourth Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Rehabilitation Treatment Department, Shanghai Fourth Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Rehabilitation Department, Shanghai Fourth Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Chengyi', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Rehabilitation Department, Shanghai Fourth Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Rehabilitation Department, Shanghai Fourth Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Rehabilitation Department, Shanghai Fourth Rehabilitation Hospital, Shanghai, China.'}]",Frontiers in neurology,['10.3389/fneur.2021.599850']
568,33776112,Influence of interpretation of pain scores on patients' perception of pain: A prospective study.,"Background and Aims


Assessment of pain using pain scales is essential. In the Numeric Rating Scale (NRS), patients are asked to score their pain intensity on a scale from 0 to 10 (10- worst pain). This requires some abstract thinking by the patient, also the pain scores (PS) may not essentially communicate the patients' need for more analgesia. We planned a study to evaluate the change in patients' self-assessed PS after understanding clinical interpretation of the NRS.
Methods


This prospective study was registered after approval from our hospital ethics board. Sample size estimated for the trial was 360 patients. All postoperative patients were recruited after informed consent. Patients having prolonged stay in Intensive Care Unit (more than 48 h), or those who underwent emergency surgeries were excluded. During Acute Pain Service (APS) rounds, patients were asked to rate their PS on the NRS. This was followed by a briefing about the clinical interpretation of the scale, and the patients were asked to re score their pain using the same scale. The change in pain severity was compared using Chi-square test.
Results


Following explanation, a change in severity was seen for PS at rest [ X   2  (9, N- 360) = 441,  P  < 0.001] and at movement [X 2  (9, N- 360) = 508,  P  < 0.001]. Overall, a change in PS severity was seen in 162 patients (45%). A decrease and an increase in the severity of pain was seen in 119 and 41 patients respectively.
Conclusion


Explaining the clinical interpretation of PS on a NRS does lead to a change in patients' self-assessed PS.",2021,"A decrease and an increase in the severity of pain was seen in 119 and 41 patients respectively.
","['Patients having prolonged stay in Intensive Care Unit (more than 48 h), or those who underwent emergency surgeries were excluded', '360 patients', ""patients' perception of pain""]",[],"['Numeric Rating Scale (NRS', 'pain scores', 'PS severity', 'pain severity', 'severity of pain']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0960359,"A decrease and an increase in the severity of pain was seen in 119 and 41 patients respectively.
","[{'ForeName': 'Sumitra G', 'Initials': 'SG', 'LastName': 'Bakshi', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital and Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Rathod', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital and Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Salunkhe', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital and Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_130_21']
569,33776089,Assessment of the perioperative effect of vasopressin in patients undergoing laparoscopic myomectomy: A double-blind randomised study.,"Background and Aims


Myomectomy is associated with perioperative bleeding. The aim of the study is to evaluate the effect of intramyometrial vasopressin on blood loss and the associated cardiovascular complications during myomectomy.
Methods


The study included 194 patients classified into two groups- 1) Vasopressin group: the vasopressin was diluted as 0.1 unit/ml and 15 ml was injected by the surgeon in the plane between the myometrium and the myoma. 2) Control group: The patients received an equal amount of normal saline. The monitored parameters included the amount of blood loss, required blood transfusion, heart rate, mean arterial blood pressure, the incidence of hypertension, hypotension, bradycardia, tachycardia, electrocardiogram (ECG) changes and the blood troponin I level.
Results


The heart rate decreased significantly in both groups, but the decrease was lower with vasopressin than the control group through the time points T3 to T5 ( P  < 0.05) The mean arterial blood pressure increased significantly in both groups, but the increase was higher with vasopressin than the control group through T3 to T5 ( P  < 0.05). The amount of blood loss decreased significantly with vasopressin than the control groups ( P  = 0.001). The number of transfused packed red blood cells was lower with vasopressin than the control group ( P  = 0.001). The incidence of hypertension, bradycardia and atrial extrasystole was higher with vasopressin than the control group ( P  = 0.005,  P  = 0.012,  P  = 0.033, respectively).
Conclusion


Intramyometrial vasopressin decreases blood loss and blood transfusion, but it is associated with cardiovascular complications that may be serious as reported in other studies. Therefore, anaesthesiologists and gynaecologists must follow the precautions to avoid and minimise the incidence of complications with intramyometrial vasopressin.",2021,"The mean arterial blood pressure increased significantly in both groups, but the increase was higher with vasopressin than the control group through T3 to T5 ( P  < 0.05).","['194 patients classified into two groups- 1', 'patients undergoing laparoscopic myomectomy']","['Vasopressin', 'intramyometrial vasopressin', 'Intramyometrial vasopressin', 'vasopressin', 'equal amount of normal saline']","['mean arterial blood pressure', 'amount of blood loss, required blood transfusion, heart rate, mean arterial blood pressure, the incidence of hypertension, hypotension, bradycardia, tachycardia, electrocardiogram (ECG) changes and the blood troponin I level', 'heart rate', 'amount of blood loss', 'cardiovascular complications', 'number of transfused packed red blood cells', 'blood loss and blood transfusion', 'incidence of hypertension, bradycardia and atrial extrasystole', 'blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C2111517', 'cui_str': 'Laparoscopic myomectomy'}]","[{'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0595837', 'cui_str': 'Intramyometrial route'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0855329', 'cui_str': 'Electrocardiogram change'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2316467', 'cui_str': 'Packed red blood cells'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}]",194.0,0.0590177,"The mean arterial blood pressure increased significantly in both groups, but the increase was higher with vasopressin than the control group through T3 to T5 ( P  < 0.05).","[{'ForeName': 'Rabie', 'Initials': 'R', 'LastName': 'Soliman', 'Affiliation': 'Aldar Hospital, Almadinah Almonwarah, Saudi Arabia.'}, {'ForeName': 'Abdelbadee', 'Initials': 'A', 'LastName': 'Yacoub', 'Affiliation': 'Department of Anaesthesia, Faculty of Medicine, Al Azhar University, Egypt.'}, {'ForeName': 'Assem A M', 'Initials': 'AAM', 'LastName': 'Elbiaa', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Ein Shams University, Egypt.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_363_20']
570,33776088,Comparison of aerosol box intubation with C-MAC video laryngoscope and direct laryngoscopy-A randomised controlled trial.,"Background and Aims


Severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is a highly infectious disease and healthcare workers are at constant risk for contracting it. Nowadays, aerosol box is used in conjunction with WHO-recommended safety kits, to avoid health workers from getting SARS-CoV-2 infection during aerosol-generating procedures. In our study, we compared the ease of oral intubation with C-MAC video laryngoscope and direct laryngoscopy, when the aerosol box was used. The secondary objectives were to compare the incidence of airway loss, haemodynamic changes, number of attempts, and time required for intubation between these two techniques.
Methods


This prospective randomised controlled study was conducted on 60 non-coronavirus disease (COVID) patients presenting for elective surgery under general anaesthesia. Patients were randomly assigned into two groups:C and D using a computer-generated random sequence of numbers by closed envelope technique. In group D, laryngoscopy was performed with Macintosh blade and in group C, with Storz® C-MAC video laryngoscope.
Results


The ease of intubation was better (grade 1) in group C than D (68.6% vs. 31.4% respectively) with a  P  value of < 0.001. 10% of patients required more than one intubation attempt in group D compared to none in group C, but this difference was not statistically significant. The intubation time was comparable between the two groups. There were no incidences of loss of airway or failure to intubate in both groups.
Conclusion


The use of C-MAC video-laryngoscopy resulted in easier orotracheal intubation as compared to intubation with direct laryngoscopy when the aerosol box was used.",2021,The ease of intubation was better (grade 1) in group C than D (68.6% vs. 31.4% respectively) with a  P  value of < 0.001.,['60 non-coronavirus disease (COVID) patients presenting for elective surgery under general anaesthesia'],"['Storz® C-MAC video laryngoscope', 'C-MAC video-laryngoscopy', 'oral intubation with C-MAC video laryngoscope and direct laryngoscopy', 'aerosol box intubation with C-MAC video laryngoscope and direct laryngoscopy']","['intubation time', 'incidence of airway loss, haemodynamic changes, number of attempts, and time required for intubation between these two techniques', 'loss of airway or failure to intubate']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",60.0,0.017163,The ease of intubation was better (grade 1) in group C than D (68.6% vs. 31.4% respectively) with a  P  value of < 0.001.,"[{'ForeName': 'Nitu', 'Initials': 'N', 'LastName': 'Puthenveettil', 'Affiliation': 'Department of Anaesthesia and Critical Care, Department of Plastic Surgery, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Sajan', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Department of Anaesthesia and Critical Care, Department of Plastic Surgery, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Vijayaraghavan', 'Affiliation': 'Department of Anaesthesia and Critical Care, Department of Plastic Surgery, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Suresh', 'Affiliation': 'Department of Anaesthesia and Critical Care, Department of Plastic Surgery, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Dilesh', 'Initials': 'D', 'LastName': 'Kadapamannil', 'Affiliation': 'Department of Anaesthesia and Critical Care, Department of Plastic Surgery, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'Department of Anaesthesia and Critical Care, Department of Plastic Surgery, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_1218_20']
571,33776087,Effect of hand-holding and conversation alone or with midazolam premedication on preoperative anxiety in adult patients-A randomised controlled trial.,"Background and Aims


Anxiety causing stress is most profound before surgery. Anxiolytics are used routinely to combat perioperative anxiety. Studies have shown that hand-holding and communication are useful in reducing anxiety levels intraoperatively. This study compares the effectiveness of the same with pharmacological interventions in allaying preoperative anxiety.
Material and Methods


This is a three-arm parallel-group randomised controlled trial. A total of 90 adult patients aged <45 years and of American Society of Anesthesiologists (ASA) grade 1-2, undergoing laparoscopic surgery were enroled in this study. Patients received either intravenous (IV) midazolam (group M) or hand-holding and conversation (group HC), or a combination of IV midazolam and holding and conversation (group HCM) in the preoperative room. Anxiety, heart rate (HR) and mean blood pressure (MBP) were recorded before and 20 minutes after the intervention. Anxiety was measured using the Amsterdam preoperative anxiety and information scale. The analysis of covariance (ANCOVA) test was done to analyse the difference between the groups.
Results


The mean anxiety scores were significantly different in the three groups (p = 0.04) after intervention, with the lowest score in group HCM, followed by group HC and the highest score in group M. The mean heart rates were also significantly different in the three groups after intervention but MBP was not significantly different in the three groups.
Conclusion


A combination of hand-holding and conversation and midazolam is best for allaying preoperative anxiety in patients undergoing laparoscopic surgeries than either method alone.",2021,"The mean heart rates were also significantly different in the three groups after intervention but MBP was not significantly different in the three groups.
","['adult patients', 'patients undergoing laparoscopic surgeries than either method alone', '90 adult patients aged <45 years and of American Society of Anesthesiologists (ASA) grade 1-2, undergoing']","['midazolam premedication', 'Anxiolytics', 'laparoscopic surgery', 'intravenous (IV) midazolam (group M) or hand-holding and conversation (group HC), or a combination of IV midazolam and holding and conversation (group HCM', 'pharmacological interventions', 'hand-holding and conversation and midazolam', 'hand-holding and conversation alone']","['MBP', 'Anxiety', 'mean anxiety scores', 'preoperative anxiety', 'Anxiety, heart rate (HR) and mean blood pressure (MBP', 'mean heart rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0441847', 'cui_str': 'Group M'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0262500', 'cui_str': 'Routine health maintenance'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",90.0,0.0737701,"The mean heart rates were also significantly different in the three groups after intervention but MBP was not significantly different in the three groups.
","[{'ForeName': 'Bhavna', 'Initials': 'B', 'LastName': 'Sriramka', 'Affiliation': 'Department of Anaesthesia and Critical Care, IMS & SUM Hospital, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Diptimayee', 'Initials': 'D', 'LastName': 'Mallik', 'Affiliation': 'Department of Anaesthesia and Critical Care, IMS & SUM Hospital, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Jayanti', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesia and Critical Care, IMS & SUM Hospital, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Khetan', 'Affiliation': 'Department of Anaesthesia and Critical Care, IMS & SUM Hospital, Bhubaneswar, Odisha, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_705_20']
572,33775464,Engaging Patients to Ask More Questions: What's the Best Way? A Pragmatic Randomized Controlled Trial.,"PURPOSE


Hand conditions are common, and often require a discussion of the tradeoffs of different treatment options. Our goal was to evaluate whether providing patients with a Question Prompt List (QPL) for common hand conditions improves their perceived involvement in care compared with providing patients with 3 generic questions.
METHODS


We performed a prospective, single-center, pragmatic randomized controlled trial. We created a QPL pamphlet for patients with common hand conditions. New patients with common hand conditions were enrolled between April 2019 and July 2019 and were randomized into either the QPL group (with 35 hand-specific questions) or the AskShareKnow group (3 generic questions: [1] What are my options? [2] What are the possible benefits and harms of those options? [3] How likely are each of these benefit and harms to happen to me?). Both groups received the questions prior to meeting with their surgeon. We used the Perceived Involvement in Care Scale (PICS), a validated instrument designed to evaluate patient participation in decision-making, as our primary outcome. The maximum PICS score is 13, and a higher score indicates higher perceived involvement.
RESULTS


One hundred twenty-six patients participated in the study, with 63 patients in the QPL group and 63 patients in the AskShareKnow group. The demographic characteristics were similar in the 2 groups. The mean AskShareKnow group PICS score was 8.3 ± 2.2 and the mean QPL PICS score was 7.5 ± 2.8, which was not deemed clinically significant.
CONCLUSIONS


The QPLs do not increase perceived involvement in care in patients with hand conditions compared with providing patients with 3 generic questions.
CLINICAL RELEVANCE


Various approaches have been evaluated to help improve patient involvement in their care. In hand surgery, 3 generic questions were no different than a lengthy QPL with respect to patient involvement in their care.",2021,"The QPLs do not increase perceived involvement in care in patients with hand conditions compared with providing patients with 3 generic questions.
","['One hundred twenty-six patients participated in the study, with 63 patients in the QPL group and 63 patients in the AskShareKnow group', 'New patients with common hand conditions were enrolled between April 2019 and July 2019', 'patients with common hand conditions']","['Question Prompt List (QPL', 'AskShareKnow group (3 generic questions: [1] What are my options', 'QPL', 'QPL pamphlet']","['mean AskShareKnow group PICS score', 'maximum PICS score', 'mean QPL PICS score']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",126.0,0.106286,"The QPLs do not increase perceived involvement in care in patients with hand conditions compared with providing patients with 3 generic questions.
","[{'ForeName': 'Allison K', 'Initials': 'AK', 'LastName': 'Roe', 'Affiliation': 'Department of Orthopaedic Surgery, VOICES Health Policy Research Center, Stanford University, Redwood City, CA.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Eppler', 'Affiliation': 'Department of Orthopaedic Surgery, VOICES Health Policy Research Center, Stanford University, Redwood City, CA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Shapiro', 'Affiliation': 'Department of Orthopaedic Surgery, VOICES Health Policy Research Center, Stanford University, Redwood City, CA.'}, {'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': 'Satteson', 'Affiliation': 'Department of Orthopaedic Surgery, VOICES Health Policy Research Center, Stanford University, Redwood City, CA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Department of Orthopaedic Surgery, VOICES Health Policy Research Center, Stanford University, Redwood City, CA.'}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Kamal', 'Affiliation': 'Department of Orthopaedic Surgery, VOICES Health Policy Research Center, Stanford University, Redwood City, CA. Electronic address: rnkamal@stanford.edu.'}]",The Journal of hand surgery,['10.1016/j.jhsa.2021.02.001']
573,33775433,[Physical exercise impact on variables related to emotional and functional well-being in older adults].,"BACKGROUND AND AIM


The benefits of the physical exercise in aging, and specially in frailty, have been associated with reduced risk of mortality, chronic disease, and cognitive and functional impairments. Multi-component training, which combines strength, endurance, balance, and gait training, represents the most beneficial kind of physical exercise in older adults.
METHODS


Given the effectiveness of the multi-component training, a physical exercise program «Actívate» (based on the methodology Vivifrail), with the focus on «active aging», was conducted in the present study. Forty-nine older adults over 60 years participated in this program.
RESULTS


The physical exercise intervention led to a reduction in diastolic blood pressure, pain threshold and sleep disturbances (e. g. hypersomnia) (t ≥ 2.72, p < 0.01), as well as an increase of walking speed (t = 7.84, p ≤ 0.001). Further, quality of life factors (GENCAT scale), like emotional well-being, personal development, physical well-being, self-determination, and social inclusion, were greater after intervention (t ≥ -2.06, p < 0.05).
CONCLUSIONS


These findings underline the benefits of multi-component training in functionality of older adults, and further, provide relevant aspects about the modulation of pain perception, sleep disturbances, social factors and physical and emotional well-being. Physical exercise programs such as «Actívate» should be promoted, in order to encourage healthy lifestyle habits, in the older adults' population.",2021,"The physical exercise intervention led to a reduction in diastolic blood pressure, pain threshold and sleep disturbances (e. g. hypersomnia) (t ≥ 2.72, p < 0.01), as well as an increase of walking speed (t = 7.84, p ≤ 0.001).","['older adults', 'Forty-nine older adults over 60 years participated in this program']","['Physical exercise', 'multi-component training, a physical exercise program «', 'Physical exercise programs', 'physical exercise intervention', 'multi-component training', 'Multi-component training', 'physical exercise']","['diastolic blood pressure, pain threshold and sleep disturbances (e. g. hypersomnia', 'walking speed', 'quality of life factors (GENCAT scale), like emotional well-being, personal development, physical well-being, self-determination, and social inclusion']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]",49.0,0.00463378,"The physical exercise intervention led to a reduction in diastolic blood pressure, pain threshold and sleep disturbances (e. g. hypersomnia) (t ≥ 2.72, p < 0.01), as well as an increase of walking speed (t = 7.84, p ≤ 0.001).","[{'ForeName': 'Saliha', 'Initials': 'S', 'LastName': 'Belmonte Darraz', 'Affiliation': 'Instituto de Investigación en Ciencias de la Salud (IUNICS) e Instituto de Investigación en Salud de las Islas Baleares (IdISBa), Universidad de las Islas Baleares (UIB), Palma, España; Área de Sanidad del Ayuntamiento de Palma de Mallorca, Palma, España.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'González-Roldán', 'Affiliation': 'Instituto de Investigación en Ciencias de la Salud (IUNICS) e Instituto de Investigación en Salud de las Islas Baleares (IdISBa), Universidad de las Islas Baleares (UIB), Palma, España.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'de María Arrebola', 'Affiliation': 'Área de Sanidad del Ayuntamiento de Palma de Mallorca, Palma, España.'}, {'ForeName': 'Casandra Isabel', 'Initials': 'CI', 'LastName': 'Montoro-Aguilar', 'Affiliation': 'Departamento de Psicología, Universidad de Jaén, Jaén, España. Electronic address: imontoro@ujaen.es.'}]",Revista espanola de geriatria y gerontologia,['10.1016/j.regg.2021.01.006']
574,33775312,Feasibility trial of metformin XR in people with pre-diabetes and stroke (MIPPS)-randomised open blinded endpoint controlled trial.,"AIMS


Pre-diabetes is a common condition that affects about 16.4% of Australian adults. Hyperglycaemia is a strong risk factor for the development of stroke. Metformin XR is an approved medication to treat type 2 diabetes in Australia but not pre-diabetes. Additionally, whether it is tolerated following a stroke is unclear. In this pilot study, we aimed to assess the feasibility of Metformin XR in people with stroke and pre-diabetes.
METHODS


In this PROBE design trial, people who had recent stroke (within 3 months) with pre-diabetes were randomized to either the active arm (n = 13) receiving usual care plus Metformin XR (500 mg daily increased to a total daily dose of 1500 mg) or the control group receiving only usual care (n = 13). At baseline & after four months of intervention, clinical and biomedical characteristics, cardiovascular risk factors and medication data were recorded. At one month and 2.5 months into the study, compliance rateandside effects were determined.
RESULTS


This trial showed that it is feasible to recruit, retain and monitor participants. However, the compliance rate was low. Adherence to metformin XR was 52% (IQR:42% to 61%) based on the remaining tablets in the container after 4 months of intervention. None of the reported side effects were deemed to be related to the study treatment and no significant differences were observed between the metformin XR and the control group.
CONCLUSION


Treatment with Metformin XR in participants admitted with stroke and with pre-diabetes is feasible and safe. Strategies are needed to improve adherence in future trials.",2021,"None of the reported side effects were deemed to be related to the study treatment and no significant differences were observed between the metformin XR and the control group.
","['people with stroke and pre-diabetes', 'people with pre-diabetes and stroke (MIPPS)-randomised', 'people who had recent stroke (within 3\xa0months) with pre-diabetes', 'participants admitted with stroke and with pre-diabetes']","['metformin XR', 'Metformin XR', 'control group receiving only usual care', 'usual care plus Metformin XR']","['compliance rateandside effects', 'compliance rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0712219,"None of the reported side effects were deemed to be related to the study treatment and no significant differences were observed between the metformin XR and the control group.
","[{'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Tabesh', 'Affiliation': 'Department of Medicine, Austin Health, University of Melbourne, Heidelberg, VIC, Australia.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Hachem', 'Affiliation': 'Department of Medicine, Austin Health, University of Melbourne, Heidelberg, VIC, Australia.'}, {'ForeName': 'Lik-Hui', 'Initials': 'LH', 'LastName': 'Lau', 'Affiliation': 'Austin Health, Endocrinology Unit, Heidelberg, VIC, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Borschmann', 'Affiliation': 'Department of Neurology, Austin Health, Heidelberg, VIC, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Department of Medicine, Austin Health, University of Melbourne, Heidelberg, VIC, Australia; Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Sarah A L', 'Initials': 'SAL', 'LastName': 'Price', 'Affiliation': 'Department of Medicine, Austin Health, University of Melbourne, Heidelberg, VIC, Australia.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Sumithran', 'Affiliation': 'Department of Medicine, Austin Health, University of Melbourne, Heidelberg, VIC, Australia; Department of Endocrinology, Austin Health, Heidelberg, VIC, Australia.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Donnan', 'Affiliation': 'Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zajac', 'Affiliation': 'Department of Medicine, Austin Health, University of Melbourne, Heidelberg, VIC, Australia; Department of Endocrinology, Austin Health, Heidelberg, VIC, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'The Florey Institute of Neuroscience & Mental Health University of Melbourne, Heidelberg, VIC, Australia; Department of Neurology, Austin Health, Heidelberg, VIC, Australia.'}, {'ForeName': 'Elif I', 'Initials': 'EI', 'LastName': 'Ekinci', 'Affiliation': 'Department of Medicine, Austin Health, University of Melbourne, Heidelberg, VIC, Australia; Department of Endocrinology, Austin Health, Heidelberg, VIC, Australia. Electronic address: elif.ekinci@unimelb.edu.au.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2021.01.006']
575,33775203,The effects of 12-months supervised periodized training on health-related physical fitness in coronary artery disease: a randomized controlled trial.,"We compared the impact of a one-year periodized exercise training versus a non-periodized exercise training on health-related physical fitness (HRPF) including body composition, cardiorespiratory and muscular fitness in patients with coronary artery disease (CAD). Fifty CAD patients (60.4 ± 9.9 years) were randomized to either a periodized training group (PG) (n = 25) or a non-periodized training group (NPG) (n = 25). Both consisted of a combined training programme, performed 3 days/week for 12 months. Thirty-six CAD patients (PG: n = 18, NPG: n = 18) successfully completed the exercise regimes. In both groups, a favourable main effect for time was evident for peak VO 2 , peak workload, anaerobic threshold and respiratory compensation point workloads and VO 2 , whole body skeletal muscle mass and quality index at 12 months.In conclusion, a periodized model is as effective as a non-periodized model in promoting increases in HRPF outcomes following a one-year intervention. These findings indicate that health-professionals can add variation to cardiac rehabilitation workouts without compromising effectiveness.",2021,"In conclusion, a periodized model is as effective as a non-periodized model in promoting increases in HRPF outcomes following a one-year intervention.","['Fifty CAD patients (60.4\xa0±\xa09.9\xa0years', 'patients with coronary artery disease (CAD', 'Thirty-six CAD patients (PG: n =\xa018, NPG: n =\xa018) successfully completed the exercise regimes', 'coronary artery disease']","['12-months supervised periodized training', 'periodized exercise training versus a non-periodized exercise training', 'periodized training group (PG) (n\xa0=\xa025) or a non-periodized training group (NPG']","['HRPF outcomes', 'peak VO 2 , peak workload, anaerobic threshold and respiratory compensation point workloads and VO 2 , whole body skeletal muscle mass and quality index', 'health-related physical fitness', 'health-related physical fitness (HRPF) including body composition, cardiorespiratory and muscular fitness']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0454291', 'cui_str': 'Exercise regime'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",50.0,0.0109503,"In conclusion, a periodized model is as effective as a non-periodized model in promoting increases in HRPF outcomes following a one-year intervention.","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'Serviço de Cardiologia, Departamento Coração E Vasos, Centro Hospitalar Universitário Lisboa Norte, CAML, CCUL, Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Melo', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Cruz Quebrada, Portugal.'}, {'ForeName': 'Vitor', 'Initials': 'V', 'LastName': 'Angarten', 'Affiliation': 'Faculdade de Motricidade Humana, Universidade de Lisboa, Cruz Quebrada, Portugal.'}, {'ForeName': 'Madalena Lemos', 'Initials': 'ML', 'LastName': 'Pires', 'Affiliation': 'Serviço de Cardiologia, Departamento Coração E Vasos, Centro Hospitalar Universitário Lisboa Norte, CAML, CCUL, Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Borges', 'Affiliation': 'Serviço de Cardiologia, Departamento Coração E Vasos, Centro Hospitalar Universitário Lisboa Norte, CAML, CCUL, Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Santos', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Cruz Quebrada, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Abreu', 'Affiliation': 'Serviço de Cardiologia, Departamento Coração E Vasos, Centro Hospitalar Universitário Lisboa Norte, CAML, CCUL, Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Santa-Clara', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Cruz Quebrada, Portugal.'}]",Journal of sports sciences,['10.1080/02640414.2021.1907062']
576,33779437,Cost-effectiveness of Guided Internet-Delivered Cognitive Behavioral Therapy in Comparison with Care-as-Usual for Patients with Insomnia in General Practice.,"Study objectives : Clinical guidelines recommend cognitive-behavioral therapy for insomnia (CBT-I) as first-line treatment. However, provision of CBT-I is limited due to insufficient time and expertise. Internet-delivered CBT-I might bridge this gap. This study aimed to estimate the cost-effectiveness of guided, internet-delivered CBT-I (i-Sleep) compared to care-as-usual for insomnia patients in general practice over 26 weeks from a societal perspective. Methods:  Primary outcomes were the Insomnia Severity Index (ISI, continuous score and clinically relevant response), and Quality-Adjusted Life Years (QALYs). Societal costs were assessed at baseline, and at 8 and 26 weeks. Missing data were imputed using multiple imputation. Statistical uncertainty around cost and effect differences was estimated using bootstrapping, and presented in cost-effectiveness planes and acceptability curves. Results:  The difference in societal costs between i-Sleep and care-as-usual was not statistically significant (-€318; 95% CI -1282 to 645). Cost-effectiveness analyses revealed a 95% probability of i-Sleep being cost-effective compared to care-as-usual at ceiling ratios of €450/extra point of improvement in ISI score and €7,000/additional response to treatment, respectively. Cost-utility analysis showed a 67% probability of cost-effectiveness for i-Sleep compared to care-as-usual at a ceiling ratio of 20,000 €/QALY gained. Conclusions:  The internet-delivered intervention may be considered cost-effective for insomnia severity in comparison with care-as-usual from the societal perspective. However, the improvement in insomnia severity symptoms did not result in similar improvements in QALYs.",2021,The difference in societal costs between i-Sleep and care-as-usual was not statistically significant (-€318; 95% CI -1282 to 645).,"['insomnia patients in general practice over 26\xa0weeks from a societal perspective', 'Patients with Insomnia in General Practice']","['guided, internet-delivered CBT-I (i-Sleep', 'Guided Internet-Delivered Cognitive Behavioral Therapy', 'cognitive-behavioral therapy']","['Insomnia Severity Index (ISI, continuous score and clinically relevant response), and Quality-Adjusted Life Years (QALYs', 'Societal costs', 'societal costs', 'ISI score', 'cost-effectiveness planes and acceptability curves', 'insomnia severity symptoms', 'Cost-effectiveness']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",,0.0232733,The difference in societal costs between i-Sleep and care-as-usual was not statistically significant (-€318; 95% CI -1282 to 645).,"[{'ForeName': 'Agni', 'Initials': 'A', 'LastName': 'Baka', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'van der Zweerde', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, & Amsterdam Public Health Research Institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Lancee', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'van Straten', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, & Amsterdam Public Health Research Institute, Vrije Universiteit, Amsterdam, The Netherlands.'}]",Behavioral sleep medicine,['10.1080/15402002.2021.1901708']
577,33779417,Effect of educative reminder telephone calls on human papillomavirus immunization rate: A randomized controlled trial.,"CONTEXT


Human papillomavirus coverage varies widely among women depending on their race, incomes, geographical location and education level.
OBJECTIVE


To evaluate whether reminder educative phone calls increase human papillomavirus vaccination rates in adult women aged 18-45 with high-risk factors of cervical cancer.
DESIGN


We conducted a single-blind randomized controlled trial in patients who consulted at a Canadian tertiary center in October 2019 during National Cervical Cancer Awareness Week.
INTERVENTIONS


We randomized women to receive three standardized educative phone calls or standard care.
MAIN OUTCOME MEASURE


We assessed the immunization rate at 6 months.
RESULTS


A total of 130 patients were randomized of which 62 patients were randomized to the intervention. Eight patients (15.4%) got immunized at 6 months in the intervention group as compared to seven (11.7%) in the control group (p = 0.5645). The main barrier to vaccination reported by non-immunized patients at 6 months was the cost of vaccination (42.3%).
CONCLUSION


Reminder educative phone calls did not increase human papillomavirus vaccination rates in adult women with risk factors of cervical cancer.ISRCTN registration number: ISRCTN58518971.",2021,"CONCLUSION


Reminder educative phone calls did not increase human papillomavirus vaccination rates in adult women with risk factors of cervical cancer.","['human papillomavirus immunization rate', 'adult women aged 18-45 with high-risk factors of cervical cancer', 'patients who consulted at a Canadian tertiary center in October 2019 during National Cervical Cancer Awareness Week', '130 patients were randomized of which 62 patients', 'adult women with risk factors of cervical cancer']","['reminder educative phone calls', 'educative reminder telephone calls', 'standardized educative phone calls or standard care']","['human papillomavirus vaccination rates', 'papillomavirus vaccination rates', 'immunization rate', 'cost of vaccination']","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0030358', 'cui_str': 'Genus Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",62.0,0.328981,"CONCLUSION


Reminder educative phone calls did not increase human papillomavirus vaccination rates in adult women with risk factors of cervical cancer.","[{'ForeName': 'Marie-Pier', 'Initials': 'MP', 'LastName': 'Bernard-Genest', 'Affiliation': 'Department of Obstetrics & Gynaecology, Division of Gynecologic Oncology, Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ruel-Laliberté', 'Affiliation': 'Department of Obstetrics & Gynaecology, Division of Gynecologic Oncology, Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Korine', 'Initials': 'K', 'LastName': 'Lapointe-Milot', 'Affiliation': 'Department of Obstetrics & Gynaecology, Division of Gynecologic Oncology, Université de Sherbrooke, Sherbrooke, QC, Canada.'}]","Women's health (London, England)",['10.1177/17455065211003821']
578,33779376,Effects of hydrocortisone and yohimbine on selective attention to emotional cues.,"INTRODUCTION


Facial expressions contain important affective information, and selective attention to facial expression provides an advantage in the face of loss, stress and danger. In addition, the sympathetic nervous system and hypothalamus-pituitary-adrenal axis mediate the organism's response to loss and danger. Here, we aimed at investigating the influence of sympathetic nervous system and hypothalamus-pituitary-adrenal axis activation on selective attention to affective facial stimuli.
METHODS AND MATERIALS


One hundred-and-four healthy men between 18-35 years old (mean (standard deviation) age: 24.1 (3.5) years) participated in the study. We used a randomised, double-blind, placebo-controlled design. Participants received either: (a) yohimbine, (b) hydrocortisone, (c) yohimbine and hydrocortisone or (d) placebo only and participated in a dot-probe task with sad, happy and neutral faces. We collected salivary samples to measure cortisol and alpha amylase activity in addition to measurements of blood pressure and heart rate. Salivary cortisol served as correlate of hypothalamus-pituitary-adrenal axis activation and salivary alpha amylase activity, blood pressure and heart rate as correlates of sympathetic nervous system activation. Measurements were carried out before and after drug administration.
RESULTS


We did not find a main effect or interaction effect of hydrocortisone or yohimbine administration on selective attention to happy faces. However, we found an interaction of yohimbine and hydrocortisone on selective attention to sad faces. Post-hoc  t -test revealed an attentional bias away from sad stimuli and towards neutral faces in the hydrocortisone-only group.
DISCUSSION


Only hydrocortisone administration led to an attentional bias away from sad faces. Future studies should investigate these effects in major depression disorder, as this disorder is characterised by glucocorticoid resistance and increased processing of sad stimuli.",2021,We did not find a main effect or interaction effect of hydrocortisone or yohimbine administration on selective attention to happy faces.,['One hundred-and-four healthy men between 18-35\u2009years old (mean (standard deviation) age: 24.1 (3.5) years) participated in the study'],"['yohimbine, (b) hydrocortisone, (c) yohimbine and hydrocortisone or (d) placebo only and participated in a dot-probe task with sad, happy and neutral faces', 'hydrocortisone or yohimbine', 'placebo', 'hypothalamus-pituitary-adrenal axis activation', 'hydrocortisone', 'hydrocortisone and yohimbine', 'yohimbine and hydrocortisone']","['selective attention to emotional cues', 'hypothalamus-pituitary-adrenal axis activation and salivary alpha amylase activity, blood pressure and heart rate', 'selective attention to happy faces', 'attentional bias away from sad faces', 'selective attention to sad faces', 'blood pressure and heart rate', 'attentional bias away from sad stimuli and towards neutral faces']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}]","[{'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",104.0,0.278918,We did not find a main effect or interaction effect of hydrocortisone or yohimbine administration on selective attention to happy faces.,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Woo R', 'Initials': 'WR', 'LastName': 'Chae', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Christian E', 'Initials': 'CE', 'LastName': 'Deuter', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881121997100']
579,33779288,Plasma kinetic enucleation vs holmium laser enucleation for treating benign prostatic hyperplasia: a randomized controlled trial with a 3-year follow-up.,"PURPOSE


To compare the efficacy and safety of plasma kinetic enucleation of the prostate (PKEP) with holmium laser enucleation of the prostate (HoLEP) for treatment of benign prostatic hyperplasia (BPH).
METHODS


A total of 160 patients with indications for the surgical treatment of BPH were randomly assigned to receive either PKEP or HoLEP prospectively. Baseline characteristics, perioperative data, and postoperative outcomes of the patients were recorded. 126 (78.75%) patients (PKEP 64 vs HoLEP 62) completed the 3-year follow-up assessment.
RESULTS


Patients in both groups had similar baseline characteristics. Compared with PKEP, HoLEP was associated with shorter operative time as well as take-out time, lower perioperative hemoglobin decrease, shorter bladder irrigation time, catheterization time, and hospital stay time. PKEP was superior to HoLEP in terms of the noise of the machine and hospitalization expenses. There were no significant differences in enucleating time, resected weight, and serum sodium levels. Both groups achieved satisfactory results and maintained improvement from baseline in terms of Qmax, IPSS, QoL, and PVR at 3-year follow-up, with no significant differences between the two procedures. Except for re-catheterization rate, postoperative data such as TRUS volume, IIEF-5, and follow-up scores of the flexible cystourethroscopy results (FC), as well as the acute and mid-to long-term complications after surgery, were statistically similar.
CONCLUSION


The 3-year follow-up data of this randomized trial confirmed that both PKEP and HoLEP were effective and safe surgical procedures for the transurethral management of BPH. HoLEP presented certain advantages compared to PKEP, such as reduced operative duration, decreased risk of blood loss and less bladder irrigation, hospital stay time, and re-catheterization rate, while PKEP had lower noise and no additional laser cost.",2021,"Both groups achieved satisfactory results and maintained improvement from baseline in terms of Qmax, IPSS, QoL, and PVR at 3-year follow-up, with no significant differences between the two procedures.","['160 patients with indications for the surgical treatment of BPH', 'benign prostatic hyperplasia (BPH', 'treating benign prostatic hyperplasia']","['plasma kinetic enucleation of the prostate (PKEP', 'PKEP and HoLEP', 'holmium laser enucleation of the prostate (HoLEP', 'PKEP', 'Plasma kinetic enucleation vs holmium laser enucleation', 'PKEP or HoLEP', 'PKEP, HoLEP']","['shorter operative time as well as take-out time, lower perioperative hemoglobin decrease, shorter bladder irrigation time, catheterization time, and hospital stay time', 'Baseline characteristics, perioperative data, and postoperative outcomes', 'enucleating time, resected weight, and serum sodium levels', 'Qmax, IPSS, QoL, and PVR', 'operative duration, decreased risk of blood loss and less bladder irrigation, hospital stay time, and re-catheterization rate, while PKEP had lower noise and no additional laser cost']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0194423', 'cui_str': 'Irrigation of urinary bladder'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",160.0,0.0306437,"Both groups achieved satisfactory results and maintained improvement from baseline in terms of Qmax, IPSS, QoL, and PVR at 3-year follow-up, with no significant differences between the two procedures.","[{'ForeName': 'Ziwei', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Shanghai 9th Peoples Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 56695, Urology, Shanghai, Shanghai, China; weiziwei2018@126.com.'}, {'ForeName': 'Yucheng', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Shanghai 9th Peoples Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 56695, Urology, Shanghai, Shanghai, China; taoyuchengmed@126.com.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': 'Shanghai 9th Peoples Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 56695, Urology, Shanghai, Shanghai, China; GMgumeng@126.com.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Shanghai 9th Peoples Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 56695, Urology, Shanghai, Shanghai, China; liuchong90@163.com.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Shanghai 9th Peoples Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 56695, Urology, Shanghai, Shanghai, China; qiqi_chenqi@163.com.'}, {'ForeName': 'Zhikang', 'Initials': 'Z', 'LastName': 'Cai', 'Affiliation': 'Shanghai 9th Peoples Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 56695, Urology, Shanghai, Shanghai, China; czx19650228@sina.com.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Shanghai 9th Peoples Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 56695, Urology, Shanghai, Shanghai, China; fantasy_cyb@msn.com.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Shanghai 9th Peoples Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 56695, Urology, Shanghai, Shanghai, China; zhongwang2000@sina.com.'}]",Journal of endourology,['10.1089/end.2021.0086']
580,33778945,"Effects of methylphenidate on executive functioning in children and adolescents with ADHD after long-term use: a randomized, placebo-controlled discontinuation study.","BACKGROUND


Methylphenidate may improve executive functioning in children with attention-deficit/hyperactivity disorder (ADHD). However, it is unclear if there are still acute effects of methylphenidate on executive functioning after long-term use.
METHODS


In a randomized double-blind, placebo-controlled discontinuation study, 94 children and adolescents (ages 8-18 years) who used methylphenidate beyond two years were either assigned to seven weeks of continued treatment with 36 or 54 mg of extended-release methylphenidate or to gradual withdrawal over three weeks to placebo for four weeks. Performance on neuropsychological tasks, measuring working memory, response inhibition, attentional flexibility and psychomotor speed was compared between both groups using mixed models for repeated measures. Additionally, we investigated within the discontinuation group if a deterioration on the investigator-rated Clinical Global Impressions Improvement scale after withdrawing to placebo was related to a worse performance on the neuropsychological tasks. This study was registered in the Netherlands Trial Register (www. Trialregister.nl) with identifier 5252.
RESULTS


After withdrawal of methylphenidate, the discontinuation group made more errors on working memory (β = -1.62, SD = 0.56, t = -2.88, p = .01, Cohen's f2 = .14), independent from reaction time compared to baseline, in contrast to the continuation group. We did not find differences in changes in response inhibition, attentional flexibility and psychomotor speed between the two groups. Also, there were no significant differences in task measures between the participants who deteriorated clinically and those who did not.
CONCLUSIONS


Our study shows that methylphenidate has a beneficial effect on working memory after two years of use. Future studies should explore whether cognitive outcomes may aid clinical decision-making on the continued use of methylphenidate, given dissociation between cognitive and behavioural effects of stimulant medication.",2021,"Performance on neuropsychological tasks, measuring working memory, response inhibition, attentional flexibility and psychomotor speed was compared between both groups using mixed models for repeated measures.","['children with attention-deficit/hyperactivity disorder (ADHD', '94 children and adolescents (ages 8-18\xa0years) who used methylphenidate beyond two years', 'Netherlands Trial Register (www. Trialregister.nl) with identifier 5252', 'children and adolescents with ADHD after long-term use']","['placebo', 'methylphenidate', 'Methylphenidate']","['response inhibition, attentional flexibility and psychomotor speed', 'investigator-rated Clinical Global Impressions Improvement scale', 'neuropsychological tasks, measuring working memory, response inhibition, attentional flexibility and psychomotor speed', 'errors on working memory (β\xa0', 'executive functioning', 'task measures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",94.0,0.222612,"Performance on neuropsychological tasks, measuring working memory, response inhibition, attentional flexibility and psychomotor speed was compared between both groups using mixed models for repeated measures.","[{'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Rosenau', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Thaïra J C', 'Initials': 'TJC', 'LastName': 'Openneer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Anne-Flore M', 'Initials': 'AM', 'LastName': 'Matthijssen', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gigi H H', 'Initials': 'GHH', 'LastName': 'van de Loo-Neus', 'Affiliation': 'Karakter Child and Adolescent Psychiatry Center Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Buitelaar', 'Affiliation': 'Karakter Child and Adolescent Psychiatry Center Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'van den Hoofdakker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Dietrich', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13419']
581,33778937,Glutamate receptor antagonist suppresses the activation of nesfatin-1 neurons following refeeding or glucose administration.,"BACKGROUND


Nesfatin-1 is a newly identified satiety peptide that has regulatory effects on food intake and glucose metabolism, and is located in the hypothalamic nuclei, including the supraoptic nucleus (SON). In this study, we have investigated the hypothesis that nesfatin-1 neurons are activated by refeeding and intraperitoneal (ip) glucose injection and that the glutamatergic system has regulatory influences on nesfatin-1 neurons in the SON.
MATERIALS AND METHODS


The first set of experiments analyzed activation of nesfatin-1 neurons after refeeding as a physiological stimulus and the effectiveness of the glutamatergic system on this physiological stimulation. The subjects were randomly divided into three groups: fasting group, refeeding group and antagonist (CNQX+refeeding) group. The second set of experiments analyzed activation of nesfatin-1 neurons by glucose injection as a metabolic stimulus and the effectiveness of the glutamatergic system on this metabolic stimulation. The subjects were randomly divided into three groups: saline group, glucose group and antagonist (CNQX+glucose) group.
RESULTS


Refeeding significantly increased the number of activated nesfatin-1 neurons by approximately 66%, and intraperitoneal glucose injection activated these neurons by about 55%, compared to the fasting and saline controls. The injections of glutamate antagonist (CNQX) greatly decreased the number of activated nesfatin-1 neurons.
CONCLUSIONS


This study suggested that nesfatin-1 neurons were activated by peripheral and/or metabolic signals and that this effect was mediated through the glutamatergic system.",2021,"RESULTS


Refeeding significantly increased the number of activated nesfatin-1 neurons by approximately 66%, and intraperitoneal glucose injection activated these neurons by about 55%, compared to the fasting and saline controls.",[],"['glutamate antagonist (CNQX', 'fasting group, refeeding group and antagonist (CNQX+refeeding', 'saline group, glucose group and antagonist (CNQX+glucose) group']",['number of activated nesfatin-1 neurons'],[],"[{'cui': 'C0242910', 'cui_str': 'Glutamate receptor antagonist'}, {'cui': 'C0099122', 'cui_str': '6-Cyano-2,3-dihydroxy-7-nitroquinoxaline'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027882', 'cui_str': 'Neuron'}]",,0.0419127,"RESULTS


Refeeding significantly increased the number of activated nesfatin-1 neurons by approximately 66%, and intraperitoneal glucose injection activated these neurons by about 55%, compared to the fasting and saline controls.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Serter Kocoglu', 'Affiliation': 'Department of Histology and Embryology, Balikesir University School of Medicine, Balikesir, Turkey. serter_bio@hotmail.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Oy', 'Affiliation': 'Department of Histology and Embryology, Bursa Uludag University School of Medicine, Bursa, Turkey.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Uygul', 'Affiliation': 'Department of Histology and Embryology, Bursa Uludag University School of Medicine, Bursa, Turkey.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cakir', 'Affiliation': 'Department of Histology and Embryology, Bursa Uludag University School of Medicine, Bursa, Turkey.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Minbay', 'Affiliation': 'Department of Histology and Embryology, Bursa Uludag University School of Medicine, Bursa, Turkey.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Eyigor', 'Affiliation': 'Department of Histology and Embryology, Bursa Uludag University School of Medicine, Bursa, Turkey.'}]",Folia morphologica,['10.5603/FM.a2021.0034']
582,33778934,Effects of Renal Impairment on the Pharmacokinetics of the Dual GIP and GLP-1 Receptor Agonist Tirzepatide.,"BACKGROUND AND AIMS


The pharmacokinetics (PK) and single-dose tolerability of tirzepatide, a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist being developed for once-weekly treatment of type 2 diabetes (T2D), weight management, and nonalcoholic steatohepatitis, was evaluated in subjects with renal impairment versus healthy subjects with normal renal function.
METHODS


Forty-five subjects, categorized by baseline renal status, i.e. mild (n = 8, estimated glomerular filtration rate [eGFR] 60-89 mL/min/1.73m 2 ), moderate (n = 8, eGFR 30-59 mL/min/1.73m 2 ), severe renal impairment (n = 7, eGFR < 30 mL/min/1.73m 2 ), end-stage renal disease requiring dialysis (n = 8), and normal renal function (n = 14, eGFR ≥ 90 mL/min/1.73m 2 ), received a single subcutaneous dose of tirzepatide 5 mg. Tirzepatide plasma concentrations up to 648 h postdose were measured to compute PK parameters. The primary analysis evaluated the ratios of area under the plasma concentration-time curves (AUCs) and maximum plasma drug concentration (C max ) of renal impairment versus the normal renal function group (90% confidence interval [CI]). In addition, the relationship between PK parameters and continuous variables of renal function was assessed by linear regression.
RESULTS


Tirzepatide exposure was similar across renal impairment groups and healthy subjects. The 90% CI of ratios of AUCs and C max  comparing each renal impairment group versus normal renal function spanned unity, except for a 25-29% increase in AUCs in the moderate renal impairment group. There was no significant relationship between tirzepatide exposure and eGFR. Few adverse events were reported across the renal impairment and normal renal function groups. The majority were mild in severity and of a gastrointestinal nature in the renal impairment groups.
CONCLUSION


There were no clinically relevant effects of renal impairment on tirzepatide PK. Dose adjustment may not be required for patients with renal impairment.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT03482024.",2021,There were no clinically relevant effects of renal impairment on tirzepatide PK.,"['patients with renal impairment', 'subjects with renal impairment versus healthy subjects with normal renal function', 'type 2 diabetes ', 'Forty-five subjects, categorized by baseline renal status, i.e. mild (n\xa0=\xa08, estimated glomerular filtration rate [eGFR] 60-89 mL/min/1.73m 2 ), moderate (n\xa0=\xa08, eGFR 30-59']",['tirzepatide 5\xa0mg'],"['severe renal impairment', 'Tirzepatide plasma concentrations', 'tirzepatide exposure and eGFR', 'T2D), weight management, and nonalcoholic steatohepatitis', 'normal renal function', 'renal function', 'ratios of area under the plasma concentration-time curves (AUCs) and maximum plasma drug concentration (C max ) of renal impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.0139512,There were no clinically relevant effects of renal impairment on tirzepatide PK.,"[{'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Urva', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. urva_shweta@lilly.com.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Quinlan', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Landry', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Loghin', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-021-01012-2']
583,33778929,"Comparable Pharmacokinetics, Safety, and Tolerability of Etrolizumab Administered by Prefilled Syringe or Autoinjector in a Randomized Trial in Healthy Volunteers.","INTRODUCTION


Etrolizumab is a novel, dual-action anti-β7 integrin antibody studied in phase 3 trials in patients with inflammatory bowel disease. An autoinjector (AI) is being developed in parallel to complement the prefilled syringe with needle safety device (PFS-NSD) for subcutaneous (SC) administration in these trials. Here we demonstrate the comparable pharmacokinetics, tolerability, and safety of both devices.
METHODS


This randomized, open-label, two-part study in healthy participants evaluated the comparability of etrolizumab exposure between the AI and the PFS-NSD. Part 1 (pilot) involved a small number of participants, and initial results were used to finalize the design of the larger part 2 (pivotal) study. In both parts, participants were randomly assigned to receive a single SC dose of etrolizumab 105 mg by AI or PFS-NSD. Randomization was stratified by body weight. Primary pharmacokinetic outcomes were C max , AUC last , and AUC 0-inf .
RESULTS


One hundred and eighty healthy participants (part 1, n = 30; part 2, n = 150) received a single SC dose of etrolizumab by AI or PFS-NSD. Primary pharmacokinetic results from part 1 supported modification of the part 2 study design. Results from part 2 demonstrated that etrolizumab exposure was equivalent between devices, with geometric mean ratios (GMRs) between AI and PFS-NSD of 102% (90% confidence interval [CI] 94.2-111) for C max , 98.0% (90% CI 89.3-107) for AUC last , and 97.6% (90% CI 88.6-107) for AUC 0-inf . Median t max  and mean terminal t 1/2  were also similar between devices. GMRs and 90% CIs of all primary pharmacokinetic parameters were fully contained within the predefined equivalence limits (80-125%).
CONCLUSION


This pharmacokinetic study demonstrated that single SC injections of etrolizumab 105 mg using an AI or a PFS-NSD resulted in equivalent etrolizumab exposure and similar safety and tolerability in healthy participants. Taken together, these results support the use of an AI for etrolizumab administration.
TRIAL REGISTRATION


NCT02996019.",2021,"GMRs and 90% CIs of all primary pharmacokinetic parameters were fully contained within the predefined equivalence limits (80-125%).
","['patients with inflammatory bowel disease', 'One hundred and eighty healthy participants (part\xa01, n\u2009=\u200930; part\xa02, n\u2009=\u2009150', 'healthy participants', 'Healthy Volunteers']","['etrolizumab by AI or PFS-NSD', 'Etrolizumab Administered by Prefilled Syringe or Autoinjector', 'etrolizumab', 'etrolizumab 105\xa0mg by AI or PFS-NSD']","['geometric mean ratios (GMRs', 'Median t max  and mean terminal t 1/2', 'pharmacokinetics, tolerability, and safety', 'Pharmacokinetics, Safety, and Tolerability', 'safety and tolerability', 'C max , AUC last , and AUC 0-inf ', 'etrolizumab exposure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C3177463', 'cui_str': 'rhuMAb Beta7'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0033612', 'cui_str': 'Protective device'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C3177463', 'cui_str': 'rhuMAb Beta7'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",180.0,0.127297,"GMRs and 90% CIs of all primary pharmacokinetic parameters were fully contained within the predefined equivalence limits (80-125%).
","[{'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA. zhang.wenhui@gene.com.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tyrrell', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Han Ting', 'Initials': 'HT', 'LastName': 'Ding', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pulley', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Boruvka', 'Affiliation': 'Hoffmann-La Roche Limited, Mississauga, ON, Canada.'}, {'ForeName': 'Rich', 'Initials': 'R', 'LastName': 'Erickson', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Abouhossein', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Ravanello', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Meina Tao', 'Initials': 'MT', 'LastName': 'Tang', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}]",Advances in therapy,['10.1007/s12325-021-01661-6']
584,33778830,[Differences of bone augmentation in patients with different bone defects by extraction site preservation].,"PURPOSE


To explore the difference of bone augmentation in patients with different bone defects by extraction site preservation.
METHODS


From January 2017 to June 2019, 85 patients with dental implants treated in Hefei Second People's Hospital were enrolled and divided into the experimental group (43 cases) and the control group (42 cases) according to random number table method. Patients in the experimental group received extraction site preservation, while patients in the control group underwent routine tooth extraction. The two groups were further divided into one-wall group (remaining one wall of the alveolar socket after surgery), two-wall group (remaining two walls), three-wall group (remaining three wall), and four-wall group (remaining four walls). Postoperative pain, wound healing, and infection were recorded. Cone-beam CT (CBCT) was performed immediately and 6 months after surgery to detect alveolar bone height, bone width, bone width recovery rate, etc. SPSS 22.0 software package was used for statistical analysis.
RESULTS


There was no significant difference in pain between the two groups after 24 hours (P>0.05). All implants healed well after 7 days, and no wound infection or bone infection occurred 6 months after operation. There was no significant difference in buccal bone volume of alveolar ridge (BV) and lingual volume (LV) before surgery between the two groups (P>0.05). BV and LV in the experimental group increased after treatment, and the increase in one- and two-wall subgroups was significantly higher than that in three- and four-wall subgroups. BV and LV in the control group decreased, the differences between the subgroups were statistically significant (P<0.05). BV and LV increased in both groups after operation, but significantly higher in the experimental group than in the control group. The increase in bone height in one- and two-wall subgroups was significantly higher than that in three- and four-wall groups (P<0.05). Bone width of all subgroups in the experimental group increased, but decreased in the control group. The increase of bone width in the experimental group was significantly different from the control group(P<0.05). In the experimental group, the increase in bone width in one- and two-wall groups was significantly higher than that in three-wall group, and the decrease in bone width in one- and two-wall group in the control group was significantly less than that in three- and four-wall group(P<0.05). The average recovery rate of bone width in the experimental group was significantly higher than that in the control group. The average recovery rate of bone width in one- and two-wall group in the experimental group was significantly higher than that in the control group(P<0.05), while there was no significant difference in the recovery rate from the control group(P>0.05). The change of bone width at 70% of root length in the same group was significantly smaller than that at 50% and 30% of root length (P<0.05).
CONCLUSIONS


Extraction site preservation after tooth extraction can relieve alveolar bone resorption and maintain bone mass in contrast to conventional tooth extraction. The smaller the bone defect, the better the bone mass recovery effect.",2020,The increase of bone width in the experimental group was significantly different from the control group(P<0.05).,"[""From January 2017 to June 2019, 85 patients with dental implants treated in Hefei Second People's Hospital"", 'patients with different bone defects by extraction site preservation']","['routine tooth extraction', 'Cone-beam CT', 'extraction site preservation']","['buccal bone volume of alveolar ridge (BV) and lingual volume (LV', 'change of bone width', 'wound infection or bone infection', 'recovery rate', 'pain', 'bone width', 'BV and LV', 'Bone width', 'Postoperative pain, wound healing, and infection', 'average recovery rate of bone width', 'alveolar bone resorption and maintain bone mass', 'bone height']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C2242472', 'cui_str': 'Infection of bone'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C3805122', 'cui_str': 'Alveolar bone resorption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",85.0,0.0136491,The increase of bone width in the experimental group was significantly different from the control group(P<0.05).,"[{'ForeName': 'Ji-Wen', 'Initials': 'JW', 'LastName': 'Xiong', 'Affiliation': ""Department of Stomatology, Hefei Second People's Hospital. Hefei 230011, Anhui Province, China. E-mail:jlplzj@163.com.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
585,33778824,[Application of different surface treatment methods in teeth restoration with nano composite resin].,"PURPOSE


To investigate the effects of different surface treatments and adhesive self-etch functional monomers on the immediate repair bond strength and integrity of the repaired resin composite interface.
METHODS


Ninety-eight resin composite blocks made of a nanohybrid resin composite were randomly divided into seven groups, each with 14 blocks, including positive control group: non-conditioned surface, Group A1: Gluma Comfort Bond, Group A2: Gluma Comfort Bond and sandblasting, Group B1: Tokuyama Bond Force IITM adhesive system, Group B2: Tokuyama Bond Force IITM adhesive system and sandblasting, Group C: polishing, and Group D: sandblasting. Resin composite identical to the substrate was applied and the repaired specimens were subjected to shear bond strength (SBS) testing. Representative samples from all groups received scanning electron microscopy and surface profilometry to determine their mode of failure. The data were processed with SPSS 20.0 software package.
RESULTS


SBS of Group D was significantly higher than that of positive control group (P<0.05). SBS of Group A1, A2, B1 and B2 was significantly higher than that of Group C and D (P<0.05). Comparison of SBS among Group B1, D and A1 showed no significant difference(P>0.05). SBS between Group B2 and positive control group had no significant difference(P>0.05). Except specimens with sandblasting and the use of TBF II system, SBS of positive control group was significantly higher than that of Group A1 and C(P<0.05). The polished specimens had significantly more adhesive failures than those with sandblasted surfaces (P<0.05). Specimens treated with polishing and Gluma Comfort Bond showed significantly more adhesive failures than those treated with polishing and TBF II system (P<0.05). The sandblasted surfaces conditioned with TBF II showed significantly more cohesive failures than those treated with polishing and TBF II (P<0.05). The sandblasted specimens provided significantly more irregular and rougher surface finish than the polishing technique (P<0.05).
CONCLUSIONS


Sandblasting of the composite substrate and the use of TBF II adhesive system shows the highest repair bond strength, higher adhesive interfacial failures and fewer cohesive failures; however, it is noteworthy that the composite substrate types yield statistically higher food residue rate, which results in poor oral hygiene maintenance. Therefore, the application of this repair protocol should match up with correct oral health behaviors.",2020,The polished specimens had significantly more adhesive failures than those with sandblasted surfaces (P<0.05).,"['teeth restoration with nano composite resin', 'Ninety-eight resin composite blocks made of a nanohybrid resin composite']","['positive control group: non-conditioned surface, Group A1: Gluma Comfort Bond, Group A2: Gluma Comfort Bond and sandblasting, Group B1: Tokuyama Bond Force IITM adhesive system, Group B2: Tokuyama Bond Force', 'scanning electron microscopy']","['cohesive failures', 'adhesive failures', 'SBS']","[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1100912', 'cui_str': 'Gluma Comfort Bond'}, {'cui': 'C4077195', 'cui_str': 'Bond Force dental cement'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",,0.030282,The polished specimens had significantly more adhesive failures than those with sandblasted surfaces (P<0.05).,"[{'ForeName': 'Yuan-Hui', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': ""Department of Stomatology,Haikou Third People's Hospital.Haikou 571100, Hainan Province, China. E-mail:chang1yhua@163.com.""}, {'ForeName': 'Kong-Cai', 'Initials': 'KC', 'LastName': 'Xing', 'Affiliation': ''}, {'ForeName': 'Yi-Ting', 'Initials': 'YT', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tao', 'Affiliation': ''}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
586,33778468,Considerations for Implementation of an Ankle-Foot Orthosis to Improve Mobility in Peripheral Artery Disease.,"Objective


To explore the perceptions of wearing an ankle-foot orthosis (AFO) in patients with peripheral artery disease (PAD) who did and did not adopt the AFO intervention. This follows a clinical trial of the effectiveness of an AFO in improving walking distances for patients with PAD-related claudication.
Design


A randomized crossover trial of standard of care and an AFO for 3 months. Semistructured interviews were conducted 1.5 months into the AFO intervention to understand acceptability, demand, implementation, and practicality. Data were analyzed using a summative content analysis approach.
Setting


Vascular surgery clinic and biomechanics research laboratory.
Participants


Patients (N=15; male, 100%; age, 71.9±.6.7y; body mass index [calculated as weight in kilograms divided by height in meters squared], 29.0±.5.5; ankle brachial index: AFO intervention withdrawal, 0.543; AFO intervention completion, 0.740) with claudication completed the study, and 6 withdrew prior to intervention completion.
Interventions


A certified orthotist fit participants with an AFO that was worn for 3 months.
Main Outcome Measures


Qualitative analysis of the semistructured interviews.
Results


Key differences were reported between AFO intervention completion and AFO intervention withdrawal. Six of 14 of AFO intervention completion participants described their initial reactions to the AFO as negative vs 3 of 6 AFO intervention withdrawal participants. Only 5 of 15 AFO intervention completion participants reported minimal use of the AFO compared with 5 of 6 AFO intervention withdrawal participants. The AFO intervention withdrawal group reported higher levels of physical discomfort with the use of the AFO (4/6 vs 7/15) and preexisting health issues becoming a barrier to the use of the AFO (3/6 vs 5/15). Positive aspects reported included ease in standing and walking for AFO intervention withdrawal (4/6) and AFO intervention completion groups (13/15) as well as walking straighter and longer with less pain for AFO intervention withdrawal (3/6) and AFO intervention completion groups (9/15).
Conclusions


Patients withdrawing prior to completion of AFO intervention tended to have more negative perceptions, more comorbidities, and more physical discomfort than those completing the intervention. Both groups reported positive aspects of the AFO. Implementation studies are needed to address barriers to AFO adoption.",2021,Only 5 of 15 AFO intervention completion participants reported minimal use of the AFO compared with 5 of 6 AFO intervention withdrawal participants.,"['patients with PAD-related claudication', 'patients with peripheral artery disease (PAD) who did and did not adopt the AFO intervention', 'Participants\n\n\nPatients (N=15; male, 100%; age, 71.9±.6.7y; body mass index [calculated as weight in kilograms divided by height in meters squared], 29.0±.5.5; ankle brachial index: AFO intervention withdrawal, 0.543; AFO intervention completion, 0.740) with claudication completed the study, and 6 withdrew prior to intervention completion']","['AFO intervention', 'AFO', 'wearing an ankle-foot orthosis (AFO']","['walking distances', 'initial reactions to the AFO', 'minimal use of the AFO', 'physical discomfort']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1283250', 'cui_str': 'Foot orthosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1283250', 'cui_str': 'Foot orthosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1283250', 'cui_str': 'Foot orthosis'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.0336343,Only 5 of 15 AFO intervention completion participants reported minimal use of the AFO compared with 5 of 6 AFO intervention withdrawal participants.,"[{'ForeName': 'Ayisha Z', 'Initials': 'AZ', 'LastName': 'Bashir', 'Affiliation': 'Department of Biomechanics, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Danae M', 'Initials': 'DM', 'LastName': 'Dinkel', 'Affiliation': 'Department of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Ganesh M', 'Initials': 'GM', 'LastName': 'Bapat', 'Affiliation': 'Department of Biomechanics, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Despiegelaere', 'Affiliation': 'Department of Surgery and Research Service, Omaha VA Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Hassan', 'Affiliation': 'Department of Biomechanics, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Johanning', 'Affiliation': 'Department of Surgery and Research Service, Omaha VA Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Iraklis I', 'Initials': 'II', 'LastName': 'Pipinos', 'Affiliation': 'Department of Surgery and Research Service, Omaha VA Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Myers', 'Affiliation': 'Department of Biomechanics, University of Nebraska at Omaha, Omaha, Nebraska.'}]",Archives of rehabilitation research and clinical translation,['10.1016/j.arrct.2020.100092']
587,33778462,Case study of a critically ill person with COVID-19 on ECMO successfully treated with leronlimab.,"The number of confirmed cases of infection with SARS-CoV-2, the virus causing Coronavirus disease 2019 (COVID-19), continues to increase and is associated with substantial morbidity and mortality in virtually every country in the world. Although in the long-term mass vaccinations remains the most promising approach to control the pandemic, evidence suggests that new variants of the virus have emerged that may be able to evade the immune responses triggered by current vaccines. Therefore despite the recent approval of a number of SARS-CoV-2 vaccines there remains considerable urgency for effective treatments for COVID-19. Severe-to-critical COVID-19 has been shown to be associated with a dysregulated host immune response to SARS-CoV-2 with elevated levels of C-C chemokine receptor type 5 (CCR5) ligands including chemokine C-C ligands 3, 4, 5, as well as interleukins 6 and 10. Leronlimab, a CCR5-specific humanised IgG4 monoclonal antibody originally developed for the treatment of HIV has been studied for the treatment of COVID-19. In the TEMPEST trial which compared leronlimab to placebo in subjects with mild-to-moderate COVID-19, a  post hoc  analysis showed that leronlimab led to improvements from baseline in National Early Warning Score 2 (NEWS2) at Day 14 in the sub-set of people with more severe disease. Data has also been released on a further ongoing, randomized, placebo-controlled phase 3 registrational trial of leronlimab in 394 people with severe-to-critical COVID-19. The results show that Day 28 mortality was reduced (P=0.0319) in the subset of participants receiving leronlimab plus other pre-specified commonly used COVID-19 treatments including dexamethasone administered as part of their standard of care (SOC) compared to participants receiving placebo plus other pre-specified commonly used COVID-19 treatments including dexamethasone as part of their SOC. Several cases have recently been reported demonstrated that treatment with leronlimab restores immune function and achieves clinical improvement in people with critical COVID-19. Here we report on a further case of a critically ill person who was treated with leronlimab. This person had been on extracorporeal membrane oxygenation (ECMO) for an extended period of time before receiving 4 doses of leronlimab. The male subject received his first dose of leronlimab on Day 79 of hospitalization he was weaned off ECMO by Day 84 and discharged from the ECMO intensive care unit on Day 91. He continues to improve and is currently in rehabilitation.",2021,The results show that Day 28 mortality was reduced (P=0.0319) in the subset of participants receiving leronlimab plus other pre-specified commonly used COVID-19 treatments including dexamethasone administered as part of their standard of care (SOC) compared to participants receiving placebo plus other pre-specified commonly used COVID-19 treatments including dexamethasone as part of their SOC.,"['critically ill person who was treated with leronlimab', '394 people with severe-to-critical COVID-19', 'critically ill person with COVID-19 on ECMO successfully treated with leronlimab', 'subjects with mild-to-moderate COVID-19']","['dexamethasone', 'placebo', 'extracorporeal membrane oxygenation (ECMO']",['Day 28 mortality'],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",394.0,0.169732,The results show that Day 28 mortality was reduced (P=0.0319) in the subset of participants receiving leronlimab plus other pre-specified commonly used COVID-19 treatments including dexamethasone administered as part of their standard of care (SOC) compared to participants receiving placebo plus other pre-specified commonly used COVID-19 treatments including dexamethasone as part of their SOC.,"[{'ForeName': 'Sohier', 'Initials': 'S', 'LastName': 'Elneil', 'Affiliation': 'University College London, National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Lalezari', 'Affiliation': 'Quest Clinical Research, 2300 Sutter Street, Suite #202 & 208, San Francisco, CA 94115.'}, {'ForeName': 'Nader Z', 'Initials': 'NZ', 'LastName': 'Pourhassan', 'Affiliation': 'CytoDyn, 1111 Main Street, Suite 660 Vancouver, WA 98660.'}]",Journal of translational autoimmunity,['10.1016/j.jtauto.2021.100097']
588,33778390,A randomized trial analyzing the effects of primary versus delayed primary closure of incision on wound healing in patients with hollow viscus perforation.,"Objectives


Delayed primary closure (DPC) of the skin has been suggested to decrease superficial surgical site infection (SSSI) in patients undergoing surgery for peritonitis secondary to hollow viscus perforation, but there is no consensus. The aim of this study was to compare the outcomes of primary closure (PC) and DPC of the skin in terms of SSSI, fascial dehiscence and length of hospital stay (LOS).
Material and Methods


Sixty patients, undergoing emergency surgery for perforation peritonitis, were randomized to PC (n= 30) and DPC (n= 30). Patients in the DPC group underwent skin closure four or more days after surgery when the wound was clinically considered appropriate for closure. Patients in the PC group had skin closure at the time of surgery.
Results


Incidence of SSSI was significantly less in the DPC group (7.4%) compared to the PC (42.9%) (p= 0.004). However, the median time of DPC was the 10th POD, i.e., these wounds required considerable time to become clinically suitable for closure. Incidence of fascial dehiscence was comparable between the two groups (p= 0.67). Length of hospital stay (LOS) was 13.8 days in the DPC group compared to 13.5 days in PC; the difference was not significant (p= 0.825).
Conclusion


DPC of the skin incision resulted in the reduction of SSSI. However, this did not translate into a reduction in hospital stay, as it took considerable time for these wounds to become appropriate for DPC, thus bringing into question any real advantage of DPC over PC.",2020,"Length of hospital stay (LOS) was 13.8 days in the DPC group compared to 13.5 days in PC; the difference was not significant (p= 0.825).
","['patients with hollow viscus perforation', 'patients undergoing surgery for peritonitis secondary to hollow viscus perforation', 'Sixty patients, undergoing emergency surgery for perforation peritonitis']","['primary versus delayed primary closure of incision', 'skin closure']","['SSSI, fascial dehiscence and length of hospital stay (LOS', 'superficial surgical site infection (SSSI', 'skin closure', 'median time of DPC', 'wound healing', 'hospital stay', 'Incidence of SSSI', 'Incidence of fascial dehiscence', 'Length of hospital stay (LOS', 'reduction of SSSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332484', 'cui_str': 'Hollow shape'}, {'cui': 'C0042779', 'cui_str': 'Viscera'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",60.0,0.0383648,"Length of hospital stay (LOS) was 13.8 days in the DPC group compared to 13.5 days in PC; the difference was not significant (p= 0.825).
","[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Baksi', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shamita', 'Initials': 'S', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Surgery, Nil Ratan Sircar Medical College and Hospital, Kolkata, India.'}, {'ForeName': 'Udipta', 'Initials': 'U', 'LastName': 'Ray', 'Affiliation': 'Department of General Surgery, Medica Super Speciality Hospital, Kolkata, India.'}, {'ForeName': 'Nilima', 'Initials': 'N', 'LastName': 'Nilima', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Washim', 'Initials': 'W', 'LastName': 'Firoz Khan', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Niladri', 'Initials': 'N', 'LastName': 'Banerjee', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}]",Turkish journal of surgery,['10.47717/turkjsurg.2020.4882']
589,33778341,"A randomized, double-blind, crossover intervention study of traffic-related air pollution and airway inflammation in healthy adults.","Background


Traffic-related air pollution (TRAP) may increase the risk of respiratory disease. The components of TRAP that are responsible for its respiratory toxicity are largely unknown. The objective was to identify the component(s) of TRAP that cause airways inflammation using fractional exhaled nitric oxide (FE NO ) and randomized interventions.
Methods


A randomized, double-blind, crossover intervention study was conducted in which 39 healthy university students spent 2 hours next to a busy road. During exposure, participants wore either a powered air-purifying respirator (PAPR) or an N95 facemask. PAPRs were fitted with a fine particle (PM 2.5 ) filter, a PM 2.5  and volatile organic carbon (VOC) filter, or a sham filter, and were blinded to filter type. The four interventions (three PAPR filters and N95) were assigned randomly for each participant and separated by at least 1 week. FE NO  was measured before and immediately after each roadside exposure, and at 1, 2, 4, and 6 hours after exposure.
Results


With the sham PAPR filter, the mean postexposure FE NO  increased an average of 2.3 ppb (±4.4) compared with the pre-exposure level. Similar increases in FE NO  were seen with both the PM 2.5  PAPR filter and the N95 mask, but no increase was seen with the combination PM 2.5  and VOC PAPR filter.
Conclusions


Because PAPR filters do not filter inorganic gases (e.g., NO 2  or carbon monoxide), it is concluded that the VOC component of TRAP rather than either the particulate matter or the inorganic gases component is responsible for the airway inflammation caused by TRAP exposure.",2019,"NO  were seen with both the PM 2.5  PAPR filter and the N95 mask, but no increase was seen with the combination PM 2.5  and VOC PAPR filter.
","['39 healthy university students spent 2 hours next to a busy road', 'healthy adults']","['\n\n\nTraffic-related air pollution (TRAP', 'powered air-purifying respirator (PAPR) or an N95 facemask', 'carbon monoxide', 'sham PAPR filter']","['FE', 'mean postexposure FE NO', 'FE NO']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0180860', 'cui_str': 'Filter'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}]",39.0,0.182366,"NO  were seen with both the PM 2.5  PAPR filter and the N95 mask, but no increase was seen with the combination PM 2.5  and VOC PAPR filter.
","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'State Key Laboratory of Environmental Criteria and Risk Assessment, Chinese Research Academy of Environmental Sciences, Beijing 100012, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Environmental Criteria and Risk Assessment, Chinese Research Academy of Environmental Sciences, Beijing 100012, China.'}, {'ForeName': 'Ruojie', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Environmental Criteria and Risk Assessment, Chinese Research Academy of Environmental Sciences, Beijing 100012, China.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Occupational and Environmental Health, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, School of Public Health, University of Washington, Seattle, Washington.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Environmental Criteria and Risk Assessment, Chinese Research Academy of Environmental Sciences, Beijing 100012, China.'}, {'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Bai', 'Affiliation': 'State Key Laboratory of Environmental Criteria and Risk Assessment, Chinese Research Academy of Environmental Sciences, Beijing 100012, China.'}, {'ForeName': 'Sverre', 'Initials': 'S', 'LastName': 'Vedal', 'Affiliation': 'State Key Laboratory of Environmental Criteria and Risk Assessment, Chinese Research Academy of Environmental Sciences, Beijing 100012, China.'}]","Environmental epidemiology (Philadelphia, Pa.)",['10.1097/EE9.0000000000000066']
590,33778329,Ibandronate Reduces the Surface Bone Resorption of Mandibular Bone Grafts: A Randomized Trial With Internal Controls.,"Autologous bone grafts are considered the gold standard for reconstruction of the edentulous alveolar ridges. However, this procedure is associated with unpredictable bone loss caused by physiological bone resorption. Bisphosphonates are antiresorptive drugs that act specifically on osteoclasts, thereby maintaining bone density, volume, and strength. It was hypothesized that the resorption of bone grafts treated with an ibandronate solution would be less advanced than bone grafts treated with saline. Ten patients who underwent bilateral sagittal split osteotomy were included in a randomized double-blind trial with internal controls. Each patient received a bone graft treated with a solution of ibandronate on one side and a graft treated with saline (controls) contralaterally. Radiographs for the measurement of bone volume were obtained at 2 weeks and at 6 months after surgery. The primary endpoint was the difference in the change of bone volume between the control and the ibandronate bone grafts 6 months after surgery. All of the bone grafts healed without complications. One patient was excluded because of reoperation. In eight of the nine patients, the ibandronate bone grafts showed an increase in bone volume compared with baseline, with an average gain of 126 mm 3  (40% more than baseline) with a range of +27 to +218 mm 3 . Only one ibandronate-treated graft had a decrease in bone volume (8%). In the controls, an average bone volume loss of -146 mm 3  (58% of baseline) with a range of -29 to -301 mm 3  was seen. In the maxillofacial field, the reconstructions of atrophic alveolar ridges, especially in the esthetical zones, are challenging. These results show that bone grafts locally treated with ibandronate solution increases the remaining bone volume. This might lead to new possibilities for the maxillofacial surgeons in the preservation of bone graft volumes and for dental implant installations. © 2021 The Authors.  JBMR Plus  published by Wiley Periodicals LLC. on behalf of American Society for Bone and Mineral Research.",2021,"In eight of the nine patients, the ibandronate bone grafts showed an increase in bone volume compared with baseline, with an average gain of 126 mm 3  (40% more than baseline) with a range of +27 to +218 mm 3 .","['Mandibular Bone Grafts', '2021', 'Ten patients who underwent bilateral sagittal split osteotomy']","['ibandronate solution', 'bone graft treated with a solution of ibandronate on one side and a graft treated with saline (controls) contralaterally', 'Bisphosphonates', 'Autologous bone grafts']","['average bone volume loss', 'change of bone volume', 'remaining bone volume', 'bone volume']","[{'cui': 'C0185725', 'cui_str': 'Bone graft to mandible'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0379199', 'cui_str': 'Ibandronate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C1699650', 'cui_str': 'Autologous bone graft'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0241778,"In eight of the nine patients, the ibandronate bone grafts showed an increase in bone volume compared with baseline, with an average gain of 126 mm 3  (40% more than baseline) with a range of +27 to +218 mm 3 .","[{'ForeName': 'Jahan', 'Initials': 'J', 'LastName': 'Abtahi', 'Affiliation': 'Department of Oral & Maxillofacial Surgery and Department of Biomedical and Clinical Sciences Linköping University Linköping Sweden.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Klintström', 'Affiliation': 'Department of Biomedical Engineering and Health Systems KTH Royal Institute of Technology Stockholm Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Klintström', 'Affiliation': 'Center for Medical Image Science and Visualization (CMIV) Linköping University Linköping Sweden.'}]",JBMR plus,['10.1002/jbm4.10468']
591,33778150,Safety and efficacy of sargramostim (GM-CSF) in the treatment of Alzheimer's disease.,"Introduction


Inflammatory markers have long been observed in the brain, cerebrospinal fluid (CSF), and plasma of Alzheimer's disease (AD) patients, suggesting that inflammation contributes to AD and might be a therapeutic target. However, non-steroidal anti-inflammatory drug trials in AD and mild cognitive impairment (MCI) failed to show benefit. Our previous work seeking to understand why people with the inflammatory disease rheumatoid arthritis are protected from AD found that short-term treatment of transgenic AD mice with the pro-inflammatory cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) led to an increase in activated microglia, a 50% reduction in amyloid load, an increase in synaptic area, and improvement in spatial memory to normal. These results called into question the consensus view that inflammation is solely detrimental in AD. Here, we tested our hypothesis that modulation of the innate immune system might similarly be used to treat AD in humans by investigating the ability of GM-CSF/sargramostim to safely ameliorate AD symptoms/pathology.
Methods


A randomized, double-blind, placebo-controlled trial was conducted in mild-to-moderate AD participants (NCT01409915). Treatments (20 participants/group) occurred 5 days/week for 3 weeks plus two follow-up (FU) visits (FU1 at 45 days and FU2 at 90 days) with neurological, neuropsychological, blood biomarker, and imaging assessments.
Results


Sargramostim treatment expectedly changed innate immune system markers, with no drug-related serious adverse events or amyloid-related imaging abnormalities. At end of treatment (EOT), the Mini-Mental State Examination score of the sargramostim group increased compared to baseline ( P  = .0074) and compared to placebo ( P  = .0370); the treatment effect persisted at FU1 ( P  = .0272). Plasma markers of amyloid beta (Aβ40 [decreased in AD]) increased 10% ( P  = .0105); plasma markers of neurodegeneration (total tau and UCH-L1) decreased 24% ( P  = .0174) and 42% ( P  = .0019), respectively, after sargramostim treatment compared to placebo.
Discussion


The innate immune system is a viable target for therapeutic intervention in AD. An extended treatment trial testing the long-term safety and efficacy of GM-CSF/sargramostim in AD is warranted.",2021,"Plasma markers of amyloid beta (Aβ40 [decreased in AD]) increased 10% ( P  = .0105); plasma markers of neurodegeneration (total tau and UCH-L1) decreased 24% ( P  = .0174) and 42% ( P  = .0019), respectively, after sargramostim treatment compared to placebo.
","['mild-to-moderate AD participants (NCT01409915', ""Alzheimer's disease""]","['GM-CSF/sargramostim', 'sargramostim (GM-CSF', 'placebo']","['Safety and efficacy', 'Plasma markers of amyloid beta', 'plasma markers of neurodegeneration (total tau and UCH-L1', 'innate immune system markers', 'Mini-Mental State Examination score']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0216231', 'cui_str': 'sargramostim'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0027746', 'cui_str': 'Nerve degeneration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C1436157', 'cui_str': 'UCHL1 protein, human'}, {'cui': 'C0020962', 'cui_str': 'Structure of immune system'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}]",,0.538214,"Plasma markers of amyloid beta (Aβ40 [decreased in AD]) increased 10% ( P  = .0105); plasma markers of neurodegeneration (total tau and UCH-L1) decreased 24% ( P  = .0174) and 42% ( P  = .0019), respectively, after sargramostim treatment compared to placebo.
","[{'ForeName': 'Huntington', 'Initials': 'H', 'LastName': 'Potter', 'Affiliation': 'Department of Neurology University of Colorado School of Medicine Aurora Colorado USA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Woodcock', 'Affiliation': 'Department of Neurology University of Colorado School of Medicine Aurora Colorado USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Boyd', 'Affiliation': ""University of Colorado Alzheimer's and Cognition Center Aurora Colorado USA.""}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Coughlan', 'Affiliation': 'Department of Neurology University of Colorado School of Medicine Aurora Colorado USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Department of Neurology University of Colorado School of Medicine Aurora Colorado USA.'}, {'ForeName': 'Manuel T', 'Initials': 'MT', 'LastName': 'Borges', 'Affiliation': 'Department of Neurology University of Colorado School of Medicine Aurora Colorado USA.'}, {'ForeName': 'Ashesh A', 'Initials': 'AA', 'LastName': 'Thaker', 'Affiliation': 'Department of Neurology University of Colorado School of Medicine Aurora Colorado USA.'}, {'ForeName': 'Balaibail A', 'Initials': 'BA', 'LastName': 'Raj', 'Affiliation': 'University of South Florida School of Medicine Tampa Florida USA.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Adamszuk', 'Affiliation': 'Bioclinica Newark California USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scott', 'Affiliation': 'Bioclinica Newark California USA.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Adame', 'Affiliation': ""University of Colorado Alzheimer's and Cognition Center Aurora Colorado USA.""}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Anton', 'Affiliation': ""University of Colorado Alzheimer's and Cognition Center Aurora Colorado USA.""}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Chial', 'Affiliation': 'Department of Neurology University of Colorado School of Medicine Aurora Colorado USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gray', 'Affiliation': 'Department of Neurology University of Colorado School of Medicine Aurora Colorado USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'Department of Neurology University of Colorado School of Medicine Aurora Colorado USA.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Stocker', 'Affiliation': 'Department of Neurology University of Colorado School of Medicine Aurora Colorado USA.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Sillau', 'Affiliation': 'Department of Neurology University of Colorado School of Medicine Aurora Colorado USA.'}]","Alzheimer's & dementia (New York, N. Y.)",['10.1002/trc2.12158']
592,33778124,Comparison of Anesthesia Results between Wide Awake Local Anesthesia no Tourniquet (WALANT) and Forearm Tourniquet Bier Block in Hand Surgeries: A Randomized Clinical Trial.,"Background


There is still some debate regarding the most proper anesthetic technique in minor hand surgeries. We hypothesized that both the WALANT and forearm tourniquet Bier block methods provide effective anesthesia in minor hand surgeries without significant difference.
Methods


A total of 85 patients consented to participate in this study and were randomized into WALANT and single tourniquet forearm Bier block groups. In WALANT group, patients received adrenaline-contained lidocaine without tourniquet while lidocaine was administered accordingly after applying a forearm tourniquet in Bier group. Due to difference in intervention methods, the study was non-blinded. Need for additional analgesia during surgery, visual analogue scale (VAS) for pain intensity during operation and an hour later, amount of bleeding and active hand movements were evaluated and recorded.
Results


The need for analgesia and severity of pain (VAS) during surgery and one hour later were significantly less in WALANT group, whereas the amount of bleeding was less in Bier block group. The ability to move hand and fingers during the operation was the same in both groups.
Conclusion


Both WALANT and single cuff forearm tourniquet Bier block are effective methods in minor hand surgeries, however, forearm Bier block provides less analgesia and pain control with a drier field than WALANT method.",2021,"The need for analgesia and severity of pain (VAS) during surgery and one hour later were significantly less in WALANT group, whereas the amount of bleeding was less in Bier block group.","['Hand Surgeries', '85 patients consented to participate in this study and were randomized into WALANT and single tourniquet forearm Bier block groups']","['adrenaline-contained lidocaine', 'lidocaine']","['visual analogue scale (VAS) for pain intensity', 'amount of bleeding', 'analgesia and severity of pain (VAS']","[{'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0580806', 'cui_str': 'Local anesthetic intravenous regional block'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",85.0,0.0771874,"The need for analgesia and severity of pain (VAS) during surgery and one hour later were significantly less in WALANT group, whereas the amount of bleeding was less in Bier block group.","[{'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Farzam', 'Affiliation': 'Department of Orthopedy, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Deilami', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Jalili', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Koorosh', 'Initials': 'K', 'LastName': 'Kamali', 'Affiliation': 'Department of Public Health, School of Public Health, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",The archives of bone and joint surgery,['10.22038/abjs.2020.49526.2487']
593,33778117,Computed Tomography and Magnetic Resonance Imaging are Similarly Reliable in the Assessment of Glenohumeral Arthritis and Glenoid Version.,"Background


The purpose of this study was to compare the intraobserver and interobserver reliability of CT and T2-weighted MRI for evaluation of the severity of glenoid wear, glenohumeral subluxation, and glenoid version.
Methods


Sixty-one shoulders with primary osteoarthritis had CT and MRI scans before shoulder arthroplasty. All slices were blinded and randomized before evaluation. Two fellowship-trained shoulder surgeons and three orthopaedic surgery trainees reviewed the images to classify glenoid wear (Walch and Mayo classifications) and glenohumeral subluxation (Mayo classification). Glenoid version was measured using Friedman's technique. After a minimum two-week interval, the process was repeated.
Results


Intraobserver reliability was good for the CT group and fair-to-good for the MRI group for the Walch, Mayo glenoid, and Mayo subluxation classifications; interobserver reliability was poor for the CT and fair-to-poor for the MRI group. For the measurement of glenoid version, intraobserver reliability was good for the CT and substantial for the MRI group; interobserver agreement was good for both groups. There were no significant differences in reliability between staff surgeons and trainees for any of the classifications or measurements.
Conclusion


CT and MRI appear similarly reliable for the classification of glenohumeral wear patterns. For the measurement of glenoid version, MRI was slightly more reliable than CT within observers. Differences in training level did not produce substantial differences in agreement, suggesting these systems can be applied by observers of different experience levels with similar reliability.",2021,"Intraobserver reliability was good for the CT group and fair-to-good for the MRI group for the Walch, Mayo glenoid, and Mayo subluxation classifications; interobserver reliability was poor for the CT and fair-to-poor for the MRI group.","['Two fellowship-trained shoulder surgeons and three orthopaedic surgery trainees', 'Methods\n\n\nSixty-one shoulders with primary osteoarthritis had CT and MRI scans before shoulder arthroplasty']","['Computed Tomography and Magnetic Resonance Imaging', 'CT']","['Glenoid version', 'Intraobserver reliability']","[{'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0409952', 'cui_str': 'Idiopathic osteoarthritis'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",61.0,0.0579013,"Intraobserver reliability was good for the CT group and fair-to-good for the MRI group for the Walch, Mayo glenoid, and Mayo subluxation classifications; interobserver reliability was poor for the CT and fair-to-poor for the MRI group.","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Hopkins', 'Affiliation': 'University of Tennessee-Campbell Clinic Department of Orthopaedic Surgery and Biomedical Engineering, Memphis, Tennessee, USA.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Azar', 'Affiliation': 'University of Tennessee-Campbell Clinic Department of Orthopaedic Surgery and Biomedical Engineering, Memphis, Tennessee, USA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Mulligan', 'Affiliation': 'Duke University Medical School, Department of Orthopaedic Surgery, Durham, North Carolina, USA.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Hollins', 'Affiliation': 'Memphis Shoulder and Orthopaedic Surgery, Memphis, Tennessee, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Smith', 'Affiliation': 'University of Tennessee-Campbell Clinic Department of Orthopaedic Surgery and Biomedical Engineering, Memphis, Tennessee, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Throckmorton', 'Affiliation': 'University of Tennessee-Campbell Clinic Department of Orthopaedic Surgery and Biomedical Engineering, Memphis, Tennessee, USA.'}]",The archives of bone and joint surgery,['10.22038/abjs.2020.38922.2035']
594,33778103,Evaluating Rapid-cycle Deliberate Practice Versus Mastery Learning in Training Nurse Anesthetists on the Universal Anaesthesia Machine Ventilator in Sierra Leone.,"Background


Underserved sub-Saharan countries have 0.1 to 1.4 anesthesia providers per 100 000 citizens, below the Lancet Commission's target of 20 per 100 000 needed for safe surgery. Most of these anesthesia providers are nurse anesthetists, with anesthesiologists numbering as few as zero in some nations and 2 per 7 million in others, such as Sierra Leone. In this study, we compared 2 simulation-based techniques for training nurse anesthetists on the Universal Anaesthesia Machine Ventilator-rapid-cycle deliberate practice and mastery learning.
Methods


A 2-week Universal Anaesthesia Machine Ventilator course was administered to 17 participants in Sierra Leone. Seven were randomized to the rapid-cycle deliberate practice group and 10 to the mastery learning group. Participants underwent baseline and posttraining evaluations in 3 scenarios: general anesthesia, intraoperative power failure, and postoperative pulmonary edema. Performance was analyzed based on checklist performance scores and the number of times participants were stopped for a mistake. Statistical significance to 0.05 was determined with the Mann-Whitney  U  Test.
Results


Checklist performance scores did not differ significantly between the 2 groups. When the groups were combined, simulation-based training resulted in a statistically significant improvement in performance. The highest-frequency problem areas were preoxygenation, switching from spontaneous to mechanical ventilation, and executing appropriate treatment interventions for a postoperative emergency.
Conclusion


Both rapid-cycle deliberate practice and mastery learning are effective methods for simulation-based training to improve nurse anesthetist performance with the Universal Anaesthesia Machine Ventilator in 3 separate scenarios. The data did not indicate any difference between these methods; however, a larger sample size may support or refute our findings.",2021,"Results


Checklist performance scores did not differ significantly between the 2 groups.","['Training Nurse Anesthetists on the Universal Anaesthesia Machine Ventilator in Sierra Leone', '17 participants in Sierra Leone']",['rapid-cycle deliberate practice group and 10 to the mastery learning group'],"['Checklist performance scores', 'performance']","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1321571', 'cui_str': 'Certified registered nurse anesthetist'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0179064', 'cui_str': 'Anesthesia machine'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0037063', 'cui_str': 'Sierra Leone'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",7.0,0.0953609,"Results


Checklist performance scores did not differ significantly between the 2 groups.","[{'ForeName': 'Oluwakemi', 'Initials': 'O', 'LastName': 'Tomobi', 'Affiliation': ''}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Toy', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Ondari', 'Affiliation': ''}, {'ForeName': 'Sabair', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Nelson-Williams', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koroma', 'Affiliation': ''}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Sampson', 'Affiliation': ''}]",The journal of education in perioperative medicine : JEPM,['10.46374/volxxiii_issue1_sampson']
595,33778107,Sponsorship Disclosures and Perceptions of E-cigarette Instagram Posts.,"Objectives


Instagram influencers have many followers and are often paid to promote products, including e-cigarettes. This experimental study assessed effects of sponsorship disclosures on perceptions of e-cigarette Instagram influencer posts.
Methods


Young adult e-cigarette users (age 18-29; N = 917) were randomly assigned to 3 experimental conditions varying the clarity of sponsorship disclosure on simulated Instagram influencer posts: clear (eg, ""#sponsored"") ambiguous (eg, ""#sp""), or no disclosure (ie, vaping-related hashtags only). After viewing each of 4 Instagram posts featuring a fictitious e-cigarette brand, participants reported hashtag recognition, ad recognition, ad trust, influencer credibility, and post engagement intentions. After viewing all posts, participants reported brand attitudes, brand use intentions, and vaping intentions.
Results


With greater recognition of clear (but not ambiguous) disclosure hashtags, ad recognition increased (p = .001), perceptions of influencer credibility decreased (p = .022), and intentions to engage with posts decreased (p = .008). Ad trust was lower with greater hashtag recognition regardless of disclosures (p < .001). Sponsorship disclosures did not significantly affect brand attitudes, brand use intentions, or vaping intentions.
Conclusions


Recognizing clear sponsorship disclosures may influence young adults' perceptions of and engagement with e-cigarette Instagram posts but may not affect perceptions or use of products.",2020,", ad recognition increased (p = .001), perceptions of influencer credibility decreased (p = .022), and intentions to engage with posts decreased (p = .008).",['Methods\n\n\nYoung adult e-cigarette users (age 18-29; N = 917'],"['sponsorship disclosures', '3 experimental conditions varying the clarity of sponsorship disclosure on simulated Instagram influencer posts: clear (eg, ""#sponsored"") ambiguous (eg, ""#sp""), or no disclosure (ie, vaping-related hashtags only']","['brand attitudes, brand use intentions, or vaping intentions', 'perceptions of influencer credibility', 'intentions to engage with posts']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4505216', 'cui_str': 'Electronic cigarette user'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191378', 'cui_str': '917'}]","[{'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C3539086', 'cui_str': 'Ambiguous'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",917.0,0.090148,", ad recognition increased (p = .001), perceptions of influencer credibility decreased (p = .022), and intentions to engage with posts decreased (p = .008).","[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Vogel', 'Affiliation': 'Stanford Prevention Research Center, Stanford University, Stanford, CA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Guillory', 'Affiliation': 'Prime Affect Research, Dublin, Ireland.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Ling', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, San Francisco, CA.'}]",Tobacco regulatory science,['10.18001/trs.6.5.5']
596,33778017,C-Reactive Protein Apheresis as Anti-inflammatory Therapy in Acute Myocardial Infarction: Results of the CAMI-1 Study.,"Background:  C-reactive protein (CRP) is a well-known marker of inflammation. It is less known that CRP mediates tissue damage in acute myocardial infarction (AMI) thus potentially worsening prognosis. A newly developed specific CRP adsorber allows efficient lowering of CRP levels and may improve survival.  Objectives:  Aim of this multi-center, controlled, non-randomized first-in-man  CRP apheresis in Acute Myocardial Infarction study (CAMI-1)  was to investigate the relationship between CRP levels (CRP gradient), myocardial infarct size and function as well as safety and efficacy of CRP apheresis in the setting of acute ST-segment Elevation Myocardial Infarction (STEMI) in humans.  Methods:  Eighty-three patients (45 apheresis, 38 controls) were recruited. CRP apheresis was performed 24 ± 12, 48 ± 12, and optionally 72 ± 12 h after onset of symptoms. First aphereses were performed at a median CRP concentration of 23.0 mg/L (range 9-279). In each apheresis session, 5,900 ± 400 mL plasma was processed  via  peripheral venous access. Primary study endpoint was a reduction in myocardial infarct size after STEMI as determined by cardiovascular magnetic resonance (CMR).  Results:  In controls, the CRP concentration significantly correlated with infarct size ( p  = 0.002) and decreased myocardial function ( p  ≤ 0.001). The CRP concentration in apheresis patients did not correlate with infarct size ( p  = 0.66) or left ventricular (LV) function ( p  = 0.79) and global strains and therefore significantly differed from controls ( p  = 0.03 and  p  = 0.002). Three major adverse cardiac events occurred in the control group after 12 months, none occurred in the apheresis group. Mean CRP depletion achieved over all apheresis procedures was 53.0 ± 15.1%. Apheresis sessions were well-tolerated. Reduced infarct size in the apheresis group compared to the control group (primary endpoint) was not achieved according to the original statistical analysis plan. Taking into account the individual CRP levels, however, revealed significant results. Modifications of the analysis plan were introduced in order to recruit a sufficient number of patients.  Conclusions:  This pilot study in humans reveals a correlation between CRP concentration and myocardial infarct size. CRP concentrations in STEMI can effectively be reduced by CRP apheresis without relevant side effects. CRP apheresis has the potential to interfere with deleterious aspects of STEMI. By lowering CRP levels, it resulted in the loss of correlation of CRP concentrations with myocardial infarct sizes as well as LV function. These results encourage a larger, randomized clinical trial.  Clinical Trial Registration:  https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00008988, DRKS00008988.",2021,"In controls, the CRP concentration significantly correlated with infarct size ( p  = 0.002) and decreased myocardial function ( p  ≤ 0.001).","['Eighty-three patients (45 apheresis, 38 controls) were recruited', 'humans', 'Acute Myocardial Infarction']","['CRP apheresis', 'CRP', ':  C-reactive protein (CRP', 'C-Reactive Protein Apheresis']","['CRP levels', 'tolerated', 'CRP concentrations', 'Mean CRP depletion', 'infarct size', 'median CRP concentration', 'CRP levels (CRP gradient), myocardial infarct size and function as well as safety and efficacy', 'adverse cardiac events', 'CRP concentration and myocardial infarct size', 'myocardial function', 'CRP concentration', 'myocardial infarct size after STEMI as determined by cardiovascular magnetic resonance (CMR', 'left ventricular (LV) function']","[{'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005791', 'cui_str': 'Apheresis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005791', 'cui_str': 'Apheresis'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}]",,0.048664,"In controls, the CRP concentration significantly correlated with infarct size ( p  = 0.002) and decreased myocardial function ( p  ≤ 0.001).","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Ries', 'Affiliation': 'Medical Clinic, Diakonissenhospital Flensburg, Flensburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Torzewski', 'Affiliation': 'Cardiovascular Center Oberallgäu-Kempten, Kempten, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Heigl', 'Affiliation': 'Medical Care Center Kempten-Allgäu, Kempten, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pfluecke', 'Affiliation': 'Department for Internal Medicine/Cardiology, Heart Center Dresden, Dresden, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kelle', 'Affiliation': 'Department of Internal Medicine/Cardiology, German Heart Center Berlin, Berlin, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Darius', 'Affiliation': 'Clinic for Cardiology, Angiology, Nephrology, Intensive Care Medicine, Vivantes Clinic Neukölln, Berlin, Germany.'}, {'ForeName': 'Hueseyin', 'Initials': 'H', 'LastName': 'Ince', 'Affiliation': 'Divisions of Cardiology and Nephrology, Department of Internal Medicine, University Medicine Rostock, Rostock, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Mitzner', 'Affiliation': 'Divisions of Cardiology and Nephrology, Department of Internal Medicine, University Medicine Rostock, Rostock, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordbeck', 'Affiliation': 'Medical Clinic (Cardiology), University Clinic Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Butter', 'Affiliation': 'Immanuel Clinic Bernau, Heart Center Brandenburg, Bernau, Germany.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Skarabis', 'Affiliation': 'Statistical Consultant, Groß-Oesingen, Germany.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Sheriff', 'Affiliation': 'Department of Gastroenterology/Infectiology/Rheumatology, Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Christoph D', 'Initials': 'CD', 'LastName': 'Garlichs', 'Affiliation': 'Medical Clinic, Diakonissenhospital Flensburg, Flensburg, Germany.'}]",Frontiers in cardiovascular medicine,['10.3389/fcvm.2021.591714']
597,33777994,"Fish Protein Ingestion Induces Neural, but Not Muscular Adaptations, Following Resistance Training in Young Adults.","Purpose:  Nutritional supplementation in conjunction with exercise is of interest for the prevention or improvement of declines in motor performances in older adults. An understanding of the effects on both young and older adults contributes to its effective application. We investigated the effect of fish protein ingestion with resistance training on neural and muscular adaptations in young adults using interventions and assessments that have already been tested in older adults.  Methods:  Eighteen young adults underwent 8 weeks of isometric knee extension training. During the intervention, nine participants ingested 5 g of fish protein ( n  = 9, Alaska pollack protein, APP), and the other nine participants ingested casein as a control ( n  = 9, CAS) in addition to daily meals. Before, during, and after the intervention, the isometric knee extension force, lower extremity muscle mass, and motor unit firing pattern of knee extensor muscles were measured.  Results:  Maximum voluntary contraction (MVC) was significantly increased in both APP and CAS groups from 0 weeks to 4, 6, and 8 weeks of intervention ( p  < 0.001), but there were no significant differences between the groups ( p  = 0.546-0.931). Muscle mass was not significantly changed during the intervention in either group ( p  = 0.250-0.698). Significant changes in motor unit firing rates ( p  = 0.02 and 0.029 for motor units recruited at 20-40% of MVC and at 40-60%) were observed following the intervention in the APP but not CAS ( p  = 0.120-0.751) group.  Conclusions:  These results suggest that dietary fish protein ingestion changes motor unit adaptations following resistance training in young adults.",2021,Muscle mass was not significantly changed during the intervention in either group ( p  = 0.250-0.698).,"['Young Adults', 'older adults', 'young and older adults', 'young adults', 'Eighteen young adults']","['fish protein ( n  = 9, Alaska pollack protein, APP), and the other nine participants ingested casein as a control ( n  = 9, CAS', 'fish protein ingestion with resistance training', 'isometric knee extension training', 'dietary fish protein ingestion']","['Maximum voluntary contraction (MVC', 'isometric knee extension force, lower extremity muscle mass, and motor unit firing pattern of knee extensor muscles', 'Muscle mass', 'neural and muscular adaptations', 'motor unit firing rates']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0598294', 'cui_str': 'Fish Proteins'}, {'cui': 'C0001905', 'cui_str': 'Alaska'}, {'cui': 'C0453004', 'cui_str': 'Pollock - dietary'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3486459', 'cui_str': 'Dietary Fish Protein'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0429366', 'cui_str': 'Motor unit firing rate'}]",18.0,0.0317524,Muscle mass was not significantly changed during the intervention in either group ( p  = 0.250-0.698).,"[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Laboratory of Neuromuscular Biomechanics, Faculty of Liberal Arts and Sciences and School of International Liberal Studies, Chukyo University, Nagoya, Japan.'}, {'ForeName': 'Aleš', 'Initials': 'A', 'LastName': 'Holobar', 'Affiliation': 'Faculty of Electrical Engineering and Computer Science, University of Maribor, Maribor, Slovenia.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Uchida', 'Affiliation': 'Nihon Suisan Kaisha, Ltd., Tokyo, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Mita', 'Affiliation': 'Department of Human Nutrition, School of Life Studies, Sugiyama Jogakuen University, Nagoya, Japan.'}]",Frontiers in nutrition,['10.3389/fnut.2021.645747']
598,33777822,Medullary Thyroid Cancer Patient's Assessment of Quality of Life Tools: Results from the QaLM Study.,"Background


Medullary thyroid cancer (MTC) is a neuroendocrine tumour and a rare variant of thyroid cancer with different aetiology, presentation and treatment to differentiated thyroid cancer. Currently available thyroid cancer-specific quality of life (QoL) tools focus on issues and treatments more relevant to patients with differentiated thyroid cancer and therefore may not address issues specific to a MTC diagnosis and cancer journey.
Method


This prospective multicentre randomised study involved 204 MTC patients completing four quality of life questionnaires (QOLQ) and stating their most and least preferred. The questionnaires were a general instrument, the EORTC QLQ-C30, two disease-specific tools, the MD Anderson Symptom Inventory (MDASI) thyroid module and the City of Hope Quality of Life Scale/THYROID (amended) and the neuroendocrine questionnaire, EORTC QLQ-GINET21. Patients were randomised to complete the four questionnaires in one of 24 possible orders and then answered questions about which tool they preferred. The primary outcome measure was patients' preferred QoL instrument for describing their concerns and for facilitating communication with their healthcare professional. Secondary analyses looked at differences between preferred QOLQs amongst patient subgroups (WHO performance status [0 and 1+], disease stage: early [T1-3, N0 or N1A], metastatic [T4, any T N1b] and advanced [any T any N M1], and type of MTC [sporadic and inherited]), identification of MTC patients' least preferred questionnaire and clinicians' views on the QoL tools in terms of their ability to highlight problems not otherwise ascertained by a standard clinical review.
Results


No evidence of a difference was observed for most preferred QOLQ ( p  = 0.650). There was however evidence of a difference in least preferred questionnaire in the cohort of 128 patients who stated their least preferred questionnaire ( p  = 0.042), with 36% (46/128) of patients choosing the EORTC QLQ-GI.NET21 questionnaire. Subgroup analyses showed that there was no evidence of a difference in patients' most preferred questionnaire in sporadic MTC patients ( p  = 0.637), patients with WHO PS 0 or 1+ ( p  = 0.844 and  p  = 0.423) nor when comparing patients with early, advanced local or metastatic disease ( p  = 0.132,  p  = 0.463 and  p  = 0.506, respectively). Similarly, subgroup analyses on patients' least preferred questionnaires showed no evidence of differences in sporadic MTC patients ( p  = 0.092), patients with WHO PS 0 or 1+ ( p  = 0.423 and  p  = 0.276), nor in early or metastatic disease patients ( p  = 0.682 and  p  = 0.345, respectively). There was however some evidence to suggest a difference in least preferred questionnaire in patients with advanced local stage disease ( p  = 0.059), with 43% (16/37) of these patients choosing the EORTC QLQ-GI.NET21 questionnaire.
Conclusions


MTC patients regardless of their performance status, disease aetiology and disease burden did not express a preference for any one particular questionnaire suggesting any of the tools studied could be utilized in this patient cohort. The least preferred questionnaire being a gastrointestinal NET specific tool suggests that diarrhoea was not a significant symptom and concern for the population studied.",2021,No evidence of a difference was observed for most preferred QOLQ ( p  = 0.650).,"['204 MTC patients completing four', 'patients with differentiated thyroid cancer']",['\n\n\nMedullary thyroid cancer (MTC'],"['Quality of Life Tools', ""patients' preferred QoL instrument for describing their concerns and for facilitating communication with their healthcare professional"", 'quality of life questionnaires (QOLQ) and stating their most and least preferred', 'advanced local or metastatic disease', 'MD Anderson Symptom Inventory (MDASI) thyroid module and the City of Hope Quality of Life Scale/THYROID (amended) and the neuroendocrine questionnaire']","[{'cui': 'C0238462', 'cui_str': 'Medullary thyroid carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4722172', 'cui_str': 'Primary differentiated carcinoma of thyroid gland'}]","[{'cui': 'C0238462', 'cui_str': 'Medullary thyroid carcinoma'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}]",204.0,0.1154,No evidence of a difference was observed for most preferred QOLQ ( p  = 0.650).,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moss', 'Affiliation': 'Velindre Cancer Centre, Velindre University NHS Trust, Cardiff, United Kingdom.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Cox', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Cancer Centre, Sheffield, United Kingdom.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Newbold', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Mark W J', 'Initials': 'MWJ', 'LastName': 'Strachan', 'Affiliation': 'Western General Hospital, Edinburgh, United Kingdom.'}, {'ForeName': 'Maralyn', 'Initials': 'M', 'LastName': 'Druce', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, London, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Tolley', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Graham', 'Affiliation': 'Beatson Oncology Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Jefferies', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Fresco', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, United Kingdom.'}, {'ForeName': 'Suganya', 'Initials': 'S', 'LastName': 'Sivabalasingham', 'Affiliation': 'University College Hospital NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Balfour', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Canterbury, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hurt', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, United Kingdom.'}]",European thyroid journal,['10.1159/000509227']
599,33777820,Therapeutic Equivalence of a New Preparation of Liquid Levothyroxine with Tablets in Patients with Overt Primary Hypothyroidism.,"Background


A new liquid levothyroxine (LT4) dissolved in glycerol and water has recently been developed by a Greek pharmaceutical company (Uni-Pharma, Athens, Greece).
Objectives


To evaluate the therapeutic equivalence of this new liquid LT4 preparation versus the already existing tablet formulation of the same manufacturer, in order to obtain approval by the Greek National Organization for Medicines.
Methods


This was a prospective, randomized, cross-over phase III study. The study included 50 patients (9 men and 41 non-pregnant women, with a mean age of 42.5 ± 12.5 years), with documented overt primary hypothyroidism. All subjects were well controlled on substitution therapy with various LT4 formulations. None of the patients had known LT4 malabsorption. The patients were randomized into 2 groups (A and B). The individuals of group A initially received T4® tablets for 10 ± 2 weeks and subsequently switched to T4® drops (100 μg/mL solution) at the same dose for another 10 ± 2 weeks. In group B, the reverse procedure was followed. Total T3 (T3), free T4 (fT4), and TSH were measured in all participants at enrollment and at the end of each 10 ± 2-week trial period.
Results


Out of the 50 recruited patients, 6 were lost to follow-up and 5 were excluded due to non-compliance with the study protocol. In the 39 patients who completed the study, the serum TSH levels after 10 ± 2 weeks of treatment either with T4® tablets or with T4® drops did not differ (1.759 ± 1.104 vs. 2.076 ± 1.334 mIU/L, mean ± SD).
Conclusions


In hypothyroid patients, the new liquid LT4 preparation (T4® drops) is therapeutically equivalent to the tablet form (T4® tablets).",2021,"In hypothyroid patients, the new liquid LT4 preparation (T4® drops) is therapeutically equivalent to the tablet form (T4® tablets).","['50 patients (9 men and 41 non-pregnant women, with a mean age of 42.5 ± 12.5 years), with documented overt primary hypothyroidism', 'Patients with Overt Primary Hypothyroidism', '39 patients', '50 recruited patients']","['T4® tablets', 'Liquid Levothyroxine with Tablets', 'levothyroxine (LT4) dissolved in glycerol']","['serum TSH levels', 'Total T3 (T3), free T4 (fT4), and TSH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0700502', 'cui_str': 'Acquired hypothyroidism'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C1549535', 'cui_str': 'Dissolve'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}]","[{'cui': 'C1277938', 'cui_str': 'Serum TSH measurement'}, {'cui': 'C0428419', 'cui_str': 'Triiodothyronine measurement'}, {'cui': 'C0202225', 'cui_str': 'T4 free measurement'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]",50.0,0.0670426,"In hypothyroid patients, the new liquid LT4 preparation (T4® drops) is therapeutically equivalent to the tablet form (T4® tablets).","[{'ForeName': 'Georgios K', 'Initials': 'GK', 'LastName': 'Markantes', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, University of Patras Medical School, Patras, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Dimitropoulos', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, University of Patras Medical School, Patras, Greece.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Mamali', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, University of Patras Medical School, Patras, Greece.'}, {'ForeName': 'Ioulia', 'Initials': 'I', 'LastName': 'Tseti', 'Affiliation': 'Uni-Pharma S.A., Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sakellaropoulos', 'Affiliation': 'Department of Medical Physics, School of Medicine, University of Patras, Patras, Greece.'}, {'ForeName': 'Kostas B', 'Initials': 'KB', 'LastName': 'Markou', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, University of Patras Medical School, Patras, Greece.'}, {'ForeName': 'Marina A', 'Initials': 'MA', 'LastName': 'Michalaki', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, University of Patras Medical School, Patras, Greece.'}]",European thyroid journal,['10.1159/000508216']
600,33777780,A Pragmatic Non-Randomized Trial of Prehabilitation Prior to Cancer Surgery: Study Protocol and COVID-19-Related Adaptations.,"Background


Experimental data highlight the potential benefits and health system cost savings related to surgical prehabilitation; however, adequately powered randomized controlled trial (RCT) data remain nascent. Emerging prehabilitation services may be informed by early RCT data but can be limited in informing real-world program development. Pragmatic trials emphasize external validity and generalizability to understand and advise intervention development and implementation in clinical settings. This paper presents the methodology of a pragmatic prehabilitation trial to complement emerging phase III clinical trials and inform implementation strategies.
Methods


This is a pilot pragmatic clinical trial conducted in a large academic hospital in Toronto, Ontario, Canada to assess feasibility of clinical implementation and derive estimates of effectiveness. Feasibility data include program referral rates, enrolment and attrition, intervention adherence and safety, participant satisfaction, and barriers and facilitators to programming. The study aims to receive 150 eligible referrals for adult, English-speaking, preoperative oncology patients with an identified indication for prehabilitation ( e.g ., frailty, deconditioning, malnutrition, psychological distress). Study participants undergo a baseline assessment and shared-decision making regarding the intervention setting: either facility-based prehabilitation or home-based prehabilitation. In both scenarios, participants receive an individualized exercise prescription, stress-reduction psychological support, nutrition counseling, and protein supplementation, and if appropriate, smoking cessation program referrals. Secondary objectives include estimating intervention effects at the week prior to surgery and 30 and 90 days postoperatively. Outcomes include surgical complications, postoperative length of stay, mortality, hospital readmissions, physical fitness, psychological well-being, and quality of life. Data from participants who decline the intervention but consent for research-related access to health records will serve as comparators. The COVID-19 pandemic required the introduction of a 'virtual program' using only telephone or internet-based communication for screening, assessments, or intervention was introduced.
Conclusion


This pragmatic trial will provide evidence on the feasibility and viability of prehabilitation services delivered under usual clinical conditions. Study amendments due to the COVID-19 pandemic are presented as strategies to maintain prehabilitation research and services to potentially mitigate the consequences of extended surgery wait times.",2021,"The COVID-19 pandemic required the introduction of a 'virtual program' using only telephone or internet-based communication for screening, assessments, or intervention was introduced.
","['Study participants undergo a baseline assessment and shared-decision making regarding the intervention setting: either', '150 eligible referrals for adult, English-speaking, preoperative oncology patients with an identified indication for prehabilitation ( e.g ., frailty, deconditioning, malnutrition, psychological distress']","['facility-based prehabilitation or home-based prehabilitation', 'Prehabilitation', 'individualized exercise prescription, stress-reduction psychological support, nutrition counseling, and protein supplementation, and if appropriate, smoking cessation program referrals']","['program referral rates, enrolment and attrition, intervention adherence and safety, participant satisfaction, and barriers and facilitators to programming', 'surgical complications, postoperative length of stay, mortality, hospital readmissions, physical fitness, psychological well-being, and quality of life']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.148553,"The COVID-19 pandemic required the introduction of a 'virtual program' using only telephone or internet-based communication for screening, assessments, or intervention was introduced.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Santa Mina', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sellers', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Au', 'Affiliation': 'Department of Anesthesia and Pain Management, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Shabbir M H', 'Initials': 'SMH', 'LastName': 'Alibhai', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Hance', 'Initials': 'H', 'LastName': 'Clarke', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Cuthbertson', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Darling', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'El Danab', 'Affiliation': 'Clinical Nutrition, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Govindarajan', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Ladha', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Matthew', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'McCluskey', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Ng', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Fayez', 'Initials': 'F', 'LastName': 'Quereshy', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Karkouti', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Randall', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}]",Frontiers in oncology,['10.3389/fonc.2021.629207']
601,33777752,"Mouthwash Containing Vitamin E, Triamcinolon, and Hyaluronic Acid Compared to Triamcinolone Mouthwash Alone in Patients With Radiotherapy-Induced Oral Mucositis: Randomized Clinical Trial.","One of the most common side effects of radiotherapy in head and neck cancers is mucositis. Despite all the studies conducted on new therapies proposed for oral mucositis caused by radiation therapy, a single standard treatment strategy has not been developed yet. In the present study, for the first time, the effectiveness of the treatment with a combined mouthwash containing vitamin E (as an antioxidant), triamcinolone (as an anti-inflammatory agent) and hyaluronic acid (HA) (as a local reducer used for reducing the effects of ROS on the mucosa, with ameliorative effects (improving the healing process) compared to triamcinolone mouthwash alone was investigated in patients with radiotherapy-induced oral mucositis. This study was a randomized triple-blind clinical trial performed on 60 patients underwent radiotherapy on an outpatient basis. The combined mouthwash containing vitamin E, triamcinolone, and hyaluronic acid compared to triamcinolone mouthwash alone was prescribed for 4 weeks. The severity of oral mucositis was assessed based on the WHO classification and the intensity of pain was assessed using the numerical pain intensity scale. According to the analysis performed in the first, second, third and fourth weeks, the reduction of oral mucositis grade in the intervention group was significantly higher than in the comparison group. In the first, second, third, and fourth weeks, the reduction in pain intensity in the intervention group was significantly higher than in the comparison group (P < 0.001). The combined mouthwash containing vitamin E, hyaluronic acid and triamcinolone acetonide can be used as an effective treatment for oral mucositis caused by radiation therapy, which is probably the result of antioxidant, anti-inflammatory and improved healing process mechanisms due to the biological nature of the components of this mouthwash.
Trial registration


This study was registered in the WHO Primary registry (IRCT) with the code IRCT20190428043407N. Registered on 20 July 2019, https://www.irct.ir/trial/39231.",2021,"In the first, second, third, and fourth weeks, the reduction in pain intensity in the intervention group was significantly higher than in the comparison group (P < 0.001).","['Patients', 'WHO Primary registry (IRCT) with the code IRCT20190428043407N. Registered on 20 July 2019, https://www.irct.ir/trial/39231', '60 patients underwent', 'patients with radiotherapy-induced oral mucositis']","['hyaluronic acid (HA', 'triamcinolone mouthwash alone', 'combined mouthwash containing vitamin E', 'triamcinolone', 'Radiotherapy-Induced Oral Mucositis', 'radiotherapy', 'Mouthwash Containing Vitamin E, Triamcinolon, and Hyaluronic Acid', 'vitamin E, triamcinolone, and hyaluronic acid', 'vitamin E, hyaluronic acid and triamcinolone acetonide', 'Triamcinolone Mouthwash Alone']","['severity of oral mucositis', 'numerical pain intensity scale', 'reduction of oral mucositis grade', 'reduction in pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",60.0,0.0683751,"In the first, second, third, and fourth weeks, the reduction in pain intensity in the intervention group was significantly higher than in the comparison group (P < 0.001).","[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Agha-Hosseini', 'Affiliation': 'Dental Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Pourpasha', 'Affiliation': 'Department of Oral Medicine, Faculty of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Massoud', 'Initials': 'M', 'LastName': 'Amanlou', 'Affiliation': 'Department of Medicinal Chemistry, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdieh-Sadat', 'Initials': 'MS', 'LastName': 'Moosavi', 'Affiliation': 'Dental Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",Frontiers in oncology,['10.3389/fonc.2021.614877']
602,33777649,Interventions to Preserve Cognitive Functioning Among Older Kidney Transplant Recipients.,"Purpose of Review


To summarize the research on effective interventions for preserving cognitive function and prevent cognitive decline in patients with end-stage kidney disease (ESKD) who are undergoing dialysis and/or kidney transplantation (KT).
Recent Findings


Among ESKD patients undergoing hemodialysis, exercise training has been administered through home-based and intradialytic interventions. Additionally, one pilot study identified intradialytic cognitive training, electronic brain games, as an intervention to preserve cognitive function among patients undergoing hemodialysis. Fewer studies have investigated interventions to preserver cognitive function among KT recipients. To date, the only randomized controlled trial in this population identified B-vitamin supplements as an intervention to preserve cognitive function. The evidence from these trials support a short-term benefit of cognitive and exercise training as well as B-vitamin supplementation among patients with ESKD. Future studies should: 1) replicate these findings, 2) identify interventions specific to KT candidates, and 3) investigate the synergistic impact of both cognitive and exercise training.
Summary


Cognitive prehabilitation, with cognitive and/or exercise training, may be novel interventions for KT candidates that not only reduces delirium risk and long-term post-KT cognitive decline but also prevents dementia.",2020,"To date, the only randomized controlled trial in this population identified B-vitamin supplements as an intervention to preserve cognitive function.","['patients with ESKD', 'Older Kidney Transplant Recipients', 'ESKD patients undergoing hemodialysis', 'patients undergoing hemodialysis', 'patients with end-stage kidney disease (ESKD) who are undergoing dialysis and/or kidney transplantation (KT']","['intradialytic cognitive training, electronic brain games', 'exercise training', 'cognitive and exercise training', 'cognitive and/or exercise training', 'vitamin supplements']","['Cognitive Functioning', 'delirium risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0356885,"To date, the only randomized controlled trial in this population identified B-vitamin supplements as an intervention to preserve cognitive function.","[{'ForeName': 'Nadia M', 'Initials': 'NM', 'LastName': 'Chu', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Dorry', 'Initials': 'D', 'LastName': 'Segev', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Mara A', 'Initials': 'MA', 'LastName': 'McAdams-DeMarco', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD.'}]",Current transplantation reports,['10.1007/s40472-020-00296-w']
603,33777585,Comparison of Analgesic Efficacy of Ultrasound-Guided Interscalene Block Versus Continuous Subacromial Infusion for Postoperative Analgesia Following Arthroscopic Rotator Cuff Repair Surgeries: A Randomized Trial.,"BACKGROUND


Arthroscopic rotator cuff repair surgery may lead to significant postoperative pain. Interscalene block (ISB) is an effective analgesic technique in these surgeries but there is a risk of the phrenic blockade. Subacromial local anesthetic infiltration is a phrenic sparing alternative technique for postoperative analgesia. The primary aim of our study was to compare the ISB with a continuous subacromial infusion (SAC) with regard to postoperative analgesia.
METHODS


This prospective randomized, interventional parallel arm trial was conducted in 60 ASA grade I and II, adult patients (30 patients in each group) posted for arthroscopic rotator cuff repair surgery. Patients were randomly assigned to receive either ultrasound-guided ISB (Group ISB: 15 ml of 0.75% ropivacaine) or continuous SAC (Group SAC: 15 ml 0.75% ropivacaine as a subacromial injection by ultrasound guidance and infusion of 3 ml/hour of 0.5% ropivacaine through the catheter placed subacromial by the surgeon). Intraoperative hemodynamic parameters, visual analog scores (VAS), and rescue analgesic requirements for 24 hours, patient satisfaction, and complications were recorded.
RESULTS


Rescue analgesic requirement was significantly higher in SAC at zero hours (P=0.000), while it was significantly higher in ISB at 12 hours (P=0.02). The VAS scores were comparable at all time points and patient satisfaction at 24 hours was similar. None of the patients had rated satisfaction related to pain relief as poor in any group. Complications like ptosis and motor weakness were seen only with ISB.
CONCLUSION


Both the techniques provided effective analgesia and comparable patient satisfaction with lesser incidence of complications in the SAC group. ISB provided more effective immediate postoperative pain relief while SAC was more effective in delayed analgesia for arthroscopic rotator cuff repair surgeries. SAC can be considered a reasonably safe alternative to ISB in patients with contraindications to the latter.",2021,ISB provided more effective immediate postoperative pain relief while SAC was more effective in delayed analgesia for arthroscopic rotator cuff repair surgeries.,"['Arthroscopic Rotator Cuff Repair Surgeries', 'patients with contraindications to the latter', '60 ASA grade I and II, adult patients (30 patients in each group']","['Ultrasound-Guided Interscalene Block Versus Continuous Subacromial Infusion', 'ISB', 'continuous subacromial infusion (SAC', 'subacromial injection by ultrasound guidance and infusion of 3 ml/hour of 0.5% ropivacaine', 'ultrasound-guided ISB (Group ISB: 15 ml of 0.75% ropivacaine) or continuous SAC (Group SAC: 15 ml 0.75% ropivacaine', 'Arthroscopic rotator cuff repair surgery', 'arthroscopic rotator cuff repair surgery', 'Interscalene block (ISB']","['ISB', 'Complications like ptosis and motor weakness', 'VAS scores', 'Intraoperative hemodynamic parameters, visual analog scores (VAS), and rescue analgesic requirements for 24 hours, patient satisfaction, and complications', 'pain relief']","[{'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",60.0,0.0681211,ISB provided more effective immediate postoperative pain relief while SAC was more effective in delayed analgesia for arthroscopic rotator cuff repair surgeries.,"[{'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Saini', 'Affiliation': 'Anesthesiology, Vardhman Mahavir Medical College and Safdarjung Hospital, Delhi, IND.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Anesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Delhi, IND.'}, {'ForeName': 'Shruti Mahesh', 'Initials': 'SM', 'LastName': 'Rao', 'Affiliation': 'Anesthesia and Critical Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Delhi, IND.'}, {'ForeName': 'Bhavya', 'Initials': 'B', 'LastName': 'Krishna', 'Affiliation': 'Anesthesiology, Vardhman Mahavir Medical College and Safdarjung Hospital, Delhi, IND.'}, {'ForeName': 'Saveena', 'Initials': 'S', 'LastName': 'Raheja', 'Affiliation': 'Anesthesia and Critical Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Delhi, IND.'}, {'ForeName': 'Rajeev Kumar', 'Initials': 'RK', 'LastName': 'Malhotra', 'Affiliation': 'Delhi Cancer Registry, All India Institute of Medical Sciences, Delhi, IND.'}, {'ForeName': 'Dr Nishkarsh', 'Initials': 'DN', 'LastName': 'Gupta', 'Affiliation': 'Onco-Anesthesiology and Palliative Medicine, All India Institute of Medical Sciences, Delhi, IND.'}]",Cureus,['10.7759/cureus.13500']
604,33777508,"Myofascial release versus Mulligan sustained natural apophyseal glides' immediate and short-term effects on pain, function, and mobility in non-specific low back pain.","Background


Myofascial release (MFR) and Mulligan Sustained Natural Apophyseal Glides (SNAGs) are manual therapy techniques routinely practiced in the management of non-specific low back pain (NSLBP). As a solo intervention or along with other therapies, both methods have reported positive results for individuals with NSLBP. However, which technique improves NSLBP-related pain, restricted range of motion (ROM) and disability, warrants further research.
Objective


To study the comparative effects of MFR and SNAGs on pain, disability, functional ability, and lumbar ROM in NSLBP.
Method


A parallel-group study was conducted at tertiary care hospitals. Sixty-five Sub-acute or chronic NSLBP patients were allocated to receive strengthening exercises along with either MFR ( n  = 33) or SNAGs ( n  = 32) for six treatment sessions over one week. An independent assessor evaluated outcome measures such as the Visual Analog Scale (VAS), Patient-Specific Function Scale (PSFS), and ROM at baseline, immediate (after 1st treatment), and short-term (post-sixth day of the intervention). The Modified Oswestry disability index (MODI) was assessed at baseline and short-term.
Results


Within-group analysis found clinically and statistically significant ( p  < 0.05) changes for VAS and PSFS at immediate and short-term for both the groups. The lumbar extension also showed improvement immediately and in the short-term. Improvement in Lumbar flexion was seen only in the SNAGs group over the short-term. A statistically significant improvement was seen for MODI in both the groups but was not clinically significant in the MFR group. The analysis observed no statistically significant difference ( p  < 0.05) between the groups at both the immediate and short-term.
Conclusions


Pain and restricted function associated with NSLBP can be improved using SNAGs or MFR, along with strengthening exercises. For limited lumbar flexion ROM, Mulligan SNAGs have a better outcome than MFR over the short-term. Hence, both manual therapy techniques can be incorporated along with exercises for immediate and short-term management of sub-acute to chronic NSLBP. Clinical Trial Registration . CTRI/2018/12/016787 (http://ctri.nic.in/Clinicaltrials/).",2021,"For limited lumbar flexion ROM, Mulligan SNAGs have a better outcome than MFR over the short-term.","['Sixty-five Sub-acute or chronic NSLBP patients', 'non-specific low back pain', 'individuals with NSLBP']","['strengthening exercises along with either MFR ( n \xa0=\xa033) or SNAGs ', 'MFR and SNAGs', '\n\n\nMyofascial release (MFR) and Mulligan Sustained Natural Apophyseal Glides (SNAGs']","['Lumbar flexion', 'MODI', 'pain, function, and mobility', 'pain, disability, functional ability, and lumbar ROM', 'Visual Analog Scale (VAS), Patient-Specific Function Scale (PSFS), and ROM at baseline, immediate (after 1st treatment), and short-term', 'NSLBP-related pain, restricted range of motion (ROM) and disability', 'VAS and PSFS', 'Modified Oswestry disability index (MODI', 'lumbar extension']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0342276', 'cui_str': 'Maturity-onset diabetes of the young'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",,0.0454591,"For limited lumbar flexion ROM, Mulligan SNAGs have a better outcome than MFR over the short-term.","[{'ForeName': 'Vignesh', 'Initials': 'V', 'LastName': 'Bhat P', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Karnataka, India.'}, {'ForeName': 'Vivek Dineshbhai', 'Initials': 'VD', 'LastName': 'Patel', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Karnataka, India.'}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Eapen', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Karnataka, India.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Shenoy', 'Affiliation': 'Department of Physical Therapy, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Milanese', 'Affiliation': 'International Centre for Allied Health Evidence, University of South Australia, Adelaide, South Australia, Australia.'}]",PeerJ,['10.7717/peerj.10706']
605,33777424,Follow-Up Study on the Effect of Cognitive Behaviour Therapy on Haemodialysis Adherence: A randomised controlled trial.,"Objectives


Patients with chronic kidney disease (CKD) undergoing haemodialysis often experience a myriad of psychosocial problems, resulting in poor adherence to their therapeutic regimen. This study aimed to examine the effect of cognitive behaviour therapy (CBT) on dialysis, fluid, drug and diet adherence among a previously reported sample of CKD patients undergoing haemodialysis.
Methods


A randomised controlled trial was conducted between January 2013 to Febrary 2014 on a random selection of 67 CKD patients attending a tertiary multispecialty hospital in India. The experimental group (n = 33) was exposed to CBT, whereas the control group (n = 34) received non-directive counselling. A haemodialysis adherence scale was developed and used to assess adherence to the treatment regimen. The effect size was calculated using Cohen's d statistics.
Results


At six months, mean reductions from baseline were observed in the experimental group in terms of interdialytic weight gain (-1.23 kg; effect size: 0.57), systolic blood pressure (-22.18 mmHg; effect size: 0.71) and diastolic blood pressure (-10.06 mmHg; effect size: 0.72), whereas mean increases were noted in haemoglobin (+0.75 g/dL; effect size: 0.31) and adherence to dialysis (+0.94; effect size: 0.51), fluids (+16.34; effect size: 2.30), diet (+61.19; effect size: 4.75) and drugs (+10.73; effect size: 1.3). Differences from baseline were significantly higher in the experimental group compared to the control group ( P  = 0.001 each).
Conclusion


These results show that CBT is more effective than non-directive counselling for improving therapeutic adherence and physiological, clinical parameters among CKD patients undergoing haemodialysis.",2021,"Differences from baseline were significantly higher in the experimental group compared to the control group ( P  = 0.001 each).
","['Haemodialysis Adherence', 'January 2013 to Febrary 2014 on a random selection of 67 CKD patients attending a tertiary multispecialty hospital in India', 'CKD patients undergoing haemodialysis', 'Patients with chronic kidney disease (CKD) undergoing haemodialysis often experience']","['Cognitive Behaviour Therapy', 'cognitive behaviour therapy (CBT', 'CBT', 'non-directive counselling']","['systolic blood pressure', 'adherence to dialysis', 'haemoglobin', 'interdialytic weight gain', 'dialysis, fluid, drug and diet adherence', 'diastolic blood pressure']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.112988,"Differences from baseline were significantly higher in the experimental group compared to the control group ( P  = 0.001 each).
","[{'ForeName': 'Blessy P', 'Initials': 'BP', 'LastName': 'Valsaraj', 'Affiliation': 'Department of Community & Mental Health, College of Nursing, Sultan Qaboos University, Muscat, Oman.'}, {'ForeName': 'Shripathy M', 'Initials': 'SM', 'LastName': 'Bhat', 'Affiliation': 'Department of Psychiatry, Kasturba Medical College, Manipal Academy of Higher Education, Udupi, India.'}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Prabhu', 'Affiliation': 'Department of Nephrology, Kasturba Hospital, Udupi, India.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Kamath', 'Affiliation': 'Department of Data Science, Prasanna School of Public Health, Manipal Academy of Higher Education, Udupi, India.'}]",Sultan Qaboos University medical journal,['10.18295/squmj.2021.21.01.008']
606,33777422,Changes in Self-Efficacy and Social Support after an Intervention to Increase Physical Activity Among Adults with Type 2 Diabetes in Oman: A 12-month follow-up of the MOVEdiabetes trial.,"Objectives


This study aimed to describe changes in self-efficacy (SE) and social support (SS) 12 months after the MOVEdiabetes trial, an intervention designed to increase physical activity (PA) among adults with type 2 diabetes mellitus in Oman.
Methods


The original MOVEdiabetes trial was conducted between April 2016 and June 2017 in Muscat, Oman. The intervention group (IG) received personalised PA consultations, pedometers and monthly messages using a web-based application, while the comparison group received usual care. Self-reported SE and SS from family and friends were assessed using validated psychosocial scales.
Results


Of the 232 original participants in the trial, a total of 174 completed the 12 months follow-up study period (response rate: 75%). However, based on intention-to-treat analysis with several imputation procedures for missing data at 3 and/or 12 months, there was a significant increase in SE scores in the IG (+10.3, 95% confidence interval [CI]: 7.1-13.5;  P  <0.001); however, the correlation with PA levels was weak (+4.2, 95% CI: 2.7-5.7;  P  <0.001). Higher SE scores were noted in those without comorbidities (+12.2, 95% CI: 6.8-17.6;  P  <0.001) and with high income levels (+9.7, 95% CI: 5.2-14.2;  P  <0.001). Additionally, SS scores increased significantly among those in the IG who received support from friends (+2.3, 95% CI: 1.1-3.7;  P  <0.001), but not family (+1.2, 95% CI: -0.4-2.8;  P  = 0.110). The reliability of the scales was acceptable for SE and SS from family, but poor for SS from friends (Cronbach's alpha coefficients = 0.82, 0.82 and 0.40, respectively).
Conclusion


The PA intervention was associated with positive changes in SE and SS from friends. However, further tools for assessing psychosocial influences on PA are needed in Arab countries.",2021,"The intervention group (IG) received personalised PA consultations, pedometers and monthly messages using a web-based application, while the comparison group received usual care.","['adults with type 2 diabetes mellitus in Oman', 'Adults with Type 2 Diabetes in Oman', '232 original participants in the trial, a total of 174 completed the 12 months follow-up study period (response rate: 75', 'April 2016 and June 2017 in Muscat, Oman']","['personalised PA consultations, pedometers and monthly messages using a web-based application, while the comparison group received usual care']","['Higher SE scores', 'SE scores', 'physical activity (PA', 'SS scores', 'PA levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0028971', 'cui_str': 'Oman'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205871', 'cui_str': 'Muscat'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0629595,"The intervention group (IG) received personalised PA consultations, pedometers and monthly messages using a web-based application, while the comparison group received usual care.","[{'ForeName': 'Thamra S', 'Initials': 'TS', 'LastName': 'Al-Ghafri', 'Affiliation': 'Department of Planning, Directorate General of Planning & Studies, Ministry of Health, Muscat, Oman.'}, {'ForeName': 'Saud', 'Initials': 'S', 'LastName': 'Al-Harthi', 'Affiliation': 'Department of Medicine, Al Nahdha Hospital, Muscat, Oman.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Al-Farsi', 'Affiliation': 'Department of Family Medicine & Public Health, College of Medicine & Health Sciences, Sultan Qaboos University, Muscat, Oman.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Craigie', 'Affiliation': 'Centre for Public Health Nutrition Research, University of Dundee, Dundee, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Bannerman', 'Affiliation': 'Global Academy of Agriculture & Food Security, Royal (Dick) School of Veterinary Studies, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Annie S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Centre for Public Health Nutrition Research, University of Dundee, Dundee, UK.'}]",Sultan Qaboos University medical journal,['10.18295/squmj.2021.21.01.006']
607,33777378,Erythropoiesis stimulating agents are associated with serum fibroblast growth factor 23 metabolism in patients on hemodialysis.,"Background


This study aimed to determine associations among short- and long-acting erythropoiesis stimulating agents (ESAs), changes in serum fibroblast growth factor 23 (FGF23) and biomarkers of iron metabolism.
Methods


Among 108 patients on hemodialysis (HD), 44 received every 2 weeks or monthly doses of continuous erythropoiesis receptor activator (CERA), 31 received weekly doses of darbepoetin-α, 24 received three doses per week of epoetin-β and 9 were not treated with an ESA. Intact and C-terminal FGF23 and transferrin saturation (TSAT), ferritin, erythroferrone and hepcidin 25 were measured in blood samples collected before the HD session at the end of the dialysis week (baseline, Day 0) and on Days 3, 5, 7 and 14 thereafter.
Results


Levels of ferritin, hepcidin 25 and erythroferrone as well as TSAT were significantly decreased or elevated in patients treated with CERA compared with other types of ESAs. Levels of C-terminal FGF23 increased in all groups during the observation period. Levels of intact FGF23 and ratios of intact FGF23 to C-terminal FGF23 gradually decreased between Days 3 and 7 in the CERA but not in the other groups. Multivariate models associated changes in hepcidin 25 and phosphate with those of intact FGF23.
Conclusion


The long-acting ESA CERA might influence levels of intact FGF23 by increasing FGF23 cleavage in patients on HD in association with prolonged hepcidin 25 suppression.",2021,"Results


Levels of ferritin, hepcidin 25 and erythroferrone as well as TSAT were significantly decreased or elevated in patients treated with CERA compared with other types of ESAs.","['patients on hemodialysis', '108 patients on hemodialysis (HD), 44 received every 2\u2009weeks or monthly doses of']","['short- and long-acting erythropoiesis stimulating agents (ESAs', 'continuous erythropoiesis receptor activator (CERA', 'CERA', 'epoetin-β and 9 were not treated with an ESA', 'darbepoetin-α']","['Levels of intact FGF23 and ratios of intact FGF23 to C-terminal FGF23', 'serum fibroblast growth factor 23 (FGF23) and biomarkers of iron metabolism', 'Levels of ferritin, hepcidin 25 and erythroferrone as well as TSAT', 'Intact and C-terminal FGF23 and transferrin saturation (TSAT), ferritin, erythroferrone and hepcidin 25', 'Levels of C-terminal FGF23']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4543210', 'cui_str': 'Receptor activator'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C3272931', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}]",108.0,0.0181033,"Results


Levels of ferritin, hepcidin 25 and erythroferrone as well as TSAT were significantly decreased or elevated in patients treated with CERA compared with other types of ESAs.","[{'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Honda', 'Affiliation': 'Department of Medicine, Division of Nephrology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Division of Dialysis, Suiyukai Clinic, Nara, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Michihata', 'Affiliation': 'Division of Dialysis, Ebara Clinic, Tokyo, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Shibagaki', 'Affiliation': 'Division of Dialysis, Shibagaki Dialysis Clinic Jiyugaoka, Tokyo, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Yuza', 'Affiliation': 'Division of Dialysis, Shibagaki Dialysis Clinic Kugahara, Tokyo, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Hirao', 'Affiliation': 'Division of Dialysis, Shibagaki Dialysis Clinic Togoshi, Tokyo, Japan.'}, {'ForeName': 'Naohisa', 'Initials': 'N', 'LastName': 'Tomosugi', 'Affiliation': 'Division of Systems Bioscience for Drug Discovery, Medical Research Institute, Kanazawa Medical University, Kanazawa, Japan.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Ganz', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA,\xa0USA.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Higashimoto', 'Affiliation': 'Department of Chemistry, Kurume University, School of Medicine, Kurume, Japan.'}]",Clinical kidney journal,['10.1093/ckj/sfaa042']
608,33777372,Change in FGF23 concentration over time and its association with all-cause mortality in patients treated with haemodialysis or haemodiafiltration.,"Background


Previous studies in patients on haemodialysis (HD) have shown an association of fibroblast growth factor 23 (FGF23) with all-cause mortality. As of yet, the result of FGF23 lowering on mortality is unknown in this population.
Methods


FGF23 was measured in a subset of 404 patients from the Dutch CONvective TRansport STudy (CONTRAST study) [a randomized trial in prevalent dialysis patients comparing HD and haemodiafiltration (HDF) with clinical outcome] at baseline and Months 6 and 12. A substantial decline of FGF23 change over time was anticipated in patients randomized to HDF since HDF induces higher dialytic clearance of FGF23. The associations of both baseline FGF23 and 6-months change in FGF23 with all-cause mortality were analysed. In addition, the difference in FGF23 change between HD and HDF was explored. Furthermore, the role of dialysis modality in the association between FGF23 change and outcome was analysed.
Results


No association was observed between quartiles of baseline FGF23 and all-cause mortality. Over 6 months, FGF23 declined in patients on HDF, whereas FGF23 remained stable in patients on HD. A decrease in FGF23 was not associated with improved survival compared with a stable FGF23 concentration. However, increasing FGF23 was associated with a significantly higher mortality risk, both in crude and fully adjusted models [hazard ratio 2.01 (95% confidence interval 1.30-3.09)].
Conclusion


Whereas no association between a single value of FGF23 and all-cause mortality was found, increasing FGF23 concentrations did identify patients at risk for mortality. Since lowering FGF23 did not improve outcome, this study found no argument for therapeutically lowering FGF23.",2021,"Whereas no association between a single value of FGF23 and all-cause mortality was found, increasing FGF23 concentrations did identify patients at risk for mortality.","['patients treated with haemodialysis or haemodiafiltration', '404 patients from the Dutch CONvective TRansport STudy (CONTRAST study) [a randomized trial in prevalent dialysis patients comparing HD and haemodiafiltration (HDF) with clinical outcome] at baseline and Months 6 and 12', 'patients on haemodialysis (HD']",[],"['dialytic clearance of FGF23', 'survival', 'FGF23 concentrations', 'FGF23', 'FGF23 change', 'mortality risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0936404,"Whereas no association between a single value of FGF23 and all-cause mortality was found, increasing FGF23 concentrations did identify patients at risk for mortality.","[{'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Bouma-de Krijger', 'Affiliation': 'Department of Nephrology, Amsterdam University Medical Center, VU University Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Camiel L M', 'Initials': 'CLM', 'LastName': 'de Roij van Zuijdewijn', 'Affiliation': 'Department of Nephrology, Amsterdam University Medical Center, VU University Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Menso J', 'Initials': 'MJ', 'LastName': 'Nubé', 'Affiliation': 'Department of Nephrology, Amsterdam University Medical Center, VU University Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Muriel P C', 'Initials': 'MPC', 'LastName': 'Grooteman', 'Affiliation': 'Department of Nephrology, Amsterdam University Medical Center, VU University Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Vervloet', 'Affiliation': 'Department of Nephrology, Amsterdam University Medical Center, VU University Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical kidney journal,['10.1093/ckj/sfaa028']
609,33777256,Yoga v. health education for attentional processes relevant to major depressive disorder.,"Objectives


Research has shown that yoga may be an effective adjunctive treatment for persistent depression, the benefits of which may accumulate over time. The objectives of this study were to evaluate the following in a sample of persistently depressed individuals: whether yoga increases mindfulness and whether yoga attenuates rumination. Rumination and mindfulness both represent attentional processes relevant for onset and maintenance of depressive episodes.
Methods


One-hundred-ten individuals who were persistently depressed despite ongoing use of pharmacological treatment were recruited into an RCT comparing yoga with a health education class. Mindfulness and rumination were assessed at baseline and across 3 time points during the ten-week intervention.
Results


Findings demonstrate that, compared to health education, yoga was associated with higher mean levels of the observe facet of mindfulness relative to the control group during the intervention period ( p  =.004,  d  =0.38), and that yoga was associated with a faster rate of increase in levels of acting with awareness over the intervention period ( p = .03,  f 2  =0.027). There were no differences between intervention groups with respect to rumination.
Conclusions


Results suggest a small effect of yoga on components of mindfulness during a 10-week intervention period. Previous research suggests that continued assessment after the initial 10 weeks may reveal continued improvement. Future research may also examine moderators of the impact of yoga on mindfulness and rumination, including clinical factors such as depression severity or depression chronicity, or demographic factors such as age.",2021,"There were no differences between intervention groups with respect to rumination.
",['Methods\n\n\nOne-hundred-ten individuals who were persistently depressed despite ongoing use of pharmacological treatment were recruited into an RCT comparing yoga with a health education class'],"['yoga increases mindfulness and whether yoga attenuates rumination', 'Yoga v. health education']","['levels of acting with awareness', 'Mindfulness and rumination']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}]",110.0,0.018066,"There were no differences between intervention groups with respect to rumination.
","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'West', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Tremont', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Ivan W', 'Initials': 'IW', 'LastName': 'Miller', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Uebelacker', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI.'}]",Mindfulness,['10.1007/s12671-020-01519-y']
610,33777254,"Mindful Eating, General Mindful Awareness, and Acceptance as Predictors of Weight Loss.","Objectives


The goal of the present study was to determine whether baseline mindful eating, general mindful awareness, or acceptance was most strongly associated with short- and long-term weight loss in a lifestyle modification program.
Methods


Data were from 178 participants (baseline BMI=40.9±5.9 kg/m 2 , age=44.2±11.2 years; 87.6% female; 71.3% black) who enrolled in a two-phase trial. All participants attended an initial 14-week lifestyle modification program that included a meal replacement diet. Participants who had lost ≥5% of initial weight ( N =137) were then randomized to 52 weeks of lifestyle modification with lorcaserin or placebo. Linear mixed models examined whether mindful eating (Mindful Eating Questionnaire) and general mindful awareness and acceptance (Philadelphia Mindfulness Scale) predicted short-term weight loss at week 14 in the full sample and long-term weight loss at the end of the trial in the subsample of randomized participants.
Results


In the full sample, higher baseline acceptance predicted greater short-term weight losses ( p =.004). At week 14, individuals low in acceptance (-1 SD ) lost an average of 8.7 kg ( SE =0.6) compared to 11.2 kg ( SE =0.6) among those high in acceptance (+1 SD ). In the subsample of participants who successfully lost weight in phase 1, the independent effect of acceptance on total losses at the end of the trial did not reach statistical significance ( p =.058). Neither mindful eating nor general mindful awareness independently predicted weight loss at either time point.
Conclusions


Acceptance was a stronger predictor than either general or eating-specific awareness of weight loss with lifestyle modification.",2020,"In the full sample, higher baseline acceptance predicted greater short-term weight losses ( p =.004).","['Participants who had lost ≥5% of initial weight ( N =137', 'All participants attended an initial 14-week lifestyle modification program that included a', '178 participants (baseline BMI=40.9±5.9 kg/m 2 , age=44.2±11.2 years; 87.6% female; 71.3% black) who enrolled in a two-phase trial']","['lorcaserin or placebo', 'meal replacement diet']","['total losses', 'weight loss', 'mindful eating (Mindful Eating Questionnaire) and general mindful awareness and acceptance (Philadelphia Mindfulness Scale) predicted short-term weight loss', 'short-term weight losses']","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2350948', 'cui_str': 'lorcaserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",137.0,0.106956,"In the full sample, higher baseline acceptance predicted greater short-term weight losses ( p =.004).","[{'ForeName': 'Jena S', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Pearl', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine.'}]",Mindfulness,['10.1007/s12671-020-01493-5']
611,33777253,Meditating in Virtual Reality 3: 360° Video of Perceptual Presence of Instructor.,"Objectives


The need for remote delivery of mental health interventions including instruction in meditation has become paramount in the wake of the current global pandemic. However, the support one may usually feel within the physical presence of an instructor may be weakened when interventions are delivered remotely, potentially impacting one's meditative experiences. Use of head-mounted displays (HMD) to display video-recorded instruction may increase one's sense of psychological presence with the instructor as compared to presentation via regular flatscreen (e.g., laptop) monitor. This research therefore evaluated a didactic, trauma-informed care approach to instruction in mindfulness meditation by comparing meditative responses to an instructor-guided meditation when delivered face-to-face vs. by pre-recorded 360° videos viewed either on a standard flatscreen monitor (2D format) or via HMD (i.e., virtual reality [VR] headset; 3D format).
Methods


Young adults ( n  = 82) were recruited from a university introductory course and experienced a 360° video-guided meditation via HMD (VR condition, 3D format). They were also randomly assigned to practice the same meditation either via scripted face-to-face instruction (in vivo [IV] format) or when viewed on a standard laptop display (non-VR condition, 2D format). Positive and negative affect and meditative experience ratings were self-reported and participants' maintenance of focused attention to breathing (i.e., meditation breath attention scores [MBAS]) were recorded during each meditation.
Results


Meditating in VR (3D format) was associated with a heightened experience of awe overall. When compared to face-to-face instruction (IV format), VR meditation was rated as less embarrassing but also less enjoyable and more tiring. When compared to 2D format, VR meditations were associated with greater experiences of relaxation, less distractibility from the process of breathing, and less fatigue. No differences were found between VR and non-VR meditation in concentration (MBAS). Baseline posttraumatic stress symptoms were risk factors for experiencing distress while meditating in either (VR and non-VR) instructional format. Of those who reported a preference for one format, approximately half preferred the VR format and approximately half preferred the IV format.
Conclusions


Recorded 360° video instruction in meditation viewed with a HMD (i.e., VR/3D format) appears to offer some experiential advantage over instructions given in 2D format and may offer a safe-and for some even preferred-alternative to teaching meditation face-to-face.
Supplementary Information


The online version contains supplementary material available at 10.1007/s12671-021-01612-w.",2021,"When compared to 2D format, VR meditations were associated with greater experiences of relaxation, less distractibility from the process of breathing, and less fatigue.",['Methods\n\n\nYoung adults ( n  = 82) were recruited from a university introductory course and experienced a 360°'],"['instructor-guided meditation when delivered face-to-face vs. by pre-recorded 360° videos viewed either on a standard flatscreen monitor (2D format) or via HMD (i.e., virtual reality [VR] headset; 3D format', 'video-guided meditation via HMD (VR condition, 3D format', 'same meditation either via scripted face-to-face instruction (in vivo [IV] format) or when viewed on a standard laptop display (non-VR condition, 2D format', 'head-mounted displays (HMD) to display video-recorded instruction']","['VR and non-VR meditation in concentration (MBAS', 'Positive and negative affect and meditative experience ratings', 'attention to breathing (i.e., meditation breath attention scores [MBAS']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319607', 'cui_str': '360'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C5197728', 'cui_str': 'Head Worn Display'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C1737642', 'cui_str': 'Laptop computer'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",82.0,0.0293742,"When compared to 2D format, VR meditations were associated with greater experiences of relaxation, less distractibility from the process of breathing, and less fatigue.","[{'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Waller', 'Affiliation': 'Departments of Psychiatry & Psychology, Western University, London, Canada.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Mistry', 'Affiliation': 'Departments of Psychiatry & Psychology, Western University, London, Canada.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Jetly', 'Affiliation': 'University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Frewen', 'Affiliation': 'Departments of Psychiatry & Psychology, Western University, London, Canada.'}]",Mindfulness,['10.1007/s12671-021-01612-w']
612,33777240,"A cross-sectional study of the relationship of proximal smoking environments and cessation history, plans, and self-efficacy among low-income smokers.","Introduction


Proximal environments could facilitate smoking cessation among low-income smokers by making cessation appealing to strive for and tenable.
Aims


We sought to examine how home smoking rules and proximal environmental factors such as other household members' and peers' smoking behaviors and attitudes related to low-income smokers' past quit attempts, readiness, and self-efficacy to quit.
Methods


This analysis used data from Offering Proactive Treatment Intervention (OPT-IN) (randomized control trial of proactive tobacco cessation outreach) baseline survey, which was completed by 2,406 participants in 2011/12. We tested the associations between predictors (home smoking rules and proximal environmental factors) and outcomes (past-year quit attempts, readiness to quit, and quitting self-efficacy).
Results


Smokers who lived in homes with more restrictive household smoking rules, and/or reported having 'important others' who would be supportive of their quitting, were more likely to report having made a quit attempt in the past year, had greater readiness to quit, and greater self-efficacy related to quitting.
Conclusions


Adjustments to proximal environments, including strengthening household smoking rules, might encourage cessation even if other household members are smokers.",2019,"We tested the associations between predictors (home smoking rules and proximal environmental factors) and outcomes (past-year quit attempts, readiness to quit, and quitting self-efficacy).
","['low-income smokers', '2,406 participants in 2011/12', 'Smokers who lived in homes with more restrictive household smoking rules']",[],"['outcomes (past-year quit attempts, readiness to quit, and quitting self-efficacy']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}]",[],"[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0306791,"We tested the associations between predictors (home smoking rules and proximal environmental factors) and outcomes (past-year quit attempts, readiness to quit, and quitting self-efficacy).
","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Widome', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota School of Public Health, MN, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Hammett', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota School of Public Health, MN, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Joseph', 'Affiliation': 'Department of Medicine, University of Minnesota Medical School, MN, USA.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Burgess', 'Affiliation': 'Department of Medicine, University of Minnesota Medical School, MN, USA.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Thomas', 'Affiliation': 'Department of Medicine, University of Minnesota Medical School, MN, USA.'}, {'ForeName': 'Jessie E', 'Initials': 'JE', 'LastName': 'Saul', 'Affiliation': 'North American Quitline Consortium, Phoenix AZ, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Clothier', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research (CCDOR), Minneapolis VA Health Care System, MN, USA.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Fu', 'Affiliation': 'Department of Medicine, University of Minnesota Medical School, MN, USA.'}]",Journal of smoking cessation,['10.1017/jsc.2019.15']
613,33776997,The Cholinergic Drug Galantamine Alleviates Oxidative Stress Alongside Anti-inflammatory and Cardio-Metabolic Effects in Subjects With the Metabolic Syndrome in a Randomized Trial.,"Background:  The metabolic syndrome (MetS) is an obesity-associated disorder of pandemic proportions and limited treatment options. Oxidative stress, low-grade inflammation and altered neural autonomic regulation, are important components and drivers of pathogenesis. Galantamine, an acetylcholinesterase inhibitor and a cholinergic drug that is clinically-approved (for Alzheimer's disease) has been implicated in neural cholinergic regulation of inflammation in several conditions characterized with immune and metabolic derangements. Here we examined the effects of galantamine on oxidative stress in parallel with inflammatory and cardio-metabolic parameters in subjects with MetS.  Trial Design and Methods:  The effects of galantamine treatment, 8 mg daily for 4 weeks or placebo, followed by 16 mg daily for 8 weeks or placebo were studied in randomly assigned subjects with MetS ( n  = 22 per group) of both genders. Oxidative stress, including superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase activities, lipid and protein peroxidation, and nitrite levels were analyzed before and at the end of the treatment. In addition, plasma cytokine and adipokine levels, insulin resistance (HOMA-IR) and other relevant cardio-metabolic indices were analyzed. Autonomic regulation was also examined by heart rate variability (HRV) before treatment, and at every 4 weeks of treatment.  Results:  Galantamine treatment significantly increased antioxidant enzyme activities, including SOD [+1.65 USOD/mg protein, [95% CI 0.39-2.92],  P  = 0.004] and CAT [+0.93 nmol/mg, [95% CI 0.34-1.51],  P  = 0.01], decreased lipid peroxidation [thiobarbituric acid reactive substances [log scale 0.72 pmol/mg, [95% CI 0.46-1.07],  P  = 0.05], and systemic nitrite levels [log scale 0.83 μmol/mg protein, [95% CI 0.57-1.20],  P  = 0.04] compared with placebo. In addition, galantamine significantly alleviated the inflammatory state and insulin resistance, and decreased the low frequency/high frequency ratio of HRV, following 8 and 12 weeks of drug treatment.  Conclusion:  Low-dose galantamine alleviates oxidative stress, alongside beneficial anti-inflammatory, and metabolic effects, and modulates neural autonomic regulation in subjects with MetS. These findings are of considerable interest for further studies with the cholinergic drug galantamine to ameliorate MetS.",2021,"Galantamine treatment significantly increased antioxidant enzyme activities, including SOD [+1.65 USOD/mg protein, [95% CI 0.39-2.92],  P  = 0.004] and CAT [+0.93 nmol/mg, [95% CI 0.34-1.51],  P  = 0.01], decreased lipid peroxidation [thiobarbituric acid reactive substances [log scale 0.72 pmol/mg, [95% CI 0.46-1.07],  P  = 0.05], and systemic nitrite levels [log scale 0.83 μmol/mg protein, [95% CI 0.57-1.20],  P  = 0.04] compared with placebo.","['Subjects With the Metabolic Syndrome', 'subjects with MetS', 'randomly assigned subjects with MetS ( n  = 22 per group) of both genders']","['placebo', 'galantamine', 'Galantamine']","['Oxidative stress, including superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase activities, lipid and protein peroxidation, and nitrite levels', 'Autonomic regulation', 'Oxidative stress, low-grade inflammation and altered neural autonomic regulation', 'antioxidant enzyme activities', 'systemic nitrite levels', 'heart rate variability (HRV', 'lipid peroxidation [thiobarbituric acid reactive substances', 'plasma cytokine and adipokine levels, insulin resistance (HOMA-IR) and other relevant cardio-metabolic indices', 'oxidative stress', 'inflammatory state and insulin resistance']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0580333', 'cui_str': 'Urine nitrite'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.252039,"Galantamine treatment significantly increased antioxidant enzyme activities, including SOD [+1.65 USOD/mg protein, [95% CI 0.39-2.92],  P  = 0.004] and CAT [+0.93 nmol/mg, [95% CI 0.34-1.51],  P  = 0.01], decreased lipid peroxidation [thiobarbituric acid reactive substances [log scale 0.72 pmol/mg, [95% CI 0.46-1.07],  P  = 0.05], and systemic nitrite levels [log scale 0.83 μmol/mg protein, [95% CI 0.57-1.20],  P  = 0.04] compared with placebo.","[{'ForeName': 'Carine Teles', 'Initials': 'CT', 'LastName': 'Sangaleti', 'Affiliation': 'Hypertension Unit, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Keyla Yukari', 'Initials': 'KY', 'LastName': 'Katayama', 'Affiliation': 'Nursing Department Graduate Program in Nanosciences and Biosciences, Nove de Julho University (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Kátia', 'Initials': 'K', 'LastName': 'De Angelis', 'Affiliation': 'Nursing Department Graduate Program in Nanosciences and Biosciences, Nove de Julho University (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Tércio', 'Initials': 'T', 'LastName': 'Lemos de Moraes', 'Affiliation': 'Nursing Department Graduate Program in Nanosciences and Biosciences, Nove de Julho University (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Amanda Aparecida', 'Initials': 'AA', 'LastName': 'Araújo', 'Affiliation': 'Department of Physiology, Federal University of São Paulo (UNIFESP), São Paulo, Brazil.'}, {'ForeName': 'Heno F', 'Initials': 'HF', 'LastName': 'Lopes', 'Affiliation': 'Hypertension Unit, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Cleber', 'Initials': 'C', 'LastName': 'Camacho', 'Affiliation': 'Nursing Department Graduate Program in Nanosciences and Biosciences, Nove de Julho University (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Luiz Aparecido', 'Initials': 'LA', 'LastName': 'Bortolotto', 'Affiliation': 'Hypertension Unit, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Lisete Compagno', 'Initials': 'LC', 'LastName': 'Michelini', 'Affiliation': 'Biomedical Sciences Institute Department of Physiology and Biophysics, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Maria Cláudia', 'Initials': 'MC', 'LastName': 'Irigoyen', 'Affiliation': 'Hypertension Unit, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Peder S', 'Initials': 'PS', 'LastName': 'Olofsson', 'Affiliation': 'Laboratory of Immunobiology, Department of Medicine, Center for Bioelectronic Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Barnaby', 'Affiliation': 'The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY, United States.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Tracey', 'Affiliation': 'The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY, United States.'}, {'ForeName': 'Valentin A', 'Initials': 'VA', 'LastName': 'Pavlov', 'Affiliation': 'The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY, United States.'}, {'ForeName': 'Fernanda Marciano', 'Initials': 'FM', 'LastName': 'Consolim Colombo', 'Affiliation': 'Hypertension Unit, University of São Paulo (USP), São Paulo, Brazil.'}]",Frontiers in immunology,['10.3389/fimmu.2021.613979']
614,33771102,The influence of exercise during pregnancy on racial/ethnic health disparities and birth outcomes.,"BACKGROUND


Non-Hispanic black (NHB) pregnant women disproportionately experience adverse birth outcomes compared to Non-Hispanic white (NHW) pregnant women. The positive effects of prenatal exercise on maternal and neonatal health may mitigate these disparities. This study evaluated the influence of prenatal exercise on racial/ethnic disparities in gestational age (GA), birthweight (BW), and risks of preterm birth (PTB), cesarean section (CS), and low-birthweight (LBW) neonates.
METHODS


This study performed a secondary data analysis using data from a 24-week, two-arm exercise intervention trial (ENHANCED by Mom). Women with singleton pregnancies (< 16 weeks), aged 18-40 years, BMI between 18.5-34.99 kg/m 2 , and no preexisting health conditions were eligible. The aerobic exercisers (EX) participated in 150 min of moderate-intensity weekly exercise while non-exercising controls (CON) attended low-intensity stretching/breathing sessions. Data on GA, PTB (< 37 weeks), BW, LBW (< 2.5 kg), and delivery mode were collected. Poisson, median and linear regressions were performed.
RESULTS


Participants with complete data (n = 125) were eligible for analyses (EX: n = 58, CON: n = 67). NHB pregnant women delivered lighter neonates (β = - 0.43 kg, 95% CI: - 0.68, - 0.18, p = 0.001). After adjusting for prenatal exercise, racial/ethnic disparities in BW were reduced (β = - 0.39 kg, 95% CI: - 0.65, - 0.13, p = 0.004). Prenatal exercise reduced borderline significant racial/ethnic disparities in PTB (p = 0.053) and GA (p = 0.07) with no effects found for CS and LBW.
CONCLUSIONS


The findings of this study demonstrate that prenatal exercise may attenuate the racial/ethnic disparities observed in neonatal BW, and possibly GA and PTB. Larger, diverse samples and inclusion of maternal biomarkers (e.g., cytokines) are encouraged to further evaluate these relationships.",2021,"Prenatal exercise reduced borderline significant racial/ethnic disparities in PTB (p = 0.053) and GA (p = 0.07) with no effects found for CS and LBW.
","['Hispanic white (NHW) pregnant women', 'Women with singleton pregnancies (<\u200916\u2009weeks), aged 18-40\u2009years, BMI between 18.5-34.99\u2009kg/m 2 , and no preexisting health conditions were eligible', 'Participants with complete data (n\u2009=\u2009125) were eligible for analyses (EX: n\u2009=\u200958, CON: n\u2009=\u200967']","['aerobic exercisers (EX) participated in 150\u2009min of moderate-intensity weekly exercise while non-exercising controls (CON) attended low-intensity stretching/breathing sessions', 'prenatal exercise']","['racial/ethnic disparities in gestational age (GA), birthweight (BW), and risks of preterm birth (PTB), cesarean section (CS), and low-birthweight (LBW) neonates']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2721216', 'cui_str': 'Aerobic exerciser'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]",,0.105089,"Prenatal exercise reduced borderline significant racial/ethnic disparities in PTB (p = 0.053) and GA (p = 0.07) with no effects found for CS and LBW.
","[{'ForeName': 'Madigan J', 'Initials': 'MJ', 'LastName': 'Raper', 'Affiliation': 'Department of Business, East Carolina University (ECU), 1851 MacGregor Downs Rd, MS#701, Greenville, NC, 27834, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'McDonald', 'Affiliation': 'Department of Kinesiology and Recreation, Illinois State University, Normal, IL, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Johnston', 'Affiliation': 'Department of Human Development and Family Science, ECU, Greenville, NC, USA.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Isler', 'Affiliation': 'Department of Obstetrics and Gynecology, ECU, Greenville, NC, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Newton', 'Affiliation': 'Department of Obstetrics and Gynecology, ECU, Greenville, NC, USA.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Kuehn', 'Affiliation': 'Department of Pediatrics, ECU, Greenville, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Collier', 'Affiliation': 'Department of Pediatrics, ECU, Greenville, NC, USA.'}, {'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Broskey', 'Affiliation': 'Department of Kinesiology, ECU, Greenville, NC, USA.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Muldrow', 'Affiliation': 'Department of Communication, ECU, Greenville, NC, USA.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'May', 'Affiliation': 'Department of Kinesiology, ECU, Greenville, NC, USA. mayl@ecu.edu.'}]",BMC pregnancy and childbirth,['10.1186/s12884-021-03717-5']
615,33770739,Effectiveness of empathic caring on stress and depression for women with recurrent miscarriage: A randomized controlled trial.,"AIM


The purpose of this study was to investigate the effectiveness of empathic caring on sleep quality, depression, stress, and social support in women with recurrent miscarriage.
MATERIALS AND METHODS


Sixty-two eligible women were randomly assigned to either the experimental group (n = 31), which received three face-to-face nursing counseling sessions, or the control group (n = 31). Outcome measures included the Pittsburgh Sleep Quality Index, Edinburgh Prenatal Depression Scale, Perceived Stress Scale, and Interpersonal Support Evaluation List.
RESULTS


Paired-sample t-tests revealed that, after receiving nursing counseling, the participants in the experimental group showed significant decreases in stress and depression. However, no significant mean differences were found in the control group between the pretest and the 12-week posttest for any of the four outcome measures.
CONCLUSION


Clinical healthcare professionals may incorporate empathic caring into health-promotion protocols to assist women with recurrent miscarriage to improve their psychosocial health.",2021,"Outcome measures included the Pittsburgh Sleep Quality Index, Edinburgh Prenatal Depression Scale, Perceived Stress Scale, and Interpersonal Support Evaluation List.
","['women with recurrent miscarriage', 'Sixty-two eligible women']",['empathic caring'],"['sleep quality, depression, stress, and social support', 'stress and depression', 'Pittsburgh Sleep Quality Index, Edinburgh Prenatal Depression Scale, Perceived Stress Scale, and Interpersonal Support Evaluation List']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000809', 'cui_str': 'Recurrent miscarriage'}, {'cui': 'C4517835', 'cui_str': '62'}]",[],"[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",62.0,0.0533335,"Outcome measures included the Pittsburgh Sleep Quality Index, Edinburgh Prenatal Depression Scale, Perceived Stress Scale, and Interpersonal Support Evaluation List.
","[{'ForeName': 'Shu-Chen', 'Initials': 'SC', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, College of Medicine, National Cheng Kung University Medical Center, Tainan, Taiwan. Electronic address: csj52@mail.ncku.edu.tw.'}, {'ForeName': 'Pao-Lin', 'Initials': 'PL', 'LastName': 'Kuo', 'Affiliation': 'Department of Obstetrics and Gynecology, College of Medicine, National Cheng-Kung University, Tainan, Taiwan. Electronic address: paolinkuo@gmail.com.'}, {'ForeName': 'Chung-Hey', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Hungkuang University, Taichung, Taiwan; Department of Nursing & Institute of Allied Health Sciences, National Cheng Kung University, Tainan, Taiwan. Electronic address: chunghey@ncku.edu.tw.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101367']
616,33770710,"High frequency repetitive transcranial magnetic stimulation of dorsomedial prefrontal cortex for negative symptoms in patients with schizophrenia: A double-blind, randomized controlled trial.","Negative symptoms are the major challenge in clinical management of schizophrenia. Dorsomedial prefrontal cortex (DMPFC) has been suggested to be highly involved in the mechanisms of negative symptoms of schizophrenia. However, the effect of repetitive Transcranial Magnetic Stimulation (rTMS) over DMPFC has not yet been well studied. In this double-blind, randomized controlled rTMS clinical trial, thirty-three participants (17 in active group and 16 in sham group) were enrolled. This study includes the rTMS treatment phase (lasts for 4 weeks) and a subsequently naturalistic follow-up phase (lasts for another 4 weeks). Schizophrenia patients with prominently negative symptoms were randomly assigned to receive 10 Hz or sham rTMS intervention. The score change in Scale of Negative Symptoms (SANS) was defined as the primary outcome measure. There was a significant decrease in negative symptoms, especially affective flattening and anhedonia in schizophrenia patients after DMPFC-rTMS intervention. Moreover, the negative symptoms improvement could maintain at least another 4 weeks. In addition, no memory impairment or serious adverse reaction of rTMS emerged. Our results suggest that high frequency rTMS over DMPF may represent a safe and effective treatment for negative symptoms in patients with schizophrenia.",2021,"There was a significant decrease in negative symptoms, especially affective flattening and anhedonia in schizophrenia patients after DMPFC-rTMS intervention.","['thirty-three participants (17 in active group and 16 in sham group) were enrolled', 'patients with schizophrenia', 'Schizophrenia patients with prominently negative symptoms']","['repetitive Transcranial Magnetic Stimulation (rTMS', 'High frequency repetitive transcranial magnetic stimulation of dorsomedial prefrontal cortex', '10 Hz or sham rTMS intervention']","['score change in Scale of Negative Symptoms (SANS', 'negative symptoms, especially affective flattening and anhedonia']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}]",33.0,0.0736496,"There was a significant decrease in negative symptoms, especially affective flattening and anhedonia in schizophrenia patients after DMPFC-rTMS intervention.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gan', 'Affiliation': 'First-episode Schizophrenia and Early Psychosis Program, Division of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Junjuan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of EEG and Imaging, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kaiming', 'Initials': 'K', 'LastName': 'Zhuo', 'Affiliation': 'First-episode Schizophrenia and Early Psychosis Program, Division of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jianye', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Imaging, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of EEG and Imaging, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhenying', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': 'Department of EEG and Imaging, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Xiang', 'Affiliation': 'First-episode Schizophrenia and Early Psychosis Program, Division of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'First-episode Schizophrenia and Early Psychosis Program, Division of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'First-episode Schizophrenia and Early Psychosis Program, Division of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jinhong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Imaging, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of EEG and Imaging, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China. Electronic address: jijunwang27@163.com.'}, {'ForeName': 'Dengtang', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'First-episode Schizophrenia and Early Psychosis Program, Division of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Institute of Mental Health, Fudan University, Shanghai, China. Electronic address: liudengtang@smhc.org.cn.'}]",Psychiatry research,['10.1016/j.psychres.2021.113876']
617,33772134,Do composite restorations in primary molar teeth have a higher survival rate following total or selective caries removal?,"Study design A double-blind randomised clinical trial, conducted between June 2009 and June 2011, in a paediatric dental department in a Brazilian dental school.Study selection Children aged 3-8 years, in good general health, with deep carious lesions (caries radiographically located in the inner quarter of dentine) affecting either one or two surfaces in primary molars were eligible for inclusion. Teeth were excluded if clinical or radiographic evidence of pulpal inflammation or necrosis or clinical mobility were observed. Pre-cooperative children were also excluded.Clinical procedures and success criteria Following a coin toss, 120 teeth were randomly assigned to two groups: 55 in the total caries removal (TCR) group and 65 in the selective caries removal (SCR) group. Procedures were carried out by three paediatric dentists under local anaesthesia and restored, using a layering technique, with composite under rubber dam. Restorations were evaluated at 3, 6, 12, 18, 24 and 36 months, using the US Public Health Service (USPHS) scale, by a single-blinded and calibrated examiner. A Charlie or Delta score, on the USPHS scale, at the margins of the restorations was considered as restoration failure. Gingival bleeding score, type of cavity (one or two surfaces) and presence of caries (active or inactive) were recorded as secondary outcomes; however, presence alone did not constitute restoration failure.Results Average survival rate of restorations across all teeth was 68% after 36 months, with SCR statistically significantly lower at 57% compared to TCR at 81% (p = 0.004). Annual failure rates for SCR and TCR were 17.3% and 6.7%, respectively. Two-surface restorations had lower survival rates (58%) compared to single-surface restorations (87%) (p = 0.02). Type of cavity and gingival bleeding statistically influenced the chance of restoration failure at 36 months.Conclusions Composite restorations placed after SCR in primary molars were found to fail more often compared to those restored after TCR. Two-surface cavities and poor gingival health negatively impacted restoration success.",2021,Two-surface restorations had lower survival rates (58%) compared to single-surface restorations (87%) (p = 0.02).,"[' 120 teeth', 'June 2009 and June 2011, in a paediatric dental department in a Brazilian dental school', 'Study selection Children aged 3-8 years, in good general health, with deep carious lesions (caries radiographically located in the inner quarter of dentine) affecting either one or two surfaces in primary molars were eligible for inclusion']",['total caries removal (TCR) group and 65 in the selective caries removal (SCR) group'],"['Annual failure rates for SCR and TCR', 'pulpal inflammation or necrosis or clinical mobility', 'US Public Health Service (USPHS) scale', 'Gingival bleeding score, type of cavity (one or two surfaces) and presence of caries (active or inactive', 'Average survival rate of restorations', 'survival rates', 'survival rate']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0036376', 'cui_str': 'Dental School'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0041734', 'cui_str': 'United States. Public Health Service'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0429154', 'cui_str': 'Gingival bleeding score'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]",120.0,0.197486,Two-surface restorations had lower survival rates (58%) compared to single-surface restorations (87%) (p = 0.02).,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Goldsmith', 'Affiliation': 'Dental Core Trainee (DCT2) in Paediatric Dentistry, Newcastle upon Tyne Hospital NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Greig', 'Initials': 'G', 'LastName': 'Taylor', 'Affiliation': 'NIHR Doctoral Research Fellow/StR in Paediatric Dentistry, School of Dental Sciences, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK; Newcastle upon Tyne Hospital NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Waterhouse', 'Affiliation': 'Newcastle upon Tyne Hospital NHS Foundation Trust, Newcastle upon Tyne, UK; Senior Lecturer/Honorary Consultant in Paediatric Dentistry, School of Dental Sciences, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}]",Evidence-based dentistry,['10.1038/s41432-021-0166-2']
618,33771837,Disability Outcomes in the N-MOmentum Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder.,"OBJECTIVE


To assess treatment effects on Expanded Disability Status Scale (EDSS) score worsening and modified Rankin Scale (mRS) scores in the N-MOmentum trial of inebilizumab, a humanized anti-CD19 monoclonal antibody, in participants with neuromyelitis optica spectrum disorder (NMOSD).
METHODS


Adults (N = 230) with aquaporin-4 immunoglobulin G-seropositive NMOSD or -seronegative neuromyelitis optica and an EDSS score ≤8 were randomized (3:1) to receive inebilizumab 300 mg or placebo on days 1 and 15. The randomized controlled period (RCP) was 28 weeks or until adjudicated attack, with an option to enter the inebilizumab open-label period. Three-month EDSS-confirmed disability progression (CDP) was assessed using a Cox proportional hazard model. The effect of baseline subgroups on disability was assessed by interaction tests. mRS scores from the RCP were analyzed by the Wilcoxon-Mann-Whitney odds approach.
RESULTS


Compared with placebo, inebilizumab reduced the risk of 3-month CDP (hazard ratio [HR]: 0.375; 95% CI: 0.148-0.952;  p  = 0.0390). Baseline disability, prestudy attack frequency, and disease duration did not affect the treatment effect observed with inebilizumab (HRs: 0.213-0.503; interaction tests: all  p  > 0.05, indicating no effect of baseline covariates on outcome). Mean EDSS scores improved with longer-term treatment. Inebilizumab-treated participants were more likely to have a favorable mRS outcome at the end of the RCP (OR: 1.663; 95% CI: 1.195-2.385;  p  = 0.0023).
CONCLUSIONS


Disability outcomes were more favorable with inebilizumab vs placebo in participants with NMOSD.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that for patients with NMOSD, inebilizumab reduces the risk of worsening disability. N-MOmentum is registered at ClinicalTrials.gov: NCT02200770.",2021,"Baseline disability, prestudy attack frequency, and disease duration did not affect the treatment effect observed with inebilizumab (HRs: 0.213-0.503; interaction tests: all  p  > 0.05, indicating no effect of baseline covariates on outcome).","['patients with NMOSD', 'participants with neuromyelitis optica spectrum disorder (NMOSD', 'participants with NMOSD', 'Adults (N = 230) with aquaporin-4 immunoglobulin G-seropositive NMOSD or -seronegative neuromyelitis optica and an EDSS score ≤8']","['inebilizumab', 'Inebilizumab', 'mRS', 'inebilizumab vs placebo', 'inebilizumab 300 mg or placebo', 'inebilizumab, a humanized anti-CD19 monoclonal antibody', 'placebo, inebilizumab']","['disability', 'Disability Outcomes', 'Expanded Disability Status Scale (EDSS) score worsening and modified Rankin Scale (mRS) scores', 'Mean EDSS scores', 'disability progression (CDP', 'Baseline disability, prestudy attack frequency, and disease duration', 'favorable mRS outcome', 'risk of 3-month CDP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027873', 'cui_str': 'Neuromyelitis optica'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0292777', 'cui_str': 'Aquaporin-4'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0008188', 'cui_str': 'Chlordiazepoxide'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",230.0,0.214965,"Baseline disability, prestudy attack frequency, and disease duration did not affect the treatment effect observed with inebilizumab (HRs: 0.213-0.503; interaction tests: all  p  > 0.05, indicating no effect of baseline covariates on outcome).","[{'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Marignier', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco. romain.marignier@chu-lyon.fr.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Bennett', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Ho Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Weinshenker', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Pittock', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Wingerchuk', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Fujihara', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Friedemann', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Ari J', 'Initials': 'AJ', 'LastName': 'Green', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Aktas', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Fred D', 'Initials': 'FD', 'LastName': 'Lublin', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Williams', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Drappa', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Dewei', 'Initials': 'D', 'LastName': 'She', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cimbora', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rees', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Ratchford', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Eliezer', 'Initials': 'E', 'LastName': 'Katz', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000978']
619,33771833,CHILD-BRIGHT READYorNot Brain-Based Disabilities Trial: protocol of a randomised controlled trial (RCT) investigating the effectiveness of a patient-facing e-health intervention designed to enhance healthcare transition readiness in youth.,"INTRODUCTION


Youth with brain-based disabilities (BBDs), as well as their parents/caregivers, often feel ill-prepared for the transfer from paediatric to adult healthcare services. To address this pressing issue, we developed the MyREADY Transition TM  BBD App, a patient-facing e-health intervention. The primary aim of this randomised controlled trial (RCT) was to determine whether the App will result in greater transition readiness compared with usual care for youth with BBD. Secondary aims included exploring the contextual experiences of youth using the App, as well as the interactive processes of youth, their parents/caregivers and healthcare providers around use of the intervention.
METHODS AND ANALYSIS


We aimed to randomise 264 youth with BBD between 15 and 17 years of age, to receive existing services/usual care (control group) or to receive usual care along with the App (intervention group). Our recruitment strategy includes remote and virtual options in response to the current requirements for physical distancing due to the COVID-19 pandemic. We will use an embedded experimental model design which involves embedding a qualitative study within a RCT. The Transition Readiness Assessment Questionnaire will be administered as the primary outcome measure. Analysis of covariance will be used to compare change in the two groups on the primary outcome measure; analysis will be intention-to-treat. Interviews will be conducted with subsets of youth in the intervention group, as well as parents/caregivers and healthcare providers.
ETHICS AND DISSEMINATION


The study has been approved by the research ethics board of each participating site in four different regions in Canada. We will leverage our patient and family partnerships to find novel dissemination strategies. Study findings will be shared with the academic and stakeholder community, including dissemination of teaching and training tools through patient associations, and patient and family advocacy groups.
TRIAL REGISTRATION NUMBER


NCT03852550.",2021,The primary aim of this randomised controlled trial (RCT) was to determine whether the App will result in greater transition readiness compared with usual care for youth with BBD.,"['youth', 'youth with BBD', 'Youth with brain-based disabilities (BBDs', '264 youth with BBD between 15 and 17 years of age, to receive']","['patient-facing e-health intervention', 'existing services/usual care (control group) or to receive usual care along with the App (intervention group']",[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],,0.11803,The primary aim of this randomised controlled trial (RCT) was to determine whether the App will result in greater transition readiness compared with usual care for youth with BBD.,"[{'ForeName': 'Jan Willem', 'Initials': 'JW', 'LastName': 'Gorter', 'Affiliation': 'CanChild, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada gorter@mcmaster.ca.'}, {'ForeName': 'Khush', 'Initials': 'K', 'LastName': 'Amaria', 'Affiliation': 'CBT Associates of Toronto Cognitive Behavioural Therapy Services, Toronto, Ontario, Canada.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Kovacs', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science Univeristy, Portland, Oregon, USA.'}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Rozenblum', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Galuppi', 'Affiliation': 'CanChild, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Nguyen', 'Affiliation': 'CanChild, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Strohm', 'Affiliation': 'CanChild, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nadilein', 'Initials': 'N', 'LastName': 'Mahlberg', 'Affiliation': 'CanChild, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Via-Dufresne Ley', 'Affiliation': 'The Research Institute of the McGill University Health Centre (RI-MUHC), Montreal, Quebec, Canada.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Marelli', 'Affiliation': 'Department of Medicine, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2021-048756']
620,33771832,"Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management: protocol for a multicentre, primary care, randomised, parallel-group, superiority trial.","BACKGROUND


Brace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients' clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists.
METHODS AND ANALYSIS


A multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions.
ETHICS AND DISSEMINATION


North West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders.
TRIAL REGISTRATION NUMBER


ISRCTN28555470.",2021,"Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation.","['knee osteoarthritis (OA', '434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral', 'symptomatic knee osteoarthritis management']","['knee bracing', 'advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone']","['KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability', 'primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0237824', 'cui_str': 'Self-referral'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0006086', 'cui_str': 'Brace'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",434.0,0.187243,"Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation.","[{'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Holden', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK m.holden@keele.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Callaghan', 'Affiliation': 'Faculty of Health, Psychology & Social Care, Manchester Metropolitan University, Manchester, Greater Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Felson', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Birrell', 'Affiliation': 'Medical Research Council Versus Arthritis Centre for Integrated Research into Musculoskeletal Ageing, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Nicholls', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kigozi', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McBeth', 'Affiliation': 'Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, Manchester, UK.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Borrelli', 'Affiliation': 'Henry M. Goldman School of Dental Medicine, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Jinks', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Krysia', 'Initials': 'K', 'LastName': 'Dziedzic', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mallen', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Ingram', 'Affiliation': 'Research User Group, Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sutton', 'Affiliation': 'Research User Group, Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lawton', 'Affiliation': 'Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Halliday', 'Affiliation': 'Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Hartshorne', 'Affiliation': 'Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Williams', 'Affiliation': 'Research in OsteoArthritis Manchester (ROAM), Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, Institute of Inflammation and Repair, The University of Manchester, Manchester, Manchester, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Browell', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, Tyne and Wear, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Hudson', 'Affiliation': 'Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Marshall', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Sowden', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Herron', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Evans', 'Initials': 'E', 'LastName': 'Asamane', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Peat', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.'}]",BMJ open,['10.1136/bmjopen-2020-048196']
621,33769858,Improved work productivity and health-related quality of life in patients with irritable bowel syndrome with diarrhea receiving eluxadoline following inadequate response to loperamide.,"BACKGROUND:  Irritable bowel syndrome with diarrhea (IBS-D) is a chronic disorder of gut-brain interaction that negatively affects work productivity and health-related quality of life (HRQOL). IBS-D therapeutic options are limited and include loperamide, an over-the-counter μ-opioid receptor agonist commonly used as an antidiarrheal agent, and eluxadoline, a mixed μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist approved in the United States for the treatment of IBS-D in adults.  OBJECTIVE:  To characterize the effect of eluxadoline on work productivity and HRQOL in patients with IBS-D with previous inadequate response to loperamide.  METHODS:  The Work Productivity and Activity Impairment Questionnaire for IBS-D (WPAI:IBS-D), Centers for Disease Control and Prevention Healthy Days Core Module (CDC HRQOL-4), and EuroQoL-5 Dimension (EQ-5D) instruments were administered at baseline and week 12 of a phase 4 clinical trial (RELIEF), assessing the efficacy and safety of eluxadoline treatment in adults with IBS-D reporting previous inadequate response to loperamide. Changes from baseline to week 12 for each assessment were evaluated using an analysis of covariance model. Indirect costs were calculated by converting overall work productivity losses into monetary values.  RESULTS:  A total of 346 patients were randomized to either eluxadoline (n = 172) or placebo (n = 174). From baseline to week 12, compared with placebo, twice-daily treatment with eluxadoline resulted in significantly greater reductions in absenteeism (2.6%;  P  = 0.046). Numerically greater decreases in presenteeism, overall work productivity loss, and daily activity impairment were also observed in patients receiving eluxadoline compared with those receiving placebo ( P  = not significant for each). Numerical reductions in overall work productivity loss from baseline to week 12 translate to approximately 2.4 hours per patient per week (123 hours annually) and correspond to an avoided overall work loss of $4,503 annually for an employee with IBS-D treated with eluxadoline. In addition, from baseline to week 12, treatment with eluxadoline led to a significantly greater reduction in the number of unhealthy days experienced (-1.7 days;  P  = 0.042), as well as numerical improvements in EQ-5D measures in comparison with placebo ( P  = not significant for each).  CONCLUSIONS:  In patients with IBS-D reporting inadequate response to loperamide, eluxadoline treatment was associated with significant reductions in absenteeism and the number of unhealthy days experienced. Eluxadoline treatment of IBS-D may lead to significant cost savings via mitigation of losses in work productivity.  DISCLOSURES:  This study was sponsored by Allergan plc (before acquisition by AbbVie, Inc.). Allergan plc and/or AbbVie, Inc., was involved in the study design, collection, analysis, interpretation of the data, writing of the report, and the decision to submit the report for publication. Abel and Burslem are employees of AbbVie, Inc., and own stock/stock options. Brenner has served as a consultant, speaker, and/or advisor for Allergan plc (before acquisition by AbbVie, Inc.), Alnylam, Alpha Sigma, Arena, Bayer, Ironwood Pharmaceuticals, Salix Pharmaceuticals, Shire, Synergy, and Takeda Pharmaceuticals. He is also supported in research by an unrestricted gift from the Irene D. Pritzker Foundation. Sayuk has served as a consultant and speaker for Allergan plc (before acquisition by AbbVie, Inc.), Gi Health Foundation, Ironwood Pharmaceuticals, Salix Pharmaceuticals, and Synergy. Portions of the current work were presented at AMCP Nexus; October 22-25, 2018; Orlando, FL.",2021,"Numerical reductions in overall work productivity loss from baseline to week 12 translate to approximately 2.4 hours per patient per week (123 hours annually) and correspond to an avoided overall work loss of $4,503 annually for an employee with IBS-D treated with eluxadoline.","['patients with irritable bowel syndrome with diarrhea receiving', '346 patients', 'adults with IBS-D reporting previous inadequate response to loperamide', 'patients with IBS-D with previous inadequate response to loperamide', '  Irritable bowel syndrome with diarrhea (IBS-D']","['Eluxadoline', 'eluxadoline', 'placebo']","['work productivity and health-related quality of life', 'work productivity and HRQOL', 'absenteeism', 'EQ-5D measures', 'efficacy and safety', 'overall work productivity loss', 'Indirect costs', 'Work Productivity and Activity Impairment Questionnaire for IBS-D', 'Healthy Days Core Module (CDC HRQOL-4), and EuroQoL-5 Dimension (EQ-5D) instruments', 'presenteeism, overall work productivity loss, and daily activity impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348898', 'cui_str': 'Irritable bowel syndrome with diarrhea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}]","[{'cui': 'C3712232', 'cui_str': 'eluxadoline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",346.0,0.0882203,"Numerical reductions in overall work productivity loss from baseline to week 12 translate to approximately 2.4 hours per patient per week (123 hours annually) and correspond to an avoided overall work loss of $4,503 annually for an employee with IBS-D treated with eluxadoline.","[{'ForeName': 'Darren M', 'Initials': 'DM', 'LastName': 'Brenner', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Sayuk', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Abel', 'Affiliation': 'AbbVie, Madison, NJ.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Burslem', 'Affiliation': 'AbbVie, Madison, NJ.'}]",Journal of managed care & specialty pharmacy,[]
622,33769847,Exposure to Diesel Exhaust and Plasma Cortisol Response: A Randomized Double-Blind Crossover Study.,,2021,,[],[],['Exposure to Diesel Exhaust and Plasma Cortisol Response'],[],[],"[{'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}]",,0.559413,,"[{'ForeName': 'Errol M', 'Initials': 'EM', 'LastName': 'Thomson', 'Affiliation': 'Environmental Health Science and Research Bureau, Healthy Environments and Consumer Safety Branch, Health Canada, Ottawa, Ontario, Canada.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Filiatreault', 'Affiliation': 'Environmental Health Science and Research Bureau, Healthy Environments and Consumer Safety Branch, Health Canada, Ottawa, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Environmental Health Science and Research Bureau, Healthy Environments and Consumer Safety Branch, Health Canada, Ottawa, Ontario, Canada.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Rider', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Carlsten', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Environmental health perspectives,['10.1289/EHP8923']
623,33772133,Is platelet-rich plasma able to accelerate orthodontic tooth movement?,"Objectives To examine whether periodontal injection of platelet-rich plasma (PRP) could accelerate orthodontic tooth movement.Methods A split-mouth randomised controlled clinical trial was conducted among 16 female participants. Canines were retracted on 0.017 x 0.025-inch stainless steel archwires through closed-coil springs attached on first molars with mini-screws for anchorage preservation. The intervention side received PRP + CaCl2 solution and the control side CaCl2 only. Intraligamental injections were performed during the canine retraction period every three weeks (zero, three and six weeks). The rate of canine retraction was assessed through superimposition of digital models every month for a total of four months. Assessment of associated pain was conducted by questionnaire.Results During the four-month period, a faster rate of canine retraction was detected on the intervention side only for the first month. Following cessation of PRP injections, the rate of canine retraction on the intervention side was initially slower than and then similar to that on the control side. An increase of pain was reported on both sides.Conclusions PRP could accelerate orthodontic tooth movement in the short term with no prolonged effects.",2021,"During the four-month period, a faster rate of canine retraction was detected on the intervention side only for the first month.",['16 female participants'],"['PRP injections', 'platelet-rich plasma (PRP', 'PRP + CaCl2 solution']","['orthodontic tooth movement', 'faster rate of canine retraction', 'rate of canine retraction', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",16.0,0.116313,"During the four-month period, a faster rate of canine retraction was detected on the intervention side only for the first month.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Orthodontics, West China Hospital of Stomatology, State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Sichuan University, Sichuan, China.'}, {'ForeName': 'Qianyun', 'Initials': 'Q', 'LastName': 'Kuang', 'Affiliation': 'Department of Orthodontics, West China Hospital of Stomatology, State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Sichuan University, Sichuan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthodontics, West China Hospital of Stomatology, State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Sichuan University, Sichuan, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Long', 'Affiliation': 'Department of Orthodontics, West China Hospital of Stomatology, State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Sichuan University, Sichuan, China.'}]",Evidence-based dentistry,['10.1038/s41432-021-0160-8']
624,33772131,Should atraumatic restorative treatment be the preferred treatment for older patients?,"Design Randomised controlled trial study.Case selection Ninety-nine subjects were chosen from 219 potential subjects. The 99 who met the inclusion criteria were randomly allocated to two treatment groups: atraumatic restorative treatment (ART) and conventional treatment (CT). To be selected, patients needed to be 65 years or over, follow oral hygiene guidance and have one or more painless dentinal carious lesions. To establish suitability, a full dental examination was performed by two calibrated dentists. Prior to receiving ART or CT, all participants received standard dental care (including extractions, non-surgical treatment and oral hygiene instructions). Following ART or CT, a dental nurse collected data regarding patient treatment preferences and a calibrated independent dentist, blind to the treatment allocation, reviewed restorations six months, one year, two years and five years after treatment.Data analysis The Cox proportional-hazards (PH) model was used to assess the cumulative survival of the variables ART and CT between the intervals. Bootstrapping was employed to estimate standard errors since the multiple restorations required by many patients were not necessarily independent of each other.Results Of the 99 subjects included, only 28 (ART: 15, CT: 13) remained after five years. After five years, of the 300 restorations undertaken, 15 ART restorations and 16 CT restorations failed. The cumulative probability of restoration survival was 85% and 79% (p = 0.8095) for ART and CT, respectively, with the Cox PH model showing the treatment used had no effect on the restorations' survival.Conclusions No significant difference was noted between the treatment methods used in terms of survival of the restorations. However, it is worth noting that 64.5% of participants preferred to have dental treatment without local anaesthesia and 71.1% without the use of a dental drill. Therefore, ART was a favourable treatment option in older patients, particularly those unable to attend the dental surgery.",2021,"The cumulative probability of restoration survival was 85% and 79% (p = 0.8095) for ART and CT, respectively, with the Cox PH model showing the treatment used had no effect on the restorations' survival.","['Case selection Ninety-nine subjects were chosen from 219 potential subjects', 'After five years, of the 300 restorations undertaken, 15 ART restorations and 16 CT restorations failed', '99 who met the inclusion criteria', 'older patients', '99 subjects included, only 28 (ART: 15, CT: 13) remained after five years', 'patients needed to be 65 years or over, follow oral hygiene guidance and have one or more painless dentinal carious lesions']","['atraumatic restorative treatment (ART) and conventional treatment (CT', 'standard dental care (including extractions, non-surgical treatment and oral hygiene instructions']","['cumulative probability of restoration survival', 'cumulative survival', ""restorations' survival"", 'survival of the restorations']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",99.0,0.0452317,"The cumulative probability of restoration survival was 85% and 79% (p = 0.8095) for ART and CT, respectively, with the Cox PH model showing the treatment used had no effect on the restorations' survival.","[{'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Oliver', 'Affiliation': 'DCT, Restorative and Research Departments, Glasgow Dental Hospital, Scotland, UK.'}]",Evidence-based dentistry,['10.1038/s41432-021-0164-4']
625,33772130,Does the exposure to 'ideal' facial images on Instagram influence facial and bodily satisfaction?,"Design Randomised controlled trial.Intervention Undergraduate students aged 18 to 35 years were randomly allocated to either navigate a bespoke Instagram page featuring 'ideal' facial images as judged by five orthodontists (n = 71) or neutral images of nature (n = 61). Participants were allowed to view the Instagram page once and for a duration of five minutes.Outcome measures The primary outcome was facial dissatisfaction which was measured using the Facial Satisfaction Scale (FSS). Secondary outcomes included: body dissatisfaction, which was measured using the Body Satisfaction Scale (BSS), and overall body and facial dissatisfaction, measured as a sum of scores of BSS and FSS.Data analysis Data were analysed using repeated measures analysis of variance (ANOVA) and multivariate regression analyses.Results Exposure to 'ideal' facial images on Instagram resulted in significantly lower facial satisfaction scores (-2.39; 95% confidence interval [CI]: -4.32, -0.46 P <0.016), with no significant difference in BSS (-2.74; CI: -5.66, 0.19) and overall scores (-3.49; CI: -6.10, -0.87) when compared to the control group. Based on the multivariate regression analysis, high baseline self-discrepancy scores negatively affected both FSS and BSS.Conclusions Exposure to 'ideal' facial images on Instagram resulted in an immediate and negative impact on FSS when compared to neutral images of nature. While this study is interesting, further robust research to clarify the effect of various social networking sites on facial and bodily satisfaction remains necessary.",2021,"Results Exposure to 'ideal' facial images on Instagram resulted in significantly lower facial satisfaction scores (-2.39; 95% confidence interval [CI]: -4.32, -0.46 P <0.016), with no significant difference in BSS (",['Intervention Undergraduate students aged 18 to 35 years'],"[""navigate a bespoke Instagram page featuring 'ideal' facial images as judged by five orthodontists (n = 71) or neutral images of nature""]","['facial dissatisfaction which was measured using the Facial Satisfaction Scale (FSS', 'facial satisfaction scores', 'body dissatisfaction, which was measured using the Body Satisfaction Scale (BSS), and overall body and facial dissatisfaction, measured as a sum of scores of BSS and FSS.Data analysis Data', 'BSS ', 'overall scores']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0260083', 'cui_str': 'Orthodontist'}, {'cui': 'C0349590', 'cui_str': 'Nature'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.201604,"Results Exposure to 'ideal' facial images on Instagram resulted in significantly lower facial satisfaction scores (-2.39; 95% confidence interval [CI]: -4.32, -0.46 P <0.016), with no significant difference in BSS (","[{'ForeName': 'Aslam', 'Initials': 'A', 'LastName': 'Alkadhimi', 'Affiliation': 'Orthodontic Specialist Registrar, University College London, Eastman Dental Institute, London and Buckinghamshire Healthcare NHS Trust, UK. aslam.alkadhimi.17@ucl.ac.uk.'}]",Evidence-based dentistry,['10.1038/s41432-021-0154-6']
626,33772124,Delivering dental health promotion in developing countries: should this be carried out by non-dental professionals?,"Design Three-armed randomised clinical trial.Study selection The study's aim was to examine the effectiveness of providing oral health promotion, prevention and a restorative programme at mother and child health clinics (MCHs) through a multidisciplinary team. This was studied by collecting data on the participants' caries rates. The study sample consisted of 368 Peruvian children, aged 0-3 years, who were from low socioeconomic areas of Peru and were studied over three different MCHs. The interventions used in this study are split into active intervention group (AG), passive intervention group (PG) and control group (CG). The AG group had multiple interventions, such as multiple training courses for nurses on dental health, oral health-related information cards (OHICs) and atraumatic restorative treatment (ART)-trained dentists. The PG implemented OHICs and ART-trained dentists, and the CG nurses received a 45-minute lecture on the importance of oral health and regular protocols followed.Data analysis/data extraction and synthesis Caries Assessment Spectrum and Treatment (CAST) scores were used to measure the participants' caries rates. The CAST scores were collected over a three-year period by two calibrated and trained dentists. The CAST scores ranged from 0 (no caries) to 8 (loss of tooth due to caries), although the authors only collected data from scores 3-8 as this was indicating disease presence.Results The results were gathered for each arm of the study and compared using analysis of variance. The results showed that it was statistically significant (P <0.001) that the AG group had a lower rate of carious dentine compared to the PG and CG groups. The percentage of carious dentine prevalence was 10%, 60.5% and 63.0%, respectively.Conclusion The conclusion of the paper is that using a multidisciplinary approach - with trained nurses, delivery of oral health inspection and advice - can reduce the rate of caries in 0-3-year-olds.",2021,The results showed that it was statistically significant (P <0.001) that the AG group had a lower rate of carious dentine compared to the PG and CG groups.,"['368 Peruvian children, aged 0-3 years, who were from low socioeconomic areas of Peru and were studied over three different MCHs', 'developing countries', ""participants' caries rates""]","['active intervention group (AG), passive intervention group (PG) and control group (CG']","['synthesis Caries Assessment Spectrum and Treatment (CAST) scores', 'percentage of carious dentine prevalence', 'rate of carious dentine', 'CAST scores', 'rate of caries']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",368.0,0.048967,The results showed that it was statistically significant (P <0.001) that the AG group had a lower rate of carious dentine compared to the PG and CG groups.,"[{'ForeName': 'Meaghan', 'Initials': 'M', 'LastName': 'Shankland', 'Affiliation': 'DCT, Glasgow Dental Hospital & School, Glasgow, UK.'}]",Evidence-based dentistry,['10.1038/s41432-021-0147-5']
627,33773357,Predictors and moderators of symptom change during cognitive-behavioral therapy or supportive psychotherapy for body dysmorphic disorder.,"BACKGROUND


Research on predictors of treatment outcome in body dysmorphic disorder, a common and severe disorder, is very limited, and no prior studies have examined moderators of outcome. Because treatment is often but not always efficacious, it is important to identify who is more likely to benefit. We examined predictors and moderators of improvement with therapist-delivered cognitive-behavioral therapy versus supportive psychotherapy in the only study of these treatments for body dysmorphic disorder. This report presents secondary analyses from a study whose primary findings have previously been published (Wilhelm et al., 2019).
METHODS


Participants (N=120) with DSM-IV body dysmorphic disorder were randomized to therapist-delivered weekly cognitive-behavioral therapy or supportive therapy for 24 weeks. Using reliable and valid measures, we tested baseline body dysmorphic disorder severity, insight/delusionality, and depression severity as predictors and moderators of overall and treatment modality-specific symptom change. We explored additional variables as predictors and moderators of outcome.
RESULTS


Greater treatment credibility (p=0.02) and presence of obsessive-compulsive personality disorder (p=0.03) predicted greater improvement. Serotonin-reuptake inhibitor treatment at baseline (unchanged during the study) (p=0.01) predicted less improvement. No other variables predicted or moderated outcome (all p>0.05).
LIMITATIONS


The study was not powered a priori to detect predictor or moderation effects, which limited our ability to detect them unless they were strong.
CONCLUSIONS


Because greater treatment credibility predicted better outcomes, fostering credibility during therapy may maximize gains. Improvement was not impeded by more severe body dysmorphic disorder, depressive symptoms, or poorer insight. No variables moderated treatment-specific improvement.",2021,"RESULTS


Greater treatment credibility (p=0.02) and presence of obsessive-compulsive personality disorder (p=0.03) predicted greater improvement.","['Participants (N=120) with DSM-IV body dysmorphic disorder', 'body dysmorphic disorder']","['therapist-delivered weekly cognitive-behavioral therapy or supportive therapy', 'therapist-delivered cognitive-behavioral therapy versus supportive psychotherapy', 'cognitive-behavioral therapy or supportive psychotherapy']","['baseline body dysmorphic disorder severity, insight/delusionality, and depression severity as predictors and moderators of overall and treatment modality-specific symptom change', 'presence of obsessive-compulsive personality disorder', 'severe body dysmorphic disorder, depressive symptoms, or poorer insight']","[{'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0005887', 'cui_str': 'Body dysmorphic disorder'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005887', 'cui_str': 'Body dysmorphic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",,0.0605692,"RESULTS


Greater treatment credibility (p=0.02) and presence of obsessive-compulsive personality disorder (p=0.03) predicted greater improvement.","[{'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Phillips', 'Affiliation': 'Rhode Island Hospital; Alpert Medical School of Brown University; New York-Presbyterian Hospital; Weill Cornell Medical College, Cornell University. Electronic address: kap9161@med.cornell.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Greenberg', 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Weingarden', 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': ""O'Keefe"", 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Keshaviah', 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School; Mathematica Policy Research.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schoenfeld', 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wilhelm', 'Affiliation': 'Massachusetts General Hospital; Harvard Medical School.'}]",Journal of affective disorders,['10.1016/j.jad.2021.03.011']
628,33773275,Sentinel lymph node biopsy and morbidity outcomes in early cervical cancer: Results of a multicentre randomised trial (SENTICOL-2).,"INTRODUCTION


Pelvic lymph node dissection has been the standard of care for patients with early cervical cancer. Sentinel node (SN) mapping is safe and feasible and may increase the detection of metastatic disease, but benefits of omitting pelvic lymph node dissection in terms of decreased morbidity have not been demonstrated.
MATERIALS AND METHODS


In an open-label study, patients with early cervical carcinoma (FIGO 2009 stage IA2 to IIA1) were randomly assigned to SN resection alone (SN arm) or SN and pelvic lymph node dissection (SN + PLND arm). SN resection was followed by radical surgery of the tumour (radical hysterectomy or radical trachelectomy). The primary end-point was morbidity related to the lymph node dissection; 3-year recurrence-free survival was a secondary end-point.
RESULTS


A total of 206 patients were eligible and randomly assigned to the SN arm (105 patients) or SN + PLND arm (101 patients). Most patients had stage IB1 lesion (87.4%). No false-negative case was observed in SN + PLND arm. Lymphatic morbidity was significantly lower in the SN arm (31.4%) than in the SN + PLND arm (51.5%; p = 0.0046), as was the rate of postoperative neurological symptoms (7.8% vs. 20.6%, p = 0.01, respectively). However, there was no significant difference in the proportion of patients with significant lymphoedema between the two groups. During the 6-month postoperative period, the difference in morbidity decreased over time. The 3-year recurrence-free survival was not significantly different (92.0% in SN arm and 94.4% in SN + PLND arm).
CONCLUSION


SN resection alone is associated with early decreased lymphatic morbidity when compared with SN + PLND in early cervical cancer.",2021,"Lymphatic morbidity was significantly lower in the SN arm (31.4%) than in the SN + PLND arm (51.5%; p = 0.0046), as was the rate of postoperative neurological symptoms (7.8% vs. 20.6%, p = 0.01, respectively).","['patients with early cervical carcinoma (FIGO 2009 stage IA2 to IIA1', 'early cervical cancer', '206 patients were eligible and randomly assigned to the SN arm (105 patients) or', 'patients with early cervical cancer']","['SN resection alone (SN arm) or SN and pelvic lymph node dissection (SN\xa0+\xa0PLND arm', 'SN resection was followed by radical surgery of the tumour (radical hysterectomy or radical trachelectomy', 'SN\xa0+\xa0PLND', 'SN resection']","['lymphatic morbidity', 'stage IB1 lesion', 'rate of postoperative neurological symptoms', 'Lymphatic morbidity', '3-year recurrence-free survival', 'morbidity', 'morbidity related to the lymph node dissection; 3-year recurrence-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix'}, {'cui': 'C0457157', 'cui_str': 'Stage 1a2'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0195331', 'cui_str': 'Amputation of cervix'}]","[{'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]",206.0,0.0916035,"Lymphatic morbidity was significantly lower in the SN arm (31.4%) than in the SN + PLND arm (51.5%; p = 0.0046), as was the rate of postoperative neurological symptoms (7.8% vs. 20.6%, p = 0.01, respectively).","[{'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Mathevet', 'Affiliation': 'Patrice Mathevet, CHU Vaudois, Service de Gynécologie, Avenue P. Decker 2, 1011, Lausanne, Switzerland; Hospices Civils de Lyon, Public Health Department, Lyon, 69003, France. Electronic address: Patrice.Mathevet@chuv.ch.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Lécuru', 'Affiliation': ""Fabrice Lécuru and Virginie Fourchotte, Breast Gynecology and Reconstructive Surgery Department, Curie Institute, 26 Rue D'Ulm, 75005 Paris, France.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Uzan', 'Affiliation': ""Catherine Uzan, Institut Gustave Roussy, 114 Rue Edouard Vaillant, 94805, Villejuif Cedex, France; Hôpital Pitié Salpétrière, Service de Gynécologie, 83 Boulevard de L'hôpital 75013 Paris, France; Institut Universitaire de Cancérologie, Université Sorbonne, INSERM U938, Paris, France.""}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Boutitie', 'Affiliation': 'Florent Boutitie, Hospices Civils de Lyon, Service de Biostatistique, 69003 Lyon, France; Université Lyon 1, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, 69100 Villeurbanne, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Magaud', 'Affiliation': 'Laurent Magaud, Hospices Civils de Lyon, Département de Santé Publique, 69003 Lyon, France; Université Lyon 1, EA 7425 HESPER, 69008 Lyon, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Guyon', 'Affiliation': ""Frédéric Guyon, Institut Bergonié, 229 Cours de L'Argonne, 33000 Bordeaux, France.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Querleu', 'Affiliation': 'Denis Querleu, Institut Claudius Regaud, 1 Av. Irène Joliot-Curie, 31059 Toulouse Cedex 9, France; ESGO, Brussels, Belgium.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Fourchotte', 'Affiliation': ""Fabrice Lécuru and Virginie Fourchotte, Breast Gynecology and Reconstructive Surgery Department, Curie Institute, 26 Rue D'Ulm, 75005 Paris, France.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Baron', 'Affiliation': ""Centre Henri Becquerel, 1 Rue D'Amiens, 76038 Rouen, France.""}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Bats', 'Affiliation': 'Anne-Sophie Bats, Hôpital Européen Georges Pompidou, Service de Gynécologie, 20-40 Rue Leblanc, 75908 Paris Cedex 15, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2021.02.009']
629,33773221,Measuring the impact of productive failure on nursing students' learning in healthcare simulation: A quasi-experimental study.,"BACKGROUND


Previous research suggests that making errors in a non-threatening simulated environment can facilitate learning. Productive failure, which combines problem-solving tasks followed by instruction, enables students to learn from making mistakes. This teaching approach has demonstrated improved learning outcomes such as explanatory knowledge and transfer of knowledge compared to a direct instruction approach where students receive instruction prior to problem-solving tasks. However, no previous studies have examined the impact of productive failure on nursing students' learning in manikin-based simulation.
OBJECTIVE


To measure the impact of productive failure on nursing students' declarative knowledge, explanatory knowledge, and transfer of knowledge compared to a direct instruction approach in a paediatric closed head injury simulation.
METHODS


Second year undergraduate nursing students (n = 349) from one Australian university were invited to participate in the study. Consenting participants (n = 344) were randomised into two groups: productive failure and direct instruction. The intervention consisted of two paediatric closed head injury simulations separated by a simulation debrief. Knowledge tests were administered before and immediately after the simulation.
RESULTS


Data from 331 participants were analysed. The productive failure group outperformed the direct instruction group in the post-test (p < 0.001). Learning gains for participants in the productive failure group were significantly higher than the direct instruction group for both explanatory knowledge (p < 0.001) and the ability to apply learning to solve novel clinical problems (p < 0.001). The difference in the median scores for declarative knowledge was not significant (p = 0.096).
CONCLUSION


This study demonstrated that a productive failure simulation that leads learners to make mistakes before receiving instruction can facilitate deeper levels of explanatory knowledge and enable the transfer of learning to new clinical situations. These results suggest the need for further exploration of pedagogies that foster learning from errors in simulation-based learning.",2021,The productive failure group outperformed the direct instruction group in the post-test (p < 0.001).,"['331 participants were analysed', 'Consenting participants (n\xa0=\xa0344', 'Second year undergraduate nursing students (n\xa0=\xa0349) from one Australian university were invited to participate in the study', ""nursing students' learning in healthcare simulation""]",['productive failure and direct instruction'],"['Learning gains', 'ability to apply learning to solve novel clinical problems', 'median scores for declarative knowledge']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",2.0,0.0873573,The productive failure group outperformed the direct instruction group in the post-test (p < 0.001).,"[{'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Palominos', 'Affiliation': 'Faculty of Health, University of Technology Sydney, 235 Jones St, Ultimo, NSW 2007, Australia. Electronic address: evelyn.m.palominosletelier@student.uts.edu.au.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Levett-Jones', 'Affiliation': 'Faculty of Health, University of Technology Sydney, 235 Jones St, Ultimo, NSW 2007, Australia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Power', 'Affiliation': 'Faculty of Health, University of Technology Sydney, 235 Jones St, Ultimo, NSW 2007, Australia.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Alcorn', 'Affiliation': 'Faculty of Health, University of Technology Sydney, 235 Jones St, Ultimo, NSW 2007, Australia.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Martinez-Maldonado', 'Affiliation': 'Faculty of Information Technologies, Monash University, Victoria, Australia.'}]",Nurse education today,['10.1016/j.nedt.2021.104871']
630,33773207,"The AMPK modulator metformin as adjunct to methotrexate in patients with rheumatoid arthritis: A proof-of-concept, randomized, double-blind, placebo-controlled trial.","BACKGROUND


Metformin (MET) may exert anti-rheumatic effects and reduce cartilage degradation through its immunomodulatory and anti-inflammatory actions.
METHODS


This was a double-blind placebo-controlled study, 120 adult patients with active rheumatoid arthritis (RA) were randomized to receive MET (1000 mg) or placebo daily with methotrexate (MTX, 7.5 mg/week) for 12 weeks. American College of Rheumatology (ACR)20, ACR50, and ACR70 response rates, Disease Activity Score in 28 joints (DAS-28), and drug safety were the efficacy endpoints. Serum levels of TNF-α, IL-1β, IL-6, IL-10, IL-17A, NF-κB, TGG-β1, MDA together with gene expression of AMPK and IGF-IR were assessed before and after the therapy.
RESULTS


A total of 80.8% of the patients in the MET group, compared with 54.7% in placebo group, met the criteria of ACR20 response after 12 weeks (P = 0.001). Statistically significant enhancements in the DAS28-3 (CRP) were observed after 4 and 8 weeks for the MET group compared with placebo and were sustained after 12 weeks. MET group showed statistically significant increase in percentage of patients achieving DAS remission after 12 weeks (P = 0.015). Significant improvements in ACR50, ACR70, Health Assessment Questionnaire Disability Index (HAQ-DI), and DAS28-3 (CRP) were also reported. MET was well-tolerated, and no serious adverse effects were reported in both groups. Furthermore, the MET group was superior in improving the measured parameters compared to the placebo.
CONCLUSIONS


MET improved the anti-rheumatic effect of MTX; suggesting it to be a beneficial adjuvant in patients with RA. Trial registration ID: NCT04068246.",2021,Statistically significant enhancements in the DAS28-3 (CRP) were observed after 4 and 8 weeks for the MET group compared with placebo and were sustained after 12 weeks.,"['patients with rheumatoid arthritis', 'patients with RA', '120 adult patients with active rheumatoid arthritis (RA']","['methotrexate', 'MTX', 'placebo', 'placebo daily with methotrexate (MTX', 'AMPK modulator metformin', 'Metformin (MET']","['Serum levels of TNF-α, IL-1β, IL-6, IL-10, IL-17A, NF-κB', 'AMPK and IGF-IR', 'DAS28-3 (CRP', 'criteria of ACR20 response', 'percentage of patients achieving DAS remission', 'ACR50, ACR70, Health Assessment Questionnaire Disability Index (HAQ-DI), and DAS28-3 (CRP', 'American College of Rheumatology (ACR)20, ACR50, and ACR70 response rates, Disease Activity Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2350345', 'cui_str': 'AMP-Activated Protein Kinase'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C2350345', 'cui_str': 'AMP-Activated Protein Kinase'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",120.0,0.812628,Statistically significant enhancements in the DAS28-3 (CRP) were observed after 4 and 8 weeks for the MET group compared with placebo and were sustained after 12 weeks.,"[{'ForeName': 'Mahmoud S', 'Initials': 'MS', 'LastName': 'Abdallah', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, University of Sadat City, Sadat City, Menoufia 32897, Egypt. Electronic address: Mahmoud.samy@fop.usc.edu.eg.'}, {'ForeName': 'Sumaiah J', 'Initials': 'SJ', 'LastName': 'Alarfaj', 'Affiliation': 'Department of Pharmacy Practice, College of Pharmacy, Princess Nourah Bint Abdulrahman University, Saudi Arabia.'}, {'ForeName': 'Dalia S', 'Initials': 'DS', 'LastName': 'Saif', 'Affiliation': 'Department of Physical Medicine, Rheumatology and Rehabilitation, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Mostafa E', 'Initials': 'ME', 'LastName': 'El-Naggar', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, University of Sadat City, Menoufia, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Elsokary', 'Affiliation': 'Department of Biostatistics, High Institute of Public Health, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Hozaifa K', 'Initials': 'HK', 'LastName': 'Elsawah', 'Affiliation': 'Department of Biostatistics, High Institute of Public Health, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Shimaa', 'Initials': 'S', 'LastName': 'Abdelsattar Zaki', 'Affiliation': 'Department of Clinical Biochemistry and Molecular Diagnostics, National Liver Institute, Menoufia University, Egypt.'}, {'ForeName': 'Engy A', 'Initials': 'EA', 'LastName': 'Wahsh', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, October 6 University, Egypt.'}, {'ForeName': 'Hend E', 'Initials': 'HE', 'LastName': 'Abo Mansour', 'Affiliation': 'Department of Biochemistry, Faculty of Pharmacy, Menoufia University, Egypt.'}, {'ForeName': 'Esraa M', 'Initials': 'EM', 'LastName': 'Mosalam', 'Affiliation': 'Department of Biochemistry, Faculty of Pharmacy, Menoufia University, Egypt.'}]",International immunopharmacology,['10.1016/j.intimp.2021.107575']
631,33776631,Brain Functional Mechanisms Determining the Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Primary Insomnia.,"Transcutaneous auricular vagus nerve stimulation (taVNS) has been reported to be effective in the treatment of primary insomnia (PI); however, its efficacy varies considerably across individuals for reasons that are unclear. In order to clarify the underlying mechanisms, this study investigated the effects of taVNS on spontaneous neuronal activity and autonomic nervous system function by functional magnetic resonance imaging (fMRI) and measurement of heart rate variability (HRV), respectively, in patients with PI. Forty patients with PI were divided into effective (group A) and ineffective (group B) groups based on their response to taVNS as determined by Pittsburgh Sleep Quality Index score reduction rate (group A ≥ 25% and group B < 25%). Spontaneous neuronal activity was measured by fractional amplitude of low-frequency fluctuations (fALFF) and HRV values and was compared between the two groups as well as before  vs  after taVNS. We then analyzed the correlations among efficacy of taVNS for 4 weeks, the fALFF and HRV values during continuous taVNS state. The results showed that the HRV parameter values (i.e., root mean square of successive differences, percentage of adjacent NN intervals differing by >50 ms, and high frequency) of group A were higher than those of group B during continuous taVNS state. In the fMRI scan, the fALFF values of the right cerebellum, right medial superior frontal gyrus, and bilateral supplementary motor area-which belong to the sensorimotor network (SMN)-were lower in group A than in group B during continuous taVNS state. The correlation analysis revealed that the efficacy of continuous taVNS and HRV and fALFF values were interrelated. These findings demonstrate that differential regulation of the SMN by the autonomic nervous system may be responsible for inter-individual variations in the efficacy of taVNS and suggest that HRV and fALFF are potential biomarkers for predicting PI patients' response to taVNS treatment.",2021,"The results showed that the HRV parameter values (i.e., root mean square of successive differences, percentage of adjacent NN intervals differing by >50 ms, and high frequency) of group A were higher than those of group B during continuous taVNS state.","['patients with PI', 'Primary Insomnia', 'Forty patients with PI']","['Transcutaneous auricular vagus nerve stimulation (taVNS', 'Transcutaneous Auricular Vagus Nerve Stimulation', 'taVNS']","['Spontaneous neuronal activity', 'fALFF and HRV values', 'Pittsburgh Sleep Quality Index score reduction rate', 'fractional amplitude of low-frequency fluctuations (fALFF) and HRV values', 'heart rate variability (HRV', 'HRV parameter values', 'efficacy of continuous taVNS and HRV and fALFF values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0549193', 'cui_str': 'Parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]",40.0,0.0327961,"The results showed that the HRV parameter values (i.e., root mean square of successive differences, percentage of adjacent NN intervals differing by >50 ms, and high frequency) of group A were higher than those of group B during continuous taVNS state.","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Chinese Medicine, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Wen-Ting', 'Initials': 'WT', 'LastName': 'Luo', 'Affiliation': 'The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Run-Ru', 'Initials': 'RR', 'LastName': 'Mai', 'Affiliation': 'Department of Sleep Disorder, Fangcun Branch, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Hou', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Zi-Qiang', 'Initials': 'ZQ', 'LastName': 'Xia', 'Affiliation': 'The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Bi-Yun', 'Initials': 'BY', 'LastName': 'Xu', 'Affiliation': 'Department of Sleep Disorder, Fangcun Branch, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}]",Frontiers in neuroscience,['10.3389/fnins.2021.609640']
632,33776569,Effects of Zinc supplementation on serum copper to Zinc and CRP to albumin ratios in hemodialysis patients.,"Background


Zinc (Zn) deficiency is a common condition and could contribute to poor outcomes in hemodialysis (HD) patients. The aim of this study was to evaluate the effects of Zn supplementation on serum copper (Cu) to Zn and C-reactive protein (CRP) to albumin ratios (CAR) in HD patients.
Methods


Seventy-seven HD patients were enrolled in a multicentre simple-blind randomized clinical trial. Only 37 HD patients completed the study; they were randomly divided into two groups and supplemented with zinc sulphate (n=17) or placebo (n=20) for two months. Serum Zn and Cu were measured by atomic absorption spectrophotometry. Serum albumin and hypersensitive-CRP were assessed by colorimetric and immunoturbidimetric method, respectively. Determinations were performed before and after supplementation.
Results


After two months of supplementation, serum Zn significantly increased, and Cu to Zn ratio decreased in Zn supplemented group, but remained unchanged in the placebo group. In parallel, serum albumin concentrations significantly increased, and CAR decreased in Zn supplemented group only.
Conclusions


Zn supplementation reduces Cu to Zn and CRP to albumin ratios in HD patients. These changes point towards an improvement in nutritional, oxidative and inflammatory status. The study findings suggest that correcting Zn deficiency reduces poor outcomes in HD patients.",2021,"In parallel, serum albumin concentrations significantly increased, and CAR decreased in Zn supplemented group only.
","['37 HD patients completed the study', 'hemodialysis patients', 'hemodialysis (HD) patients', 'HD patients', 'Methods\n\n\nSeventy-seven HD patients']","['Zn supplementation', 'placebo', 'Zinc supplementation', 'zinc sulphate']","['Serum Zn and Cu', 'CAR', 'serum copper (Cu) to Zn and C-reactive protein (CRP) to albumin ratios (CAR', 'Serum albumin and hypersensitive-CRP', 'Cu to Zn ratio', 'serum albumin concentrations', 'nutritional, oxidative and inflammatory status', 'serum copper to Zinc and CRP to albumin ratios']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}]","[{'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0858105', 'cui_str': 'Serum copper'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",77.0,0.0892714,"In parallel, serum albumin concentrations significantly increased, and CAR decreased in Zn supplemented group only.
","[{'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Hajji', 'Affiliation': 'University of Tunis El Manar, Faculty of Medicine of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Khedher', 'Affiliation': 'University of Tunis El Manar, Faculty of Medicine of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Mrad', 'Affiliation': 'University of Tunis El Manar, Faculty of Medicine of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Hammami Mohamed', 'Initials': 'HM', 'LastName': 'Bassem', 'Affiliation': 'University of Tunis El Manar, Faculty of Medicine of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Nawel', 'Initials': 'N', 'LastName': 'Rafrafi', 'Affiliation': 'Radial Hemodialysis Clinic, Manouba, Tunisia.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Chouchi', 'Affiliation': 'Udial Hemodialysis Clinic, Tunis, Tunisia.'}, {'ForeName': 'Moncef', 'Initials': 'M', 'LastName': 'Feki', 'Affiliation': 'University of Tunis El Manar, Faculty of Medicine of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Afef', 'Initials': 'A', 'LastName': 'Bahlous', 'Affiliation': 'University of Tunis El Manar, Faculty of Medicine of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Zouaghi', 'Affiliation': 'University of Tunis El Manar, Faculty of Medicine of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Hayet', 'Initials': 'H', 'LastName': 'Fellah', 'Affiliation': 'University of Tunis El Manar, Faculty of Medicine of Tunis, Tunis, Tunisia.'}]",Journal of medical biochemistry,['10.5937/jomb0-26698']
633,33776475,Single and Repeated Intrapleural Ropivacaine Administration: A Plasma Concentration and Pharmacodynamics Study.,"Background


Intrapleural analgesia has been increasingly recommended for postoperative analgesia after thoracic surgery. However, the analgesic effect provided by a single intrapleural administration is time limited. This study reports the efficacy and safety of repeated intrapleural 0.75% ropivacaine administration after thoracoscopic surgery.
Methods


Twenty patients were randomly divided into two groups: a single administration group receiving a single intrapleural injection of 0.75% ropivacaine 15 mL (single administration group, SA group), and a repeated administration group with an intrapleural injection of 0.75% ropivacaine 15 mL every 4h for 4 doses (repeated administration group, RA group). The primary outcomes of this study were the peak plasma concentration of ropivacaine and 24h morphine consumption. The secondary outcomes were pain score, patient satisfaction, extubation time, hospital length of stay, and adverse reactions.
Results


In SA group, the highest plasma concentration after intrapleural administration of 0.75% ropivacaine 15 mL was 1345±364 μg/L. The highest plasma concentration in RA group after the fourth administration was 1864±492 μg/L. The 24h morphine consumption in RA group was significantly less than that in SA group (9.0±5.66 vs 15.9±3.48 mg,  P =0.004). The NRS scores at rest and while coughing of patients in RA group were significantly lower than those in SA group at 5, 9, 13, 17 and 24h after operation. The patients in RA group had higher satisfaction than those in SA group. There was no significant difference in postoperative adverse events, drainage tube placement days and hospital length of stay between the two groups.
Conclusion


Repeated intrapleural administration with 0.75% ropivacaine, 15 mL every 4h for 4 doses after video-assisted thoracoscopic lobectomies, can provide a more durable and more effective analgesic effect than single intrapleural administration. Repeated intrapleural administration of ropivacaine is an effective postoperative method of analgesia resulting in higher patient satisfaction. Moreover, it was also able to keep the plasma concentration of ropivacaine within a possible safe range.
Clinical Trial Registration Number


ChiCTR-IOR-17010560.",2021,"There was no significant difference in postoperative adverse events, drainage tube placement days and hospital length of stay between the two groups.
",['Methods\n\n\nTwenty patients'],"['ropivacaine', 'Ropivacaine', 'single administration group receiving a single intrapleural injection of 0.75% ropivacaine 15 mL (single administration group, SA', 'intrapleural injection of 0.75% ropivacaine']","['plasma concentration', 'NRS scores at rest and while coughing', 'efficacy and safety', 'highest plasma concentration', 'peak plasma concentration of ropivacaine and 24h morphine consumption', 'higher satisfaction', 'effective analgesic effect', 'pain score, patient satisfaction, extubation time, hospital length of stay, and adverse reactions', 'postoperative adverse events, drainage tube placement days and hospital length of stay']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0595451', 'cui_str': 'Intrapleural route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4068882', 'cui_str': '0.75'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",20.0,0.122622,"There was no significant difference in postoperative adverse events, drainage tube placement days and hospital length of stay between the two groups.
","[{'ForeName': 'Yuanqing', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, People's Republic of China.""}, {'ForeName': 'Yaoyao', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, People's Republic of China.""}, {'ForeName': 'Yingchao', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Papadimos', 'Affiliation': 'Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, People's Republic of China.""}, {'ForeName': 'Xuzhong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Private Anesthesiology Consultant, Wenzhou, People's Republic of China.""}, {'ForeName': 'Quanguang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, People's Republic of China.""}, {'ForeName': 'Kejian', 'Initials': 'K', 'LastName': 'Shi', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, People's Republic of China.""}, {'ForeName': 'Yiquan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S295913']
634,33776469,Evaluation of Adjunctive Photobiomodulation (PBMT) for COVID-19 Pneumonia via Clinical Status and Pulmonary Severity Indices in a Preliminary Trial.,"Purpose


Evidence-based and effective treatments for COVID-19 are limited, and a new wave of infections and deaths calls for novel, easily implemented treatment strategies. Photobiomodulation therapy (PBMT) is a well-known adjunctive treatment for pain management, wound healing, lymphedema, and cellulitis. PBMT uses light to start a cascade of photochemical reactions that lead to local and systemic anti-inflammatory effects at multiple levels and that stimulate healing. Numerous empirical studies of PBMT for patients with pulmonary disease such as pneumonia, COPD and asthma suggest that PBMT is a safe and effective adjunctive treatment. Recent systematic reviews suggest that PBMT may be applied to target lung tissue in COVID-19 patients. In this preliminary study, we evaluated the effect of adjunctive PBMT on COVID-19 pneumonia and patient clinical status.
Patients and Methods


We present a small-scale clinical trial with 10 patients randomized to standard medical care or standard medical care plus adjunctive PBMT. The PBMT group received four daily sessions of near-infrared light treatment targeting the lung tissue via a Multiwave Locked System (MLS) laser. Patient outcomes were measured via blood work, chest x-rays, pulse oximetry and validated scoring tools for pneumonia.
Results


PBMT patients showed improvement on pulmonary indices such as SMART-COP, BCRSS, RALE, and CAP (Community-Acquired Pneumonia questionnaire). PBMT-treated patients showed rapid recovery, did not require ICU admission or mechanical ventilation, and reported no long-term sequelae at 5 months after treatment. In the control group, 60% of patients were admitted to the ICU for mechanical ventilation. The control group had an overall mortality of 40%. At a 5-month follow-up, 40% of the control group experienced long-term sequelae.
Conclusion


PBMT is a safe and effective potential treatment for COVID-19 pneumonia and improves clinical status in COVID-19 pneumonia.",2021,"Results


PBMT patients showed improvement on pulmonary indices such as SMART-COP, BCRSS, RALE, and CAP (Community-Acquired Pneumonia questionnaire).",['patients with pulmonary disease'],"['near-infrared light treatment targeting the lung tissue via a Multiwave Locked System (MLS) laser', 'PBMT', 'Photobiomodulation therapy (PBMT', 'standard medical care or standard medical care plus adjunctive PBMT', 'adjunctive PBMT', 'Adjunctive Photobiomodulation (PBMT']","['long-term sequelae', 'overall mortality', 'pulmonary indices such as SMART-COP, BCRSS, RALE, and CAP (Community-Acquired Pneumonia questionnaire', 'ICU admission or mechanical ventilation', 'via blood work, chest x-rays, pulse oximetry and validated scoring tools for pneumonia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}]","[{'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0021431', 'cui_str': 'Infrared radiation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0034642', 'cui_str': 'Respiratory crackles'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",10.0,0.0272267,"Results


PBMT patients showed improvement on pulmonary indices such as SMART-COP, BCRSS, RALE, and CAP (Community-Acquired Pneumonia questionnaire).","[{'ForeName': 'Mariana A', 'Initials': 'MA', 'LastName': 'Vetrici', 'Affiliation': 'Department of Biological Sciences, University of Lethbridge, Lethbridge, AB, Canada.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Mokmeli', 'Affiliation': 'Training Institute, Canadian Optic and Laser Center, Victoria, BC, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Bohm', 'Affiliation': 'Department of Orthopedics, Lenox Hill Hospital, New York, NY, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Monici', 'Affiliation': 'ASA Campus J.L., ASA Res. Division - Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sigman', 'Affiliation': 'Department of Orthopedics, Lowell General Hospital, Lowell, MA, 01863, USA.'}]",Journal of inflammation research,['10.2147/JIR.S301625']
635,33776335,Antibiotics are not necessary during routine cystoscopic stent removal: A randomized controlled trial at UC San Diego.,"Introduction


Current American Urological Association (AUA) Best Practice Statement recommends antibiotic prophylaxis for cystoscopy with manipulation, including stent removal; although no Level 1b trials explicitly address prophylaxis for stent removal. We sought to determine the efficacy of prophylactic antibiotics to prevent infectious complications after stent removal.
Materials and Methods


Following institutional review board approval, patients undergoing removal of ureteral stent placed during stone surgery were recruited from July 2016 to March 2019. Patients were recruited at the time of stent removal and randomized to treatment (single dose 500 mg oral ciprofloxacin) or control group (no antibiotics). Telephone contact was attempted within 14 days of stent removal to assess for urinary tract infection (UTI) symptoms, antibiotic prescriptions, or Emergency Department visits.  Primary outcome  was UTI within 1 month of stent removal - defined by irritative voiding symptoms, fever or abdominal pain associated with positive urine culture (Ucx) (>100k colony-forming units/mL).
Results


Seventy-seven patients were enrolled, with 58 meeting final inclusion criteria for the analysis (33 treatment, 25 controls). No differences were seen with clinical and demographic variables, except a higher body mass index in the treatment group ( P  = 0.007). Positive Ucx rate before stone surgery (16.7% vs. 11.8%,  P  = 0.819) and at the time of stent removal (16.0% vs. 11.1%,  P  = 0.648) was not significantly different in treatment versus control groups, respectively.  Primary outcome : No patients in either cohort developed symptomatic culture-diagnosed UTI within 1 month of stent removal. Of patients with documented phone follow-up (treatment  n  = 29, control  n  = 22), only one patient (control) reported any positive response on phone survey.
Conclusions


We found a low infectious complication rate regardless of antibiotic prophylaxis use during cystoscopic stent removal. The necessity of antibiotics during routine cystoscopic stent removal warrants possible reevaluation of the AUA best practice statement.",2020,"Positive Ucx rate before stone surgery (16.7% vs. 11.8%,  P  = 0.819) and at the time of stent removal (16.0% vs. 11.1%,  P  = 0.648) was not significantly different in treatment versus control groups, respectively.  ","['patients undergoing removal of ureteral stent placed during stone surgery were recruited from July 2016 to March 2019', 'Seventy-seven patients were enrolled, with 58 meeting final inclusion criteria for the analysis (33 treatment, 25 controls']","['Antibiotics', 'Introduction\n\n\nCurrent American Urological Association (AUA', 'ciprofloxacin) or control group (no antibiotics', 'prophylactic antibiotics']","['UTI within 1 month of stent removal - defined by irritative voiding symptoms, fever or abdominal pain associated with positive urine culture (Ucx) (>100k colony-forming units/mL', 'symptomatic culture-diagnosed UTI', 'Positive Ucx rate before stone surgery', 'urinary tract infection (UTI) symptoms, antibiotic prescriptions, or Emergency Department visits', 'body mass index', 'time of stent removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1278795', 'cui_str': 'Removal of ureteral stent'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0522778', 'cui_str': 'Removal of stent'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0430404', 'cui_str': 'Urine culture'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",77.0,0.259103,"Positive Ucx rate before stone surgery (16.7% vs. 11.8%,  P  = 0.819) and at the time of stent removal (16.0% vs. 11.1%,  P  = 0.648) was not significantly different in treatment versus control groups, respectively.  ","[{'ForeName': 'Aaron W', 'Initials': 'AW', 'LastName': 'Bradshaw', 'Affiliation': 'UC San Diego Health, San Diego, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pe', 'Affiliation': 'Genesis Healthcare, San Diego, CA, USA.'}, {'ForeName': 'Seth K', 'Initials': 'SK', 'LastName': 'Bechis', 'Affiliation': 'UC San Diego Health, San Diego, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dipina', 'Affiliation': 'UC San Diego Health, San Diego, CA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Zupkas', 'Affiliation': 'UC San Diego Health, San Diego, CA, USA.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Abbott', 'Affiliation': 'UC San Diego Health, San Diego, CA, USA.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Papagiannopoulos', 'Affiliation': 'UC San Diego Health, San Diego, CA, USA.'}, {'ForeName': 'Kaitlan D', 'Initials': 'KD', 'LastName': 'Cobb', 'Affiliation': 'UC San Diego Health, San Diego, CA, USA.'}, {'ForeName': 'Roger L', 'Initials': 'RL', 'LastName': 'Sur', 'Affiliation': 'UC San Diego Health, San Diego, CA, USA.'}]",Urology annals,['10.4103/UA.UA_130_19']
636,33776333,Single course of intravesical Bacillus Calmette-Guerin versus single course with maintenance therapy in the management of nonmuscle invasive bladder cancer: A prospective randomized study.,"Objective


The objective of the study was to compare maintenance versus single course of intravesical Bacillus Calmette-Guerin (BCG) in the management of high-risk nonmuscle invasive bladder cancer (NMIBC) regarding recurrence, progression, survival, and complications.
Patients and Methods


After transurethral resection of bladder tumor (TURBT), Group I patients (33) received weekly doses of 90 mg of live attenuated Pasteur strain of BCG. The course was started 14 days after the second TURBT for 6 consecutive weeks. In Group II: 35 patients, the induction schedule was followed by 3 weekly instillations at months 3, 6, and 12 as a maintenance course. Recurrence, progression rates, survival, and toxicity were assessed in both the groups.
Results


Patients with induction therapy alone had significantly higher recurrence rate than those received maintenance therapy (55.6% vs. 19.2%,  P  = 0.01). The 5-year recurrence-free survival rate was 41% and 78% in both the groups, respectively. There was no significant difference regarding the progression rate for both the groups. The mean 5-year progression-free time was comparable between the two groups. The 5-year progression-free survival was 69.8% for patients who underwent induction therapy alone compared to 70.7% for maintenance therapy. Overall local adverse events were significantly higher in patients who underwent maintenance treatment protocol.
Statistical Analysis Used


SPSS package version 20 and Kaplan-Meier curves were used to evaluate the survival rate.
Conclusions


Maintenance doses of BCG significantly decrease and delay the recurrence of high-risk NMIBC. However, there is no significant favor as regards tumor progression. Maintenance doses of BCG are significantly associated with a higher incidence of local adverse effects than induction doses alone.",2020,The 5-year progression-free survival was 69.8% for patients who underwent induction therapy alone compared to 70.7% for maintenance therapy.,['nonmuscle invasive bladder cancer'],"['intravesical Bacillus Calmette-Guerin (BCG', 'transurethral resection of bladder tumor (TURBT', 'BCG', 'intravesical Bacillus Calmette-Guerin versus single course with maintenance therapy']","['Recurrence, progression rates, survival, and toxicity', 'local adverse effects', '5-year recurrence-free survival rate', 'recurrence rate', '5-year progression-free survival', 'progression rate', 'survival rate', 'high-risk nonmuscle invasive bladder cancer (NMIBC) regarding recurrence, progression, survival, and complications', 'Overall local adverse events', 'mean 5-year progression-free time']","[{'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C1289970', 'cui_str': 'Intravesical BCG'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0555842,The 5-year progression-free survival was 69.8% for patients who underwent induction therapy alone compared to 70.7% for maintenance therapy.,"[{'ForeName': 'Mohamed Bakr', 'Initials': 'MB', 'LastName': 'Mohamed', 'Affiliation': 'Department of Urology, Faculty of Medicine, Port Said University, Port Said, Egypt.'}, {'ForeName': 'Mohamed Hassan', 'Initials': 'MH', 'LastName': 'Ali', 'Affiliation': 'Department of Urology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Mostafa A', 'Initials': 'MA', 'LastName': 'Shamaa', 'Affiliation': 'Department of Urology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Sami M', 'Initials': 'SM', 'LastName': 'Shaaban', 'Affiliation': 'Department of Urology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}]",Urology annals,['10.4103/UA.UA_137_19']
637,33776279,Effectiveness of cognitive behavioral therapy on social anxiety disorder: A comparative study.,"Background


Both cognitive behavior therapy (CBT) and paroxetine (PX) are the preferred treatments for social anxiety disorder (SAD). However, in literature, there have been divided opinions for the efficacy of the combination of these treatments. This study intended to evaluate whether the combination of CBT and PX would be superior to monotherapy of PX in the treatment of SAD.
Methods


This was a single centre, rater-blind, non randomised study which included 40 consenting adult participants who received CBT+PX or PX only. The Liebowitz Social Anxiety Scale, Social Interaction Anxiety Scale, and Brief Fear of Negative Evaluation scale (BFNE) were assessed at baseline (0 weeks), immediate posttreatment (16-18 weeks for CBT + PX and 16-20 weeks for PX only), and at follow-ups 2 months after posttreatment.
Results


Both the treatment groups have a statistically significant difference in mean scores in all outcome measures in posttreatment and follow-up stages compared with pretreatment scores. However, CBT + PX has a better treatment and maintenance gain as compared to PX alone in the posttreatment and follow-up stages.
Conclusions


In SAD management, combinations of CBT + PX are superior to PX alone, and the treatment gains are also better maintained in former than latter.",2020,Both the treatment groups have a statistically significant difference in mean scores in all outcome measures in posttreatment and follow-up stages compared with pretreatment scores.,"['social anxiety disorder (SAD', '40 consenting adult participants who received']","['CBT+PX or PX only', 'cognitive behavioral therapy', 'CBT and PX', '\n\n\nBoth cognitive behavior therapy (CBT) and paroxetine (PX', 'CBT + PX']","['Liebowitz Social Anxiety Scale, Social Interaction Anxiety Scale, and Brief Fear of Negative Evaluation scale (BFNE', 'mean scores', 'social anxiety disorder']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]",40.0,0.0258306,Both the treatment groups have a statistically significant difference in mean scores in all outcome measures in posttreatment and follow-up stages compared with pretreatment scores.,"[{'ForeName': 'Nirupama', 'Initials': 'N', 'LastName': 'Behera', 'Affiliation': 'Department of Clinical Psychology, Mental Health Institute (Centre of Excellence), SCB Medical College and Hospital, Cuttack, India.'}, {'ForeName': 'Narendra Nath', 'Initials': 'NN', 'LastName': 'Samantaray', 'Affiliation': 'Department of Clinical Psychology, Mental Health Institute (Centre of Excellence), SCB Medical College and Hospital, Cuttack, India.'}, {'ForeName': 'Nilamadhab', 'Initials': 'N', 'LastName': 'Kar', 'Affiliation': 'Consultant Psychiatrist and College Tutor, Black Country Partnership NHS Foundation Trust, Wolverhampton, England.'}, {'ForeName': 'Mihir Ranjan', 'Initials': 'MR', 'LastName': 'Nayak', 'Affiliation': 'Department of Psychiatry, SCB Medical College and Hospital, Cuttack, India.'}, {'ForeName': 'Supraksh', 'Initials': 'S', 'LastName': 'Chaudhury', 'Affiliation': 'Department of Psychiatry, Dr. D. Y. Patil Medical College, Hospital and Research Center, Dr. D. Y. Patil University, Pimpri, Pune, Maharashtra, India.'}]",Industrial psychiatry journal,['10.4103/ipj.ipj_2_20']
638,33776137,Closing the Word-Problem Achievement Gap in First Grade: Schema-Based Word-Problem Intervention with Embedded Language Comprehension Instruction.,"The main purpose of this study was to test the effects of word-problem intervention, with versus without embedded language comprehension instruction, on at-risk 1 st  graders' word-problem performance. We also isolated the need for a structured approach to word-problem intervention and tested the efficacy of schema-based instruction at 1 st  grade. Children (n=391; mean age = 6.53,  SD  = 0.32) were randomly assigned to 4 conditions: schema-based word-problem intervention with embedded language instruction, the same word-problem intervention but without language comprehension instruction, structured number knowledge intervention without a structured word-problem component, and a control group. Each intervention included 45 30-min sessions. Multilevel models, accounting for classroom and school effects, revealed the efficacy of schema-based word-problem intervention at 1 st  grade, with both word-problem conditions outperforming the number knowledge condition and the control group. Yet, word-problem performance was significantly stronger for the schema-based condition with embedded language comprehension instruction compared to the schema-based condition without language comprehension instruction. Number knowledge intervention conveyed no word-problem advantage over the control group, even though all 3 intervention conditions outperformed the control group on arithmetic. Results demonstrate the importance of a structured approach to word-problem intervention; the efficacy of schema-based instruction at 1 st  grade; and the added value of language comprehension instruction within word-problem intervention. Results also provide causal evidence on the role of language comprehension in word-problem solving.",2021,"Number knowledge intervention conveyed no word-problem advantage over the control group, even though all 3 intervention conditions outperformed the control group on arithmetic.","['Children (n=391; mean age = 6.53,  SD  = 0.32']","['word-problem intervention, with versus without embedded language comprehension instruction', '4 conditions: schema-based word-problem intervention with embedded language instruction, the same word-problem intervention but without language comprehension instruction, structured number knowledge intervention without a structured word-problem component, and a control group']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517448', 'cui_str': '0.32'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0233733', 'cui_str': 'Language comprehension'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0360802,"Number knowledge intervention conveyed no word-problem advantage over the control group, even though all 3 intervention conditions outperformed the control group on arithmetic.","[{'ForeName': 'Lynn S', 'Initials': 'LS', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Seethaler', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Sonya K', 'Initials': 'SK', 'LastName': 'Sterba', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Craddock', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Compton', 'Affiliation': 'Florida State University.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Geary', 'Affiliation': 'University of Missouri.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Changas', 'Affiliation': 'Metropolitan-Nashville Public Schools.'}]",Journal of educational psychology,['10.1037/edu0000467']
639,33243761,"Evaluation of a mental health drop-in centre offering brief transdiagnostic psychological assessment and treatment for children and adolescents with long-term physical conditions and their families: a single-arm, open, non-randomised trial.","BACKGROUND


Children and young people with long-term physical conditions have significantly elevated mental health needs. Transdiagnostic, brief psychological interventions have the potential to increase access to evidence-based psychological treatments for patients who attend health services primarily for physical health needs.
OBJECTIVE


A non-randomised study was conducted to assess the impact of brief, transdiagnostic psychological interventions in children and young people presenting at a drop-in mental health centre in the reception area of a paediatric hospital.
METHODS


186 participants attending a transdiagnostic mental health drop-in centre were allocated to assessment and psychological intervention based on a clinical decision-making algorithm. Interventions included signposting, guided self-help based on a modular psychological treatment and referral to the hospital's paediatric psychology service. The primary transdiagnostic mental health outcome measure was the parent-reported Strengths and Difficulties Questionnaire (SDQ), which was given at baseline and 6 months post-baseline.
FINDINGS


There was a significant positive impact of attending the drop-in mental health centre on the SDQ (Cohen's d=0.22) and on the secondary outcome measure of Paediatric Quality of life (Cohen's d=0.55).
CONCLUSIONS


A mental health drop-in centre offering brief, transdiagnostic assessment and treatment may reduce emotional and behavioural symptoms and improve quality of life in children and young people with mental health needs in the context of long-term physical conditions. A randomised controlled trial to investigate the specificity of any effects is warranted.
CLINICAL IMPLICATIONS


Drop-in centres for mental health needs may increase access and have beneficial effects for children and young people with physical conditions.",2021,"There was a significant positive impact of attending the drop-in mental health centre on the SDQ (Cohen's d=0.22) and on the secondary outcome measure of Paediatric Quality of life (Cohen's d=0.55).
","['Children and young people with long-term physical conditions', 'children and young people presenting at a drop-in mental health centre in the reception area of a paediatric hospital', 'children and young people with mental health', 'children and young people with physical conditions', '186 participants attending a transdiagnostic mental health drop-in centre', 'children and adolescents with long-term physical conditions and their families', 'patients who attend health services primarily for physical health needs']","['psychological intervention based on a clinical decision-making algorithm', ""signposting, guided self-help based on a modular psychological treatment and referral to the hospital's paediatric psychology service"", 'transdiagnostic psychological interventions', 'mental health drop-in centre offering brief transdiagnostic psychological assessment and treatment']","['quality of life', 'parent-reported Strengths and Difficulties Questionnaire (SDQ', 'Paediatric Quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C1273868', 'cui_str': 'Health needs (community)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0587654', 'cui_str': 'Psychology service'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0204452', 'cui_str': 'Psychological assessment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]",186.0,0.27072,"There was a significant positive impact of attending the drop-in mental health centre on the SDQ (Cohen's d=0.22) and on the secondary outcome measure of Paediatric Quality of life (Cohen's d=0.55).
","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Catanzano', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Sophie D', 'Initials': 'SD', 'LastName': 'Bennett', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Kerry', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Holan', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Heyman', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Coughtrey', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Fifield', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dalgleish', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Shafran', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, UK r.shafran@ucl.ac.uk.'}]",Evidence-based mental health,['10.1136/ebmental-2020-300197']
640,33776375,Prospective single-blinded single-center randomized controlled trial of Prep Kit-C and Moviprep: Does underlying inflammatory bowel disease impact tolerability and efficacy?,"BACKGROUND


Colonoscopy remains the gold standard for detection of colonic disease. An optimal evaluation depends on adequate bowel cleansing. Patients with inflammatory bowel disease (IBD), require frequent endoscopic assessment for both activity and dysplasia assessment. Two commonly used bowel preparations in Australia are Prep Kit-C (Pc) and Moviprep (Mp). Little is known about tolerability, efficacy and safety of split protocols of Mp and Pc in both IBD and non-IBD patients.
AIM


To primary aim was to compare the tolerability, efficacy and safety of split protocols of Mp and Pc in patients having a colonoscopy. The secondary aim was to compare the efficacy, tolerability and safety of either preparation in patients with or without IBD.
METHODS


Patients were randomized to Pc or Mp bowel preparation. Patients completed a questionnaire to assess tolerability. Efficacy was assessed using the Ottawa Bowel Preparation Score. Serum electrolytes and renal function were collected one week prior to colonoscopy and on the day of colonoscopy.
RESULTS


Of 338 patients met the inclusion criteria. Of 168 patients randomized to Mp and 170 to Pc. The efficacy of bowel preparation (mean Ottawa Bowel Preparation Score) was similar between Mp (5.4 ± 2.4) and Pc (5.1 ± 2.1) ( P  = 0.3). Mean tolerability scores were similar in Mp (11.84 ± 5.4) and Pc (10.99 ± 5.2;  P  = 0.17). 125 patients had IBD (73 had Crohn's Disease and 52 had Ulcerative colitis). Sixty-four IBD patients were allocated to Mp and 61 to Pc. In non-IBD patients, 104 were allocated to Mp and 109 to Pc. The mean tolerability score in the IBD group was lower than the non-IBD group (mean tolerability scores: IBD: 10.3 ± 5.1 and non-IBD: 12.0 ± 5.3;  P  = 0.01). IBD patients described more abdominal pain with Mp when compared with Pc; (Mp: 5.7 ± 4.4  vs  Pc: 3.6 ± 2.6,  P  = 0.046). Serum magnesium level increased with Pc compared with Mp in all patients (mean increase in mmol/L: Mp: 0.03 ± 0.117 and Pc: 0.11 ± 0.106;  P  < 0.0001).
CONCLUSION


In this study, the efficacy, tolerability and safety of Mp and Pc were similar in all patients. However, patients with IBD reported lower tolerability with both preparations. Specifically, IBD patients had more abdominal pain with Mp. These results should be considered when recommending bowel preparation especially to IBD patients.",2021,"IBD patients described more abdominal pain with Mp when compared with Pc; (Mp: 5.7 ± 4.4  vs  Pc: 3.6 ± 2.6,  P  = 0.046).","['Patients with inflammatory bowel disease (IBD', 'patients having a colonoscopy', 'patients with or without IBD', '338 patients met the inclusion criteria', ""125 patients had IBD (73 had Crohn's Disease and 52 had Ulcerative colitis"", '168 patients randomized to Mp and 170 to Pc', 'Sixty-four IBD patients', 'Patients were randomized to Pc or Mp bowel preparation']",['Prep Kit-C and Moviprep'],"['Serum magnesium level', 'tolerability', 'efficacy, tolerability and safety of Mp and Pc', 'Efficacy', 'efficacy, tolerability and safety', 'efficacy of bowel preparation (mean Ottawa Bowel Preparation Score', 'Mean tolerability scores', 'Ottawa Bowel Preparation Score', 'abdominal pain', 'mean tolerability score', 'Serum electrolytes and renal function', 'tolerability, efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C1815369', 'cui_str': 'MoviPrep'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}]","[{'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C1815369', 'cui_str': 'MoviPrep'}]","[{'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1815369', 'cui_str': 'MoviPrep'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",168.0,0.0502327,"IBD patients described more abdominal pain with Mp when compared with Pc; (Mp: 5.7 ± 4.4  vs  Pc: 3.6 ± 2.6,  P  = 0.046).","[{'ForeName': 'Waled', 'Initials': 'W', 'LastName': 'Mohsen', 'Affiliation': 'Department of Digestive Diseases, Gold Coast University Hospital, Gold Coast, 4215, Queensland, Australia. wmoh6298@uni.sydney.edu.au.'}, {'ForeName': 'Astrid-Jane', 'Initials': 'AJ', 'LastName': 'Williams', 'Affiliation': 'Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Wark', 'Affiliation': 'Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Sechi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia.'}, {'ForeName': 'Jenn-Hian', 'Initials': 'JH', 'LastName': 'Koo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xuan', 'Affiliation': 'South West Sydney Clinical School, University of New South Wales, Sydney 2170, New South Wales, Australia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Bassan', 'Affiliation': 'Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia.'}, {'ForeName': 'Watson', 'Initials': 'W', 'LastName': 'Ng', 'Affiliation': 'Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Connor', 'Affiliation': 'Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia.'}]",World journal of gastroenterology,['10.3748/wjg.v27.i11.1090']
641,33776366,"Ursodeoxycholic acid as a means of preventing atherosclerosis, steatosis and liver fibrosis in patients with nonalcoholic fatty liver disease.","BACKGROUND


Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in patients with nonalcoholic fatty liver disease (NAFLD). Weight loss is a key factor for successful NAFLD and CVD therapy. Ursodeoxycholic acid (UDCA), which is one of the first-line therapeutic agents for treatment of NAFLD, is reported to have a beneficial effect on dyslipidemia and ASCVD risk because of antioxidant properties.
AIM


To evaluate the effects of 6 mo of UDCA treatment on hepatic function tests, lipid profile, hepatic steatosis and fibrosis, atherogenesis, and ASCVD risk in men and women with NAFLD, as well as to assess the impact of > 5% weight reduction on these parameters.
METHODS


An open-label, multicenter, international noncomparative trial was carried out at primary health care settings and included 174 patients with ultrasound-diagnosed NAFLD who received 15 mg/kg/d UDCA for 6 mo and were prescribed lifestyle modification with diet and exercise. The efficacy criteria were liver enzymes, lipid profile, fatty liver index (FLI), noninvasive liver fibrosis tests (nonalcoholic fatty liver disease fibrosis score and liver fibrosis index), carotid intima-media thickness (CIMT), and ASCVD risk score. To test statistical hypotheses, the Wilcoxon test, paired  t -test, Fisher's exact test, and Pearson's chi-squared test were used.
RESULTS


The alanine aminotransferase (ALT) level changed by -14.1 U/L (-31.0; -5.3) from baseline to 3 mo and by -6.5 U/L (-14.0; 0.1) from 3 to 6 mo. The magnitude of ALT, aspartate transaminase, and glutamyltransferase decrease was greater during the first 3 mo of treatment compared to the subsequent 3 mo ( P  < 0.001,  P  < 0.01,  P  < 0.001, respectively). At 6 mo, in the total sample, we observed a statistically significant decrease in body weight and levels of FLI: 84.9 ± 10.4  vs  72.3 ± 17.6,  P  < 0.001, total cholesterol: 6.03 ± 1.36  vs  5.76 ± 1.21,  Р  < 0.001, low-density lipoprotein: 3.86 ± 1.01  vs  3.66 ± 0.91,  Р  < 0.001, and triglyceride: 3.18 (2.00; 4.29)  vs  2.04 (1.40; 3.16),  Р  < 0.001. No effect on nonalcoholic fatty liver disease fibrosis score or liver fibrosis index was found. The CIMT decreased significantly in the total sample (0.985 ± 0.243  vs  0.968 ± 0.237,  P  = 0.013), whereas the high-density lipoprotein ( Р  = 0.036) and 10-year ASCVD risk ( Р  = 0.003) improved significantly only in women. Fifty-four patients (31%) achieved > 5% weight loss. At the end of the study, the FLI decreased significantly in patients with (88.3 ± 10.2  vs  71.4 ± 19.6,  P  < 0.001) and without > 5% weight loss (83.5 ± 10.3  vs  72.8 ± 16.7,  P  < 0.001). The changes in ALT, aspartate transaminase, glutamyltransferase, total cholesterol, and low-density lipoprotein levels were similar between the subgroups.
CONCLUSION


UDCA normalizes liver enzymes greatly within the first 3 mo of treatment, improves lipid profile and hepatic steatosis independent of weight loss, and has a positive effect on CIMT in the total sample and 10-year ASCVD risk in women after 6 mo of treatment.",2021,"The magnitude of ALT, aspartate transaminase, and glutamyltransferase decrease was greater during the first 3 mo of treatment compared to the subsequent 3 mo ( P  < 0.001,  P  < 0.01,  P  < 0.001, respectively).","['men and women with NAFLD', 'primary health care settings and included 174 patients with ultrasound-diagnosed NAFLD who received 15 mg/kg/d UDCA for 6 mo and were prescribed', 'patients with nonalcoholic fatty liver disease', 'patients with nonalcoholic fatty liver disease (NAFLD']","['Ursodeoxycholic acid', 'lifestyle modification with diet and exercise', 'UDCA', 'Ursodeoxycholic acid (UDCA']","['hepatic function tests, lipid profile, hepatic steatosis and fibrosis, atherogenesis, and ASCVD risk', 'CIMT', '10-year ASCVD risk', 'nonalcoholic fatty liver disease fibrosis score or liver fibrosis index', 'Weight loss', 'alanine aminotransferase (ALT) level', 'liver enzymes, lipid profile, fatty liver index (FLI), noninvasive liver fibrosis tests (nonalcoholic fatty liver disease fibrosis score and liver fibrosis index), carotid intima-media thickness (CIMT), and ASCVD risk score', 'body weight and levels of FLI', 'high-density lipoprotein', 'FLI', 'changes in ALT, aspartate transaminase, glutamyltransferase, total cholesterol, and low-density lipoprotein levels', 'weight loss', 'lipid profile and hepatic steatosis independent of weight loss', 'magnitude of ALT, aspartate transaminase, and glutamyltransferase decrease']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1563937', 'cui_str': 'Atherogenesis'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",174.0,0.0656249,"The magnitude of ALT, aspartate transaminase, and glutamyltransferase decrease was greater during the first 3 mo of treatment compared to the subsequent 3 mo ( P  < 0.001,  P  < 0.01,  P  < 0.001, respectively).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Nadinskaia', 'Affiliation': 'Department of Propaedeutics of Internal Diseases, Gastroenterology and Hepatology, Sechenov First Moscow State Medical University (Sechenov University), Moscow 119991, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Maevskaya', 'Affiliation': 'Vasilenko Clinic of Internal Diseases Propedeutics, Gastroenterology and Hepatology, University Clinical Hospital №2, Sechenov First Moscow State Medical University (Sechenov University), Moscow 119991, Russia. liver.orc@mail.ru.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Ivashkin', 'Affiliation': 'Department of Propaedeutics of Internal Diseases, Gastroenterology and Hepatology, Sechenov First Moscow State Medical University (Sechenov University), Moscow 119991, Russia.'}, {'ForeName': 'Khava', 'Initials': 'K', 'LastName': 'Kodzoeva', 'Affiliation': 'Department of Propaedeutics of Internal Diseases, Gastroenterology and Hepatology, Sechenov First Moscow State Medical University (Sechenov University), Moscow 119991, Russia.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Pirogova', 'Affiliation': 'LLC MC ""Lotus"", Center for Gastroenterology and Hepatology, Chelyabinsk 454092, Russia.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Chesnokov', 'Affiliation': 'Department of Hospital Therapy with the Course of Endocrinology and Clinical Pharmacology, Tyumen State Medical University, Tyumen 625003, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nersesov', 'Affiliation': 'Department of Gastroenterology, S. Asfendiyarov Kazakh National Medical University, Almaty 050000, Kazakhstan.'}, {'ForeName': 'Jamilya', 'Initials': 'J', 'LastName': 'Kaibullayeva', 'Affiliation': 'Department of Gastroenterology, S. Asfendiyarov Kazakh National Medical University, Almaty 050000, Kazakhstan.'}, {'ForeName': 'Akzhan', 'Initials': 'A', 'LastName': 'Konysbekova', 'Affiliation': 'Functional and Ultrasound Diagnostics, Scientific and Research Institute of Cardiology and Internal Diseases, Almaty 050000, Kazakhstan.'}, {'ForeName': 'Aigul', 'Initials': 'A', 'LastName': 'Raissova', 'Affiliation': 'Department of Internal Diseases, Scientific and Research Institute of Cardiology and Internal Diseases, Almaty 050000, Kazakhstan.'}, {'ForeName': 'Feruza', 'Initials': 'F', 'LastName': 'Khamrabaeva', 'Affiliation': 'Faculty of Therapy, Tashkent Institute of Advanced Medical Studies, Tashkent 100007, Uzbekistan.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zueva', 'Affiliation': 'Department of Therapy № 1 with Training General Practitioners, Tashkent Medical Academy, Tashkent 100109, Uzbekistan.'}]",World journal of gastroenterology,['10.3748/wjg.v27.i10.959']
642,33776351,Vestibular Incision Subperiosteal Tunnel Access Technique with Platelet-Rich Fibrin Compared to Subepithelial Connective Tissue Graft for the Treatment of Multiple Gingival Recessions: A Randomized Controlled Clinical Trial.,"Background


The aim of this study was to compare the effectiveness of root coverage through vestibular incision subperiosteal tunnel access (VISTA) technique using platelet rich fibrin (PRF) or subepithelial connective tissue graft (SCTG) in multiple gingival recessions.
Materials and Methods


A total of 20 patients with multiple gingival recessions were included, and 10 subjects were randomly allocated to test group (VISTA with PRF) and 10 patients to control group (VISTA with SCTG). Clinical parameters were recorded at baseline, 3 months, and 6 months. Patient's response toward the treatment was also assessed by questionnaire.
Results


All the clinical parameters in the study have showed better results in test group when compared to control group after a follow up period of 6 months with statistical significance.
Conclusion


The results of the present study suggested that multiple gingival recessions can be successfully treated with both procedures, but better root coverage and a greater increase in keratinized tissue were achieved with the VISTA technique with SCTG. All the patients in both groups felt it was worth undergoing the treatment.",2020,"All the clinical parameters in the study have showed better results in test group when compared to control group after a follow up period of 6 months with statistical significance.
","['20 patients with multiple gingival recessions were included, and 10 subjects', 'Multiple Gingival Recessions']","['Subepithelial Connective Tissue Graft', 'control group (VISTA with SCTG', 'test group (VISTA with PRF', 'vestibular incision subperiosteal tunnel access (VISTA) technique using platelet rich fibrin (PRF) or subepithelial connective tissue graft (SCTG', 'Vestibular Incision Subperiosteal Tunnel Access Technique with Platelet-Rich Fibrin']",['keratinized tissue'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",20.0,0.0259472,"All the clinical parameters in the study have showed better results in test group when compared to control group after a follow up period of 6 months with statistical significance.
","[{'ForeName': 'Bukkapatnam Venkata', 'Initials': 'BV', 'LastName': 'Subbareddy', 'Affiliation': 'Department of Periodontics, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'Penmetsa S', 'Initials': 'PS', 'LastName': 'Gautami', 'Affiliation': 'Department of Periodontics, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Dwarakanath', 'Affiliation': 'Department of Periodontics, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'Panda Kausalya', 'Initials': 'PK', 'LastName': 'Devi', 'Affiliation': 'Department of Periodontics, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'Parimisetti', 'Initials': 'P', 'LastName': 'Bhavana', 'Affiliation': 'Department of Periodontics, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Radharani', 'Affiliation': 'Department of Periodontics, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_405_19']
643,33776086,Preoperative gabapentin versus bisoprolol for haemodynamic and surgical field optimisation during endoscopic sinus surgery: A randomised controlled trial.,"Background and Aims


Appropriate premedication can optimise haemodynamics and hence surgical field visibility during endoscopic sinus surgery (ESS). This study aimed to compare the intraoperative effect of gabapentin 1200 mg versus bisoprolol 2.5 mg, given 2 hours before ESS.
Methods


Patients were assigned into one of three groups. Patients of gabapentin group received preoperative oral gabapentin 1200 mg while, patients of bisoprolol and control groups received oral bisoprolol 2.5 mg and placebo respectively 2 hours before ESS. Primary outcome: reduction of blood loss and surgical field quality. Secondary outcome: haemodynamic control. mean arterial pressure (MAP) and heart rate (HR) were recorded as baseline, before and after induction of anaesthesia, at 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery. Data also included Fromm and Boezaart category scale (assessed every 15 min), intraoperative blood loss, surgeon satisfaction score, intraoperative anaesthetic/analgesic and vasoactive medications requirements.
Results


Out of 66 eligible patients, 60 patients completed the study. Intraoperative MAP and HR were significantly lower and more stable in gabapentin and bisoprolol groups compared to control group (p < 0.05). The volume of blood loss was significantly lower (p 0.000) and operative field was more visible in gabapentin and bisoprolol groups than those in control group (p 0.000).
Conclusion


The beneficial effect of gabapentin 1200 mg on intraoperative haemodynamic control and surgical field visibility is comparable to that of bisoprolol 2.5 mg when either of them is given as a single oral dose 2 hours before ESS.",2021,Intraoperative MAP and HR were significantly lower and more stable in gabapentin and bisoprolol groups compared to control group (p < 0.05).,"['endoscopic sinus surgery (ESS', '66 eligible patients', 'endoscopic sinus surgery', '60 patients completed the study']","['Preoperative gabapentin versus bisoprolol', 'gabapentin', 'bisoprolol and control groups received oral bisoprolol 2.5 mg and placebo', 'preoperative oral gabapentin', 'bisoprolol']","['Intraoperative MAP and HR', 'mean arterial pressure (MAP) and heart rate (HR', 'blood loss and surgical field quality', 'operative field', 'intraoperative blood loss, surgeon satisfaction score, intraoperative anaesthetic/analgesic and vasoactive medications requirements', 'volume of blood loss']","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",66.0,0.17479,Intraoperative MAP and HR were significantly lower and more stable in gabapentin and bisoprolol groups compared to control group (p < 0.05).,"[{'ForeName': 'Abeer M', 'Initials': 'AM', 'LastName': 'Elnakera', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Head and Neck Surgery, Faculty of Medicine, Zagazig University, Zagazig, Alsharqiah, Egypt.'}, {'ForeName': 'Maram H', 'Initials': 'MH', 'LastName': 'Wagdy', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Head and Neck Surgery, Faculty of Medicine, Zagazig University, Zagazig, Alsharqiah, Egypt.'}, {'ForeName': 'Aymen A', 'Initials': 'AA', 'LastName': 'Abd-Elgelyl', 'Affiliation': 'Department of Anaesthesia and Surgical Intensive Care, Head and Neck Surgery, Faculty of Medicine, Zagazig University, Zagazig, Alsharqiah, Egypt.'}, {'ForeName': 'Mohamed W', 'Initials': 'MW', 'LastName': 'El-Anwar', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Zagazig University, Zagazig, Alsharqiah, Egypt.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_619_20']
644,33776085,Postoperative analgesic efficacy of the pulmonary recruitment manoeuvre compared to intraperitoneal hydrocortisone in laparoscopic gynaecological surgeries.,"Background and Aims


Laparoscopic surgeries are becoming attractive because of early recovery. Adequate postoperative pain relief may be a major concern. Several methods have been used to relieve laparoscopic postoperative pain.
Methodology


This prospective, randomised, controlled study was conducted during the period between February and June 2019. Patients were assigned into three groups. Patients in the hydrocortisone group received intraperitoneal 100mg hydrocortisone in 150 ml normal saline together with the routine method to remove carbondioxide (CO2). For patients in the pulmonary recruitment group, CO 2  was exsufflated by pulmonary recruitment manoeuvre together with the routine method to remove CO 2 . In the control group CO 2  was removed by applying gentle abdominal pressure allowing passive exsufflation through the port site.
Results


A total of 57 patients were included in the study. There was no statistically significant difference between the three groups as regards demographic characteristics. There was a statistically significant difference in the 24 h postoperative analgesic consumption (primary outcome) in the hydrocortisone and pulmonary recruitment groups in comparison to the control group:P value <0.001. Also, time to first request for analgesia was significantly longer and the visual analogue scale (VAS) score was significantly lower in the hydrocortisone and pulmonary recruitment groups compared to the control group:P value <0.001.
Conclusion


Intraperitoneal hydrocortisone and pulmonary recruitment manoeuvre could both effectively reduce pain after gynaecological laparoscopic surgeries, however, intraperitoneal hydrocortisone might give a longer pain-free time.",2021,There was a statistically significant difference in the 24 h postoperative analgesic consumption (primary outcome) in the hydrocortisone and pulmonary recruitment groups in comparison to the control group:P value <0.001.,"['A total of 57 patients were included in the study', 'laparoscopic gynaecological surgeries', 'period between February and June 2019']","['Intraperitoneal hydrocortisone', 'intraperitoneal hydrocortisone', 'intraperitoneal 100mg hydrocortisone', 'hydrocortisone', 'pulmonary recruitment manoeuvre']","['postoperative analgesic consumption', 'visual analogue scale (VAS) score', 'pain', 'Postoperative analgesic efficacy', 'time to first request for analgesia']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",57.0,0.119807,There was a statistically significant difference in the 24 h postoperative analgesic consumption (primary outcome) in the hydrocortisone and pulmonary recruitment groups in comparison to the control group:P value <0.001.,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elsakka', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine Cairo University, Egypt.'}, {'ForeName': 'Nisreen', 'Initials': 'N', 'LastName': 'Elrefai', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine Cairo University, Egypt.'}, {'ForeName': 'Jihan', 'Initials': 'J', 'LastName': 'Shehata', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine Cairo University, Egypt.'}, {'ForeName': 'Atef Galal', 'Initials': 'AG', 'LastName': 'Abdel Mawla', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine Cairo University, Egypt.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_423_20']
645,33776083,"Comparison of analgesic efficacy of intrathecal 1% 2-chloroprocaine with or without fentanyl in elective caesarean section: A prospective, double-blind, randomised study.","Background and Aims


Preservative free 1% 2-chlorprocaine is a short acting local anaesthetic agent suitable for day care surgical procedures. Potentiation of analgesic action of intrathecal local anaesthetics by the addition of opioids is well known. In this study, we investigated the effect of intrathecal fentanyl as an adjuvant to 1% 2-chloroprocaine (2-CP) in parturients undergoing elective lower segment caesarean section (LSCS).
Methods


This prospective randomised comparative study was performed on 150 healthy, term parturients planned for elective low risk LSCS, divided into two equal groups. The group CS received 1% preservative-free 2-CP 3 ml (30 mg) + 0.5 ml normal saline and group CF received 1% preservative-free 2-CP 3 ml (30 mg) + 0.5 ml fentanyl (25 μg) with a total volume of 3.5 ml intrathecally in both groups. The duration of sensory blockade, duration of motor blockade, maximum height of sensory block, haemodynamic parameters, quality of block, neonatal outcome, patient satisfaction and any side effects were recorded.
Results


There were no significant differences in demographic characteristics, haemodynamic parameters, onset of sensory block, onset of motor block and duration of motor block between the groups. The duration of sensory block and duration of analgesia was statistically prolonged in group CF than group CS ( P  value < 0.0001). There was no statistical difference in the Apgar score of newborns in both groups. The adverse effects (hypotension, bradycardia, nausea/vomiting, shivering and transient neurological symptoms) were comparable in both the groups.
Conclusion


The addition of fentanyl to 1% 2-chloroprocaine intrathecally prolonged the duration of sensory block and postoperative analgesia in patients undergoing LSCS.",2021,The duration of sensory block and duration of analgesia was statistically prolonged in group CF than group CS ( P  value < 0.0001).,"['patients undergoing LSCS', '150 healthy, term parturients planned for elective low risk LSCS, divided into two equal groups', 'elective caesarean section', 'parturients undergoing elective lower segment caesarean section (LSCS']","['intrathecal fentanyl', 'preservative-free 2-CP 3 ml (30 mg) + 0.5 ml normal saline and group CF received 1% preservative-free 2-CP', 'intrathecal 1% 2-chloroprocaine with or without fentanyl', '2-chlorprocaine', '2-chloroprocaine', '2-chloroprocaine (2-CP']","['demographic characteristics, haemodynamic parameters, onset of sensory block, onset of motor block and duration of motor block', 'adverse effects (hypotension, bradycardia, nausea/vomiting, shivering and transient neurological symptoms', 'duration of sensory block and postoperative analgesia', 'duration of sensory blockade, duration of motor blockade, maximum height of sensory block, haemodynamic parameters, quality of block, neonatal outcome, patient satisfaction and any side effects', 'Apgar score of newborns', 'analgesic efficacy', 'duration of sensory block and duration of analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0195620', 'cui_str': 'Low cervical cesarean section'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0473298', 'cui_str': 'Elective lower segment cesarean section'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0055443', 'cui_str': 'chloroprocaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0581882', 'cui_str': 'Transient neurological symptoms'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",150.0,0.0990599,The duration of sensory block and duration of analgesia was statistically prolonged in group CF than group CS ( P  value < 0.0001).,"[{'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Singariya', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Dr S N Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Kusum', 'Initials': 'K', 'LastName': 'Choudhary', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Dr S N Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Bihani', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Dr S N Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Himani', 'Initials': 'H', 'LastName': 'Pahuja', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Dr S N Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Saini', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Dr S N Medical College, Jodhpur, Rajasthan, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_816_20']
646,33776082,Deep versus superficial erector spinae block for modified radical mastectomy: A randomised controlled pilot study.,"Background and Aims


Forero  et al . described two approaches of erector spinae (ES) plane block: superficial and deep to erector spinae muscle. We hypothesised that the superficial technique would not lead to optimum analgesia as the drug would have to cross one more muscle layer. We aimed to compare the techniques in terms of analgesia and sensory blockade in patients undergoing modified radical mastectomy (MRM).
Methods


Forty American Society of Anesthesiologists (ASA) I/II female patients in age group 18-60 years undergoing unilateral MRM were included in this prospective study. Group D patients received 20 mL 0.2% ropivacaine deep to erector spinae at the T4 level. Group S patients received 20 mL 0.2% ropivacaine superficial to erector spinae. Sensory level of block, perioperative opioid consumption, and adverse effects were noted.
Results


Twenty four hours morphine consumption was less in group D: 5.47 ± 1.1 mg and in group S was 7.66 ± 0.74 mg ( P  < 0.001). The sensory spread was more in deep group in the posterior axillary and mid axillary line. There were no reported adverse effects in either group.
Conclusion


Injection of drug deep to ES muscle provides more cranio-caudal blockade of posterior and lateral chest wall, hence providing better analgesia following breast surgery. Injection of the drug superficial to the muscle leads to inferior analgesia.",2021,four hours morphine consumption was less in group D: 5.47 ± 1.1 mg and in group S was 7.66 ± 0.74 mg ( P  < 0.001).,"['I/II female patients in age group 18-60 years undergoing unilateral MRM', 'patients undergoing modified radical mastectomy (MRM', 'modified radical mastectomy', 'Methods\n\n\nForty American Society of Anesthesiologists (ASA']","['ropivacaine', 'Deep versus superficial erector spinae block', 'ropivacaine superficial to erector spinae']","['Sensory level of block, perioperative opioid consumption, and adverse effects', 'adverse effects']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",40.0,0.0992932,four hours morphine consumption was less in group D: 5.47 ± 1.1 mg and in group S was 7.66 ± 0.74 mg ( P  < 0.001).,"[{'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Sinha', 'Affiliation': 'Department of Anaesthesiology, AIIMS, Patna, Bihar, India.'}, {'ForeName': 'Amarjeet', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Trauma and Emergency (Anaesthesiology), AIIMS, Patna, Bihar, India.'}, {'ForeName': 'Ajeet', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology, AIIMS, Patna, Bihar, India.'}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Kumari', 'Affiliation': 'Department of Anaesthesiology, AIIMS, Patna, Bihar, India.'}, {'ForeName': 'Jitendra Kumar', 'Initials': 'JK', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology, AIIMS, Patna, Bihar, India.'}, {'ForeName': 'Chandan Kumar', 'Initials': 'CK', 'LastName': 'Jha', 'Affiliation': 'Department of General Surgery, AIIMS, Patna, Bihar, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_513_20']
647,33775615,Myeloablative versus Reduced-Intensity Conditioning for Hematopoietic Cell Transplantation in Acute Myelogenous Leukemia and Myelodysplastic Syndromes-Long-Term Follow-Up of the BMT CTN 0901 Clinical Trial.,"Several prospective randomized trials comparing conditioning intensity before allogeneic hematopoietic cell transplantation (HCT) have been performed, with conflicting results. Although reduced-intensity conditioning (RIC) leads to lower treatment-related mortality (TRM), this is offset by higher rates of relapse. Long-term follow-up of randomized comparative trials are limited. Here we present long-term follow-up of a randomized comparison of myeloablative conditioning (MAC) compared with RIC before HCT for acute myelogenous leukemia (AML) or myelodysplasia (MDS). Long-term comparative analyses of overall survival, relapse, and relapse-free survival were performed. Patients age 18 to 65 years with <5% marrow myeloblasts were randomized to receive MAC (n = 135) or RIC (n = 137), followed by HCT from an HLA-matched donor. The primary endpoint of the trial was an 18-month pointwise comparison of overall survival. The analyses were performed using a proportional hazards model. The median follow-up of the entire cohort was 51 months. At 4 years, the TRM was 25.1% for MAC, compared with 9.9% for RIC (P < .001). Patients who received RIC had a significantly higher risk of relapse compared to those who received MAC (hazard ratio [HR], 4.06; 95% CI, 2.59 to 6.35; P < 0.001). Among the patients who relapsed after HCT, postrelapse survival was similar at 3 years (24% for MAC and 26% for RIC). Overall survival was superior for patients who received MAC compared to those who received RIC (HR, 1.54; 95% CI, 1.07 to 2.2; P = .03). Our data show that patients who received MAC were at higher risk of late TRM compared with those who received RIC; however, because of the exceedingly high rates of relapse in the RIC arm, overall survival remained significantly better for patients who received MAC. Among patients with MDS or AML eligible for either MAC or RIC regimens, long-term follow up demonstrates a survival advantage for patients who received MAC.",2021,"Overall survival was superior for patients who received MAC compared to those who received RIC (HR, 1.54; 95% CI, 1.07 to 2.2; P = .03).","['Patients age 18 to 65 years with <5% marrow myeloblasts', 'patients with MDS or AML eligible for either', 'acute myelogenous leukemia (AML) or myelodysplasia (MDS']","['RIC', 'myeloablative conditioning (MAC', 'RIC before HCT', 'allogeneic hematopoietic cell transplantation (HCT', 'Myeloablative versus Reduced-Intensity Conditioning for Hematopoietic Cell Transplantation', 'MAC', 'HCT from an HLA-matched donor']","['TRM', 'overall survival, relapse, and relapse-free survival', '18-month pointwise comparison of overall survival', 'risk of relapse', 'survival advantage', 'risk of late TRM', 'Overall survival', 'postrelapse survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0229633', 'cui_str': 'Myeloblast'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",,0.134456,"Overall survival was superior for patients who received MAC compared to those who received RIC (HR, 1.54; 95% CI, 1.07 to 2.2; P = .03).","[{'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Scott', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington. Electronic address: bscott@fhcrc.org.'}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'Pasquini', 'Affiliation': 'BMT & Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Fei', 'Affiliation': 'BMT & Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Fraser', 'Affiliation': 'BMT & Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Steve M', 'Initials': 'SM', 'LastName': 'Devine', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Porter', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Maziarz', 'Affiliation': 'Orgeon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Warlick', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Hugo F', 'Initials': 'HF', 'LastName': 'Fernandez', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Soiffer', 'Affiliation': 'Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Alyea', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hamadani', 'Affiliation': 'BMT & Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Bashey', 'Affiliation': 'Northside Hospital Cancer Institute, Atlanta, Georgia.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Geller', 'Affiliation': 'National Heart Lung and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Leifer', 'Affiliation': 'National Heart Lung and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Hourigan', 'Affiliation': 'National Heart Lung and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Gege', 'Initials': 'G', 'LastName': 'Gui', 'Affiliation': 'National Heart Lung and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Mendizabal', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': 'BMT & Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'H Joachim', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Horwitz', 'Affiliation': 'Duke University, Durham, North Carolina.'}]",Transplantation and cellular therapy,['10.1016/j.jtct.2021.02.031']
648,33775558,Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC).,"BACKGROUND


The phase 3 MYSTIC study of durvalumab ± tremelimumab versus chemotherapy in metastatic non-small-cell lung cancer (NSCLC) patients with tumor cell (TC) programmed cell death ligand 1 (PD-L1) expression ≥ 25% did not meet its primary endpoints. We report patient-reported outcomes (PROs).
PATIENTS AND METHODS


Treatment-naïve patients were randomized (1:1:1) to durvalumab, durvalumab + tremelimumab, or chemotherapy. PROs were assessed in patients with PD-L1 TC ≥ 25% using EORTC Quality of Life Questionnaire (QLQ)-C30/LC13. Changes from baseline (12 months) for prespecified PRO endpoints of interest were analyzed by mixed model for repeated measures (MMRM) and time to deterioration (TTD) by stratified log-rank tests.
RESULTS


There were no between-arm differences in baseline PROs (N = 488). Between-arm differences in MMRM-adjusted mean changes from baseline favored at least one of the durvalumab-containing arms versus chemotherapy (nominal P < .01) for C30 fatigue: durvalumab (-9.5; 99% confidence interval [CI], -17.0 to -2.0), durvalumab + tremelimumab (-11.7; 99% CI, -19.4 to -4.1); and for C30 appetite loss: durvalumab (-11.9; 99% CI, -21.1 to -2.7). TTD was longer with at least one of the durvalumab-containing arms versus chemotherapy (nominal P < .01) for global health status/quality of life: durvalumab (hazard ratio [HR] = 0.7; 95% CI, 0.5-1.0), durvalumab + tremelimumab (HR = 0.7; 95% CI, 0.5-1.0); and for physical functioning: durvalumab (HR = 0.6; 95% CI, 0.4-0.8), durvalumab + tremelimumab (HR = 0.6; 95% CI, 0.5-0.9) (both C30); as well as for the key symptoms of dyspnea: durvalumab (HR = 0.6; 95% CI, 0.5-0.9), durvalumab + tremelimumab (HR = 0.7; 95% CI, 0.5-1.0) (both LC13); fatigue: durvalumab + tremelimumab (HR = 0.6; 95% CI, 0.4-0.8); and appetite loss: durvalumab (HR = 0.5; 95% CI, 0.4-0.7), durvalumab + tremelimumab (HR = 0.7; 95% CI, 0.5-0.9) (both C30).
CONCLUSION


Durvalumab ± tremelimumab versus chemotherapy reduced symptom burden and improved TTD of PROs, suggesting it had no detrimental effects on quality of life in metastatic NSCLC patients.",2021,"TTD was longer with at least one of the durvalumab-containing arms versus chemotherapy (nominal P < .01) for global health status/quality of life: durvalumab (hazard ratio [HR] = 0.7; 95% CI, 0.5-1.0), durvalumab + tremelimumab (HR = 0.7; 95% CI, 0.5-1.0); and for physical functioning: durvalumab (HR = 0.6; 95% CI, 0.4-0.8), durvalumab + tremelimumab (HR = 0.6; 95% CI, 0.5-0.9) (both C30); as well as for the key symptoms of dyspnea: durvalumab (HR = 0.6; 95% CI, 0.5-0.9), durvalumab + tremelimumab (HR = 0.7; 95% CI, 0.5-1.0) (both LC13); fatigue: durvalumab + tremelimumab (HR = 0.6; 95% CI, 0.4-0.8); and appetite loss: durvalumab (HR = 0.5; 95% CI, 0.4-0.7), durvalumab + tremelimumab (HR = 0.7; 95% CI, 0.5-0.9) (both C30).
","['metastatic non-small-cell lung cancer (NSCLC) patients with tumor cell (TC) programmed cell death ligand 1', 'metastatic NSCLC patients', 'Treatment-naïve patients']","['durvalumab, durvalumab\u202f+\u202ftremelimumab, or chemotherapy', 'durvalumab ± tremelimumab versus chemotherapy', 'Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy']","['quality of life', 'C30 appetite loss: durvalumab', 'appetite loss: durvalumab', 'repeated measures (MMRM) and time to deterioration (TTD', 'TTD', 'global health status/quality of life: durvalumab', 'PROs']","[{'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",,0.38256,"TTD was longer with at least one of the durvalumab-containing arms versus chemotherapy (nominal P < .01) for global health status/quality of life: durvalumab (hazard ratio [HR] = 0.7; 95% CI, 0.5-1.0), durvalumab + tremelimumab (HR = 0.7; 95% CI, 0.5-1.0); and for physical functioning: durvalumab (HR = 0.6; 95% CI, 0.4-0.8), durvalumab + tremelimumab (HR = 0.6; 95% CI, 0.5-0.9) (both C30); as well as for the key symptoms of dyspnea: durvalumab (HR = 0.6; 95% CI, 0.5-0.9), durvalumab + tremelimumab (HR = 0.7; 95% CI, 0.5-1.0) (both LC13); fatigue: durvalumab + tremelimumab (HR = 0.6; 95% CI, 0.4-0.8); and appetite loss: durvalumab (HR = 0.5; 95% CI, 0.4-0.7), durvalumab + tremelimumab (HR = 0.7; 95% CI, 0.5-0.9) (both C30).
","[{'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine, University of California/TRIO-US Network, Los Angeles, CA. Electronic address: egaron@mednet.ucla.edu.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Asklepios Lung Clinic, Munich-Gauting, Germany.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Oncology No. 1 (Thoracic Surgery), Leningrad Regional Clinical Hospital, St. Petersburg, Russia.'}, {'ForeName': 'Myung-Ju', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Robinet', 'Affiliation': 'Institut de Cancerologie, Centre Hospitalier Régional Universitaire de Brest-Hôpital Morvan, Brest, France.'}, {'ForeName': 'Sylvestre', 'Initials': 'S', 'LastName': 'Le Moulec', 'Affiliation': 'Department of Medical Oncology, Institut Bergonnié, Bordeaux Cedex, France.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Natale', 'Affiliation': 'Cedars-Sinai Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Department of Hematology and Oncology, NYU Winthrop Hospital, Mineola, NY.'}, {'ForeName': 'Frances A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'Princess Margaret Cancer Centre and the Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Marina Chiara', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Sarayut Lucien', 'Initials': 'SL', 'LastName': 'Geater', 'Affiliation': 'Department of Internal Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Zsolt Papai', 'Initials': 'ZP', 'LastName': 'Szekely', 'Affiliation': 'St. George Hospital of Fejer County, Szekesfehervar, Hungary.'}, {'ForeName': 'Tran', 'Initials': 'T', 'LastName': 'Van Ngoc', 'Affiliation': 'Cho Ray Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Scheuring', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Nikunj', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland.'}, {'ForeName': 'Naiyer A', 'Initials': 'NA', 'LastName': 'Rizvi', 'Affiliation': 'Division of Hematology/Oncology, Columbia University Medical Center, New York, NY.'}]",Clinical lung cancer,['10.1016/j.cllc.2021.02.010']
649,33775526,Progressive hyperthermia elicits distinct responses in maximum and rapid torque production.,"OBJECTIVES


To investigate the effect of progressive whole-body hyperthermia on maximal, and rapid voluntary torque production, and their neuromuscular determinants.
DESIGN


Repeated measures, randomised.
METHODS


Nine participants performed sets of neuromuscular assessments in HOT conditions (∼50°C, ∼35% relative humidity) at rectal temperatures (T re ) of 37, 38.5 and 39.5°C and in CON conditions (∼22°C, ∼35% relative humidity) at a T re  of ∼37°C and pre-determined comparative time-points. Electrically evoked twitch (single impulse) and octet (8 impulses at 300Hz) responses were measured at rest. Maximum voluntary torque (MVT), surface electromyography (EMG) normalised to maximal M-wave, and voluntary activation (VA) were measured during 3-5s isometric maximal voluntary contractions. Rate of torque development (RTD) and normalised EMG were measured during rapid voluntary isometric contractions from rest.
RESULTS


All neuromuscular variables were unaffected by time in CON. In HOT, MVT, normalised EMG at MVT and VA were lower at 39.5°C compared to 37°C (p<0.05). Early- (0-50ms) and middle- (50-100ms) phase voluntary RTD were unaffected by increased T re  (p>0.05), despite lower normalised EMG at T re  39.5°C (p<0.05) in rapid contractions. In contrast, late-phase (100-150ms) voluntary RTD was lower at 38.5°C and 39.5°C compared to 37°C (p<0.05) in HOT. Evoked twitch and octet RTD increased with increased T re  (p<0.05).
CONCLUSIONS


Hyperthermia reduced late-phase voluntary RTD, likely due to reduced neural drive and the reduction in MVT. In contrast, early- and middle-phase voluntary RTD were unaffected by hyperthermia, likely due to the conflicting effects of reduced neural drive but faster intrinsic contractile properties.",2021,"phase voluntary RTD were unaffected by increased T re  (p>0.05), despite lower normalised EMG at T re  39.5°C (p<0.05) in rapid contractions.","['Nine participants performed sets of neuromuscular assessments in HOT conditions (∼50°C, ∼35% relative humidity) at rectal temperatures (T re ) of 37, 38.5 and 39.5°C and in CON conditions (∼22°C, ∼35% relative humidity']",['Early'],"['phase voluntary RTD', 'Electrically evoked twitch (single impulse) and octet (8 impulses at 300Hz) responses', 'Rate of torque development (RTD) and normalised EMG', 'HOT, MVT, normalised EMG at MVT and VA', 'Evoked twitch and octet RTD', 'Maximum voluntary torque (MVT), surface electromyography (EMG) normalised to maximal M-wave, and voluntary activation (VA']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0428696', 'cui_str': 'Relative humidity'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0266313', 'cui_str': 'Renal tubular dysgenesis'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]",9.0,0.131299,"phase voluntary RTD were unaffected by increased T re  (p>0.05), despite lower normalised EMG at T re  39.5°C (p<0.05) in rapid contractions.","[{'ForeName': 'Ralph J F H', 'Initials': 'RJFH', 'LastName': 'Gordon', 'Affiliation': 'Department of Life Sciences, University of Roehampton, UK. Electronic address: gordonr@roehampton.ac.uk.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Tyler', 'Affiliation': 'Department of Life Sciences, University of Roehampton, UK.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Castelli', 'Affiliation': 'Department of Life Sciences, University of Roehampton, UK.'}, {'ForeName': 'Ceri E', 'Initials': 'CE', 'LastName': 'Diss', 'Affiliation': 'Department of Life Sciences, University of Roehampton, UK.'}, {'ForeName': 'Neale A', 'Initials': 'NA', 'LastName': 'Tillin', 'Affiliation': 'Department of Life Sciences, University of Roehampton, UK.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2021.03.007']
650,33775499,The effect of physician self-disclosure on patient self-disclosure and patient perceptions of the physician.,"OBJECTIVES


Physician self-disclosure is typically seen as patient-centered communication because it creates rapport and is seen as an expression of empathy. Given that many physician behaviors affect patients differently depending on whether they are shown by a female or male physician, we set out to test whether physician self-disclosure affects patients' intentions to self-disclose and patients' perceptions of their physicians depending on physicians' gender.
METHOD


Two hundred and forty-four participants were recruited and randomly assigned to read one of 4 vignettes as if they were the patient in the dialogue (analogue patient design). They were then asked to report how they would react to the physician and how they perceived the him or her.
RESULTS


Physicians who self-disclosed were perceived as more empathic than physicians who did not, regardless of physician and patient gender. Physician self-disclosure had an effect on the behavioral intentions of the analogue patients, and this was moderated by physician gender. Analogue patients indicated to be more willing to self-disclose to female than to male physicians who self-disclosed.
CONCLUSION


It is important to consider physician gender when training physicians in patient-centered communication because the same behavior can have different effects on patients depending on whether it originates from a female or a male physician.
PRACTICAL IMPLICATIONS


Physicians can use self-disclosure to express empathy. When female physicians do so, they might obtain more personal information from patients, which can positively affect diagnosis and treatment.",2021,"RESULTS


Physicians who self-disclosed were perceived as more empathic than physicians who did not, regardless of physician and patient gender.","['patient self-disclosure and patient perceptions of the physician', 'Two hundred and forty-four participants']",['physician self-disclosure'],['behavioral intentions'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036596', 'cui_str': 'Self Disclosure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C4517660', 'cui_str': '244'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0036596', 'cui_str': 'Self Disclosure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",244.0,0.0109941,"RESULTS


Physicians who self-disclosed were perceived as more empathic than physicians who did not, regardless of physician and patient gender.","[{'ForeName': 'Keou', 'Initials': 'K', 'LastName': 'Kadji', 'Affiliation': 'Department of Organizational Behavior, University of Lausanne, HEC, Switzerland. Electronic address: keoukambiwa.kadji@unil.ch.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Schmid Mast', 'Affiliation': 'Department of Organizational Behavior, University of Lausanne, HEC, Switzerland.'}]",Patient education and counseling,['10.1016/j.pec.2021.02.030']
651,33775200,"Sclerotherapy of ranulas with OK-432 - a prospective, randomized, double-blinded placebo-controlled study.","BACKGROUND


Ranula is a rare benign cystic lesion in the floor of the mouth, which can herniate through the mylohyoid muscle and become a plunging ranula. Treatment for ranulas is currently surgical excision of the sublingual gland. Sclerotherapy with OK-432 is a well-established treatment of lymphatic malformations, but not yet thoroughly evaluated on ranulas. Objectives: To evaluate sclerotherapy of ranulas with OK-432 in a randomized double-blinded trial.
MATERIALS AND METHODS


20 patients with plunging or intraoral ranula were randomized to two double-blinded injections with OK-432 or saline. Effect on the ranula and evaluation of symptoms and QOL were investigated.
RESULTS


Treatment response differed significantly between OK-432 and placebo,  p  = .041(student's T-test). All patients with intraoral ranulas had a complete response, but only 1/4 of the patients with plunging ranula. The inflammatory reaction after injection with OK-432 caused a mild to moderate impact on QOL. No serious complications were observed.
CONCLUSION


This study suggests that sclerotherapy with OK-432 in ranula is a very effective treatment for intraoral ranulas, but possibly less useful in plunging ranulas.
SIGNIFICANCE


This is a limited study, but we believe that sclerotherapy with OK-432 should be recommended as primary treatment at least for intraoral ranulas.",2021,"RESULTS


Treatment response differed significantly between OK-432 and placebo,  p  = .041(student's T-test).",['20 patients with plunging or intraoral ranula'],"['sclerotherapy with OK-432', 'Sclerotherapy with OK-432', 'Sclerotherapy', 'OK-432', 'placebo', 'OK-432 or saline']","['serious complications', 'QOL', 'ranula and evaluation of symptoms and QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0026686', 'cui_str': 'Mucocele of salivary gland'}]","[{'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0918027', 'cui_str': 'Streptococcal OK-432'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026686', 'cui_str': 'Mucocele of salivary gland'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",20.0,0.308327,"RESULTS


Treatment response differed significantly between OK-432 and placebo,  p  = .041(student's T-test).","[{'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Wendt', 'Affiliation': 'Division of Ear, Nose and Throat Diseases, Department of Clinical Sciences Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Papatziamos', 'Affiliation': 'Division of Ear, Nose and Throat Diseases, Department of Clinical Sciences Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Munck-Wikland', 'Affiliation': 'Division of Ear, Nose and Throat Diseases, Department of Clinical Sciences Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Marklund', 'Affiliation': 'Division of Ear, Nose and Throat Diseases, Department of Clinical Sciences Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}]",Acta oto-laryngologica,['10.1080/00016489.2021.1889660']
652,33775198,"The Effect of Bilateral Anodal Transcranial Direct Current Stimulation versus Treadmill Training on Brain Activities, Gait Functions, Level of Participation and Enjoyment of Children with Cerebral Palsy: A Randomized Controlled Trial Protocol.","Background : Cerebral palsy (CP) possesses bilateral sensory-motor cortical excitability alterations. In past studies, researchers have applied unilateral anodal transcranial direct stimulation (tDCS) with inconsistent findings. Objective : Examining the effects of treadmill training with either unilateral or bilateral anodal tDCS stimulation on brain activities, gait, and body functions of children with CP. Design : Randomized-clinical-trial. Participants : Eighty children with CP will be allocated into: treadmill/bilateral-tDCS, treadmill/unilateral-tDCS, treadmill/sham-tDCS, and treadmill groups. Additional 20 neurotypical children will be recruited for comparison. Intervention : Planned intervention will implement ten-sessions of treadmill training (50% of maximum-ground speed) either with unilateral-tDCS over left sensory-motor, or bilateral-tDCS over left/right sensory-motor areas. Brain activities, gait, body functions, and participation will be assessed at pre-intervention, post-intervention, and at one-month follow-up. Result and Discussion : This study would contribute to extant findings on the use of tDCS stimulation in children with CP and to our understanding of the appropriateness of the planned outcome measures.",2021,": Examining the effects of treadmill training with either unilateral or bilateral anodal tDCS stimulation on brain activities, gait, and body functions of children with CP.","['Participants ', 'Children with Cerebral Palsy', 'Additional 20 neurotypical children', 'Eighty children with CP', 'children with CP']","['treadmill/bilateral-tDCS, treadmill/unilateral-tDCS, treadmill/sham-tDCS, and treadmill groups', 'treadmill training (50% of maximum-ground speed) either with unilateral-tDCS over left sensory-motor, or bilateral-tDCS over left/right sensory-motor areas', 'treadmill training with either unilateral or bilateral anodal tDCS stimulation', 'Bilateral Anodal Transcranial Direct Current Stimulation versus Treadmill Training', 'Intervention ', 'unilateral anodal transcranial direct stimulation (tDCS']","['brain activities, gait, and body functions', 'Brain activities, gait, body functions, and participation', 'Brain Activities, Gait Functions, Level of Participation and Enjoyment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",80.0,0.0623555,": Examining the effects of treadmill training with either unilateral or bilateral anodal tDCS stimulation on brain activities, gait, and body functions of children with CP.","[{'ForeName': 'Hikmat', 'Initials': 'H', 'LastName': 'Hadoush', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Applied Medical Sciences at Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Nihad A', 'Initials': 'NA', 'LastName': 'Almasri', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Alnuman', 'Affiliation': 'Department of Biomedical Engineering, School of Applied Medical Sciences, German-Jordan University, Jordan.'}]",Developmental neurorehabilitation,['10.1080/17518423.2021.1905730']
653,33775175,Caregiver-guided pain coping skills training for patients with advanced cancer: Results from a randomized clinical trial.,"BACKGROUND


Pain is a major concern among patients with advanced cancer and their family caregivers. Evidence suggests that pain coping skills training interventions can improve outcomes, however they have rarely been tested in this population.
AIM


To test the efficacy of a caregiver-guided pain coping skills training intervention. The primary outcome was caregiver self-efficacy for helping the patient manage pain.
DESIGN


A randomized controlled trial compared the intervention to an enhanced treatment-as-usual control. Dyads in both conditions received pain education, and those in the intervention received three sessions of pain coping skills training. Caregiver outcomes (self-efficacy; caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy, pain intensity and interference, psychological distress) were collected at baseline and post-intervention.
SETTING/PARTICIPANTS


Two hundred two patients with stage III-IV cancer and pain and their family caregivers were enrolled from four outpatient oncology clinics and a free-standing hospice/palliative care organization.
RESULTS


Compared to those in the control arm, caregivers in the intervention reported significant increases in caregiving satisfaction ( p  < 0.01) and decreased anxiety ( p  = 0.04). In both conditions, caregivers reported improvements in self-efficacy, and patients reported improvements in self-efficacy, pain severity and interference, and psychological distress.
CONCLUSIONS


This is the first study to test a pain coping skills intervention targeted to patients and caregivers facing advanced cancer. Findings suggest that pain education provides benefits for patients and caregivers, and coping skills training may be beneficial for caregivers. Further research is needed to optimize the benefits of education and pain coping skills training for improving cancer pain outcomes. Trial registration:  ClinicalTrials.gov NCT02430467, Caregiver-Guided Pain Management Training in Palliative Care.",2021,"In both conditions, caregivers reported improvements in self-efficacy, and patients reported improvements in self-efficacy, pain severity and interference, and psychological distress.
","['patients with advanced cancer', 'patients with advanced cancer and their family caregivers', 'patients and caregivers facing advanced cancer', 'Two hundred two patients with stage III-IV cancer and pain and their family caregivers were enrolled from four outpatient oncology clinics and a free-standing hospice/palliative care organization']","['pain coping skills intervention', 'caregiver-guided pain coping skills training intervention', 'Caregiver-guided pain coping skills training', 'Caregiver-Guided Pain Management Training', 'pain coping skills training']","['self-efficacy, pain severity and interference, and psychological distress', 'caregiver self-efficacy for helping the patient manage pain', 'caregiving satisfaction', 'decreased anxiety', 'Caregiver outcomes (self-efficacy; caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy, pain intensity and interference, psychological distress', 'self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",202.0,0.210389,"In both conditions, caregivers reported improvements in self-efficacy, and patients reported improvements in self-efficacy, pain severity and interference, and psychological distress.
","[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Steel', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Fairclough', 'Affiliation': 'Colorado School of Public Health, Arora, CO, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'LeBlanc', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Bull', 'Affiliation': 'Four Seasons Compassion for Life, Hendersonville, NC, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Hanson', 'Affiliation': 'Division of Geriatric Medicine & Palliative Care Program, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Fischer', 'Affiliation': 'University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}]",Palliative medicine,['10.1177/02692163211004216']
654,33775160,Comparison of the Effect of Traffic Park-Based and School-Based Educational Interventions on Safe Road Crossing in Yazd Elementary School Students.,"INTRODUCTION


Traffic accidents are one of the most important health problems that cause many deaths every year. Scientific-practical interventions are needed to prevent traffic accidents. This study aimed to compare the effectiveness of traffic-based and school-based interventions on the safe road crossing in Yazd elementary school students.
METHODS


This interventional study was conducted on 132 students (66 males and 66 females) in two groups of school-based and traffic park-based intervention. A questionnaire was used to determine the safe crossing behavior score. Then, an educational intervention was administered to both groups. Two months after the intervention, safe crossing behavior was evaluated in both groups. Finally, the data were analyzed using SPSS software version 22.
RESULTS


In both groups, the score of safe crossing behavior was significantly increased after the intervention. The school-based group had significantly better behaviors compared to the traffic park-based group (P=0.001). There was a significant difference in the mean score of behavior between males and females and the intervention had a greater effect on female students (P=0.017).
CONCLUSION


Educational interventions and especially school-based intervention can be effective in improving the students' safe crossing behaviors.",2021,The school-based group had significantly better behaviors compared to the traffic park-based group (P=0.001).,"['Yazd Elementary School Students', 'Yazd elementary school students', '132 students (66 males and 66 females) in two groups of school-based and traffic park-based intervention']","['traffic-based and school-based interventions', 'Traffic Park-Based and School-Based Educational Interventions', 'Educational interventions and especially school-based intervention']","['safe crossing behavior score', 'safe crossing behavior', 'score of safe crossing behavior', 'mean score of behavior']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}]","[{'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",132.0,0.00854334,The school-based group had significantly better behaviors compared to the traffic park-based group (P=0.001).,"[{'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Zare', 'Affiliation': 'Department of Occupational Health, School of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Dehghanitafti', 'Affiliation': 'Department of Health Education, School of Health, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Rahaei', 'Affiliation': 'Department of Health Education, School of Health, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Jambarsang', 'Affiliation': 'Department of Health Education, School of Health, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Tolide', 'Affiliation': 'Department of Health Education, School of Health, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",International quarterly of community health education,['10.1177/0272684X211004952']
655,33775153,Effects of Emotion Dysregulation on Post-treatment Post-traumatic Stress Disorder and Depressive Symptoms Among Women Veterans With Military Sexual Trauma.,"Military sexual trauma (MST), defined as sexual assault or repeated, threatening sexual harassment while in the military, is associated with increased risk of long-term mental and physical health problems, with the most common being symptoms of post-traumatic stress disorder (PTSD) and depression. In addition to PTSD and depression, MST is linked to difficulties in emotion regulation as well as poor treatment engagement. Thus, it is important to examine these correlates, and how they affect postintervention symptom reduction in this vulnerable population. The current study presents secondary data analyses from a randomized clinical trial comparing the efficacy of in-person versus telemedicine delivery of prolonged exposure therapy for female veterans with MST-related PTSD ( n  = 151). Results of the study found that changes in difficulties with emotion regulation predicted postintervention depressive symptoms but not postintervention PTSD symptoms. Neither postintervention depressive nor PTSD symptoms were affected by treatment dosing (i.e., number of sessions attended) nor treatment condition (i.e., in-person vs. telemedicine). Findings from the current study provide preliminary evidence that decreases in difficulties with emotion regulation during PTSD treatment are associated with decreases in depressive symptom severity.",2021,Results of the study found that changes in difficulties with emotion regulation predicted postintervention depressive symptoms but not postintervention PTSD symptoms.,"['female veterans with MST-related PTSD ( n  = 151', 'Women Veterans With Military Sexual Trauma']","['person versus telemedicine delivery of prolonged exposure therapy', 'Emotion Dysregulation']","['postintervention depressive nor PTSD symptoms', 'depressive symptom severity', 'difficulties with emotion regulation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0358384,Results of the study found that changes in difficulties with emotion regulation predicted postintervention depressive symptoms but not postintervention PTSD symptoms.,"[{'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Lopez', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Gilmore', 'Affiliation': 'Georgia State University Atlanta, GA, USA.'}, {'ForeName': 'Wilson J', 'Initials': 'WJ', 'LastName': 'Brown', 'Affiliation': 'Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Hahn', 'Affiliation': 'Georgia State University Atlanta, GA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Muzzy', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Grubaugh', 'Affiliation': 'Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Acierno', 'Affiliation': 'University of Texas Health Sciences Center at Houston, TX, USA.'}]",Journal of interpersonal violence,['10.1177/08862605211005134']
656,33773697,"Epicatechin and quercetin exhibit in vitro antioxidant effect, improve biochemical parameters related to metabolic syndrome, and decrease cellular genotoxicity in humans.","Metabolic syndrome is a condition whose incidence has been increasing around the world. It promotes a metabolic state of chronic systemic inflammation, correlated to cellular stress and genetic mutations, and subsequently with deadly chronic diseases, such as type 2 diabetes mellitus, cardiovascular diseases, and cancer. A randomized placebo-controlled study (n = 156) was conducted to determine the effects of consuming an enriched bread with 0.05% of a 1:1 mixture of (-)-epicatechin and quercetin on anthropometric and biochemical parameters of the participants. As a result, total cholesterol, LDL-cholesterol, total triglycerides, and fasting plasma glucose significantly decreased after three months of daily enriched bread consumption. Nuclear abnormalities in buccal epithelium cells also decreased (15.8 ± 3.2 down to 8.3 ± 1.0), showing a genoprotective effect. The antioxidant properties of these compounds were observed by monitoring changes in the cytoplasmic redox tone of intact Caco-2 cells expressing HyPer, a fluorescent redox biosensor. The combination of (-)-epicatechin and quercetin changes the cytoplasmic redox ambient in living cells and significantly improves biochemical parameters related to metabolic syndrome, and decreases the number of cell abnormalities in buccal epithelium cells of patients.",2021,"As a result, total cholesterol, LDL-cholesterol, total triglycerides, and fasting plasma glucose significantly decreased after three months of daily enriched bread consumption.",['controlled study (n\xa0=\xa0156'],"['placebo', '1:1 mixture of (-)-epicatechin and quercetin']","['Nuclear abnormalities in buccal epithelium cells', 'total cholesterol, LDL-cholesterol, total triglycerides, and fasting plasma glucose']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0014485', 'cui_str': '(-)-Epicatechin'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}]","[{'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",,0.0473975,"As a result, total cholesterol, LDL-cholesterol, total triglycerides, and fasting plasma glucose significantly decreased after three months of daily enriched bread consumption.","[{'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Leyva-Soto', 'Affiliation': 'Facultad de Ciencias Químicas e Ingeniería, Universidad Autónoma de Baja California (UABC) - Campus Tijuana, Calzada Universidad 14418, Parque Industrial Internacional Tijuana, 22390 Tijuana, B.C., Mexico.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Alejandra Chavez-Santoscoy', 'Affiliation': 'Escuela de Ingeniería y Ciencias, Centro de Biotecnologia FEMSA, Tecnológico de Monterrey, Av. Eugenio Garza Sada 2501 Sur, C.P. 64849 Monterrey, N.L., Mexico. Electronic address: ale.santoscoy@gmail.com.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Porras', 'Affiliation': 'Laboratory for Research in Functional Nutrition, Instituto de Nutrición y Tecnología de los Alimentos (INTA), Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Miltha', 'Initials': 'M', 'LastName': 'Hidalgo-Ledesma', 'Affiliation': 'Laboratory for Research in Functional Nutrition, Instituto de Nutrición y Tecnología de los Alimentos (INTA), Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Aracely', 'Initials': 'A', 'LastName': 'Serrano-Medina', 'Affiliation': 'Facultad de Medicina y Psicología, Universidad Autónoma de Baja California (UABC) - Campus Tijuana, Calzada Universidad 14418, Parque Industrial Internacional Tijuana, 22390 Tijuana, B.C., Mexico.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Alejandra Ramírez-Rodríguez', 'Affiliation': 'Facultad de Ciencias Químicas e Ingeniería, Universidad Autónoma de Baja California (UABC) - Campus Tijuana, Calzada Universidad 14418, Parque Industrial Internacional Tijuana, 22390 Tijuana, B.C., Mexico.'}, {'ForeName': 'Nydia', 'Initials': 'N', 'LastName': 'Alejandra Castillo-Martinez', 'Affiliation': 'Facultad de Ciencias de la Salud, Universidad Autónoma de Baja California, Blvd Universitario No. 1000, Valle San Pedro, 21500 Tijuana, B.C., Mexico.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2020.110101']
657,33773639,Reducing anticholinergic medication exposure among older adults using consumer technology: Protocol for a randomized clinical trial.,"INTRODUCTION


A growing body of scientific evidence points to the potentially harmful cognitive effects of anticholinergic medications among older adults. Most interventions designed to promote deprescribing of anticholinergics have directly targeted healthcare professionals and have had mixed results. Consumer-facing technologies may provide a unique benefit by empowering patients and can complement existing healthcare professional-centric efforts.
METHODS


We initiated a randomized clinical trial to evaluate the effectiveness of a patient-facing mobile application (Brain Safe app) compared to an attention control medication list app in reducing anticholinergic exposure among community-dwelling older adults. Study participants are adults aged 60 years and above, currently using at least one prescribed strong anticholinergic, and receiving primary care. The trial plans to enroll a total of 700 participants, randomly allocated in 1:1 proportion to the two study arms. Participants will have the Brain Safe app (intervention arm) or attention control medication list app (control arm) loaded onto a smartphone (study provided or personal device). All participants will be followed for 12 months and will have data collected at baseline, at 6 months, and 12 months by blinded outcome assessors. The primary outcome of the study is anticholinergic exposure measured as total standard daily dose (TSDD) computed from medication prescription electronic records. Secondary outcomes of the study are cognitive function and health-related quality of life.
DISCUSSION


A consumer-facing intervention to promote deprescribing of potentially high-risk medications can be part of a multi-pronged approach to reduce inappropriate medication use among older adult patients. Delivering a deprescribing intervention via a mobile app is a novel approach and may hold great promise to accelerate deployment of medication safety initiatives across diverse patient populations.
CLINICAL TRIAL REGISTRATION


Registered at ClinicalTrials.gov on October 10, 2019. Identifier number: NCT04121858.",2021,"Consumer-facing technologies may provide a unique benefit by empowering patients and can complement existing healthcare professional-centric efforts.
","['Study participants are adults aged 60 years and above, currently using at least one prescribed strong anticholinergic, and receiving primary care', 'older adult patients', 'older adults', 'community-dwelling older adults', '700 participants']","['patient-facing mobile application (Brain Safe app', 'anticholinergic medications', 'attention control medication list app (control arm) loaded onto a smartphone (study provided or personal device']","['cognitive function and health-related quality of life', 'anticholinergic exposure measured as total standard daily dose (TSDD']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517862', 'cui_str': '700'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",700.0,0.390496,"Consumer-facing technologies may provide a unique benefit by empowering patients and can complement existing healthcare professional-centric efforts.
","[{'ForeName': 'Ephrem', 'Initials': 'E', 'LastName': 'Abebe', 'Affiliation': 'Department of Pharmacy Practice, Purdue University College of Pharmacy, West Lafayette, IN, USA; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Noll L', 'Initials': 'NL', 'LastName': 'Campbell', 'Affiliation': 'Department of Pharmacy Practice, Purdue University College of Pharmacy, West Lafayette, IN, USA; Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA; Center for Health Innovation and Implementation Science, Indiana University School of Medicine, Indianapolis, IN, USA; Eskenazi Health, Indianapolis, IN, USA.'}, {'ForeName': 'Daniel O', 'Initials': 'DO', 'LastName': 'Clark', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Wanzhu', 'Initials': 'W', 'LastName': 'Tu', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Jordan R', 'Initials': 'JR', 'LastName': 'Hill', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Addison B', 'Initials': 'AB', 'LastName': 'Harrington', 'Affiliation': 'Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Gracen', 'Initials': 'G', 'LastName': ""O'Neal"", 'Affiliation': 'Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Trowbridge', 'Affiliation': 'Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vallejo', 'Affiliation': 'Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Ziyi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Bo', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Alexxus', 'Initials': 'A', 'LastName': 'Knight', 'Affiliation': 'Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Khalid A', 'Initials': 'KA', 'LastName': 'Alamer', 'Affiliation': 'Department of Pharmacy Practice, Purdue University College of Pharmacy, West Lafayette, IN, USA.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Carter', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Adeoye', 'Affiliation': 'Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Malaz A', 'Initials': 'MA', 'LastName': 'Boustani', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA; Indiana Clinical and Translational Sciences Institute, Indianapolis, IN, USA; Sandra Eskenazi Center for Brain Care Innovation, Eskenazi Health, Indianapolis, IN, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Holden', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA; Center for Health Innovation and Implementation Science, Indiana University School of Medicine, Indianapolis, IN, USA. Electronic address: rjholden@iu.edu.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.10.010']
658,33773631,"Discontinuing β-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial.","BACKGROUND


Shortening the duration of antibiotic therapy for patients admitted to hospital with community-acquired pneumonia should help reduce antibiotic consumption and thus bacterial resistance, adverse events, and related costs. We aimed to assess the need for an additional 5-day course of β-lactam therapy among patients with community-acquired pneumonia who were stable after 3 days of treatment.
METHODS


We did this double-blind, randomised, placebo-controlled, non-inferiority trial (the Pneumonia Short Treatment [PTC]) in 16 centres in France. Adult patients (aged ≥18 years) admitted to hospital with moderately severe community-acquired pneumonia (defined as patients admitted to a non-critical care unit) and who met prespecified clinical stability criteria after 3 days of treatment with β-lactam therapy were randomly assigned (1:1) to receive β-lactam therapy (oral amoxicillin 1 g plus clavulanate 125 mg three times a day) or matched placebo for 5 extra days. Randomisation was done using a web-based system with permuted blocks with random sizes and stratified by randomisation site and Pneumonia Severity Index score. Participants, clinicians, and study staff were masked to treatment allocation. The primary outcome was cure 15 days after first antibiotic intake, defined by apyrexia (temperature ≤37·8°C), resolution or improvement of respiratory symptoms, and no additional antibiotic treatment for any cause. A non-inferiority margin of 10 percentage points was chosen. The primary outcome was assessed in all patients who were randomly assigned and received any treatment (intention-to-treat [ITT] population) and in all patients who received their assigned treatment (per-protocol population). Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT01963442, and is now complete.
FINDINGS


Between Dec 19, 2013, and Feb 1, 2018, 706 patients were assessed for eligibility, and after 3 days of β-lactam treatment, 310 eligible patients were randomly assigned to receive either placebo (n=157) or β-lactam treatment (n=153). Seven patients withdrew consent before taking any study drug, five in the placebo group and two in the β-lactam group. In the ITT population, median age was 73·0 years (IQR 57·0-84·0) and 123 (41%) of 303 participants were female. In the ITT analysis, cure at day 15 occurred in 117 (77%) of 152 participants in the placebo group and 102 (68%) of 151 participants in the β-lactam group (between-group difference of 9·42%, 95% CI -0·38 to 20·04), indicating non-inferiority. In the per-protocol analysis, 113 (78%) of 145 participants in the placebo treatment group and 100 (68%) of 146 participants in the β-lactam treatment group were cured at day 15 (difference of 9·44% [95% CI -0·15 to 20·34]), indicating non-inferiority. Incidence of adverse events was similar between the treatment groups (22 [14%] of 152 in the placebo group and 29 [19%] of 151 in the β-lactam group). The most common adverse events were digestive disorders, reported in 17 (11%) of 152 patients in the placebo group and 28 (19%) of 151 patients in the β-lactam group. By day 30, three (2%) patients had died in the placebo group (one due to bacteraemia due to Staphylococcus aureus, one due to cardiogenic shock after acute pulmonary oedema, and one due to heart failure associated with acute renal failure) and two (1%) in the β-lactam group (due to pneumonia recurrence and possible acute pulmonary oedema).
INTERPRETATION


Among patients admitted to hospital with community-acquired pneumonia who met clinical stability criteria, discontinuing β-lactam treatment after 3 days was non-inferior to 8 days of treatment. These findings could allow substantial reduction of antibiotic consumption.
FUNDING


French Ministry of Health.",2021,"The most common adverse events were digestive disorders, reported in 17 (11%) of 152 patients in the placebo group and 28 (19%) of 151 patients in the β-lactam group.","['16 centres in France', 'Between Dec 19, 2013, and Feb 1, 2018, 706 patients were assessed for eligibility, and after 3 days of β-lactam treatment, 310 eligible patients', 'patients with community-acquired pneumonia who were stable after 3 days of treatment', 'patients admitted to hospital with community-acquired pneumonia', 'patients admitted to hospital with community-acquired pneumonia who met clinical stability criteria, discontinuing β-lactam treatment after 3 days was non-inferior to 8 days of treatment', 'patients with community-acquired pneumonia in non-critical care wards (PTC', 'Adult patients (aged ≥18 years) admitted to hospital with moderately severe community-acquired pneumonia (defined as patients admitted to a non-critical care unit) and who met prespecified clinical stability criteria after 3 days of treatment with β-lactam therapy', 'In the ITT population, median age was 73·0 years (IQR 57·0-84·0) and 123 (41%) of 303 participants were female']","['β-lactam treatment', 'placebo', 'β-lactam therapy (oral amoxicillin 1 g plus clavulanate 125 mg three times a day) or matched placebo', 'Pneumonia Short Treatment [PTC', 'β-lactam therapy', 'Discontinuing β-lactam', 'antibiotic therapy']","['Incidence of adverse events', 'Safety', 'cure 15 days after first antibiotic intake, defined by apyrexia (temperature ≤37·8°C), resolution or improvement of respiratory symptoms, and no additional antibiotic treatment for any cause', 'pneumonia recurrence and possible acute pulmonary oedema']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0022914', 'cui_str': 'Lactam'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0022914', 'cui_str': 'Lactam'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1126575', 'cui_str': 'Clavulanate 125 MG'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0277797', 'cui_str': 'Apyrexial'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0155919', 'cui_str': 'Acute pulmonary edema'}]",706.0,0.791349,"The most common adverse events were digestive disorders, reported in 17 (11%) of 152 patients in the placebo group and 28 (19%) of 151 patients in the β-lactam group.","[{'ForeName': 'Aurélien', 'Initials': 'A', 'LastName': 'Dinh', 'Affiliation': 'Infectious Disease Unit, Raymond-Poincaré University Hospital, AP-HP, Paris Saclay University, Garches, France. Electronic address: aurelien.dinh@aphp.fr.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Ropers', 'Affiliation': 'Clinical research unit, Pitié-Salpêtrière University Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Duran', 'Affiliation': 'Infectious Disease Unit, Raymond-Poincaré University Hospital, AP-HP, Paris Saclay University, Garches, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Davido', 'Affiliation': 'Infectious Disease Unit, Raymond-Poincaré University Hospital, AP-HP, Paris Saclay University, Garches, France.'}, {'ForeName': 'Laurène', 'Initials': 'L', 'LastName': 'Deconinck', 'Affiliation': 'Infectious Disease Department, Bichat University Hospital, AP-HP, University of Paris, Paris, France.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Matt', 'Affiliation': 'Infectious Disease Unit, Raymond-Poincaré University Hospital, AP-HP, Paris Saclay University, Garches, France.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Senard', 'Affiliation': 'Infectious Disease Department, Marne La Vallée Hospital, GHEF, Marne La Vallée, France.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Lagrange', 'Affiliation': 'Pneumology Department, Pontoise Hospital, Pontoise, France.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Makhloufi', 'Affiliation': 'Infectious Disease Unit, Raymond-Poincaré University Hospital, AP-HP, Paris Saclay University, Garches, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Mellon', 'Affiliation': 'Infectious Disease Unit, Raymond-Poincaré University Hospital, AP-HP, Paris Saclay University, Garches, France.'}, {'ForeName': 'Victoire', 'Initials': 'V', 'LastName': 'de Lastours', 'Affiliation': 'Internal Medicine Department, Beaujon University Hospital, AP-HP, University of Paris, Clichy, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Bouchand', 'Affiliation': 'Pharmacy, Raymond-Poincaré University Hospital, AP-HP, Paris Saclay University, Garches, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Mathieu', 'Affiliation': 'Emergency Department, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Jean-Emmanuel', 'Initials': 'JE', 'LastName': 'Kahn', 'Affiliation': 'Internal Medicine Department, Ambroise Paré University Hospital, AP-HP, Paris Saclay University, Boulogne-Billancourt, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Rouveix', 'Affiliation': 'Internal Medicine Department, Ambroise Paré University Hospital, AP-HP, Paris Saclay University, Boulogne-Billancourt, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Grenet', 'Affiliation': 'Emergency Department, Ambroise Paré University Hospital, AP-HP, Paris Saclay University, Boulogne-Billancourt, France.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dumoulin', 'Affiliation': 'Pneumology Department, Ambroise Paré University Hospital, AP-HP, Paris Saclay University, Boulogne-Billancourt, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Chinet', 'Affiliation': 'Pneumology Department, Ambroise Paré University Hospital, AP-HP, Paris Saclay University, Boulogne-Billancourt, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Pépin', 'Affiliation': 'Geriatric Department, Ambroise Paré University Hospital, AP-HP, Paris Saclay University, Boulogne-Billancourt, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Delcey', 'Affiliation': 'Internal Medicine Department, Lariboisière Hospital, AP-HP, University of Paris, Paris, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Diamantis', 'Affiliation': 'Infectious Disease Department, Melun Hospital, Melun, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Benhamou', 'Affiliation': 'Pneumology Department, Bois-Guillaume University Hospital, Rouen, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Vitrat', 'Affiliation': 'Internal Medicine, Annecy Hospital, Annecy, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Dombret', 'Affiliation': 'Pneumology Department, Bichat University Hospital, AP-HP, University of Paris, Paris, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Renaud', 'Affiliation': 'Emergency Department, Cochin University Hospital, AP-HP, Paris Centre University, Paris, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Perronne', 'Affiliation': 'Infectious Disease Unit, Raymond-Poincaré University Hospital, AP-HP, Paris Saclay University, Garches, France.'}, {'ForeName': 'Yann-Erick', 'Initials': 'YE', 'LastName': 'Claessens', 'Affiliation': 'Emergency Department, Princesse Grace Hospital, Monaco.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Labarère', 'Affiliation': 'Quality of Care Unit, Grenoble University Hospital, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bedos', 'Affiliation': 'Intensive Care Unit, André Mignot Hospital, Versailles, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Aegerter', 'Affiliation': 'UMRS 1169 VIMA, INSERM, Versailles Saint-Quentin University, Versailles, France.'}, {'ForeName': 'Anne-Claude', 'Initials': 'AC', 'LastName': 'Crémieux', 'Affiliation': 'Infectious Disease Department, Saint-Louis University Hospital, AP-HP, University of Paris, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)00313-5']
659,33773580,"Lidocaine combined with magnesium sulfate preserved hemodynamic stability during general anesthesia without prolonging neuromuscular blockade: a randomized, double-blind, controlled trial.","BACKGROUND


Lidocaine and magnesium sulfate have become increasingly utilized in general anesthesia. The present study evaluated the effects of these drugs, isolated or combined, on hemodynamic parameters as well as on the cisatracurium-induced neuromuscular blockade (NMB).
METHODS


At a university hospital, 64 patients, ASA physical status I and II, undergoing elective surgery with similar pain stimuli were randomly assigned to four groups. Patients received a bolus of lidocaine and magnesium sulfate before the tracheal intubation and a continuous infusion during the operation as follows: 3 mg.kg - 1  and 3 mg.kg - 1 .h - 1  (lidocaine - L group), 40 mg.kg - 1  and 20 mg.kg - 1 .h - 1  (magnesium - M group), equal doses of both drugs (magnesium plus lidocaine - ML group), and an equivalent volume of isotonic solution (control - C group). Hemodynamic parameters and neuromuscular blockade features were continuously monitored until spontaneous recovery of the train of four (TOF) ratio (TOFR > 0.9).
RESULTS


The magnesium sulfate significantly prolonged all NMB recovery features, without changing the speed of onset of cisatracurium. The addition of lidocaine to Magnesium Sulfate did not influence the cisatracurium neuromuscular blockade. A similar finding was observed when this drug was used alone, with a significantly smaller fluctuation of mean arterial pressure (MAP) and heart rate (HR) measures during anesthesia induction and maintenance. Interestingly, the percentage of patients who achieved a TOFR of 90% without reaching T1-95% was higher in the M and ML groups. Than in the C and L groups. There were no adverse events reported in this study.
CONCLUSION


Intravenous lidocaine plays a significant role in the hemodynamic stability of patients under general anesthesia without exerting any additional impact on the NMB, even combined with magnesium sulfate. Aside from prolonging all NMB recovery characteristics without altering the onset speed, magnesium sulfate enhances the TOF recovery rate without T1 recovery. Our findings may aid clinical decisions involving the use of these drugs by encouraging their association in multimodal anesthesia or other therapeutic purposes.
TRIAL REGISTRATION


NCT02483611 (registration date: 06-29-2015).",2021,"Aside from prolonging all NMB recovery characteristics without altering the onset speed, magnesium sulfate enhances the TOF recovery rate without T1 recovery.","['64 patients, ASA physical status I and II, undergoing elective surgery with similar pain stimuli', 'general anesthesia without prolonging neuromuscular blockade', 'patients under general anesthesia']","['magnesium sulfate', 'lidocaine to Magnesium Sulfate', '40\u2009mg.kg -\u20091  and 20\u2009mg.kg -\u20091 .h -\u20091  (magnesium - M group), equal doses of both drugs (magnesium plus lidocaine - ML group), and an equivalent volume of isotonic solution (control - C group', 'lidocaine and magnesium sulfate', 'lidocaine', 'Lidocaine and magnesium sulfate', 'Lidocaine']","['hemodynamic stability', 'Hemodynamic parameters and neuromuscular blockade features', 'mean arterial pressure (MAP) and heart rate (HR) measures', 'cisatracurium neuromuscular blockade', 'TOF recovery rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0022260', 'cui_str': 'Isotonic Solutions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}]",,0.103585,"Aside from prolonging all NMB recovery characteristics without altering the onset speed, magnesium sulfate enhances the TOF recovery rate without T1 recovery.","[{'ForeName': 'Waynice N', 'Initials': 'WN', 'LastName': 'Paula-Garcia', 'Affiliation': 'Department of Orthopedics and Anesthesiology, Faculty of Medicine of Ribeirao Preto, University of São Paulo, Ribeirão Preto, SP, 14049900, Brazil. wgarcia@fmrp.usp.br.'}, {'ForeName': 'Gustavo H', 'Initials': 'GH', 'LastName': 'Oliveira-Paula', 'Affiliation': 'Albert Einstein College of Medicine, New York 1300 Morris Park Ave, The Bronx, NY, 10461, USA.'}, {'ForeName': 'Hans Donald', 'Initials': 'HD', 'LastName': 'de Boer', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Procedural Sedation and Analgesia, Martini General Hospital Groningen, van Swietenplein 1, 9728, NT, Groningen, The Netherlands.'}, {'ForeName': 'Luis Vicente', 'Initials': 'LV', 'LastName': 'Garcia', 'Affiliation': 'Department of Orthopedics and Anesthesiology, Faculty of Medicine of Ribeirao Preto, University of São Paulo, Ribeirão Preto, SP, 14049900, Brazil.'}]",BMC anesthesiology,['10.1186/s12871-021-01311-y']
660,33773577,"Comparison of lidocaine, huffing maneuver and combination of both in prevention fentanyl induced cough before induction of anesthesia: a double-blind, prospective, randomized placebo-controlled study.","BACKGROUND


Intravenous bolus injection of fentanyl has been frequently reported to be associated with cough reflex during patient anesthesia. However, the search for the most effective protocol continues. This study aimed to compare the effect of reducing cough reflex after injection of fentanyl in a fusion protocol by combining the injections of lidocaine and Huffing maneuver and comparing with a placebo control group, before anesthesia induction.
METHODS


This prospective randomized controlled trial study was performed on 400 patients who were divided into four groups of combined protocol (group 1), lidocaine group (group 2), Huffing maneuver group (group 3), and the control receiving normal saline (group 4). Then patients were injected with 2. 5 μg /kg fentanyl and monitored for 2 min regarding their cough reflex, as well as the severity.
RESULTS


In group one, 9 patients (9%), in group two, 45 patients (45%), 22 patients (22%) in group three, and in group four, 75 patients (75%), developed cough reflex following fentanyl injection. Also, 13 patients (13%) developed moderate and 4 (4%) developed severe coughs in the control group reported, while no reports of severe or moderate cough were among the intervention groups. There was a significant difference between the intervention group and the control group both in terms of the rate and severity of the fentanyl-induced cough.
CONCLUSION


By using a combination of lidocaine injection along and Huffing maneuver, better results can be obtained in reducing the frequency, and also the severity of cough followed by fentanyl injection.
TRIAL REGISTRATION


The trial was registered with IRCT.IR (09/03/2018-No. IRCT20141009019470N74 ).",2021,"There was a significant difference between the intervention group and the control group both in terms of the rate and severity of the fentanyl-induced cough.
","['cough before induction of anesthesia', '400 patients who were divided into four groups of']","['lidocaine and Huffing maneuver and comparing with a placebo control', 'combined protocol', 'lidocaine injection along and Huffing maneuver', 'Huffing maneuver group', 'fentanyl', 'placebo', 'IRCT.IR', 'lidocaine', 'control receiving normal saline']","['rate and severity of the fentanyl-induced cough', 'severe coughs', 'cough reflex', 'severe or moderate cough']","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0566520', 'cui_str': 'Does huff'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4049857', 'cui_str': 'Lidocaine Injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0232051', 'cui_str': 'Cough reflex'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",400.0,0.0254991,"There was a significant difference between the intervention group and the control group both in terms of the rate and severity of the fentanyl-induced cough.
","[{'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Dehghanpisheh', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammadhossein', 'Initials': 'M', 'LastName': 'Eghbal', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Bagheri Baravati', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Vatankhah', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Pvatankhah@sums.ac.ir.'}]",BMC anesthesiology,['10.1186/s12871-021-01313-w']
661,33773565,A Randomized Clinical Trial of Levonorgestrel Intrauterine System with or without Metformin for Treatment of Endometrial Hyperplasia without Atypia in Indian Women.,"BACKGROUND


Endometrial cancer is the second most frequent genital malignancy in women, which is showing a constant rise all over world. Endometrial hyperplasia is the precursor of endometrial cancer. Levonorgestrel intrauterine system is the first line management in patients with endometrial hyperplasia without atypia. Metformin has shown to reverse endometrial hyperplasia, but its effectiveness and safety in endometrial hyperplasia is uncertain.
OBJECTIVE


To compare the efficacy in terms of histopathological response, clinical response and safety at the end of 6 months in patients with endometrial hyperplasia without atypia managed with Levonorgestrel intrauterine system alone versus patients managed with Levonorgestrel intrauterine system plus metformin.
METHODS


The randomized control trial was conducted on 51 cases of endometrial hyperplasia without atypia. Twenty-five subjects were prescribed metformin 500mg twice daily with Levonorgestrel intrauterine system and 26 subjects, with Levonorgestrel intrauterine system only for 6 months. At the end of 6 months, endometrial sampling was performed for histopathological response.
RESULTS


Clinical response was observed in 23 of 25 subjects in metformin group and 22 of 24 in Levonorgestrel only group. The metformin group responded significantly with amenorrhea (p= 0.0053), while Levonorgestrel only group responded with regular cycles (p=0.027). At the end of study, of 46 subjects available for histopathological evaluation, 100% subjects in metformin group and 95.45% in Levonorgestrel only group (p=0.47826) showed complete response. The metformin group had a significant reduction in body mass index at end of study [P = 0∙023, 95% confidence interval (-1.7802, -0.1418)].
CONCLUSION


No significant difference in regression of endometrial hyperplasia was observed on adjunctive use of metformin but a significant reduction in BMI was observed. Use of metformin in obese patients may improve the treatment response.",2021,"The metformin group had a significant reduction in body mass index at end of study [P = 0∙023, 95% confidence interval (-1.7802, -0.1418)].
","['Twenty-five subjects were prescribed', '46 subjects available for histopathological evaluation, 100% subjects in', 'patients with endometrial hyperplasia without atypia', '51 cases of endometrial hyperplasia without atypia', 'obese patients', 'Endometrial Hyperplasia without Atypia in Indian Women', 'patients with endometrial hyperplasia without atypia managed with']","['Metformin', 'metformin 500mg twice daily with Levonorgestrel intrauterine system', 'Levonorgestrel intrauterine system plus metformin', 'metformin', 'Levonorgestrel', 'Levonorgestrel intrauterine system alone', 'Levonorgestrel Intrauterine System with or without Metformin', 'Levonorgestrel intrauterine system']","['regression of endometrial hyperplasia', 'BMI', 'complete response', 'amenorrhea', 'body mass index', 'histopathological response, clinical response and safety']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2712711', 'cui_str': 'Benign endometrial hyperplasia'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0014173', 'cui_str': 'Endometrial hyperplasia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",25.0,0.0446423,"The metformin group had a significant reduction in body mass index at end of study [P = 0∙023, 95% confidence interval (-1.7802, -0.1418)].
","[{'ForeName': 'Ramya Dinnekere', 'Initials': 'RD', 'LastName': 'Ravi', 'Affiliation': 'Department of Obstetrics & Gynaecology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Jasvinder', 'Initials': 'J', 'LastName': 'Kalra', 'Affiliation': 'Department of Obstetrics & Gynaecology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Cytology & Gynecological Pathology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Bagga', 'Affiliation': 'Department of Obstetrics & Gynaecology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Department of Obstetrics & Gynaecology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Suri', 'Affiliation': 'Department of Obstetrics & Gynaecology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Sachdeva', 'Affiliation': 'Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2021.22.3.983']
662,33773552,Pharmacokinetics of Dexamethasone when Administered with Fosaprepitant for Chemotherapy-Induced Nausea and Vomiting and Differences in Dose-Dependent Antiemetic Effects.,"BACKGROUND


Fosaprepitant, an NK1 receptor antagonist, inhibits and induces cytochrome P450 3A4 (CYP3A4) as its substrate. Contrarily dexamethasone is metabolized by CYP3A4. Therefore, in combination therapy wherein both agents interact with each other, it is recommended that the dexamethasone dose be reduced in the first two days. Thus far, there are only a few studies on the optimum dose of dexamethasone after day 3. Thus, we aimed to determine the pharmacokinetics of dexamethasone on day3 when administered together with fosaprepitant and investigate the dose-dependent differences in its antiemetic effect in patients with cancer.
METHODS


Twelve patients with esophageal, stomach, or lung cancer received primary highly emetogenic chemotherapy (HEC). We intravenously administered 9.9 mg and 6.6 mg of dexamethasone on days 1 and 2, respectively, and 6.6 mg or 13.2 mg on day 3 together with the administration of 150 mg fosaprepitant and 0.75 mg palonosetron. We assessed the pharmacokinetics of dexamethasone on day 3 by dose and examined the dose-dependent antiemetic effect.
RESULTS


No differences were observed in the time-to-maximum concentration and blood half-life of dexamethasone between patient groups that received dexamethasone at doses of 6.6 mg and 13.2 mg. In contrast, the area under the blood concentration-time curve and the maximum concentration of dexamethasone correlated with its dose. Moreover, the blood dexamethasone concentration on day 3 increased by twofold after the administration of a higher dose than after a lower dose. The severity of nausea in the delayed phase significantly decreased in a dose-dependent manner.
CONCLUSION


Administration of a higher dexamethasone dose on day 3 improved the antiemetic effect of the combined regimen in patients with cancer who underwent HEC.<br />.",2021,No differences were observed in the time-to-maximum concentration and blood half-life of dexamethasone between patient groups that received dexamethasone at doses of 6.6 mg and 13.2 mg.,"['patients with cancer', 'Twelve patients with esophageal, stomach, or lung cancer received primary highly emetogenic chemotherapy (HEC', 'patients with cancer who underwent HEC.<br ']","['Contrarily dexamethasone', 'dexamethasone', 'fosaprepitant and 0.75 mg palonosetron', 'Dexamethasone']","['antiemetic effect', 'blood dexamethasone concentration', 'blood concentration-time curve and the maximum concentration of dexamethasone', 'time-to-maximum concentration and blood half-life of dexamethasone', 'severity of nausea', 'Nausea and Vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2349941', 'cui_str': 'fosaprepitant'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}]","[{'cui': 'C1516011', 'cui_str': 'Antiemetic Effects'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",12.0,0.0924468,No differences were observed in the time-to-maximum concentration and blood half-life of dexamethasone between patient groups that received dexamethasone at doses of 6.6 mg and 13.2 mg.,"[{'ForeName': 'Fukutaro', 'Initials': 'F', 'LastName': 'Shimamoto', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College Hospital, 2-7, Daigaku-machi, Takatsuki, Osaka 569-8686, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College Hospital, 2-7, Daigaku-machi, Takatsuki, Osaka 569-8686, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Terazawa', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College Hospital, 2-7, Daigaku-machi, Takatsuki, Osaka 569-8686, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Asaishi', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College Hospital, 2-7, Daigaku-machi, Takatsuki, Osaka 569-8686, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Miyamoto', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College Hospital, 2-7, Daigaku-machi, Takatsuki, Osaka 569-8686, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Higuchi', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical College, 2-7, Daigaku-machi, Takatsuki, Osaka 569-8686, Japan.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2021.22.3.871']
663,33780106,Efficacy and safety of tamsulosin versus its combination with mirabegron in the management of lower urinary tract non-neurogenic overactive bladder symptoms (OABS) due to Benign Prostatic Enlargement (BPE)-An open label randomised controlled clinical study.,"PURPOSE


The efficacy and safety of βeta-3 agonists (Mirabegron 50 mg) has been sparingly assessed in the published English literature. We aim to do an efficacy-safety analysis of Mirabegron-Tamsulosin combination therapy versus tamsulosin-placebo monotherapy in a select subset of medication virgin Benign Prostatic Enlargement (BPE) patients with coexisting predominant non-neurogenic overactive bladder symptoms (OABS).
METHODS


After prior written informed consent and IEC, 80 patients of uncomplicated BPE with coexisting non-neurogenic OABS and IPSS of >7 without contraindications to drug therapy were computer randomized/allocated to receive either[50mg Mirabegron plus Tamsulosin 0.4 mg (Intervention arm-I)]or [Tamsulosin 0.4 mg plus capsule lactobacillus (Comparator arm-II)] once daily for 8 weeks. Efficacy was evaluated using the OABS Score (OABSS), mean change in nocturnal frequency(NF), PVR and IPSS while safety was assessed by recording treatment emergent adverse events (TEAE). Follow up visits were done at 2 nd  , 4 th  and 8 th  week.
RESULTS


Patient data in both groups was generally comparable with the exception of NF and IPSS storage sub score(IPSS-ss). Significant improvements were visualised in the 8 th  week primary endpoint total OABS sub score (OABSS-ss) in combination group (p< 0.001).Similar significant improvements were seen with most secondary parameters such as the mean change in NF, IPSS, IPSS-ss, OABS-ss, voided volume, Qmax, and Quality of life index (QOL) (p<0.001). No significant increase in PVR was observed in the Mirabegron arm and no patient developed urinary retention. The TEAE were minor, self-limiting and managed symptomatically without drug discontinuity.
CONCLUSION


Mirabegron can be significantly efficacious and safe in ameliorating non-neurogenic OABS induced by BPE versus placebo by initiating combination therapy from the start as opposed to the usual 'add on therapy' protocol. This combination appeared to be superior in terms of overall safety, minimal side effects, better compliance and tolerability versus Tamsulosin monotherapy in select BPE patients with predominant non-neurogenic OABS.",2021,"Significant improvements were visualised in the 8 th  week primary endpoint total OABS sub score (OABSS-ss) in combination group (p< 0.001).Similar significant improvements were seen with most secondary parameters such as the mean change in NF, IPSS, IPSS-ss, OABS-ss, voided volume, Qmax, and Quality of life index (QOL) (p<0.001).","['medication virgin Benign Prostatic Enlargement (BPE) patients with coexisting predominant non-neurogenic overactive bladder symptoms (OABS', 'select BPE patients with predominant non-neurogenic OABS', '80 patients of uncomplicated BPE with coexisting non-neurogenic OABS and IPSS of >7 without contraindications to drug therapy', 'lower urinary tract non-neurogenic overactive bladder symptoms (OABS) due to Benign Prostatic Enlargement']","['Mirabegron-Tamsulosin combination therapy versus tamsulosin-placebo monotherapy', 'either[50mg Mirabegron plus Tamsulosin 0.4 mg (Intervention arm-I)]or [Tamsulosin 0.4 mg plus capsule lactobacillus', 'tamsulosin', 'βeta-3 agonists (Mirabegron 50 mg', 'Tamsulosin monotherapy', 'BPE versus placebo']","['urinary retention', 'OABS Score (OABSS), mean change in nocturnal frequency(NF), PVR and IPSS while safety', 'PVR', 'Efficacy', 'total OABS sub score', 'mean change in NF, IPSS, IPSS-ss, OABS-ss, voided volume, Qmax, and Quality of life index (QOL', 'Efficacy and safety']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0426732', 'cui_str': 'Large prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3474335', 'cui_str': 'mirabegron 50 MG'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0426732', 'cui_str': 'Large prostate'}]","[{'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",80.0,0.0354671,"Significant improvements were visualised in the 8 th  week primary endpoint total OABS sub score (OABSS-ss) in combination group (p< 0.001).Similar significant improvements were seen with most secondary parameters such as the mean change in NF, IPSS, IPSS-ss, OABS-ss, voided volume, Qmax, and Quality of life index (QOL) (p<0.001).","[{'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, University College of Medical Sciences (University of Delhi, & GTB Hospital, Delhi-95, India.'}, {'ForeName': 'Dibya Priyadarsin', 'Initials': 'DP', 'LastName': 'Behera', 'Affiliation': 'Department of Surgery, University College of Medical Sciences (University of Delhi, & GTB Hospital, Delhi-95, India.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Aravind', 'Affiliation': 'Department of Surgery, University College of Medical Sciences (University of Delhi, & GTB Hospital, Delhi-95, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Surgery, University College of Medical Sciences (University of Delhi, & GTB Hospital, Delhi-95, India.'}]",International journal of clinical practice,['10.1111/ijcp.14184']
664,33780099,Assessment of chronic disease management mode (CDMM) on participants with primary hypertension.,"OBJECTIVE


Hypertension requires continuous and long-term care to prevent associated complications. Chronic disease management mode (CDMM) was developed to improve patients' self-management. We aimed to evaluate quality of care and clinical outcomes of CDMM versus routine care.
METHODS


300 patients aged >30 years with primary hypertension were randomly allocated to the CDMM intervention group (n=162) or the usual care control group (n=138). CDMM comprised nursing consultations, telephone contact, online WeChat link, health education, and appropriate referrals during hospitalization and after discharge. QLICD-HY (V 2.0) scale was used to evaluate the quality of life. Care outcomes were biochemical parameters, body mass index, blood pressure levels, waist circumference, psychological indicators and quality of life assessed on admission (baseline) and one month post-care for both groups. Data were collected and analyzed using SPSS 20.0.
RESULTS


After one month, the intervention group had 6 mm Hg (95% CI: -5.12 to -9.08) lower SBP and 0.6 mM/L (95% CI: -0.52 to -0.68) lower LDL than the control group. In terms of improvements in BMI, UmAlb or waist circumference there were no differences between both groups. The intervention group scored better on psychological indicators than controls (P < 0.05), and scores reflecting social and psychological function in the intervention group were significantly higher than scores at baseline, and higher than scores of controls after one month (P<0.05). In the control group there was no statistically significant difference between the scores at baseline and after one month.
CONCLUSIONS


Under CDMM hypertension care, improvement of blood pressure and LDL were clinically significant. Intervention care further improves social and psychological function among participants with primary hypertension.",2021,"The intervention group scored better on psychological indicators than controls (P < 0.05), and scores reflecting social and psychological function in the intervention group were significantly higher than scores at baseline, and higher than scores of controls after one month (P<0.05).","['300 patients aged >30 years with primary hypertension', 'participants with primary hypertension']","['chronic disease management mode (CDMM', 'Chronic disease management mode (CDMM', 'CDMM intervention', 'usual care control group', 'CDMM']","['scores reflecting social and psychological function', 'BMI, UmAlb or waist circumference', 'quality of life', 'blood pressure and LDL', 'psychological indicators', 'biochemical parameters, body mass index, blood pressure levels, waist circumference, psychological indicators and quality of life assessed on admission (baseline) and one month post-care', 'QLICD-HY (V 2.0) scale', 'social and psychological function']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}]","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",300.0,0.0212633,"The intervention group scored better on psychological indicators than controls (P < 0.05), and scores reflecting social and psychological function in the intervention group were significantly higher than scores at baseline, and higher than scores of controls after one month (P<0.05).","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ling', 'Affiliation': ""Department of Cardiology, Second Affiliated Hospital of Xi 'an Jiaotong University, Xi 'an City, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wan', 'Affiliation': ""Department of Cardiology, Second Affiliated Hospital of Xi 'an Jiaotong University, Xi 'an City, China.""}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': ""Institute of Endemic Diseases, Key Laboratory of Trace Elements and Endemic Diseases, Xi'an Jiaotong University Health Science Center, Xi'an, China.""}, {'ForeName': 'Xinyuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Second Affiliated Hospital of Xi 'an Jiaotong University, Xi 'an City, China.""}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': ""Department of Cardiology, Second Affiliated Hospital of Xi 'an Jiaotong University, Xi 'an City, China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Endocrinology, School of Biomedical Sciences, Faculty of Medicine, University of Queensland, St Lucia, Australia.'}, {'ForeName': 'Xiaoman', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': ""Department of Cardiology, Second Affiliated Hospital of Xi 'an Jiaotong University, Xi 'an City, China.""}, {'ForeName': 'Zhaoheng', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Shandong Shenghua Electronic New Materials Co., Ltd, Laiyang City, China.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13577']
665,33780091,Safety of an improved pediatric epidural tunneling technique for catheter shear.,"BACKGROUND


Epidural tunneling could help with prolonged catheterization and be effective in preventing infection and dislodgement. However, epidural tunneling techniques carry a risk of catheter shear or needlestick injuries.
AIMS


This study aimed to examine the safety of our epidural tunneling technique in terms of catheter shear.
METHODS


This study was designed as a double-blinded, single-crossover, in vitro study. Each of the operators performed two techniques to create a subcutaneous tunnel. We compared outcomes between the control tunneling technique (group C) and our improved technique (group I). Microscopic findings of catheter shear were assessed as the primary outcome. Secondary outcomes included the tension and displacement required to break the epidural catheter and the frequency of catheter breakage due to catheter shear. Data were analyzed using the Fisher's exact test and Mann-Whitney U test. A P-value of <0.05 was considered statistically significant.
RESULTS


Ten catheters were assessed in each group. The frequency of catheter shear was 10% in group I and 90% in group C (odds ratio, 0.019; 95% confidence interval [CI], 0.01-0.31; p<0.001). The frequency of catheter breakage due to catheter shear was significantly lower in group I (0%) than in group C (80%; p<0.001). The mean tension and displacement required to break the catheter were significantly higher in group I than in group C (4.13±0.37 N vs. 3.14±1.00 N; mean difference, 0.99 N; 95% CI, 0.25-1.73 N; p=0.013 and 222±59.9 mm vs. 122±77.7 mm; mean difference, 100 mm; 95% CI, 34.1-165 mm; p=0.005).
CONCLUSIONS


Our improved epidural tunneling technique, which was designed for pediatric cases, could reduce the risk of catheter shear.",2021,The frequency of catheter breakage due to catheter shear was significantly lower in group,[],"['epidural tunneling technique', 'control tunneling technique']","['Microscopic findings of catheter shear', 'tension and displacement required to break the epidural catheter and the frequency of catheter breakage due to catheter shear', 'risk of catheter shear', 'frequency of catheter breakage due to catheter shear', 'mean tension and displacement required to break the catheter', 'frequency of catheter shear']",[],"[{'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3665944', 'cui_str': 'Catheter breakage'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",10.0,0.189956,The frequency of catheter breakage due to catheter shear was significantly lower in group,"[{'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Sakai', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, East 17, South 1, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Tachibana', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, East 17, South 1, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Chaki', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, East 17, South 1, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Nakazato', 'Affiliation': 'The Laboratory of Advanced Structural Development and Analysis, Muroran Institute of Technology, 27-1, Mizumoto-cho, Muroran, Hokkaido, 050-8585, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Horiguchi', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, East 17, South 1, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Nawa', 'Affiliation': 'Department of Anesthesiology, Hokkaido Medical Center for Child Health and Rehabilitation, 6, 1-240, 1 Chome, 1 Jyo, Kanayama, Teine, Sapporo, Hokkaido, 006-0041, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, East 17, South 1, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan.'}]",Paediatric anaesthesia,['10.1111/pan.14186']
666,33780086,"Separating EEG Correlates of Stress: Cognitive Effort, Time Pressure, and Social-evaluative Threat.","The prefrontal cortex is a key player in stress response regulation. Electroencephalographic (EEG) responses, such as a decrease in frontal alpha and an increase in frontal beta power, have been proposed to reflect stress-related brain activity. However, the stress response is likely composed of different parts such as cognitive effort, time pressure, and social-evaluative threat, which have not been distinguished in previous studies. This distinction, however, is crucial if we aim to establish reliable tools for early detection of stress-related conditions and monitoring of stress responses throughout treatment. This randomized cross-over study (N = 38) aimed to disentangle EEG correlates of stress. With linear mixed models accounting for missing values in some conditions, we found a decrease in frontal alpha and increase in beta power when performing the Paced Auditory Serial Addition Test (PASAT; cognitive effort; n = 32) compared to resting state (n = 33). No change in EEG power was found when the PASAT was performed under time pressure (n = 29) or when adding social-evaluative threat (video camera; n = 29). These findings suggest that frontal EEG power can discriminate stress from resting state but not more fine-grained differences of the stress response.",2021,No change in EEG power was found when the PASAT was performed under time pressure (n = 29) or when adding social-evaluative threat (video camera; n = 29).,[],['PASAT'],"['Separating EEG Correlates of Stress: Cognitive Effort, Time Pressure, and Social-evaluative Threat', 'Electroencephalographic (EEG) responses', 'EEG power', 'frontal alpha and increase in beta power']",[],"[{'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]",,0.013259,No change in EEG power was found when the PASAT was performed under time pressure (n = 29) or when adding social-evaluative threat (video camera; n = 29).,"[{'ForeName': 'Nina M', 'Initials': 'NM', 'LastName': 'Ehrhardt', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fietz', 'Affiliation': 'Department of Translational Research in Psychiatry, Max-Planck-Institute of Psychiatry, Munich, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kopf-Beck', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kappelmann', 'Affiliation': 'Department of Translational Research in Psychiatry, Max-Planck-Institute of Psychiatry, Munich, Germany.'}, {'ForeName': 'Anna-Katharine', 'Initials': 'AK', 'LastName': 'Brem', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany.'}]",The European journal of neuroscience,['10.1111/ejn.15211']
667,33779938,Rationale and Design of the ADIDAS Study: Association Between Dapagliflozin-Induced Improvement and Anemia in Heart Failure Patients.,"BACKGROUND


Heart failure (HF) is one of the most serious health concerns worldwide. Anemia is a highly prevalent comorbidity and outcome predictor in HF patients. Sodium glucose co-transport 2 (SGLT2) inhibitors have been demonstrated to reduce the risk of cardiovascular death and HF hospitalization in HF patients.
PURPOSE


This investigator-initiated, interventional, prospective, double-blind, multicenter study is designed to investigate whether anemia correction is one of the prerequisites and determinants related to the beneficial effects of dapagliflozin in HF patients.
METHODS AND RESULTS


Up to 2030 HF participants receiving standard care will be randomly assigned to either oral dapagliflozin 10 mg once daily or placebo 10 mg once daily for 12 months. The primary outcome is the composite incidence of hospital admission for HF and all-cause death. Secondary outcomes include change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score and change in 6-min walk distance and hemoglobin level. Patients will be followed for 12 months after randomization.
CONCLUSIONS


The ADIDAS trial offers an opportunity to assess the hemoglobin change and association between hemoglobin change and readmissions due to heart failure and all-cause death in patients with heart failure treated with dapagliflozin or placebo. This study could highlight if dynamic hemoglobin change is related to the outcome for HF patients.
TRIAL REGISTRATION


ClinicalTrials.gov ; NCT04707261. Registration date, 2020/12/01, ""retrospectively registered"".",2021,Up to 2030 HF participants receiving standard care will be randomly assigned to either oral dapagliflozin 10 mg once daily or placebo 10 mg once daily for 12 months.,"['HF patients', 'Heart Failure Patients', '2030 HF participants receiving standard care', 'patients with heart failure treated with']","['dapagliflozin', 'Sodium glucose co-transport 2 (SGLT2) inhibitors', 'oral dapagliflozin 10 mg once daily or placebo', 'dapagliflozin or placebo']","['change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score and change in 6-min walk distance and hemoglobin level', 'composite incidence of hospital admission for HF and all-cause death', 'risk of cardiovascular death and HF hospitalization']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",2030.0,0.467705,Up to 2030 HF participants receiving standard care will be randomly assigned to either oral dapagliflozin 10 mg once daily or placebo 10 mg once daily for 12 months.,"[{'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': ""Department of Cardiology, Xiangtan Central Hospital, Xiangtan, Hunan, 411100, People's Republic of China. xhjiang2@hnust.edu.cn.""}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Cardiology, Xiangtan Central Hospital, Xiangtan, Hunan, 411100, People's Republic of China.""}, {'ForeName': 'Wenjiao', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiology, Xiangtan Central Hospital, Xiangtan, Hunan, 411100, People's Republic of China.""}, {'ForeName': 'Mingxing', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiology, Xiangtan Central Hospital, Xiangtan, Hunan, 411100, People's Republic of China.""}, {'ForeName': 'Haobo', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': ""Department of Cardiology, Xiangtan Central Hospital, Xiangtan, Hunan, 411100, People's Republic of China.""}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': ""Department of Cardiology, Xiangtan Central Hospital, Xiangtan, Hunan, 411100, People's Republic of China.""}, {'ForeName': 'ChunFeng', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiology, Xiangtan Central Hospital, Xiangtan, Hunan, 411100, People's Republic of China.""}, {'ForeName': 'XiaoLin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ""Department of Cardiology, Xiangtan Central Hospital, Xiangtan, Hunan, 411100, People's Republic of China.""}, {'ForeName': 'ShengHua', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ""Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China.""}, {'ForeName': 'ChengMing', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Zhuzhou Central Hospital, Zhuzhou, Hunan, 412000, People's Republic of China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Yin', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Xiangtan City, Xiangtan, Hunan, 411100, People's Republic of China.""}, {'ForeName': 'FangHua', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Xiangtan City, Xiangtan, Hunan, 411100, People's Republic of China.""}, {'ForeName': 'ZhiQiang', 'Initials': 'Z', 'LastName': 'Cai', 'Affiliation': ""Department of Cardiology, The People's Hospital of Xiangtan County, Xiangtan, Hunan, 411100, People's Republic of China.""}, {'ForeName': 'Xinyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Xiangxiang People's Hospital, Xiangtan, Hunan, 411400, People's Republic of China.""}, {'ForeName': 'Huiheng', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': ""Department of Cardiology, The Second People's Hospital of Xiangxiang, Xiangtan, Hunan, 411400, People's Republic of China.""}, {'ForeName': 'Youwen', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': ""Department of Cardiology, JiangNan Hospital in Xiangtan, Xiangtan, Hunan, 411100, People's Republic of China.""}, {'ForeName': 'Zhuqing', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': ""Department of Cardiology, Shaoshan People's Hospital, Xiangtan, Hunan, 411300, People's Republic of China.""}, {'ForeName': 'Xiaoyong', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Cardiology, The Third People's Hospital of Xiangtan, Xiangtan, Hunan, 411100, People's Republic of China.""}, {'ForeName': 'Dexiang', 'Initials': 'D', 'LastName': 'Liao', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Zhuzhou County, Zhuzhou, Hunan, 412000, People's Republic of China.""}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, The Second People's Hospital of Xiangtan, Xiangtan, Hunan, 411100, People's Republic of China.""}]",Cardiovascular drugs and therapy,['10.1007/s10557-021-07176-0']
668,33779741,Assessment of Diagnosis and Triage in Validated Case Vignettes Among Nonphysicians Before and After Internet Search.,"Importance


When confronted with new medical symptoms, many people turn to the internet to understand why they are ill as well as whether and where they should get care. Such searches may be harmful because they may facilitate misdiagnosis and inappropriate triage.
Objective


To empirically measure the association of an internet search for health information with diagnosis, triage, and anxiety by laypeople.
Design, Setting, and Participants


This survey study used a nationally representative sample of US adults who were recruited through an online platform between April 1, 2019, and April 15, 2019. A total of 48 validated case vignettes of both common (eg, viral illness) and severe (eg, heart attack) conditions were used. Participants were asked to relay their diagnosis, triage, and anxiety regarding 1 of these cases before and after searching the internet for health information.
Exposures


Short, validated case vignettes written at or below the sixth-grade reading level randomly assigned to participants.
Main Outcomes and Measures


Correct diagnosis, correct triage, and flipping (changing) or anchoring (not changing) diagnosis and triage decisions were the main outcomes. Multivariable modeling was performed to identify patient factors associated with correct triage and diagnosis.
Results


Of the 5000 participants, 2549 were female (51.0%), 3819 were White (76.4%), and the mean (SD) age was 45.0 (16.9) years. Mean internet search time was 12.1 (95% CI, 10.7-13.5) minutes per case. No difference in triage accuracy was found before and after search (74.5% vs 74.1%; difference, -0.4 [95% CI, -1.4 to 0.6]; P = .06), but improved diagnostic accuracy was found (49.8% vs 54.0%; difference, 4.2% [95% CI, 3.1%-5.3%]; P < .001). Most participants (4254 [85.1%]) were anchored on their diagnosis. Of the 14.9% of participants (n = 746) who flipped their diagnosis, 9.6% (n = 478) flipped from incorrect to correct and 5.4% (n = 268) flipped from correct to incorrect. The following groups had an increased rate of correct diagnosis: adults 40 years or older (eg, 40-49 years: 5.1 [95% CI, 0.8-9.4] percentage points better than those aged <30 years; P = .02), women (9.4 [95% CI, 6.8-12.0] percentage points better than men; P < .001), and those with perceived poor health status (16.3 [95% CI, 6.9-25.6] percentage points better than those with excellent status; P = .001) and with more than 2 chronic diseases (6.8 [95% CI, 1.5-12.1] percentage points better than those with 0 conditions; P = .01).
Conclusions and Relevance


This study found that an internet search for health information was associated with small increases in diagnostic accuracy but not with triage accuracy.",2021,This study found that an internet search for health information was associated with small increases in diagnostic accuracy but not with triage accuracy.,"['5000 participants, 2549 were female (51.0%), 3819 were White (76.4%), and the mean (SD) age was 45.0 (16.9) years', 'nationally representative sample of US adults who were recruited through an online platform between April 1, 2019, and April 15, 2019', 'A total of 48 validated case vignettes of both common (eg, viral illness) and severe (eg, heart attack) conditions', 'adults 40 years or older']",[],"['poor health status', 'triage accuracy', 'Measures\n\n\nCorrect diagnosis, correct triage, and flipping (changing) or anchoring (not changing) diagnosis and triage decisions', 'diagnostic accuracy', 'Mean internet search time', 'chronic diseases', 'rate of correct diagnosis']","[{'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]",5000.0,0.297766,This study found that an internet search for health information was associated with small increases in diagnostic accuracy but not with triage accuracy.,"[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Levine', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Ateev', 'Initials': 'A', 'LastName': 'Mehrotra', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.3287']
669,33779716,Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: Quality of Life (ROMA:QOL) - Rationale and Study Protocol.,"The objective of the Randomized comparison of the Outcome of single vs Multiple Arterial grafts: Quality of Life (ROMA:QOL) trial is to evaluate the impact of coronary artery bypass graft surgery (CABG) on quality of life (QOL). The primary hypothesis of ROMA:QOL is that participants in the multiple arterial group (MAG) will report time-varying changes in QOL that will be lower in the post-operative recovery period and higher after 12 months compared to patients in the single arterial group (SAG). The secondary hypotheses are that both groups will have improvements in symptoms at 12 months, and that compared to the SAG group, participants in the MAG group will experience better physical functioning and physical and mental health symptoms. An estimated 2,111 participants will be enrolled from the parent ROMA trial from 13 countries. Outcome assessments include the Seattle Angina Questionnaire (SAQ) (primary outcome), Short Form-12v2, EQ-5D-5L, PROMIS-29 and PROMIS Neuropathic Pain measured at baseline, first post-operative visit, 6, 12, 24, 36, 48 and 60- months. The analysis for the primary outcome, the change in the SAQ from baseline to 12- months, will be compared across all time-points between the two treatment arms. The ROMA:QOL trial will answer whether there are differences in QOL, physical and mental health symptoms overall for CABG, by MAG and SAG intervention arms, by sex, and between patients with and without diabetes.",2021,"QOL trial will answer whether there are differences in QOL, physical and mental health symptoms overall for CABG, by MAG and SAG intervention arms, by sex, and between patients with and without diabetes.","['2,111 participants will be enrolled from the parent ROMA trial from 13 countries']","['coronary artery bypass graft surgery (CABG', 'ROMA', 'single versus Multiple Arterial grafts: Quality of Life', 'MAG', 'single vs Multiple Arterial grafts: Quality of Life (ROMA:QOL', 'SAG']","['physical functioning and physical and mental health symptoms', 'quality of life (QOL', 'Seattle Angina Questionnaire (SAQ) (primary outcome), Short Form-12v2, EQ-5D-5L, PROMIS-29 and PROMIS Neuropathic Pain', 'QOL, physical and mental health symptoms overall for CABG']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0018422', 'cui_str': 'Gypsies'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0018422', 'cui_str': 'Gypsies'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0450140', 'cui_str': 'Arterial graft'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]",2111.0,0.173671,"QOL trial will answer whether there are differences in QOL, physical and mental health symptoms overall for CABG, by MAG and SAG intervention arms, by sex, and between patients with and without diabetes.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Masterson Creber', 'Affiliation': 'Department of Population Health Sciences, Division of Health Informatics, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Safford', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Ballman', 'Affiliation': 'Department of Population Health Sciences, Division of Health Informatics, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Myers', 'Affiliation': 'Department of Population Health Sciences, Division of Health Informatics, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Fremes', 'Affiliation': 'Schulich Heart Centre, Sunnybrook Health Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Gaudino', 'Affiliation': 'Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA.'}]",European heart journal. Quality of care & clinical outcomes,['10.1093/ehjqcco/qcab022']
670,33779698,Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial.,"Importance


To our knowledge, the Oral Ponesimod Versus Teriflunomide In Relapsing Multiple Sclerosis (OPTIMUM) trial is the first phase 3 study comparing 2 oral disease-modifying therapies for relapsing multiple sclerosis (RMS).
Objective


To compare the efficacy of ponesimod, a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator with teriflunomide, a pyrimidine synthesis inhibitor, approved for the treatment of patients with RMS.
Design, Setting, and Participants


This multicenter, double-blind, active-comparator, superiority randomized clinical trial enrolled patients from April 27, 2015, to May 16, 2019, who were aged 18 to 55 years and had been diagnosed with multiple sclerosis per 2010 McDonald criteria, with a relapsing course from the onset, Expanded Disability Status Scale (EDSS) scores of 0 to 5.5, and recent clinical or magnetic resonance imaging disease activity.
Interventions


Patients were randomized (1:1) to 20 mg of ponesimod or 14 mg of teriflunomide once daily and the placebo for 108 weeks, with a 14-day gradual up-titration of ponesimod starting at 2 mg to mitigate first-dose cardiac effects of S1P1 modulators and a follow-up period of 30 days.
Main Outcomes and Measures


The primary end point was the annualized relapse rate. The secondary end points were the changes in symptom domain of Fatigue Symptom and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS) at week 108, the number of combined unique active lesions per year on magnetic resonance imaging, and time to 12-week and 24-week confirmed disability accumulation. Safety and tolerability were assessed. Exploratory end points included the percentage change in brain volume and no evidence of disease activity (NEDA-3 and NEDA-4) status.
Results


For 1133 patients (567 receiving ponesimod and 566 receiving teriflunomide; median [range], 37.0 [18-55] years; 735 women [64.9%]), the relative rate reduction for ponesimod vs teriflunomide in the annualized relapse rate was 30.5% (0.202 vs 0.290; P < .001); the mean difference in FSIQ-RMS, -3.57 (-0.01 vs 3.56; P < .001); the relative risk reduction in combined unique active lesions per year, 56% (1.405 vs 3.164; P < .001); and the reduction in time to 12-week and 24-week confirmed disability accumulation risk estimates, 17% (10.1% vs 12.4%; P = .29) and 16% (8.1% vs 9.9; P = .37), respectively. Brain volume loss at week 108 was lower by 0.34% (-0.91% vs -1.25%; P < .001); the odds ratio for NEDA-3 achievement was 1.70 (25.0% vs 16.4%; P < .001). Incidence of treatment-emergent adverse events (502 of 565 [88.8%] vs 499 of 566 [88.2%]) and serious treatment-emergent adverse events (49 [8.7%] vs 46 [8.1%]) was similar for both groups. Treatment discontinuations because of adverse events was more common in the ponesimod group (49 of 565 [8.7%] vs 34 of 566 [6.0%]).
Conclusions and Relevance


In this study, ponesimod was superior to teriflunomide on annualized relapse rate reduction, fatigue, magnetic resonance imaging activity, brain volume loss, and no evidence of disease activity status, but not confirmed disability accumulation. The safety profile was in line with the previous safety observations with ponesimod and the known profile of other S1P receptor modulators.
Trial Registration


ClinicalTrials.gov Identifier: NCT02425644.",2021,"In this study, ponesimod was superior to teriflunomide on annualized relapse rate reduction, fatigue, magnetic resonance imaging activity, brain volume loss, and no evidence of disease activity status, but not confirmed disability accumulation.","['Patients', 'enrolled patients from April 27, 2015, to May 16, 2019, who were aged 18 to 55 years and had been diagnosed with multiple sclerosis per 2010 McDonald criteria, with a relapsing course from the onset, Expanded Disability Status Scale (EDSS) scores of 0 to 5.5, and recent clinical or magnetic resonance imaging disease activity', '1133 patients (567 receiving ponesimod and 566 receiving teriflunomide; median [range], 37.0 [18-55] years; 735 women [64.9', 'patients with RMS']","['Teriflunomide', 'Oral Ponesimod Versus Teriflunomide', 'ponesimod or 14 mg of teriflunomide once daily and the placebo']","['number of combined unique active lesions per year on magnetic resonance imaging, and time to 12-week and 24-week confirmed disability accumulation', 'serious treatment-emergent adverse events', 'Safety and tolerability', 'Incidence of treatment-emergent adverse events', 'annualized relapse rate reduction, fatigue, magnetic resonance imaging activity, brain volume loss, and no evidence of disease activity status', 'relative risk reduction', 'odds ratio for NEDA-3 achievement', 'adverse events', 'percentage change in brain volume and no evidence of disease activity (NEDA-3 and NEDA-4) status', 'disability accumulation risk estimates', 'Brain volume loss', 'changes in symptom domain of Fatigue Symptom and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS', 'annualized relapse rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205336', 'cui_str': 'Relapsing course'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2934701', 'cui_str': 'ponesimod'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]","[{'cui': 'C1718383', 'cui_str': 'teriflunomide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2934701', 'cui_str': 'ponesimod'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]",,0.411691,"In this study, ponesimod was superior to teriflunomide on annualized relapse rate reduction, fatigue, magnetic resonance imaging activity, brain volume loss, and no evidence of disease activity status, but not confirmed disability accumulation.","[{'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurology and Research Center for Clinical Neuroimmunology and Neuroscience Basel, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering University Hospital and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Fox', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Burcklen', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'Department of Medicine, University of Ottawa, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Eva K', 'Initials': 'EK', 'LastName': 'Havrdová', 'Affiliation': 'Department of Neurology, First Medical Faculty, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hennessy', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Hohlfeld', 'Affiliation': 'Institute of Clinical Neuroimmunology, Ludwig Maximilians University Munich, Munich, Germany.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Lublin', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Department of Neurology-Neuroimmunology, Multiple Sclerosis Center of Catalonia, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Pozzilli', 'Affiliation': ""Sant'Andrea Multiple Sclerosis Centre, Sapienza University of Rome, Rome, Italy.""}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Scherz', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': ""D'Ambrosio"", 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Linscheid', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vaclavkova', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Pirozek-Lawniczek', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Hilke', 'Initials': 'H', 'LastName': 'Kracker', 'Affiliation': 'Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'Neurology and Research Center for Clinical Neuroimmunology and Neuroscience Basel, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering University Hospital and University of Basel, Basel, Switzerland.'}]",JAMA neurology,['10.1001/jamaneurol.2021.0405']
671,33779569,"Telehealth Transition Assistance Program for Acute Spinal Cord Injury Caregivers: Protocol for a Mixed-Methods, Randomized Controlled Trial.","BACKGROUND


While spinal cord injury (SCI) caregiving can be a rewarding experience, caregivers often experience reduced mental and physical health.
OBJECTIVE


This article describes the methodology of a study examining the efficacy of a newly developed telehealth Transition Assistance Program (TAP) for caregivers of individuals with acute SCI.
METHODS


A mixed-methods, randomized controlled trial is comparing TAP outcomes to that of a standard-of-care control. The study is recruiting for 48 months and incorporating quantitative outcome measures.
RESULTS


This study was funded by the Craig H. Neilsen Foundation in April 2017. It was approved by the institutional review boards at Virginia Commonwealth University and the Hunter Holmes McGuire Veterans Affairs Medical Center that same year. Participant recruitment and data collection began in 2018.
CONCLUSIONS


This study is implementing and testing an SCI caregiver intervention unlike any created before, targeting a critical time period that, until now, other SCI caregiver interventions have overlooked. Research personnel intend to disseminate the intervention and study findings through the publication of manuscripts and presentations at conferences. If the current study shows improvements in caregiver or patient well-being, the TAP for SCI caregivers could become part of the standard of care for acute SCI.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03244098; https://www.clinicaltrials.gov/ct2/show/NCT03244098.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/28256.",2021,"This article describes the methodology of a study examining the efficacy of a newly developed telehealth Transition Assistance Program (TAP) for caregivers of individuals with acute SCI.
METHODS


A mixed-methods, randomized controlled trial is comparing TAP outcomes to that of a standard-of-care control.","['caregivers of individuals with acute SCI', 'Acute Spinal Cord Injury Caregivers']","['Telehealth Transition Assistance Program', 'standard-of-care control', 'telehealth Transition Assistance Program (TAP']",[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.484689,"This article describes the methodology of a study examining the efficacy of a newly developed telehealth Transition Assistance Program (TAP) for caregivers of individuals with acute SCI.
METHODS


A mixed-methods, randomized controlled trial is comparing TAP outcomes to that of a standard-of-care control.","[{'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Perrin', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'McDonald', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Jack D', 'Initials': 'JD', 'LastName': 'Watson', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Bradford S', 'Initials': 'BS', 'LastName': 'Pierce', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Elliott', 'Affiliation': 'Texas A&M University, College Station, TX, United States.'}]",JMIR research protocols,['10.2196/28256']
672,33779567,Diabetes Engagement and Activation Platform for Implementation and Effectiveness of Automated Virtual Type 2 Diabetes Self-Management Education: Randomized Controlled Trial.,"BACKGROUND


Patients with type 2 diabetes require recommendations for self-management education and support.
OBJECTIVE


In this study, we aim to design the Diabetes Engagement and Activation Platform (DEAP)-an automated patient education tool integrated into primary care workflow-and examine its implementation and effectiveness.
METHODS


We invited patients aged 18-85 years with a hemoglobin A 1c  (HbA 1c ) level ≥8 to participate in a randomized controlled trial comparing DEAP with usual care. DEAP modules addressing type 2 diabetes self-management education and support domains were programmed into patient portals, each with self-guided educational readings, videos, and questions. Care teams received patient summaries and were alerted to patients with low confidence or requesting additional help. HbA 1c , BMI, and systolic and diastolic blood pressure (DBP) were measured.
RESULTS


Out of the 680 patients invited to participate, 337 (49.5%) agreed and were randomized. All of the 189 intervention patients accessed the first module, and 140 patients (74.1%) accessed all 9 modules. Postmodule knowledge and confidence scores were high. Only 18 patients requested additional help from the care team. BMI was lower for intervention patients than controls at 3 months (31.7 kg/m 2  vs 32.1 kg/m 2 ; P=.04) and 6 months (32.5 kg/m 2  vs 33.0 kg/m 2 ; P=.003); improvements were even greater for intervention patients completing at least one module. There were no differences in 3- or 6-month HbA 1c  or blood pressure levels in the intent-to-treat analysis. However, intervention patients completing at least one module compared with controls had a better HbA 1c  level (7.6% vs 8.2%; P=.03) and DBP (72.3 mm Hg vs 75.9 mm Hg; P=.01) at 3 months.
CONCLUSIONS


The findings of this study concluded that a significant proportion of patients will participate in an automated virtual diabetes self-management program embedded into patient portals and health systems show promise in helping patients manage their diabetes, weight, and blood pressure.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02957721; https://clinicaltrials.gov/ct2/show/NCT02957721.",2021,There were no differences in 3- or 6-month HbA 1c  or blood pressure levels in the intent-to-treat analysis.,"['patients aged 18-85 years with a hemoglobin', 'Automated Virtual Type 2 Diabetes Self-Management Education', '680 patients invited to participate, 337 (49.5%) agreed and were randomized', '189 intervention patients accessed the first module, and 140 patients (74.1%) accessed all 9 modules', '18 patients requested additional help from the care team', 'Patients with type 2 diabetes require recommendations for self-management education and support']","['Diabetes Engagement and Activation Platform', 'DEAP']","['DBP', 'better HbA 1c  level', 'Postmodule knowledge and confidence scores', 'BMI', '3- or 6-month HbA 1c  or blood pressure levels', 'HbA 1c , BMI, and systolic and diastolic blood pressure (DBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0332153', 'cui_str': 'Requested by patient'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",680.0,0.172735,There were no differences in 3- or 6-month HbA 1c  or blood pressure levels in the intent-to-treat analysis.,"[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Sabo', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Robins', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Lutz', 'Affiliation': 'Privia Health, LLC, Arlington, VA, United States.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Kashiri', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Day', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Webel', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Krist', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States.'}]",JMIR diabetes,['10.2196/26621']
673,33779532,Mental health problems moderate the association between teacher violence and children's social status in East Africa: A multi-informant study combining self- and peer-reports.,"School victimization has been negatively associated with children's social status. However, previous studies have primarily focused on peer victimization, leaving a significant knowledge gap regarding violence by teachers. We hypothesized that, when almost all children experience violence by teachers, not only the experience of violence, but also other factors, for example, mental health problems, may influence children's social preference and centrality. We therefore examined potential moderation effects of children's internalizing and externalizing problems. We implemented a multistage cluster randomized sampling approach to randomly chose fifth- and sixth-grade students from primary schools throughout Tanzania. Using a multi-informant approach, data were collected from 643 children (51.0% girls, Mage = 12.79 years). Results showed inconsistent direct associations between teacher violence and social status, whereas mental health problems were consistently associated with lower social status. Significant interaction effects were found for internalizing problems; that is, teacher violence was associated with lower social status for increasing internalizing problems. However, no interaction effects were found for externalizing problems. The findings underline the burden of exposure to violence by teachers and the importance of mental health for children's social functioning. Knowledge about interrelations can be applied in interventions to effectively reduce violence by teachers toward students.",2021,"Results showed inconsistent direct associations between teacher violence and social status, whereas mental health problems were consistently associated with lower social status.","[""children's internalizing and externalizing problems"", ""Mental health problems moderate the association between teacher violence and children's social status in East Africa"", 'randomly chose fifth- and sixth-grade students from primary schools throughout Tanzania', '643 children (51.0% girls, Mage = 12.79 years']",[],"['mental health problems', 'externalizing problems', 'teacher violence and social status']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0699806', 'cui_str': 'Social status'}, {'cui': 'C0001741', 'cui_str': 'Eastern Africa'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0699806', 'cui_str': 'Social status'}]",643.0,0.0150174,"Results showed inconsistent direct associations between teacher violence and social status, whereas mental health problems were consistently associated with lower social status.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hecker', 'Affiliation': 'Department of Psychology, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Dumke', 'Affiliation': 'Department of Psychology, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Neuner', 'Affiliation': 'Department of Psychology, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Faustine B', 'Initials': 'FB', 'LastName': 'Masath', 'Affiliation': 'Department of Psychology, Bielefeld University, Bielefeld, Germany.'}]",Development and psychopathology,['10.1017/S095457942000228X']
674,33779523,Effects of Humor and Bystander Gender on Responses to Antigay Harassment.,"Individuals perceived to be LGBTQ+ are at risk for harassment. Although bystanders who confront harassers and support targets of harassment may promote inclusivity, the use of humor to express antigay harassment may inhibit prosocial bystander intervention. Non-LGBTQ+ undergraduates ( N  = 326) were randomly assigned to respond to a scenario in which a male peer disparaged another peer with antigay comments involving either the presence or absence of humor. Results showed that bystanders reported less intent to intervene in the presence of humor than in its absence. Bystander gender moderated perceptions of humorous harassing speech but not intent to intervene. In the presence of humor, men but not women perceived antigay harassment as more amusing; they also perceived the harassing peer more favorably. To promote ally behavior, bystander education may explicitly address critical thinking about the functions and effects of disparaging humor.",2021,Bystander gender moderated perceptions of humorous harassing speech but not intent to intervene.,['LGBTQ+ undergraduates ( N  =\xa0326'],[],[],"[{'cui': 'C5191353', 'cui_str': '326'}]",[],[],326.0,0.0369727,Bystander gender moderated perceptions of humorous harassing speech but not intent to intervene.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of Psychology, SUNY Geneseo, Geneseo, New York, USA.'}, {'ForeName': 'Dillon', 'Initials': 'D', 'LastName': 'Federici', 'Affiliation': 'Department of Counseling Psychology, Oklahoma State University, Stillwater, Oklahoma, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Department of Psychology, SUNY Geneseo, Geneseo, New York, USA.'}]",Journal of homosexuality,['10.1080/00918369.2021.1898804']
675,33779520,Promoting Sexual Health in High School: A Feasibility Study of A Web-based Media Literacy Education Program.,"Comprehensive sexual health education (SHE) is an effective strategy for improving adolescent sexual health. However, few of these programs address media influence on sexual cognitions and behaviors. Also, more research is needed on using web-based instruction for SHE. Seventeen classes ( N  = 331 students) in one high school in the United States were enrolled in a pre-post randomized controlled trial to assess the feasibility of  Media Aware , a web-based SHE program that uses a media literacy education (MLE) approach. Compared to a delayed-intervention group, students who received  Media Aware  had significant reductions in their perceived realism of and similarity to media messaging, improved cognitive elaboration of media messages, more realistic perceptions of teen sex norms and risky sex norms, increased efficacy and intention to act as a bystander to potential sexual assault, increased intent to communicate before sex, and increased efficacy to use contraception/protection. These students reported being less willing to hook up, being less willing to have unprotected sex (for males), and positive feedback on their experiences using a web-based program. This study provides evidence that web-based MLE sexual health programming is a feasible and acceptable strategy for improving media-related and sexual health outcomes among adolescents.",2021,"Compared to a delayed-intervention group, students who received  Media Aware  had significant reductions in their perceived realism of and similarity to media messaging, improved cognitive elaboration of media messages, more realistic perceptions of teen sex norms and risky sex norms, increased efficacy and intention to act as a bystander to potential sexual assault, increased intent to communicate before sex, and increased efficacy to use contraception/protection.","['Seventeen classes ( N  =\xa0331 students) in one high school in the United States', 'High School', 'adolescents']","['A Web-based Media Literacy Education Program', 'Comprehensive sexual health education (SHE', 'Media Aware , a web-based SHE program that uses a media literacy education (MLE) approach']","['sexual cognitions and behaviors', 'perceived realism of and similarity to media messaging, improved cognitive elaboration of media messages, more realistic perceptions of teen sex norms and risky sex norms, increased efficacy and intention to act as a bystander to potential sexual assault, increased intent to communicate before sex, and increased efficacy to use contraception/protection']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0036879', 'cui_str': 'Sexuality education'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C4546343', 'cui_str': 'Uses contraception'}]",331.0,0.0105676,"Compared to a delayed-intervention group, students who received  Media Aware  had significant reductions in their perceived realism of and similarity to media messaging, improved cognitive elaboration of media messages, more realistic perceptions of teen sex norms and risky sex norms, increased efficacy and intention to act as a bystander to potential sexual assault, increased intent to communicate before sex, and increased efficacy to use contraception/protection.","[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Scull', 'Affiliation': 'Innovation Research & Training, Durham, NC, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Malik', 'Affiliation': ''}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'Elyse', 'Initials': 'E', 'LastName': 'Keefe', 'Affiliation': ''}]",Journal of health communication,['10.1080/10810730.2021.1893868']
676,33779514,The effect of different resistance training protocols equalized by time under tension on the force-position relationship after 10 weeks training period.,"This study investigated the impact of 10 weeks performing two equalized resistance training (RT) protocols that differ only by repetition duration and number in the force-position and EMG-position relationship. Participants performed an equalized (36 s of time under tension; 3-4 sets; 3 min between sets; 50-55% of one-repetition maximum; 3x week) RT intervention on the bench press and the only different change between protocols were repetition number (RN; 12vs.6) or duration (RD; 3s vs. 6s). Two experimental groups (RN 12 RD 3 , n= 12; and RN 6 RD 6 , n=12) performed the RT, while one group was the control (Control, n=11). Maximal isometric contractions at 10%, 50%, and 90% of total bench press range of motion were performed pre- and post-RT, while electromyography was recorded. It was demonstrated an increase in isometric force (+14% to 24%, P<0.001) shifting up the force-position relationship of the training groups after RT, although no difference between training groups compared to Control. Neuromuscular activation from pectoralis major presented an increase after training for both RT groups (+44%; P<0.001) compared to Control. However, although not significantly different, triceps brachii also presented an increase depending on the protocol (+25%). In conclusion, 10 weeks of an equalized RT with longer RN and shorter RD (or opposite) similarly increases the ability to produce maximal isometric force during the bench exercise across different angles, while neuromuscular activation of the pectoralis major partially explained the shift-up of the force-position relationship after training.",2021,"It was demonstrated an increase in isometric force (+14% to 24%, P<0.001) shifting up the force-position relationship of the training groups after RT, although no difference between training groups compared to Control.",[],"['RT intervention', 'equalized resistance training (RT']","['Neuromuscular activation', 'triceps brachii', 'maximal isometric force', 'Maximal isometric contractions', 'isometric force']",[],"[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}]",,0.0112846,"It was demonstrated an increase in isometric force (+14% to 24%, P<0.001) shifting up the force-position relationship of the training groups after RT, although no difference between training groups compared to Control.","[{'ForeName': 'Hugo C', 'Initials': 'HC', 'LastName': 'Martins-Costa', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Marcel B', 'Initials': 'MB', 'LastName': 'Lanza', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Rodrigo C', 'Initials': 'RC', 'LastName': 'Diniz', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Lucas T', 'Initials': 'LT', 'LastName': 'Lacerda', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Matheus C', 'Initials': 'MC', 'LastName': 'Gomes', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Fernando V', 'Initials': 'FV', 'LastName': 'Lima', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Mauro H', 'Initials': 'MH', 'LastName': 'Chagas', 'Affiliation': 'Weight Training Laboratory, School of Physical Education, Physiotherapy and Occupational Therapy, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}]",European journal of sport science,['10.1080/17461391.2021.1910346']
677,33779480,An Ecological Momentary Intervention for people with social anxiety: A descriptive case study.,"This study describes the development and pilot evaluation of a smartphone- delivered Ecological Momentary Intervention (EMI) for people with social anxiety symptoms. Using a software engineering framework (agile modeling, model-driven development, bottom-up development), mental health experts and software developers collaborated to develop a 4-module EMI app designed to reduce social anxiety in real-time. Fifty-five participants with social anxiety were randomly allocated to the EMI or a wait-list control arm. App downloads, usage and user satisfaction data were collected and mental health outcomes assessed at baseline and post-intervention. Software development practices allowed mental health experts to distil core elements of a psychological intervention into discrete software components but there were challenges in engaging mental health experts in the process. Relative to control there was no significant reduction in social anxiety among the EMI participants in the pilot trial. However, post-test data were available for only 4 intervention and 10 control participants and only 2 (4.0%) of the EMI participants downloaded the app. The two participants who both accessed the app and completed the post-test reported being satisfied with the intervention. Future research should address managing resources and providing additional training to support ongoing engagement with key stakeholders.",2021,Relative to control there was no significant reduction in social anxiety among the EMI participants in the pilot trial.,"['people with social anxiety symptoms', 'people with social anxiety', 'Fifty-five participants with social anxiety']","['smartphone- delivered Ecological Momentary Intervention (EMI', 'Ecological Momentary Intervention', 'EMI or a wait-list control arm']",['social anxiety'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0450382', 'cui_str': '55'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}]",55.0,0.0284762,Relative to control there was no significant reduction in social anxiety among the EMI participants in the pilot trial.,"[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Loo Gee', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra ACT, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Batterham', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra ACT, Australia.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Gulliver', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra ACT, Australia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Reynolds', 'Affiliation': 'Research School of Psychology, The Australian National University, Canberra ACT, Australia.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Griffiths', 'Affiliation': 'Research School of Psychology, The Australian National University, Canberra ACT, Australia.'}]",Informatics for health & social care,['10.1080/17538157.2021.1896525']
678,33779438,Effects of a 16-week Tai Chi intervention on cutaneous sensitivity and proprioception among older adults with and without sensory loss.,"This study investigated the effects of a 16-week Tai Chi (TC) intervention on cutaneous sensitivity and proprioception among older adults with and without sensory loss. Thirty-six older adults were divided into sensory loss and control groups, and they underwent a 16-week TC intervention. Significant interactions were detected in heel cutaneous sensitivity ( p  = 0.046,  F  = 4.419) and knee flexion ( p  = 0.043,  F  = 4.580), extension ( p  = 0.027,  F  = 5.529) and ankle plantar-flexion proprioception ( p  = 0.037,  F  = 4.860). The post hoc test indicated that in the sensory loss group, heel cutaneous sensitivity threshold ( p  = 0.034) and knee flexion ( p  = 0.004), extension ( p  = 0.002) and ankle plantar-flexion ( p  = 0.023) proprioception threshold decreased at week 17, whereas in the control group, knee flexion ( p  = 0.029) proprioception threshold decreased at week 17. TC intervention improved cutaneous sensitivity at more sites and proprioception in more joints among the older adults with sensory loss. TC intervention is a good option for older adults to exercise, and it is more effective among older adults with sensory loss.",2021,"Significant interactions were detected in heel cutaneous sensitivity ( p  = 0.046,  F  = 4.419) and knee flexion ( p  = 0.043,  F  = 4.580), extension ( p  = 0.027,  F  = 5.529) and ankle plantar-flexion proprioception ( p  = 0.037,  F  = 4.860).","['older adults with sensory loss', 'older adults', 'Thirty-six older adults', 'older adults with and without sensory loss']","['TC intervention', 'Tai Chi (TC) intervention', 'Tai Chi intervention']","['proprioception threshold', 'heel cutaneous sensitivity threshold', 'knee flexion', 'cutaneous sensitivity', 'heel cutaneous sensitivity', 'cutaneous sensitivity and proprioception', 'ankle plantar-flexion', 'ankle plantar-flexion proprioception']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0278134', 'cui_str': 'Absence of sensation'}, {'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}]",36.0,0.0151424,"Significant interactions were detected in heel cutaneous sensitivity ( p  = 0.046,  F  = 4.419) and knee flexion ( p  = 0.043,  F  = 4.580), extension ( p  = 0.027,  F  = 5.529) and ankle plantar-flexion proprioception ( p  = 0.037,  F  = 4.860).","[{'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'College of Sports and Health, Shandong Sport University, Jinan, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Mao', 'Affiliation': 'Department of Allied Health, University of North Carolina at Chapel Hill, Chapel Hill, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'College of Sports and Health, Shandong Sport University, Jinan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Health Sciences and Kinesiology, Georgia Southern University, Statesboro, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'College of Sports and Health, Shandong Sport University, Jinan, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Lab of Biomechanics, Shandong Institute of Sport Science, Jinan, China.'}, {'ForeName': 'Xinyan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics and Analytical Sciences, Kennesaw State University, Kennesaw, USA.'}, {'ForeName': 'Qipeng', 'Initials': 'Q', 'LastName': 'Song', 'Affiliation': 'College of Sports and Health, Shandong Sport University, Jinan, China.'}]",Research in sports medicine (Print),['10.1080/15438627.2021.1906673']
679,33779212,Sexually Unexperienced Adolescents Benefit the Most From a Sexual Education Program for Adolescents: A Longitudinal Cluster Randomized Controlled Study.,"Using a longitudinal cluster-randomized controlled design, we examined whether the effects of Competencies for Adolescents with a Healthy Sexuality (COMPAS), an evidence-based sexual health promotion intervention, differ by adolescents' sexual experience. Participants were 699 students aged 14-16, 45.9% were sexually experienced, and assessed in the baseline, posttest, and 12- and 24-month follow-ups. All were recruited from 10 schools that were randomly assigned to the COMPAS program and waiting-list groups (WLG). Using an intent-to-treat analyses, longitudinal changes in psychosocial and behavioral outcomes were explored using generalized estimating equations. Compared to the WLG, COMPAS had a positive impact on six of the seven psychological and behavioral outcomes. Non-sexually experienced reported more favorable HIV-related attitudes, higher condom use intention, lower number of sexual partners, and higher condom use than those sexually experienced. Findings support the importance of implementing sex education actions before adolescents get involved in their first intimate relationships in order to achieve greater impact.",2020,"Non-sexually experienced reported more favorable HIV-related attitudes, higher condom use intention, lower number of sexual partners, and higher condom use than those sexually experienced.","['Sexually Unexperienced Adolescents Benefit the Most From a Sexual Education Program for Adolescents', ""Adolescents with a Healthy Sexuality (COMPAS), an evidence-based sexual health promotion intervention, differ by adolescents' sexual experience"", 'All were recruited from 10 schools', 'Participants were 699 students aged 14-16, 45.9% were sexually experienced, and assessed in the baseline, posttest, and 12- and 24-month follow-ups']","['COMPAS program and waiting-list groups (WLG', 'WLG, COMPAS']",[],"[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],699.0,0.0486886,"Non-sexually experienced reported more favorable HIV-related attitudes, higher condom use intention, lower number of sexual partners, and higher condom use than those sexually experienced.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Morales', 'Affiliation': 'Miguel Hernández University, Elche, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Orgilés', 'Affiliation': 'Miguel Hernández University, Elche, Spain.'}, {'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Espada', 'Affiliation': 'Miguel Hernández University, Elche, Spain.'}]",AIDS education and prevention : official publication of the International Society for AIDS Education,['10.1521/aeap.2020.32.6.493']
680,33779195,Public support for sentencing reform: A policy-capturing experiment.,"While research has shown magnitude of harm drives punishment decisions for crimes resulting in a prison sentence, many states impose probation rather than incarceration. A two-session experiment investigated how punishment type influences sentence length decisions. In session 1,347 participants answered online questions about their support for punishment justifications (i.e., retribution, deterrence, incapacitation, and rehabilitation). In session 2, the online participants read a randomly assigned scenario about a clerk who stole either a smaller or larger amount of money from his employer (magnitude of harm), which the employer was either likely or unlikely to detect (detection), and the clerk received either a term of prison or probation (type of punishment). Results revealed that magnitude of harm influenced punishment severity and sentence length judgments despite participants' self-reported support for retribution as a justification showing no influence. Punishment type also affected sentence length decisions. Furthermore, punishment severity judgments mediated the effect of the magnitude of harm on sentence length after controlling for punishment justifications but only in the probation condition, showing demand for harsher punishment was greater for probation. Thus, we concluded that the retribution motive is prevalent if offenders with a more severe crime receive probation rather than a prison sentence. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Furthermore, punishment severity judgments mediated the effect of the magnitude of harm on sentence length after controlling for punishment justifications but only in the probation condition, showing demand for harsher punishment was greater for probation.",['offenders with a more severe crime receive probation rather than a prison sentence'],"['randomly assigned scenario about a clerk who stole either a smaller or larger amount of money from his employer (magnitude of harm), which the employer was either likely or unlikely to detect (detection), and the clerk received either a term of prison or probation (type of punishment']","['punishment type influences sentence length decisions', 'punishment severity and sentence length judgments']","[{'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010325', 'cui_str': 'Crime'}, {'cui': 'C0392751', 'cui_str': 'In prison'}]","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1321772', 'cui_str': 'Clerk'}, {'cui': 'C0039751', 'cui_str': 'Theft'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0006912', 'cui_str': 'Death Penalty'}]","[{'cui': 'C0006912', 'cui_str': 'Death Penalty'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}]",,0.0656571,"Furthermore, punishment severity judgments mediated the effect of the magnitude of harm on sentence length after controlling for punishment justifications but only in the probation condition, showing demand for harsher punishment was greater for probation.","[{'ForeName': 'Trace C', 'Initials': 'TC', 'LastName': 'Vardsveen', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Wiener', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. Applied,['10.1037/xap0000339']
681,33779064,"Effect of serum urate lowering with allopurinol on blood pressure in young adults: A randomized, controlled, crossover trial.","OBJECTIVE


To determine whether serum urate reduction with allopurinol lowers blood pressure (BP) in young adults and the mechanisms mediating this hypothesized effect.
METHODS


Single-center, double-blind, randomized, crossover clinical trial. Adults ages 18-40 with baseline systolic BP (SBP) ≥ 120 and < 160 mm Hg or diastolic BP (DBP) ≥ 80 and < 100 mm Hg, and serum urate ≥ 5.0 mg/dL for men or ≥ 4.0 mg/dL for women were enrolled. Main exclusion criteria included chronic kidney disease, gout, or past use of urate-lowering therapies. Participants received oral allopurinol (300 mg daily) or placebo for one month followed by a 2-4 week washout and then were crossed over. Study outcomes were change in SBP from baseline, endothelial function estimated as flow-mediated dilation (FMD), and high-sensitivity C-reactive protein (hs-CRP) levels. Assessments of adverse effects were conducted.
RESULTS


99 participants were randomized and 82 completed all visits. Mean age was 28.0 ± 7.0 years, 62.6% were men, and 40.4% were African-American. In the primary intention-to-treat analysis, SBP did not change during the allopurinol (-1.39 ± 1.16 mm Hg [mean ± standard error mean]) or placebo (-1.06 ± 1.08 mm Hg) treatment periods. FMD increased during allopurinol treatment periods compared to placebo (2.5% ± 0.55% versus -0.1% ± 0.42%, p<0.001). There were no changes in hs-CRP and no serious adverse events.
CONCLUSIONS


Urate-lowering therapy with allopurinol in young adults did not lower SBP or hs-CRP when compared with placebo, despite improvements in FMD. These findings do not support urate-lowering as a treatment for hypertension in young adults.",2021,"There were no changes in hs-CRP and no serious adverse events.
","['99 participants were randomized and 82 completed all visits', 'Adults ages 18-40 with baseline systolic BP (SBP) ≥ 120 and < 160 mm Hg or diastolic BP (DBP) ≥ 80 and < 100 mm Hg, and serum urate ≥ 5.0 mg/dL for men or ≥ 4.0 mg/dL for women were enrolled', 'Mean age was 28.0 ± 7.0 years, 62.6% were men, and 40.4% were African-American', 'young adults']","['allopurinol', 'placebo', 'oral allopurinol']","['blood pressure (BP', 'blood pressure', 'adverse effects', 'change in SBP from baseline, endothelial function estimated as flow-mediated dilation (FMD), and high-sensitivity C-reactive protein (hs-CRP) levels', 'hs-CRP and no serious adverse events', 'FMD']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",99.0,0.618412,"There were no changes in hs-CRP and no serious adverse events.
","[{'ForeName': 'Angelo L', 'Initials': 'AL', 'LastName': 'Gaffo', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Calhoun', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Disease, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Rahn', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Disease, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Dudenbostel', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Disease, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Feig', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Nephrology, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Redden', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'Phillip J', 'Initials': 'PJ', 'LastName': 'Foster', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'Stephanie R', 'Initials': 'SR', 'LastName': 'Biggers-Clark', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Mudano', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'Sebastian E', 'Initials': 'SE', 'LastName': 'Sattui', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Saddekni', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'S Louis', 'Initials': 'SL', 'LastName': 'Bridges', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA, 35294.'}, {'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'Department of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, AL, USA, 35294.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41749']
682,33779051,Automated assessment of cortical mastoidectomy performance in virtual reality.,"INTRODUCTION


Cortical mastoidectomy is a core skill that Otolaryngology trainees must gain competency in. Automated competency assessments have the potential to reduce assessment subjectivity and bias, as well as reducing the workload for surgical trainers.
OBJECTIVES


This study aimed to develop and validate an automated competency assessment system for cortical mastoidectomy.
PARTICIPANTS


Data from 60 participants (Group 1) were used to develop and validate an automated competency assessment system for cortical mastoidectomy. Data from 14 other participants (Group 2) were used to test the generalisability of the automated assessment.
DESIGN


Participants drilled cortical mastoidectomies on a virtual reality temporal bone simulator. Procedures were graded by a blinded expert using the previously validated Melbourne Mastoidectomy Scale: a different expert assessed procedures by Groups 1 and 2. Using data from Group 1, simulator metrics were developed to map directly to the individual items of this scale. Metric value thresholds were calculated by comparing automated simulator metric values to expert scores. Binary scores per item were allocated using these thresholds. Validation was performed using random sub-sampling. The generalisability of the method was investigated by performing the automated assessment on mastoidectomies performed by Group 2, and correlating these with scores of a second blinded expert.
RESULTS


The automated binary score compared with the expert score per item had an accuracy, sensitivity and specificity of 0.9450, 0.9547 and 0.9343, respectively, for Group 1; and 0.8614, 0.8579 and 0.8654, respectively, for Group 2. There was a strong correlation between the total scores per participant assigned by the expert and calculated by the automatic assessment method for both Group 1 (r = .9144, P < .0001) and Group 2 (r = .7224, P < .0001).
CONCLUSION


This study outlines a virtual reality-based method of automated assessment of competency in cortical mastoidectomy, which proved comparable to the assessment provided by human experts.",2021,"The generalisability of the method was investigated by performing the automated assessment on mastoidectomies performed by Group 2, and correlating these with scores of a second blinded expert.
",['Data from 60 participants (Group 1'],['virtual reality temporal bone simulator'],[],"[{'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039484', 'cui_str': 'Temporal bone structure'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]",[],60.0,0.0670268,"The generalisability of the method was investigated by performing the automated assessment on mastoidectomies performed by Group 2, and correlating these with scores of a second blinded expert.
","[{'ForeName': 'Sudanthi', 'Initials': 'S', 'LastName': 'Wijewickrema', 'Affiliation': 'Department of Surgery (Otolaryngology), University of Melbourne, Royal Victorian Eye and Ear Hospital, Melbourne, Vic., Australia.'}, {'ForeName': 'Benjamin James', 'Initials': 'BJ', 'LastName': 'Talks', 'Affiliation': 'Department of Surgery (Otolaryngology), University of Melbourne, Royal Victorian Eye and Ear Hospital, Melbourne, Vic., Australia.'}, {'ForeName': 'Jesslyn', 'Initials': 'J', 'LastName': 'Lamtara', 'Affiliation': 'Department of Surgery (Otolaryngology), University of Melbourne, Royal Victorian Eye and Ear Hospital, Melbourne, Vic., Australia.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Gerard', 'Affiliation': 'Department of Surgery (Otolaryngology), University of Melbourne, Royal Victorian Eye and Ear Hospital, Melbourne, Vic., Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Surgery (Otolaryngology), University of Melbourne, Royal Victorian Eye and Ear Hospital, Melbourne, Vic., Australia.'}]",Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery,['10.1111/coa.13760']
683,33778994,Sustaining peer support groups: Insights from women living with HIV in rural Kenya.,"OBJECTIVE


As HIV transitions to a chronic disease, measures that foster continued health are critical. Peer support groups can help in reducing stigma and ensuring wellbeing for those living with HIV. The purpose of our study was to gain an understanding of the ways in which women living with HIV in rural areas sustain peer support groups.
DESIGN AND SAMPLE


For this descriptive qualitative study, 20 women living with HIV participated in the study. Women were randomly divided into two peer support groups of ten women each; the groups met over a 12-month period. monthly for the first two months and then every three months for the remainder of the year.
RESULTS


Discussion themes indicated women found ways to sustain the groups by using them as a platform for engaging in income generation; starting and participating in table banking; addressing food security; and finding financial and moral support. Problem-solving challenges of sustaining peer support groups was also a major theme.
CONCLUSION


As people live longer with HIV, long-term peer support will be needed to maintain wellbeing. Community-based peer support groups can be sustained by engaging women in common income-generation activities.",2021,Women were randomly divided into two peer support groups of ten women each; the groups met over a 12-month period.,"['women living with HIV in rural areas sustain peer support groups', 'women living with HIV in rural Kenya', '20 women living with HIV participated in the study']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],20.0,0.0596682,Women were randomly divided into two peer support groups of ten women each; the groups met over a 12-month period.,"[{'ForeName': 'Peninnah M', 'Initials': 'PM', 'LastName': 'Kako', 'Affiliation': 'College of Nursing, University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Ngui', 'Affiliation': 'Zilber School of Public Health, University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Tavonna', 'Initials': 'T', 'LastName': 'Kako', 'Affiliation': 'University of Alabama at Birmingham Medical Center, Birmingham, AL, USA.'}, {'ForeName': 'Florine', 'Initials': 'F', 'LastName': 'Ndakuya-Fitzgerald', 'Affiliation': 'Clement J Zablocki VA Medical Center-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Mkandawire-Valhmu', 'Affiliation': 'College of Nursing, University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Dressel', 'Affiliation': 'College of Nursing, University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Augustine', 'Initials': 'A', 'LastName': 'Kiplagat', 'Affiliation': 'College of Nursing, University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Leonard E', 'Initials': 'LE', 'LastName': 'Egede', 'Affiliation': 'Center for Advancing Population Science, Medical College of Wisconsin, Milwaukee, WI, USA.'}]","Public health nursing (Boston, Mass.)",['10.1111/phn.12879']
684,33778908,Asthma and high-intensity interval training have no effect on clustered cardiometabolic risk or arterial stiffness in adolescents.,"PURPOSE


Cardiometabolic risk, including arterial stiffness, is increasing in youth. Those with asthma are suggested to be particularly at risk of cardiovascular disease. Efficient and effective strategies are required to prevent the atherosclerotic process in youth. The purpose of this study was to investigate the effect of 6 months high-intensity interval training (HIIT) on cardiometabolic risk in youth with and without asthma.
METHODS


65 adolescents (31 mild asthma; 34 non-asthma) were recruited, 32 (16 asthma) of whom were randomly allocated to receive HIIT three times per week for 6 months. At baseline, mid-intervention, post-intervention and at a 3-month follow-up, anthropometric, metabolic and vascular determinants of cardiometabolic risk were assessed. Following principal component analysis (PCA), linear mixed models were used to assess the influence of asthma, HIIT and their interaction.
RESULTS


Seven factors were identified which explained 88% of the common variance shared among the parameters. Those with asthma demonstrated lower arterial stiffness factor scores mid-intervention (P = 0.047) and lower cholesterol factor scores post-intervention (P = 0.022) but there was no effect of the intervention, or interaction effects, on any PCA-identified factor, at any time-point. HIIT was associated with a lower low-density lipoprotein and diastolic blood pressure at mid-intervention.
DISCUSSION


Neither arterial stiffness nor clustered cardiometabolic risk are influenced by HIIT in adolescents with or without asthma, despite important changes in blood lipid and pressure profiles. Blood pressure, augmentation and pulse wave velocity should be considered physiologically distinct constructs and as potential markers of cardiovascular health.",2021,"Those with asthma demonstrated lower arterial stiffness factor scores mid-intervention (P = 0.047) and lower cholesterol factor scores post-intervention (P = 0.022) but there was no effect of the intervention, or interaction effects, on any PCA-identified factor, at any time-point.","['65 adolescents (31 mild asthma; 34 non-asthma) were recruited, 32 (16 asthma', 'youth with and without asthma', 'adolescents']",['6\xa0months high-intensity interval training (HIIT'],"['low-density lipoprotein and diastolic blood pressure', 'Blood pressure, augmentation and pulse wave velocity', 'blood lipid and pressure profiles', 'cholesterol factor scores', 'cardiometabolic risk', 'arterial stiffness factor scores mid-intervention']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0398249,"Those with asthma demonstrated lower arterial stiffness factor scores mid-intervention (P = 0.047) and lower cholesterol factor scores post-intervention (P = 0.022) but there was no effect of the intervention, or interaction effects, on any PCA-identified factor, at any time-point.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'McNarry', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine Research Centre, College of Engineering, Swansea University, Bay Campus, Swansea, SA1 8EN, UK. m.mcnarry@swansea.ac.uk.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lester', 'Affiliation': 'School of Human Sciences, University of Western Australia, Perth, 6009, Australia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Ellins', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, SA2 8PP, UK.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Halcox', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, SA2 8PP, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Davies', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, SA2 8PP, UK.'}, {'ForeName': 'C O N', 'Initials': 'CON', 'LastName': 'Winn', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine Research Centre, College of Engineering, Swansea University, Bay Campus, Swansea, SA1 8EN, UK.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Mackintosh', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine Research Centre, College of Engineering, Swansea University, Bay Campus, Swansea, SA1 8EN, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04590-4']
685,33778854,A Brief Motivational Intervention Differentially Reduces Sugar-sweetened Beverage (SSB) Consumption.,"BACKGROUND


Environmental and behavioral interventions hold promise to reduce sugar-sweetened beverage (SSBs) consumption.
PURPOSE


To test, among frequent SSB consumers, whether motivations to consume SSBs moderated the effects of (a) a workplace SSB sales ban (environmental intervention) alone, and (b) a ""brief motivational intervention"" (BI) in addition to the sales ban, on changes in SSB consumption.
METHODS


We assessed whether (1) baseline motivations to consume SSBs (craving, psychological stress, or taste enjoyment) impacted changes in daily SSB consumption at 6-month follow-up among frequent (>12oz of SSBs/day) SSB consumers (N = 214); (2) participants randomized to the BI (n = 109) versus to the sales ban only (n = 105) reported greater reductions in SSB consumption at follow-up; and (3) motivations to consume SSBs moderated any changes in SSB consumption.
RESULTS


In response to the sales ban alone, individuals with stronger SSB cravings (+1 SD) at baseline showed significantly smaller reductions in daily SSB consumption at 6-month follow-up relative to individuals with weaker (-1 SD) SSB cravings (2.5 oz vs. 22.5 oz), p < .01. Receiving the BI significantly increased reductions for those with stronger SSB cravings: Among individuals with stronger cravings, those who received the BI evidenced significantly greater reductions in daily SSB consumption [M(SE) = -19.2 (2.74) oz] than those who did not [M(SE) = -2.5 (2.3) oz, p < .001], a difference of 16.72 oz.
CONCLUSIONS


Frequent SSB consumers with stronger SSB cravings report minimal reductions in daily SSB consumption with a sales ban only, but report greater reductions if they also receive a motivational intervention. Future multilevel interventions for institutions should consider both environmental and individualized multi-level interventions.
CLINICAL TRIAL INFORMATION


NCT02585336.",2021,"Receiving the BI significantly increased reductions for those with stronger SSB cravings: Among individuals with stronger cravings, those who received the BI evidenced significantly greater reductions in daily SSB consumption [M(SE) =",['SSB consumers (N = 214'],[],"['daily SSB consumption', 'SSB consumption', 'SSB cravings', 'daily SSB consumption [M(SE) ', 'SSBs (craving, psychological stress, or taste enjoyment) impacted changes in daily SSB consumption', 'Sugar-sweetened Beverage (SSB) Consumption']",[],[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}]",214.0,0.153469,"Receiving the BI significantly increased reductions for those with stronger SSB cravings: Among individuals with stronger cravings, those who received the BI evidenced significantly greater reductions in daily SSB consumption [M(SE) =","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Mason', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco (UCSF), San Francisco, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schmidt', 'Affiliation': 'Phillip R. Lee Institute for Health Policy Studies, UCSF, San Francisco, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ishkanian', 'Affiliation': 'Campus Life Services, UCSF Wellness Program, UCSF, San Francisco, USA.'}, {'ForeName': 'Laurie M', 'Initials': 'LM', 'LastName': 'Jacobs', 'Affiliation': 'Phillip R. Lee Institute for Health Policy Studies, UCSF, San Francisco, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Leung', 'Affiliation': 'Department of Nutritional Sciences, School of Public Health, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Leeane', 'Initials': 'L', 'LastName': 'Jensen', 'Affiliation': 'Campus Life Services, UCSF Wellness Program, UCSF, San Francisco, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Cohn', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco (UCSF), San Francisco, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Schleicher', 'Affiliation': 'Department of Medicine, University of Maryland, College Park, USA.'}, {'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Hartman', 'Affiliation': 'Department of Psychology, College of Arts & Sciences, Drexel University, Philadelphia, USA.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Wojcicki', 'Affiliation': 'Department of Pediatrics, UCSF, San Francisco, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Lustig', 'Affiliation': 'Phillip R. Lee Institute for Health Policy Studies, UCSF, San Francisco, USA.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco (UCSF), San Francisco, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa123']
686,33778836,[Effect of different orthodontic techniques on alveolar bone changes in the upper incisor area of patients with periodontitis].,"PURPOSE


To explore the effects of different orthodontic techniques on the changes of alveolar bone density, height and gingival crevicular fluid (GCF) bleeding in upper incisor in patients with periodontitis.
METHODS


Twenty-three patients with moderate periodontitis who underwent orthodontic treatment from January 2016 to December 2019 in the Department of Stomatology of Jiangxi Pingxiang People's Hospital were divided into experimentalexperimental group(n=12) and control group(n=11). Patients in the experimental group were treated with bracket-less invisible appliance, while patients in the control group were treated with conventional lip-side fixed appliance. Changes of gingival crevicular hemorrhage index, probing depth, alveolar bone height and bone density in the incisor area were compared between the two groups before and after treatment. Statistical analysis was performed on data using SPSS 22.0 software package.
RESULTS


After treatment, the bone mineral density of the upper incisor alveolar crest (L1) of the two groups decreased, and the rate of decrease in the experimental group was significantly less than that in the control group (P<0.05). The bone density at the apical point of the anatomical root of the control group at 1 mm (L3) was also significantly reduced, but there was no significant change in the experimental group. There was no significant change in the alveolar bone height of the upper incisor area between the two groups before and after treatment (P>0.05). Root resorption of the upper incisors in the experimental group was significantly lower than that in the control group(P<0.05). After treatment, the probing depth and GCF bleeding index of the two groups decreased, and the change in the experimental group was significantly greater than that in the control group(P<0.05).
CONCLUSIONS


Bracket-free invisible appliance for periodontitis is more conducive to the restoration of alveolar bone mineral density in the upper incisor than the conventional lip-side fixed appliance, and both of which have the same effect on bone height and are safe and effective orthodontic treatment.",2020,There was no significant change in the alveolar bone height of the upper incisor area between the two groups before and after treatment (P>0.05).,"[""Twenty-three patients with moderate periodontitis who underwent orthodontic treatment from January 2016 to December 2019 in the Department of Stomatology of Jiangxi Pingxiang People's Hospital were divided into experimentalexperimental group(n=12) and control group(n=11"", 'patients with periodontitis']","['bracket-less invisible appliance', 'orthodontic techniques', 'conventional lip-side fixed appliance']","['alveolar bone density, height and gingival crevicular fluid (GCF) bleeding', 'Root resorption of the upper incisors', 'bone mineral density of the upper incisor alveolar crest (L1', 'gingival crevicular hemorrhage index, probing depth, alveolar bone height and bone density in the incisor area', 'alveolar bone mineral density', 'alveolar bone changes', 'alveolar bone height of the upper incisor area', 'probing depth and GCF bleeding index', 'bone density']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205398', 'cui_str': 'Invisible'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0035851', 'cui_str': 'Root Resorption'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",23.0,0.0111088,There was no significant change in the alveolar bone height of the upper incisor area between the two groups before and after treatment (P>0.05).,"[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Stomatology，Pingxiang People's Hospital.Pingxiang 337000, Jiangxi Province，China. E-mail:LI13691008082@163.com.""}, {'ForeName': 'Xu-Chun', 'Initials': 'XC', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Ming-Lang', 'Initials': 'ML', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
687,33778831,"[Effect of pulp revascularization on CCL21, IFN-γ-inducible protein 10 in chronic periapical periodontitis].","PURPOSE


To investigate the effect of pulp revascularization on the levels of CCL21 and IFN-γ-inducible protein 10（IP-10）in chronic periapical periodontitis.
METHODS


One hundred patients with chronic periapical periodontitis treated from September 2018 to May 2019 were selected as the research subjects. They were divided into two groups by using random number table method. The patients in both groups were taken cone-beam CT(CBCT) film for filing before operation. Patients in the experimental group were treated by pulp revascularization, while patients in the control group were treated by apexification. The level of CCL21 and IP-10 was measured within 4 weeks. The results of operation, the ratio of crown to root and the thickness of root canal wall were analyzed. Statistical analysis of the data was conducted with SPSS 25.0 software package.
RESULTS


CCL21 and IP-10 levels of the two groups increased in the course of 1-3 weeks, but decreased after 4 weeks. CCL21 levels were significantly different at 2 weeks, 3 weeks and 4 weeks(P<0.05), but there was no significant difference at one week(P<0.05). There was no significant difference in IP-10 level between the two groups at 1, 2 and 3 weeks of treatment(P<0.05), but there was significant difference at 4 weeks of treatment (P<0.05). The success rate of the experimental group was 90% and that of the control group was 50%，there was a significant difference between the two groups(P<0.05). There was no significant difference in the ratio of crown to root and the thickness of root canal wall between the two groups(P<0.05).
CONCLUSIONS


For chronic periapical diseases, pulp revascularization, apical induction can promote the secretion of chemokines CCL21 and IP-10 in the early stage of treatment, the level of CCL21 changes greatly in the early stage of treatment, while changes of IP-10 can be seen in the later stage.",2020,"There was no significant difference in IP-10 level between the two groups at 1, 2 and 3 weeks of treatment(P<0.05), but there was significant difference at 4 weeks of treatment (P<0.05).","['One hundred patients with chronic periapical periodontitis treated from September 2018 to May 2019 were selected as the research subjects', 'chronic periapical periodontitis']",['pulp revascularization'],"['success rate', 'ratio of crown to root and the thickness of root canal', 'CCL21 levels', 'ratio of crown to root and the thickness of root canal wall', 'level of CCL21 and IP-10', 'CCL21 and IP-10 levels', 'IP-10 level']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C1700396', 'cui_str': 'CCL21 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}]",100.0,0.0673983,"There was no significant difference in IP-10 level between the two groups at 1, 2 and 3 weeks of treatment(P<0.05), but there was significant difference at 4 weeks of treatment (P<0.05).","[{'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Wuhan Hospital of Traditional Chinese Medicine. Wuhan 430000, Hubei Province, China. E-mail:ym136272@163.com.'}, {'ForeName': 'Jin-Xian', 'Initials': 'JX', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[]
688,33247344,Oedema on STIR modified the effect of amoxicillin as treatment for chronic low back pain with Modic changes-subgroup analysis of a randomized trial.,"OBJECTIVE


To evaluate potential MRI-defined effect modifiers of amoxicillin treatment in patients with chronic low back pain and type 1 or 2 Modic changes (MCs) at the level of a previous lumbar disc herniation (index level).
METHODS


In a prospective trial (AIM), 180 patients (25-64 years; mean age 45; 105 women) were randomised to receive amoxicillin or placebo for 3 months. Primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (0-24 scale) at 1 year. Mean RMDQ score difference between the groups at 1 year defined the treatment effect; 4 RMDQ points defined the minimal clinically important effect. Predefined baseline MRI features of MCs at the index level(s) were investigated as potential effect modifiers. The predefined primary hypothesis was a better effect of amoxicillin when short tau inversion recovery (STIR) shows more MC-related high signal. To evaluate this hypothesis, we pre-constructed a composite variable with three categories (STIR1/2/3). STIR3 implied MC-related STIR signal increases with volume ≥ 25% and height > 50% of vertebral body and maximum intensity increase ≥ 25% and presence on both sides of the disc. As pre-planned, interaction with treatment was analysed using ANCOVA in the per protocol population (n = 155).
RESULTS


The STIR3 composite group (n = 41) and STIR signal volume ≥ 25% alone (n = 45) modified the treatment effect of amoxicillin. As hypothesised, STIR3 patients reported the largest effect (- 5.1 RMDQ points; 95% CI - 8.2 to - 1.9; p for interaction = 0.008).
CONCLUSIONS


Predefined subgroups with abundant MC-related index-level oedema on STIR modified the effect of amoxicillin. This finding needs replication and further support.
KEY POINTS


• In the primary analysis of the AIM trial, the effect of amoxicillin in patients with chronic low back pain and type 1 or 2 MCs did not reach the predefined cut-off for clinical importance. • In the present MRI subgroup analysis of AIM, predefined subgroups with abundant MC-related oedema on STIR reported an effect of amoxicillin. • This finding requires replication and further support.",2020,"As hypothesised, STIR3 patients reported the largest effect (- 5.1 RMDQ points; 95% CI - 8.2 to - 1.9; p for interaction = 0.008).
","['patients with chronic low back pain and type 1 or 2 Modic changes (MCs) at the level of a previous lumbar disc herniation (index level', 'patients with chronic low back pain and type 1 or 2 MCs did not reach the predefined cut-off for clinical importance', '180 patients (25-64\xa0years; mean age 45; 105 women']","['amoxicillin or placebo', 'STIR3', 'amoxicillin']","['Roland-Morris Disability Questionnaire (RMDQ) score', 'Mean RMDQ score difference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0560523', 'cui_str': 'Does not reach'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",180.0,0.252974,"As hypothesised, STIR3 patients reported the largest effect (- 5.1 RMDQ points; 95% CI - 8.2 to - 1.9; p for interaction = 0.008).
","[{'ForeName': 'Per Martin', 'Initials': 'PM', 'LastName': 'Kristoffersen', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway. per.martin.kristoffersen@helse-bergen.no.'}, {'ForeName': 'Lars C H', 'Initials': 'LCH', 'LastName': 'Bråten', 'Affiliation': 'Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956, 0424, Oslo, Nydalen, Norway.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Vetti', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grøvle', 'Affiliation': 'Department of Rheumatology, Østfold Hospital Trust, P.O. Box 300, 1714, Grålum, Norway.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hellum', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ulleval, P.O. Box 4950, Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Storheim', 'Affiliation': 'Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956, 0424, Oslo, Nydalen, Norway.'}, {'ForeName': 'John-Anker', 'Initials': 'JA', 'LastName': 'Zwart', 'Affiliation': 'Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956, 0424, Oslo, Nydalen, Norway.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Assmus', 'Affiliation': 'Competence Centre for Clinical Research, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.'}, {'ForeName': 'Ansgar', 'Initials': 'A', 'LastName': 'Espeland', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.'}]",European radiology,['10.1007/s00330-020-07542-w']
689,33248880,Effect of oral immunotherapy in children with milk allergy: The ORIMA study.,"BACKGROUND


This study was aimed at evaluating the efficacy and safety of oral immunotherapy (OIT) in children with severe cow's milk allergy.
METHODS


The subjects comprised 28 children (aged 3-12 years) with allergic symptoms that were induced by ≤ 10 mL of cow's milk in an oral food challenge test (OFC). The subjects were randomly allocated to the treatment group (n = 14) and control group (n = 14); the former received rush immunotherapy for 2 weeks, followed by a gradual increase of cow's milk volume to 100 mL for 1 year, and the latter completely eliminated cow's milk for 1 year. Both groups underwent an OFC with 100 mL of cow's milk after 1 year.
RESULTS


The treatment group had significantly higher rates of a negative OFC [7/14 (50%) vs. 0/14 (0%), p < 0.01] compared with the control group. The cow's milk-specific IgE level significantly decreased in the treatment group (p < 0.01) but not in the control group (p = 0.63). During the study period, adrenaline was required in 6/14 patients (43%) of the treatment group and in 0/14 patients (0%) of the control group. Long follow-up data were available at the 2-year point after the study for 8 in the treatment group and 7 (87.5%) of these continued to ingest milk (>100 mL).
CONCLUSIONS


The effect of immunotherapy was 50%, but the incidence of adverse events was not low. Further studies focusing on safety is necessary to standardize OIT for cow's milk allergy.",2021,The cow's milk-specific IgE level significantly decreased in the treatment group (p < 0.01) but not in the control group (p = 0.63).,"[""children with severe cow's milk allergy"", 'children with milk allergy', ""28 children (aged 3-12 years) with allergic symptoms that were induced by\xa0≤\xa010\xa0mL of cow's milk in an oral food challenge test (OFC""]","['immunotherapy', 'OFC', 'oral immunotherapy', 'rush immunotherapy', 'adrenaline', 'oral immunotherapy (OIT']","[""cow's milk-specific IgE level"", 'rates of a negative OFC', 'adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0079840', 'cui_str': 'Milk allergy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443052', 'cui_str': 'Rush'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C1997483', 'cui_str': 'Cow milk specific immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0272081,The cow's milk-specific IgE level significantly decreased in the treatment group (p < 0.01) but not in the control group (p = 0.63).,"[{'ForeName': 'Mayu', 'Initials': 'M', 'LastName': 'Maeda', 'Affiliation': 'Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshinori', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Kamiya', 'Affiliation': 'Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'Department of Pediatrics, Daisan Hospital, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fujita', 'Affiliation': 'Department of Pediatrics, Daisan Hospital, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Akashi', 'Affiliation': 'Department of Pediatrics, Daisan Hospital, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Division of Enzyme Chemistry, Institute for Enzyme Research, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Morita', 'Affiliation': 'Department of Allergy and Clinical Immunology, National Research Institute for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Allergy and Clinical Immunology, National Research Institute for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Katsunuma', 'Affiliation': 'Department of Pediatrics, Daisan Hospital, The Jikei University School of Medicine, Tokyo, Japan. Electronic address: tkatsunuma@jikei.ac.jp.'}]",Allergology international : official journal of the Japanese Society of Allergology,['10.1016/j.alit.2020.09.011']
690,33242153,A randomised trial of the effectiveness of instructor versus automated manikin feedback for training junior doctors in life support skills.,"INTRODUCTION


Australian Standards require that clinicians undergo regular training in skills required to respond to the acute deterioration of a patient. Training focuses on the ability to appropriately respond to cardiac arrest, including delivering cardiac compressions, ventilation and appropriate defibrillation. Providing such training comes at a significant cost to the organisation and impacts on clinician time in direct patient care. If effective, the use of an automated manikin could significantly reduce costs and provide consistent training experiences.
METHODS


Fifty-six resident medical officers were randomised to two groups to test two skills components of hospital life support training under two feedback conditions. The skills components were cardiac compressions and bag-valve-mask ventilation. The feedback conditions were automated feedback delivered by a simulation manikin and traditional feedback delivered by an instructor. All participants were exposed to both skills components and both feedback conditions in a counterbalanced block design. Participants completed surveys before and after training.
RESULTS


The results demonstrated significantly better performance in cardiac compressions under the automated manikin feedback condition compared with the instructor feedback condition. This difference was not observed in bag-valve-mask ventilation. The majority of participants found the automated manikin feedback more useful than the instructor feedback.
DISCUSSION


Automated manikin feedback was not inferior to instructor feedback for skill acquisition in cardiac compressions training. The automated feedback condition did not achieve the same level of significance in bag-valve-mask ventilation training. Results suggest training with automated feedback presents a cost-effective opportunity to lessen the training burden, whilst improving skill acquisition.",2021,The results demonstrated significantly better performance in cardiac compressions under the automated manikin feedback condition compared with the instructor feedback condition.,"['Fifty-six resident medical officers', 'training junior doctors in life support skills']","['instructor versus automated manikin feedback', 'hospital life support training under two feedback conditions']",[],"[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0557516', 'cui_str': 'Medical officer'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],56.0,0.0223614,The results demonstrated significantly better performance in cardiac compressions under the automated manikin feedback condition compared with the instructor feedback condition.,"[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': 'Medical Education Unit, Fiona Stanley Fremantle Hospitals Group, Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Furness', 'Affiliation': 'Medical Education Unit, Fiona Stanley Fremantle Hospitals Group, Fiona Stanley Hospital, Murdoch, WA, Australia. Erin.Furness@health.wa.gov.au.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Proctor', 'Affiliation': 'Medical Education Unit, Fiona Stanley Fremantle Hospitals Group, Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Sweetman', 'Affiliation': 'Medical Education Unit, Fiona Stanley Fremantle Hospitals Group, Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hird', 'Affiliation': 'School of Medicine, University of Notre Dame Australia, Fremantle, WA, Australia.'}]",Perspectives on medical education,['10.1007/s40037-020-00631-y']
691,33252985,"Reduced All-Cause Mortality in the ETHOS Trial of Budesonide/Glycopyrrolate/Formoterol for Chronic Obstructive Pulmonary Disease. A Randomized, Double-Blind, Multicenter, Parallel-Group Study.","Rationale:  In the phase III, 52-week ETHOS (Efficacy and Safety of Triple Therapy in Obstructive Lung Disease) trial in chronic obstructive pulmonary disease (COPD) (NCT02465567), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) significantly reduced all-cause mortality compared with glycopyrrolate/formoterol fumarate (GFF). However, 384 of 8,509 patients were missing vital status at Week 52 in the original analyses. Objectives:  To assess the robustness of the ETHOS mortality findings after additional data retrieval for patients missing Week 52 vital status in the original analyses. Methods:  Patients with moderate to very severe COPD and prior history of exacerbation received twice-daily dosing with 320/18/9.6 μg of BGF (BGF 320), 160/18/9.6 μg of BGF (BGF 160), 18/9.6 μg of GFF, or 320/9.6 μg of budesonide/formoterol fumarate (BFF) (all delivered via a single metered-dose Aerosphere inhaler). Time to death (all-cause) was a prespecified secondary endpoint. Measurements and Main Results:  In the final retrieved dataset, which included Week 52 vital status for 99.6% of the intent-to-treat population, risk of death with BGF 320 was significantly lower than GFF (hazard ratio, 0.51; 95% confidence interval, 0.33-0.80; unadjusted  P  = 0.0035). There were no significant differences in mortality when comparing BGF 320 with BFF (hazard ratio, 0.72; 95% confidence interval, 0.44-1.16;  P  = 0.1721), nor were significant differences observed when comparing BGF 160 against either dual comparator. Results were similar when the first 30, 60, or 90 days of treatment were excluded from the analysis. Deaths from cardiovascular causes occurred in 0.5%, 0.8%, 1.4%, and 0.5% of patients in the BGF 320, BGF 160, GFF, and BFF groups, respectively. Conclusions:  Using final retrieved vital status data, triple therapy with BGF 320 reduced the risk of death compared with GFF, but was not shown to significantly reduce the risk of death compared with BFF, in patients with COPD. Triple therapy containing a lower dose of inhaled corticosteroid (BGF 160) was not shown to significantly reduce the risk of death compared with the dual therapy comparators.",2021,"There were no significant differences in mortality when comparing BGF 320 to BFF (HR 0.72, 95% CI 0.44‒1.16; P=0.1721), nor were significant differences observed when comparing BGF 160 against either dual comparator.","['COPD', 'patients missing Week 52 vital status in the original analyses', '384 out of 8,509 patients were', 'patients with COPD', 'Patients with moderate-to-very severe COPD and prior history of exacerbation received twice-daily dosing with BGF 320/18/9.6 µg or 160/18/9.6 μg, GFF 18/9.6 µg, or']","['glycopyrrolate/formoterol fumarate (GFF', 'budesonide/formoterol fumarate (BFF', 'Budesonide/Glycopyrrolate/Formoterol', 'inhaled corticosteroid', 'budesonide/glycopyrrolate/formoterol fumarate (BGF']","['Deaths from cardiovascular causes', 'mortality', 'risk of death', 'Time to death', 'missing vital status']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",8509.0,0.384893,"There were no significant differences in mortality when comparing BGF 320 to BFF (HR 0.72, 95% CI 0.44‒1.16; P=0.1721), nor were significant differences observed when comparing BGF 160 against either dual comparator.","[{'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan.'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'National Heart and Lung Institute, London, United Kingdom.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester, United Kingdom.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Centre for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Rossman', 'Affiliation': 'AstraZeneca, Morristown, New Jersey.'}, {'ForeName': 'Earl', 'Initials': 'E', 'LastName': 'St Rose', 'Affiliation': 'AstraZeneca, Morristown, New Jersey.'}, {'ForeName': 'Roopa', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'AstraZeneca, Durham, North Carolina.'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Ballal', 'Affiliation': 'AstraZeneca, Morristown, New Jersey.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Darken', 'Affiliation': 'AstraZeneca, Wilmington, Delaware; and.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Aurivillius', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'AstraZeneca, Morristown, New Jersey.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'AstraZeneca, Durham, North Carolina.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202006-2618OC']
692,33246911,Long-term azithromycin use is not associated with QT prolongation in children with cystic fibrosis.,"Chronic Azithromycin (AZM) is a common treatment for lung infection. Among adults at risk of cardiac events, AZM use has been associated with cardiovascular harm. We assessed cardiovascular safety of AZM among children with CF, as a secondary analysis of a placebo-controlled, clinical trial, in which study drug was taken thrice-weekly for a planned 18 months. Safety assessments using electrocardiogram (ECG) occurred at study enrollment, and then after 3 weeks and 18 months of participation. Among 221 study participants with a median of 18 months follow-up, increased corrected QT interval (QTc) of ≥30 msec was rare, at 3.4 occurrences per 100 person-years; and incidence of QTc prolongation was no higher in the AZM arm than the placebo arm (1.8 versus 5.4 per 100 person-years). No persons experienced QTc intervals above 500 msec. Long-term chronic AZM use was not associated with increased QT prolongation.",2021,Long-term chronic AZM use was not associated with increased QT prolongation.,"['children with CF', 'children with cystic fibrosis']","['azithromycin', 'Chronic Azithromycin (AZM', 'placebo']","['incidence of QTc prolongation', 'corrected QT interval (QTc', 'QT prolongation', 'QTc intervals', 'cardiovascular safety of AZM', 'Safety assessments using electrocardiogram (ECG']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0855333', 'cui_str': 'Electrocardiogram QT corrected interval prolonged'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",221.0,0.146974,Long-term chronic AZM use was not associated with increased QT prolongation.,"[{'ForeName': 'Amalia S', 'Initials': 'AS', 'LastName': 'Magaret', 'Affiliation': ""Division of Pulmonary and Sleep Medicine, Department of Pediatrics, University of Washington, Seattle, WA, United States; Department of Biostatistics, University of Washington, Seattle, WA, United States; Seattle Children's Hospital, Seattle, WA, United States. Electronic address: amag@uw.edu.""}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Salerno', 'Affiliation': ""Division of Pulmonary and Sleep Medicine, Department of Pediatrics, University of Washington, Seattle, WA, United States; Seattle Children's Hospital, Seattle, WA, United States.""}, {'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Deen', 'Affiliation': ""Division of Cardiology, Department of Medicine, University of Washington, Seattle, WA, United States; Seattle Children's Hospital, Seattle, WA, United States.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kloster', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA, United States.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mayer-Hamblett', 'Affiliation': ""Division of Pulmonary and Sleep Medicine, Department of Pediatrics, University of Washington, Seattle, WA, United States; Department of Biostatistics, University of Washington, Seattle, WA, United States; Seattle Children's Hospital, Seattle, WA, United States.""}, {'ForeName': 'Bonnie W', 'Initials': 'BW', 'LastName': 'Ramsey', 'Affiliation': ""Division of Pulmonary and Sleep Medicine, Department of Pediatrics, University of Washington, Seattle, WA, United States; Seattle Children's Hospital, Seattle, WA, United States.""}, {'ForeName': 'Dave P', 'Initials': 'DP', 'LastName': 'Nichols', 'Affiliation': ""Division of Pulmonary and Sleep Medicine, Department of Pediatrics, University of Washington, Seattle, WA, United States; Seattle Children's Hospital, Seattle, WA, United States.""}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.11.005']
693,31982599,Home-based cycling using connected ergometric bicycles for people with lumbar spinal stenosis (FLEXCAL): Protocol for a randomised trial.,,2021,,['people with lumbar spinal stenosis (FLEXCAL'],['Home-based cycling using connected ergometric bicycles'],[],"[{'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region (disorder)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}]",[],,0.118468,,"[{'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': ""UFR médecine de Paris Centre, faculté de santé, université de Paris, Sorbonne-Paris-Cité, 75006 Paris, France; Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, hôpital Cochin, AP-HP. Centre-Université de Paris, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMRS-1124, toxicité environnementale, cibles thérapeutiques, signalisation cellulaire et biomarqueurs, centre universitaire des Saints-Pères, 75006 Paris, France. Electronic address: christelle.nguyen2@aphp.fr.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutron', 'Affiliation': ""UFR médecine de Paris Centre, faculté de santé, université de Paris, Sorbonne-Paris-Cité, 75006 Paris, France; Centre d'épidémiologie clinique, hôpital Hôtel-Dieu, AP-HP. Centre-Université de Paris, 75004 Paris, France; INSERM UMRS-1153, centre de recherche épidémiologie et statistique Sorbonne Paris Cité, METHODS team, 75004 Paris, France.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Roren', 'Affiliation': ""Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, hôpital Cochin, AP-HP. Centre-Université de Paris, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMRS-1153, centre de recherche épidémiologie et statistique Sorbonne Paris Cité, ECaMO team, 75004 Paris, France; Institut fédératif de recherche sur le handicap, 75013 Paris, France.""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Baron', 'Affiliation': 'INSERM UMRS-1153, centre de recherche épidémiologie et statistique Sorbonne Paris Cité, METHODS team, 75004 Paris, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pauwels', 'Affiliation': ""Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, hôpital Cochin, AP-HP. Centre-Université de Paris, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France.""}, {'ForeName': 'Marie-Martine', 'Initials': 'MM', 'LastName': 'Lefèvre-Colau', 'Affiliation': ""UFR médecine de Paris Centre, faculté de santé, université de Paris, Sorbonne-Paris-Cité, 75006 Paris, France; Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, hôpital Cochin, AP-HP. Centre-Université de Paris, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMRS-1153, centre de recherche épidémiologie et statistique Sorbonne Paris Cité, ECaMO team, 75004 Paris, France; Institut fédératif de recherche sur le handicap, 75013 Paris, France.""}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Poiraudeau', 'Affiliation': ""UFR médecine de Paris Centre, faculté de santé, université de Paris, Sorbonne-Paris-Cité, 75006 Paris, France; Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, hôpital Cochin, AP-HP. Centre-Université de Paris, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMRS-1153, centre de recherche épidémiologie et statistique Sorbonne Paris Cité, ECaMO team, 75004 Paris, France; Institut fédératif de recherche sur le handicap, 75013 Paris, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Dupeyron', 'Affiliation': 'Service de médecine physique et de réadaptation, hôpital universitaire Carémeau, CHU de Carémeau-Nîmes, 30000 Nîmes, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Coudeyre', 'Affiliation': 'Service de médecine physique et de réadaptation, INRA, centre hospitalo-universitaire de Clermont-Ferrand, université Clermont-Auvergne, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Rannou', 'Affiliation': ""UFR médecine de Paris Centre, faculté de santé, université de Paris, Sorbonne-Paris-Cité, 75006 Paris, France; Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, hôpital Cochin, AP-HP. Centre-Université de Paris, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMRS-1124, toxicité environnementale, cibles thérapeutiques, signalisation cellulaire et biomarqueurs, centre universitaire des Saints-Pères, 75006 Paris, France.""}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2019.12.006']
694,31809308,"Brief Report: Anal Intercourse, HIV-1 Risk, and Efficacy in a Trial of a Dapivirine Vaginal Ring for HIV-1 Prevention.","OBJECTIVES


To describe receptive anal intercourse (RAI) behaviors and correlates in a cohort of sub-Saharan African women, evaluate the association of RAI with HIV-1 risk, and evaluate whether the HIV-1 prevention efficacy of a dapivirine vaginal ring differs among women who reported RAI.
DESIGN


Secondary analysis of the MTN-020/ASPIRE trial, a randomized, double-blind, placebo-controlled trial evaluating a dapivirine vaginal ring for HIV-1 prevention.
METHODS


At enrollment and month 3, women reported RAI in the prior 3 months in audio computer-assisted self-interviews. We evaluated associations between RAI and participant characteristics with χ and t-tests adjusted for study site. Cox proportional hazards models stratified by study site tested the association of RAI with HIV-1 acquisition and effect modification by RAI.
RESULTS


Eighteen percent of women reported any RAI at enrollment and/or month 3, with a median of 2 (interquartile range: 1-4) RAI acts in the prior 3 months, accounting for 1.5% of total sex acts. RAI prevalence was higher among women with lower educational attainment and those reporting transactional sex. In adjusted models, RAI was not associated with HIV-1 acquisition (aHR: 0.93, 95% CI: 0.57 to 1.54). The ring reduced HIV-1 risk by 27% (95% CI: -5 to 49) among women reporting no RAI and by 18% (95% CI: -57 to 57) among women reporting any RAI (interaction P-value = 0.77).
CONCLUSIONS


RAI was modestly infrequent and was not associated with reduced HIV-1 protection from the ring, suggesting that, in populations with rates of RAI similar to this cohort, RAI may not appreciably reduce the population-level impact of the dapivirine vaginal ring.",2020,"The ring reduced HIV-1 risk by 27% (95% CI: -5, 49) among women reporting no RAI and by 18% (95% CI: -57, 57) among women reporting any RAI (interaction p-value=0.77).
",['women who reported RAI'],"['dapivirine-containing vaginal ring for HIV-1 prevention', 'dapivirine-containing vaginal ring', 'placebo']","['HIV-1 risk', 'RAI prevalence', 'receptive anal intercourse (RAI) behaviors', 'Anal intercourse, HIV-1 risk, and efficacy', 'HIV-1 protection']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.333294,"The ring reduced HIV-1 risk by 27% (95% CI: -5, 49) among women reporting no RAI and by 18% (95% CI: -57, 57) among women reporting any RAI (interaction p-value=0.77).
","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Peebles', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""RTI International, Women's Global Health Imperative (WGHI), San Francisco, CA.""}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Krishnaveni', 'Initials': 'K', 'LastName': 'Reddy', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Department of Medicine (Clinical Pharmacology), Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Ishana', 'Initials': 'I', 'LastName': 'Harkoo', 'Affiliation': 'Centre for the AIDS Program of Research in South Africa, Durban, South Africa.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Gati Mirembe', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Nitesha', 'Initials': 'N', 'LastName': 'Jeenarain', 'Affiliation': 'South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Brown', 'Affiliation': 'Vaccine and Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Research Center, Seattle, WA; and.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002253']
695,32098509,Simulation can replace part of speech-language pathology placement time: A randomised controlled trial.,"PURPOSE


Simulation is increasingly used within speech-language pathology education. Research has primarily explored students' perceptions of learning in simulation. The aim of this study was to determine if speech-language pathology students achieved a statistically-equivalent level of competency when a mean of 20% of placement time was replaced with simulation compared to placements without a simulation component.
METHOD


This non-inferiority randomised controlled trial involved students from six Australian universities. Students were randomised to either a simulation + traditional placement group attending 5 days of simulation prior to their traditional placement, or a traditional only placement group. Their end-placement clinical competency was assessed using Competency Assessment in Speech Pathology (COMPASS ® ).
RESULT


Final data were available for 325 students: 150 students in traditional placements, 138 students in protocol-compliant simulation + traditional placements, and 37 students in non-protocol simulation + traditional placements. There were no statistically significant differences between groups (traditional vs protocol-compliant simulation + traditional Mann-Whitney-Wilcoxon  z  = 1.23,  df  = 286,  p  = 0.22; traditional vs intention-to-treat simulation + traditional Mann-Whitney-Wilcoxon  z  = 0.23,  df  = 323,  p  = 0.81).
CONCLUSION


This research contributes to the evidence base which suggests that simulation can partially replace traditional placement time for speech-language pathology students without loss of competency, substantiating its value as an alternative placement model in speech-language pathology programmes.",2021,"There were no statistically significant differences between groups (traditional vs protocol-compliant simulation + traditional Mann-Whitney-Wilcoxon  z  = 1.23,  df  = 286,  p  = 0.22; traditional vs intention-to-treat simulation + traditional Mann-Whitney-Wilcoxon  z  = 0.23,  df  = 323,  p  = 0.81).","['325 students: 150 students in traditional placements, 138 students in protocol-compliant simulation\u2009+\u2009traditional placements, and 37 students in non-protocol simulation\u2009+\u2009traditional placements', 'students from six Australian universities', 'speech-language pathology students']","['simulation\u2009+\u2009traditional placement group attending 5\xa0days of simulation prior to their traditional placement, or a traditional only placement group']",[],"[{'cui': 'C4517714', 'cui_str': 'Three hundred and twenty-five'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0566588', 'cui_str': 'Compliant (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0037825', 'cui_str': 'Speech-Language Pathology'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1720467', 'cui_str': 'Only'}]",[],,0.0565514,"There were no statistically significant differences between groups (traditional vs protocol-compliant simulation + traditional Mann-Whitney-Wilcoxon  z  = 1.23,  df  = 286,  p  = 0.22; traditional vs intention-to-treat simulation + traditional Mann-Whitney-Wilcoxon  z  = 0.23,  df  = 323,  p  = 0.81).","[{'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Hill', 'Affiliation': 'Discipline of Speech Pathology, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ward', 'Affiliation': 'Discipline of Speech Pathology, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Heard', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'McAllister', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'McCabe', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Penman', 'Affiliation': 'Discipline of Speech Pathology, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Caird', 'Affiliation': 'Discipline of Speech Pathology, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Aldridge', 'Affiliation': 'Discipline of Speech Pathology, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Baldac', 'Affiliation': 'Speech Pathology Australia, Melbourne, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cardell', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Davenport', 'Affiliation': 'School of Allied Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Davidson', 'Affiliation': 'Department of Audiology and Speech Pathology, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hewat', 'Affiliation': 'School of Humanities and Social Science, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Howells', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Purcell', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Walters', 'Affiliation': 'School of Humanities and Social Science, The University of Newcastle, Callaghan, Australia.'}]",International journal of speech-language pathology,['10.1080/17549507.2020.1722238']
696,32160827,Successful recruitment of a multi-site international randomized placebo-controlled trial in people with HIV with attention to diversity of race and ethnicity: critical role of central coordination.,"Background:  The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a multicenter, randomized, placebo-controlled trial, designed to test whether a statin medication can prevent cardiovascular disease in people with HIV. REPRIEVE recently completed enrollment of 7557 participants at over 100 clinical sites globally. Participant groups of focus were women, and racial and ethnic minorities. Objective:  To describe recruitment methods and strategies developed by the REPRIEVE Clinical Coordinating Center (CCC) and share best practices learned from the recruitment process. Methods:  Enrollment targets were agreed upon with the primary funder, the National Heart, Lung, and Blood Institute (NHLBI) and were milestone driven. Milestones included number of sites activated, number of participants enrolled within specific time frames, and proportion of women and minorities enrolled. Strategies to achieve these milestones included structured interviews with site-designated REPRIEVE Recruitment Champions to develop best practices, development of a multimedia campaign, and site level recruitment support. Results:  Recruitment initiated March, 2015 and completed March, 2019. The final accrual target was 7500 participants over 48 months. The trial met this target within the time specified. Overall, 10,613 screens were completed, 48% of participants enrolled from sites outside of North America, 32% were female, 44% were Black or African American, and 25% were Hispanic or Latino. Conclusions:  REPRIEVE met its overall projected recruitment goal by using multiple, simultaneous strategies to specifically target a diverse population including minority subgroups. REPRIEVE benefited from the development of recruitment strategies with clear targets and communication of accrual targets to study teams.",2020,"The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a multicenter, randomized, placebo-controlled trial, designed to test whether a statin medication can prevent cardiovascular disease in people with HIV.","['people with HIV with attention to diversity of race and ethnicity', '7557 participants at over 100 clinical sites globally', 'people with HIV', '10,613 screens were completed, 48% of participants enrolled from sites outside of North America, 32% were female, 44% were Black or African American, and 25% were Hispanic or Latino', '7500 participants over 48\u2009months', 'Participant groups of focus were women, and racial and ethnic minorities']","['statin medication', 'placebo']","['cardiovascular disease', 'number of sites activated, number of participants enrolled within specific time frames, and proportion of women and minorities enrolled']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C4517869', 'cui_str': 'Seven thousand five hundred'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0445108', 'cui_str': 'Number of sites (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",10613.0,0.546729,"The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a multicenter, randomized, placebo-controlled trial, designed to test whether a statin medication can prevent cardiovascular disease in people with HIV.","[{'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Kileel', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Looby', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Markella V', 'Initials': 'MV', 'LastName': 'Zanni', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Sanchez', 'Affiliation': 'Division of Infectious Diseases, Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Fichtenbaum', 'Affiliation': 'Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Malvestutto', 'Affiliation': 'Division of Infectious Diseases, Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Karin L', 'Initials': 'KL', 'LastName': 'Klingman', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Alston-Smith', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Lavelle', 'Affiliation': 'Office of the Director, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rancourt', 'Affiliation': 'Office of the Director, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Sharlaa', 'Initials': 'S', 'LastName': 'Badal-Faesen', 'Affiliation': 'Clinical HIV Research Unit, Department of Internal Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Sandra Wagner', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': 'Fundação Oswaldo Cruz, Instituto Nacional de Infectologia Evandro Chagas (INI/Fiocruz), Rio de Janeiro, Brazil.'}, {'ForeName': 'Anchalee', 'Initials': 'A', 'LastName': 'Avihingsanon', 'Affiliation': 'HIV-NAT, Thai Red Cross AIDS Research Centre; and Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Sandesh', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Byramjee Jeejeebhoy Medical College, Johns Hopkins University Clinical Research Site, Pune, India.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sponseller', 'Affiliation': 'Kowa Pharmaceuticals America, Inc, Montgomery, AL, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Melbourne', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Cooper-Arnold', 'Affiliation': 'National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",HIV research & clinical practice,['10.1080/25787489.2020.1733794']
697,32050214,Prospective Randomized Comparative Trial: Visual Performance Comparison Of Two Enhanced Depth Of Focus IOLs - Symfony and IC-8.,"PURPOSE


To compare the visual acuity and satisfaction outcomes of two different concepts of enhanced depth of focus intraocular lenses (EDOF IOLs).
SETTING


University Eye Hospital Bochum, Germany DESIGN:: Prospective randomized comparative clinical trial METHODS:: This study included a sample of 76 eyes of 38 patients undergoing cataract surgery with the implantation of two different EDOF concepts. In the first group (IC-8 group) a monofocal 1-piece Tecnis Z B00 IOL (Johnson & Johnson Vision) was implanted in the dominant eye and an IC-8 IOL (AcuFocus) was implanted in the non-dominant eye. In the second group (Symfony group) a Tecnis Symfony IOL (Johnson & Johnson Vision) was implanted in both eyes. The target refraction of the dominat eye was emmetropia and slight myopia (mini-monovision; -0.75 D) in the non-dominant eye. Visual and refractive outcomes and patient satisfaction rates were evaluated 3 months after surgery.
RESULTS


In both groups no intra- or postoperative complications occurred. The target refraction was reached in both groups without statistical significant differences. The uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions) was excellent in both groups with statistically significant better results in the IC-8 goup (logMAR; IC-8 group -0.1 ± 0.07, Symfony group 0.07 ± 0.1, p-value 0.02 (photopic); IC-8 group 0.12 ± 0.09, Symfony group 0.22 ± 0.1, p-value <0.01 (mesopic)). Binocular uncorrected intermediate visual acuity (UIVA) and uncorrected near visual acuity (UNVA) were also good in both groups without significant differences (UIVA IC-8 group 0.01 ± 0.07, Symfony group -0.01 ± 0.08, p-value 0.35; UNVA IC-8 group 0.14 ± 0.11, Symfony group 0.09 ± 0.08, p-value 0.14). Subjective satisfaction was high in both groups.
CONCLUSION


Both EDOF IOLs provided a very good UDVA with superior results in the IC-8 group, good UIVA and UNVA under photopic light conditions. Subjective patient satisfaction was higher in the IC-8 group.",2020,"The uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions) was excellent in both groups with statistically significant better results in the IC-8 goup (logMAR; IC-8 group -0.1 ± 0.07, Symfony group 0.07 ± 0.1, p-value 0.02","['sample of 76 eyes of 38 patients undergoing cataract surgery with the implantation of two different EDOF concepts', 'University Eye Hospital Bochum, Germany DESIGN']","['enhanced depth of focus intraocular lenses (EDOF IOLs', 'Two Enhanced Depth Of Focus IOLs - Symfony and IC-8', 'Tecnis Symfony IOL (Johnson & Johnson Vision']","['target refraction', 'uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions', 'visual acuity and satisfaction outcomes', 'postoperative complications', 'Visual and refractive outcomes and patient satisfaction rates', 'Binocular uncorrected intermediate visual acuity (UIVA) and uncorrected near visual acuity (UNVA', 'Subjective patient satisfaction', 'Subjective satisfaction']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0042789', 'cui_str': 'Vision'}]","[{'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",38.0,0.0530222,"The uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions) was excellent in both groups with statistically significant better results in the IC-8 goup (logMAR; IC-8 group -0.1 ± 0.07, Symfony group 0.07 ± 0.1, p-value 0.02","[{'ForeName': 'Merita', 'Initials': 'M', 'LastName': 'Schojai', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Tim Schultz', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Corinna Jerke', 'Affiliation': ''}, {'ForeName': 'Dipl Ing', 'Initials': 'DI', 'LastName': 'Jörg Böcker', 'Affiliation': ''}, {'ForeName': 'H Burkhard', 'Initials': 'HB', 'LastName': 'Dick', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000068']
698,31764068,Use of the dapivirine vaginal ring and effect on cervical cytology abnormalities.,"OBJECTIVE


We aimed to determine if the dapivirine vaginal ring and the ring device alone (flexible silicone matrix polymer) was associated with the development of cervical cytology abnormalities.
DESIGN


Secondary analysis comparing cervical cytology results between two randomized controlled microbicide trials (MTN-020/ASPIRE and MTN-003/VOICE).
METHODS


Data from ASPIRE, a phase III, placebo-controlled trial of the dapivirine vaginal ring, were used in this analysis. Cervical cytology smears were evaluated at baseline and at the final visit with product use. We compared cytology results between women randomized to dapivirine versus placebo vaginal ring. We further assessed for the effect of the vaginal ring device on cervical cytology by comparing results with data from the oral placebo arm of VOICE, a prior HIV-1 prevention trial conducted in a similar population.
RESULTS


Cervical cytology results for 2394 women from ASPIRE (1197 per study arm) were used in this analysis; median time between baseline and final visit with product use was 22.1 months. Cytology smear findings were comparable between dapivirine and placebo vaginal ring arms: at final visit, normal: 90.6 versus 91.5%, ASC-US//LSIL: 7.8 versus 7.4%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 1.7 versus 1.1%, P = 0.44. Cytology data from VOICE had findings (normal: 87.8%, ASC-US/LSIL: 9.8%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 2.4%) comparable with that of both dapivirine (P = 0.93) and placebo vaginal ring arms (P = 0.24).
CONCLUSION


These findings indicate that neither use of the dapivirine vaginal ring nor the vaginal ring device alone, over a period of 2 years, is associated with development of cervical cytology abnormalities that could lead to precancerous or cancerous lesions.",2020,"Cytology smear findings were comparable between dapivirine and placebo vaginal ring arms: at final visit, normal: 90.6% vs. 91.5%, ASC-US//LSIL: 7.8% vs. 7.4%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 1.7% vs. 1.1%, p = 0.44.",['2394 women from ASPIRE (1197 per study arm'],"['dapivirine vaginal ring and the ring device alone (flexible silicone matrix polymer', 'vaginal ring device', 'dapivirine vaginal ring', 'placebo', 'placebo vaginal ring', 'dapivirine']","['Cytology smear findings', 'Cervical cytology smears', 'cervical cytology abnormalities']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0856201', 'cui_str': 'Cervical cytology'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",2394.0,0.16241,"Cytology smear findings were comparable between dapivirine and placebo vaginal ring arms: at final visit, normal: 90.6% vs. 91.5%, ASC-US//LSIL: 7.8% vs. 7.4%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 1.7% vs. 1.1%, p = 0.44.","[{'ForeName': 'Krishnaveni', 'Initials': 'K', 'LastName': 'Reddy', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, School of Clinical Medicine, Johannesburg, South Africa.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Brown', 'Affiliation': 'Vaccine and Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Research Center, Seattle.'}, {'ForeName': 'Nitesha', 'Initials': 'N', 'LastName': 'Jeenarain', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban.'}, {'ForeName': 'Logashvari', 'Initials': 'L', 'LastName': 'Naidoo', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Siva', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Gonasagrie', 'Initials': 'G', 'LastName': 'Nair', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Bonus', 'Initials': 'B', 'LastName': 'Makanani', 'Affiliation': 'College of Medicine-Johns Hopkins University Research Project Queen Elizabeth Central Hospital, Blantyre.'}, {'ForeName': 'Lameck', 'Initials': 'L', 'LastName': 'Chinula', 'Affiliation': 'UNC Project, Lilongwe, Malawi.'}, {'ForeName': 'Nyaradzo', 'Initials': 'N', 'LastName': 'Mgodi', 'Affiliation': 'University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Zvavahera', 'Initials': 'Z', 'LastName': 'Chirenje', 'Affiliation': 'University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Flavia Matovu', 'Initials': 'FM', 'LastName': 'Kiweewa', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Marrazzo', 'Affiliation': 'University of Alabama at Birmingham School of Medicine, Birmingham, Alabama.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bunge', 'Affiliation': 'University of Pittsburg.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Soto-Torres', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jeanna', 'Initials': 'J', 'LastName': 'Piper', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, School of Clinical Medicine, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002451']
699,32202619,The Role of Multimicronutrient Supplementation in Pediatric HIV Management in Nigeria: A Randomized Controlled Study.,"BACKGROUND


We aimed to compare the immunologic and hematologic effects of 3 multimicronutrient supplements in human immunodeficiency virus-positive children in Lagos, Nigeria.
METHODS


This double-blind, randomized controlled study included 190 children, aged 5-12 years, in Lagos, Nigeria. Sixty-four, 63, and 63 participants were assigned to multimicronutrient group A, B, or C, respectively, for 6 months. Supplements A, B, and C contained 7 micronutrients at the recommended daily allowance (RDA) (comparable to standard-of-care multivitamin), 22 micronutrients at the RDA, and 22 micronutrients at 3 times the recommended daily allowance (3RDA), respectively. Using paired sample t tests and factorial repeat-measures analysis of variance (ANOVA), within- and between-group changes in CD4 count and hemoglobin levels were evaluated after 6 months.
RESULTS


After 6 months of supplementation, paired-sample t test showed that CD4 cell count did not significantly differ from baseline for all 3 groups. Between-subject effect also did not significantly differ in the 3 groups after 6 months (factorial repeat-measures ANOVA (F [degrees of freedom {df} = 2, 187] = 0.846; P = .436; partial η 2 = 0.009). Hemoglobin levels were significantly increased after supplementation in all 3 supplement groups. Increases were not significantly different between groups (factorial repeat-measures ANOVA (F [df = 2, 187] = 0.549; P = .591; partial η 2 = 0.006).
CONCLUSIONS


Equivalent effects were observed. After 6 months of supplementation, mean CD4 count was not significantly different between groups. Hemoglobin concentration was significantly increased in all 3 groups, but increase did not differ between groups.
CLINICAL TRIALS REGISTRATION


NCT02552602.",2021,"After 6 months of supplementation, paired-sample t test showed that CD4 cell count did not significantly differ from baseline for all 3 groups.","['human immunodeficiency virus-positive children in Lagos, Nigeria', '190 children, aged 5-12 years, in Lagos, Nigeria', 'Pediatric HIV Management in Nigeria', 'Sixty-four, 63, and 63 participants']","['Multimicronutrient Supplementation', 'multimicronutrient supplements']","['Hemoglobin concentration', 'Hemoglobin levels', 'mean CD4 count', 'CD4 cell count', 'CD4 count and hemoglobin levels']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4517839', 'cui_str': '64'}]",[],"[{'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]",190.0,0.307492,"After 6 months of supplementation, paired-sample t test showed that CD4 cell count did not significantly differ from baseline for all 3 groups.","[{'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Esiovwa', 'Affiliation': 'School of Health and Life Sciences, University of the West of Scotland, Paisley, Scotland, United Kingdom.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rankin', 'Affiliation': 'School of Health and Life Sciences, University of the West of Scotland, Paisley, Scotland, United Kingdom.'}, {'ForeName': 'Agatha', 'Initials': 'A', 'LastName': 'David', 'Affiliation': 'Nigerian Institute of Medical Research, Lagos, Nigeria.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Disu', 'Affiliation': 'Lagos State University Teaching Hospital, Lagos, Nigeria.'}, {'ForeName': 'Agatha', 'Initials': 'A', 'LastName': 'Wapmuk', 'Affiliation': 'Nigerian Institute of Medical Research, Lagos, Nigeria.'}, {'ForeName': 'Olufemi', 'Initials': 'O', 'LastName': 'Amoo', 'Affiliation': 'Nigerian Institute of Medical Research, Lagos, Nigeria.'}]",Journal of the Pediatric Infectious Diseases Society,['10.1093/jpids/piaa025']
700,31296073,Comparison of three natural surfactants according to lung ultrasonography scores in newborns with respiratory distress syndrome.,"INTRODUCTION


Lung ultrasonography (LUS) is a noninvasive bed-side test and increasingly used by clinicians in the management and follow-up of respiratory distress syndrome (RDS) in premature infants.
OBJECTIVE


To compare the results of three natural surfactants according to LUS scores in premature infants with RDS.
METHODS


This was a prospective study on 62 preterm infants (25-34 weeks) with RDS and receiving surfactant according to 2016 European guidelines. All patients underwent a clinical evaluation and chest X-ray at three study points; at the first hours of life (presurfactant), and at 6-12th hour (early postsurfactant) and 24th hour (late postsurfactant) of surfactant. Simultaneously fractional inspired oxygen (FiO 2 ) need, arterial PaO 2  values, Downes and LUS scores were noted. The patients were randomized into three groups; Group 1 ( n  = 23), poractant alpha; Group 2 ( n  = 20), beractant; and Group 3 ( n  = 19), calfactant. The groups were compared according to clinical, laboratory and radiological variables as well as LUS scores.
RESULTS


Gestational age ( p  = .05), birthweight ( p  = .07), and SNAPPE-II scores ( p  = .57) were similar in three groups. Repeated dose need was the highest in Group 3 ( p  = .04). FiO 2  need ( p  = .04) was the highest and PaO 2  values ( p  = .03) were the lowest at late postsurfactant point in the same group. LUS scores were also the highest in Group 3 at this period ( p  = .02). Downes scores were similar in groups at all points ( p  > .05). NICU stay were similar in groups ( p  = .53). The durations of total oxygen supplementation, mechanical ventilation, and hospital stay were the same in groups ( p  > .05).
CONCLUSIONS


In newborns with RDS, poractant alpha and beractant have similarly reduced oxygen need in accordance to the LUS findings. However, they seem to be superior compared to calfactant.",2021,FiO 2  need ( p  = .04) was the highest and PaO 2  values ( p  = .03) were the lowest at late postsurfactant point in the same group.,"['premature infants', 'premature infants with RDS', '62 preterm infants (25-34\xa0weeks) with RDS and receiving surfactant according to 2016 European guidelines', 'newborns with respiratory distress syndrome']",['Lung ultrasonography (LUS'],"['durations of total oxygen supplementation, mechanical ventilation, and hospital stay', 'NICU stay', 'Simultaneously fractional inspired oxygen (FiO 2 ) need, arterial PaO 2  values, Downes and LUS scores', 'LUS scores', 'lung ultrasonography scores', 'SNAPPE-II scores']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}]","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]",,0.0169247,FiO 2  need ( p  = .04) was the highest and PaO 2  values ( p  = .03) were the lowest at late postsurfactant point in the same group.,"[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Dilli', 'Affiliation': 'Department of Neonatology, Dr Sami Ulus Gynecology Obstetrics and Child Health and Diseases Training and Research Hospital, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Emin', 'Initials': 'E', 'LastName': 'Çakmakçı', 'Affiliation': 'Department of Radiology, Dr Sami Ulus Gynecology Obstetrics and Child Health and Diseases Training and Research Hospital, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Akduman', 'Affiliation': 'Department of Neonatology, Dr Sami Ulus Gynecology Obstetrics and Child Health and Diseases Training and Research Hospital, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Oktem', 'Affiliation': 'Department of Neonatology, Dr Sami Ulus Gynecology Obstetrics and Child Health and Diseases Training and Research Hospital, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Aydoğan', 'Affiliation': 'Department of Neonatology, Dr Sami Ulus Gynecology Obstetrics and Child Health and Diseases Training and Research Hospital, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Rumeysa', 'Initials': 'R', 'LastName': 'Çitli', 'Affiliation': 'Department of Neonatology, Dr Sami Ulus Gynecology Obstetrics and Child Health and Diseases Training and Research Hospital, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Aysegul', 'Initials': 'A', 'LastName': 'Zenciroğlu', 'Affiliation': 'Department of Neonatology, Dr Sami Ulus Gynecology Obstetrics and Child Health and Diseases Training and Research Hospital, University of Health Sciences, Ankara, Turkey.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1643313']
701,31981713,High-dose rifapentine with or without moxifloxacin for shortening treatment of pulmonary tuberculosis: Study protocol for TBTC study 31/ACTG A5349 phase 3 clinical trial.,"INTRODUCTION


Phase 2 clinical trials of tuberculosis treatment have shown that once-daily regimens in which rifampin is replaced by high dose rifapentine have potent antimicrobial activity that may be sufficient to shorten overall treatment duration. Herein we describe the design of an ongoing phase 3 clinical trial testing the hypothesis that once-daily regimens containing high dose rifapentine in combination with other anti-tuberculosis drugs administered for four months can achieve cure rates not worse than the conventional six-month treatment regimen.
METHODS/DESIGN


S31/A5349 is a multicenter randomized controlled phase 3 non-inferiority trial that compares two four-month regimens with the standard six-month regimen for treating drug-susceptible pulmonary tuberculosis in HIV-negative and HIV-positive patients. Both of the four-month regimens contain high-dose rifapentine instead of rifampin, with ethambutol replaced by moxifloxacin in one regimen. All drugs are administered seven days per week, and under direct observation at least five days per week. The primary outcome is tuberculosis disease-free survival at twelve months after study treatment assignment. A total of 2500 participants will be randomized; this gives 90% power to show non-inferiority with a 6.6% margin of non-inferiority.
DISCUSSION


This phase 3 trial formally tests the hypothesis that augmentation of rifamycin exposures can shorten tuberculosis treatment to four months. Trial design and standardized implementation optimize the likelihood of obtaining valid results. Results of this trial may have important implications for clinical management of tuberculosis at both individual and programmatic levels.
TRIAL REGISTRATION


NCT02410772. Registered 8 April 2015,https://www.clinicaltrials.gov/ct2/show/NCT02410772?term=02410772&rank=1.",2020,A total of 2500 participants will be randomized; this gives 90% power to show non-inferiority with a 6.6% margin of,"['pulmonary tuberculosis', '2500 participants', 'treating drug-susceptible pulmonary tuberculosis in HIV-negative and HIV-positive patients']","['moxifloxacin', 'rifapentine with or without moxifloxacin']","['cure rates', 'tuberculosis disease-free survival']","[{'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0073372', 'cui_str': 'rifapentine'}]","[{'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",2500.0,0.389641,A total of 2500 participants will be randomized; this gives 90% power to show non-inferiority with a 6.6% margin of,"[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Dorman', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA. Electronic address: dorman@musc.edu.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Nahid', 'Affiliation': 'University of California, San Francisco, California, USA.'}, {'ForeName': 'Ekaterina V', 'Initials': 'EV', 'LastName': 'Kurbatova', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Stefan V', 'Initials': 'SV', 'LastName': 'Goldberg', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Bozeman', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Burman', 'Affiliation': 'Denver Public Health, Denver, CO, USA.'}, {'ForeName': 'Kwok-Chiu', 'Initials': 'KC', 'LastName': 'Chang', 'Affiliation': 'Tuberculosis and Chest Service, Department of Health, Hong Kong.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cotton', 'Affiliation': 'Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Engle', 'Affiliation': 'Audie L. Murphy Veterans Affairs Medical Center / University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Pei-Jean', 'Initials': 'PJ', 'LastName': 'Feng', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Courtney V', 'Initials': 'CV', 'LastName': 'Fletcher', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Phan', 'Initials': 'P', 'LastName': 'Ha', 'Affiliation': 'Vietnam National TB Program (NTP)/UCSF Research Collaboration, Hanoi, Viet Nam.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Heilig', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': 'Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA; Uganda-Case Western Reserve University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Lessem', 'Affiliation': 'Treatment Action Group, NY, New York, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Metchock', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Miro', 'Affiliation': 'Hospital Clinic-IDIBAPS, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Nguyen Viet', 'Initials': 'NV', 'LastName': 'Nhung', 'Affiliation': 'Vietnam National TB Program (NTP)/UCSF Research Collaboration, Hanoi, Viet Nam.'}, {'ForeName': 'April C', 'Initials': 'AC', 'LastName': 'Pettit', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Infectious Diseases, Nashville, TN, USA.'}, {'ForeName': 'Patrick P J', 'Initials': 'PPJ', 'LastName': 'Phillips', 'Affiliation': 'University of California, San Francisco, California, USA.'}, {'ForeName': 'Anthony T', 'Initials': 'AT', 'LastName': 'Podany', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Purfield', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA; U.S. Public Health Service Commissioned Corps, Rockville, MD, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Robergeau', 'Affiliation': 'Westat, Inc., Rockville, MD, USA.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': 'Parirenyatwa Clinical Research Site, Harare, Zimbabwe.'}, {'ForeName': 'Nigel A', 'Initials': 'NA', 'LastName': 'Scott', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Sizemore', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vernon', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Weiner', 'Affiliation': 'Audie L. Murphy Veterans Affairs Medical Center / University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Swindells', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Chaisson', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.105938']
702,30862293,Do outcomes of cognitive-behaviour therapy for co-occurring alcohol misuse and depression differ for participants with symptoms of posttraumatic stress?,"BACKGROUND


Although post-traumatic stress disorder (PTSD) often co-occurs with depression and alcohol use disorder (AUD), treatment settings may not screen for PTSD symptoms.
AIMS


To explore the effects of PTSD symptoms in participants seeking treatment for depression and alcohol misuse by capitalising on the DAISI (Depression and Alcohol Integrated and Single focussed Interventions) project.
METHODS


Participants ( N  = 220) with current depressive symptoms and alcohol misuse were recruited from the DAISI project, a randomised controlled trial with four treatment arms. PTSD symptoms were assessed at baseline by the Posttraumatic Stress Diagnostic Scale and again at the 3-month assessment.
RESULTS


McNemars  t -test assessed for changes in PTSD symptom severity and PTSD symptom clusters at the 3-month assessment. Repeated measures multivariate analysis of variance assessed for changes in PTSD symptoms, by DAISI treatment allocation. At the 3-month assessment, participants with PTSD reported significant reductions in PTSD symptoms (except intrusion) and a lower rate of PTSD, and responded better to integrated depression-alcohol misuse CBT than to the alcohol/depression single-focussed or brief interventions.
CONCLUSION


Integrated depression and alcohol misuse CBT may be effective for PTSD symptoms, but intrusions may need to be addressed specifically.",2021,"At the 3-month assessment, participants with PTSD reported significant reductions in PTSD symptoms (except intrusion) and a lower rate of PTSD, and responded better to integrated depression-alcohol misuse CBT than to the alcohol/depression single-focussed or brief interventions.
","['participants seeking treatment for depression and alcohol misuse by capitalising on the DAISI (Depression and Alcohol Integrated and Single focussed Interventions) project', 'participants with symptoms of posttraumatic stress', 'Participants (N\u2009=\u2009220) with current depressive symptoms and alcohol misuse were recruited from the DAISI project']",['cognitive-behaviour therapy'],"['PTSD symptom severity and PTSD symptom clusters', 'PTSD symptoms', 'Posttraumatic Stress Diagnostic Scale']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0222045'}]",220.0,0.0136969,"At the 3-month assessment, participants with PTSD reported significant reductions in PTSD symptoms (except intrusion) and a lower rate of PTSD, and responded better to integrated depression-alcohol misuse CBT than to the alcohol/depression single-focussed or brief interventions.
","[{'ForeName': 'Kylie A', 'Initials': 'KA', 'LastName': 'Bailey', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, University Drive, Callaghan, Australia.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Baker', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, University Drive, Callaghan, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McElduff', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, University Drive, Callaghan, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Kay-Lambkin', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, University Drive, Callaghan, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kavanagh', 'Affiliation': 'Child Health Research. Institute of Health and Biomedical Innovation, School of Psychology and Counselling, Queensland University of Technology, Brisbane, Australia.'}]","Journal of mental health (Abingdon, England)",['10.1080/09638237.2019.1581354']